OPM July 2012, Vol 2, No 4

Baltimore, MD—Quality reporting is one of the cornerstones of the health-care reform. Now is the time to integratequality improvement mechanisms at your cancer center, suggested CynthiaJones, BSHA, CPHQ, Quality ProgramCoordinator at Rex Cancer Center, NC,at the 2012 Association of CommunityCancer Centers meeting.Rex Cancer Center—with practices in

Wakefield and in Raleigh, NC—consistsof 2 hematology/oncology sites with infu-

sion suites, and 4 radiation oncologysites. The center employs morethan 1100 medical personneland treats an average of 150new patients monthly.In 2008, 2009, and

Recent estimates have put the costof cancer care at an excess of $100billion annually, much of which is

borne by government payers, includingMedicare, Medicaid, and TRICARE foroutpatient treatments, including chemo -therapy, its administration, and radiationtherapy. The Affordable Care Act (ACA) pro-

vided in part for the creation of account-

able care organizations (ACOs) and hasencouraged the concept of medicalhomes. Throughout the United States,payers and physicians have been workingon developing creative payment strategiesthat recognize quality care and value,while reducing cost. One particular organization—Oncol -

ogy Resource Networks—has worked dili-gently to build clinically integrated oncol-

From the publishers of

©2012 Engage Healthcare Communications, LLC

www.OncPracticeManagement.com

ONCOLOGY PRACTICEMANAGEMENT

™

JULY 2012 VOLUME 2 • NUMBER 4

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

Rex Cancer Center: IntegratingQuality Improvement StandardsBy Neil Canavan

Continued on page 18

Continued on page 9

PATIENT AND PROVIDER ACCESS

Brought to you by the Association of

Community Cancer Centers

Hot Topics in

Com

mun

ity C

ancer

Centers:

The A

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Continued on page 6

Seeing CancerCare Through theEyes of a PatientBy Dawn Holcombe, MBA, FACMPE, ACHE President, DGH Consulting, andExecutive Director, ConnecticutOncology Association, SouthWindsor, CT

Chicago, IL—LouLevine, a cancer sur-vivor from Chicago,IL, reminded a roomfull of cancer pro-gram executives atthe American Col -lege of Oncology Ad -min istrators (ACOA)2012 an nual confer-

ence of the unique perspective thatpatients with cancer have on their treat-ment and care. Ms Levine is a 10-year survivor who

was treated at the Robert H. LurieComprehensive Cancer Center ofNorthwestern University, Chicago. Shespoke simply and eloquently about the little things that are easy to forget whentreating patients, but that can have a sig-nificant impact on the patient and his/herjourney with cancer.

1Patient perspective. Ms Levine askedus to remember that patients with can-

cer may appreciate help in shaping their

Practice ManagementStrategies for a New Age:Oncology Resource Networks By Craig Deligdish, MDOncology Resource Networks, Orlando, FL

2012 ACOA Conference

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The media and political pun-dits were having a field daywith predictions and count-

downs. No matter what your politicswere, opinions resonated all aroundyou: What would the SupremeCourt do? What would it mean?Then the decision came down.

With a 5 to 4 vote, the AffordableCare Act (ACA) was largely upheldand justified as a “tax.” States wouldretain the right to decide whether toparticipate in the Medicaid expan-sion portion of the bill and not riskfederal expulsion from Medicaid ifthey refuse to enact the portion ofthe ACA related to Medicaid eligi-bility expansion.Immediately after, Republicans

and Democrats found ways to presentthe ruling as a victory. People whohave not read much, if any, of this con-troversial healthcare reform bill in itsentirety voiced strong opinions aboutthe findings of the Supreme Court.

Yes, there are aspects of the ACAbill that provide for deeper coveragefor many people, including thosewith cancer, buried in the ACA law.These include coverage of preven-tive screenings for cancer and forother diseases, without copaymentsor coinsurance charges to individu-als; continued coverage of youngpeople through age 26 under theirparents’ insurance plan; eliminationof lifetime caps on insurance cover-age; coverage protections on thebasis of preexisting conditions; andpatient access to clinical trialsexpanded to private insurance. Likemotherhood and apple pie, it is diffi-cult to argue against most of thoseprovisions, and, indeed, some majorprivate insurers had already an -nounced that they intended to con-tinue many of those provisions evenif the Supreme Court ruled againstthe ACA law.The issue that we are having diffi-

culty facing is that weare still left with alengthy bill that fewpeople have fully read,let alone understood,and a virtual battle ofthe politicos loomingto play tug of war overthe specifics of the ACA provisions.We are left with even more ques-tions unanswered, such as: • Who will be insured under thehealth insurance exchanges oncethey are implemented?

• Will health insurance exchangesbe implemented as set forthunder the law? Several states arestill not yet engaged in develop-ment efforts, and there will comea time when it is just too late toget started to meet the 2014deadline—what happens then?

• Will commercial insurance beturned off by employers in

From the Editor

3July 2012 I www.OncPracticeManagement.com I

Dawn Holcombe, MBA,FACMPE, ACHEPresidentDGH ConsultingSouth Windsor, CT

Ronald Barkley, MS, JDPresidentCancer Center BusinessDevelopment GroupBedford, NH

Peggy Barton, RNPractice ManagerToledo Clinic, OH

Risë Marie ClelandPresidentOplinc, IncLawton, OK

Bruce A. Cutter, MDPresidentCutter HealthCareConsultingSpokane, WA

Craig Deligdish, MDChief Medical OfficerOncology Medical OfficerOncology Resource NetworksOrlando, FL

Patrick A. Grusenmeyer,ScD, FACHEPresidentChristiana Care HealthInitiativesNewark, DE

Teri U. Guidi, MBA,FAAMAPresident & CEOOncology ManagementConsulting GroupPipersville, PA

Ruth Linné Lander,FACMPEPractice AdministratorColumbus Oncology &Hematology Associates, IncColumbus, OH

Bonnie J. Miller, RN,BSN, OCN, FAAMAAdministrative DirectorWomen’s Cancer CenterFox Chase Cancer CenterPhiladelphia, PA

Cindy C. Parman, CPC,CPC-H, RCCCSI Coding Strategies IncPowder Springs, GA

Jeffrey A. Scott, MDSenior Vice PresidentCardinal HealthDublin, OH

Carla C. Wood, CPC, MS PresidentAltos Solutions, IncLos Altos, CA

Editorial Advisory BoardEditor-in-Chief

Continued on page 8

Supreme Court Wait Is Over, but Was It Worth It? Dawn Holcombe, MBA, FACMPE, ACHE

4 I ONCOLOGY PRACTICE MANAGEMENT I July 2012

In This Issue

PUBLISHING STAFFPublisherNicholas [email protected]

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MISSION STATEMENTOncology healthcare requires providers tofocus attention on financial concerns andstrategic decisions that affect the bottom line.To continue to provide the high-quality carecancer patients deserve, providers must masterthe ever-changing business of oncology.Oncology Practice Management will offerprocess solutions for members of the cancercare team—medical, surgical, and radiationoncologists, as well as executives, administra-tors, and coders/billers—to assist them inreimbursement, staffing, electronic healthrecords, REMS, and compliance with stateand federal regulations.

Oncology Practice Management™, ISSN 2164-4403(print), is published 6 times a year by Engage Healthcare Communications, LLC, 241 Forsgate Drive, Suite205A, Monroe Township, NJ 08831. Copyright © 2012 by Engage Healthcare Communications, LLC. All rights reserved. Oncology Practice Management™ isa registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by anymeans now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without writtenpermission from the publisher. Printed in the United States of America.

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FROM THE EDITORSupreme Court Wait Is Over, but Was It Worth It?........ . . . . .3By Dawn Holcombe, MBA, FACMPE, ACHE

FEATURESPractice Management Strategies for a New Age: Oncology Resource Newtworks ..........................................1By Craig Deligdish, MD

ACOA Addresses Quality and Accreditation in Oncology ..........................................................................9By Dawn Holcombe, MBA, FACMPE, ACHE

Measuring Oncology Quality through QOPI: A GrowingIndustry Standard ...............................................................11By Dawn Holcombe, MBA, FACMPE, ACHE

DRUG CODINGMedications Used for the Treatment of Lung Cancer .................. ............................................28

DEPARTMENTS

PATIENT AND PROVIDER ACCESSBrought to you by the Association of Community Cancer Centers

Hot Topics in Community Cancer Centers: The AffordableCare Act ..................................................................................22By Sydney Abbott, JD

MEDICAL LEGAL UPDATEProtecting Against Disallowance through Practice Structure ....................................................................32By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

PHYSICIAN WEALTH MANAGEMENTRetirement Plans and Your Medical Practice.......................34By Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF, and Peter M. Coleman, ASA, EA,FCA, MAAA. MBA

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2011, Rex Cancer Center’s Hema -tology/Oncology Associates re ceivednational recognition as one of thebest national outpatient cancer pro-grams for patient satisfaction byProfessional Research Consultants, as well as the highest score in thenational Outpatient Oncology Ser -vice Line database.“So, given these accolades,” said

Ms Jones, “why would Rex hiresomeone to do quality assessments?”The center is growing, treating morepatients, becoming organizationallymore complex, and facing increasing competition.

Getting Started: Assessingthe ProblemMs Jones’ first day at Rex Cancer

Center was in February 2011. “Thestaff was somewhat frightened abouthaving someone there who works forthe director and is coming out to beher eyes and ears,” she recalled. “Itwas unsettling for them. So, my firsttask was to engage them and to makeit clear that I was there for the greatergood,” not only for the patient, butalso to find ways to protect and main-tain the staff that had already earnedsuch high recognition.Ms Jones set out to communicate

to the directors that she was notinterested in “mission values thathang on the wall,” as much as in dis-covering what was going on in thetreatment areas.“I first needed to know what we

do really well,” which would (1)clarify how the awards for excellencewere earned, and (2) show the staffan appreciation of skills and talentsthat were already contributing to thecenter’s success, to foster coopera-tion rather than blame.Ms Jones started with an assess-

ment of high-risk activities, includ-ing chemotherapy administration(740 bags mixed monthly) andblood products (150 blood/blood

products transfused monthly).“There was already a variance

reporting system at Rex—most acutecare centers have a risk managementreporting system,” said Ms Jones.They had quantitative data, but theywere missing any qualitative compo-nent. “The problem was that thereporting was not detailed enough toexplain why anything happened.”

She started to spend time in thewards. “My goal was not to putBand-Aids on what goes wrong, butto identify the problem as it occurs,and as it will likely occur again.” Shewanted to fix the workflow, whichrequired more information.

Improving theCommunication Procedures“Initially, nurses said, ‘I don’t have

time for detailed reports.’ They justjot a brief note. But when you’rereporting events, you want to knowthe key facts that led to the event.You should be able to do that in 3lines or less,” Ms Jones said. The newprocess seemed like a huge culturechange initially, but within weeks it began to bear fruit. “We have arobust reporting system now thatincludes the details I need to iden -tify how a process is not working.”For example, “We were seeing

medical events that were tied toordering,” she said. By going to thewards and talking to all the play-

ers—the nurses, the pharmacists,and the physicians—she establishedthat there were basic miscommuni-cations that were directly related tothe order form. Yet, everyone was wedded to that

form, because they were used to it. “Ihad to convince them to revise it,because it did not communicatewell with anyone.”A simple revisionto the document’s formatting, tohow it looked and read, improved its performance. “It became a muchimproved communication tool,” MsJones said. Errors and events werereduced.Gaining the qualitative informa-

tion was key to addressing treatmentvariance, which involved the rightattitude to ensure the staff that thegoal was not punitive, as well aspatience, because, Ms Jones said, “atfirst you hear complaints. You needto deescalate the complaint, andthen try to get at the facts.” These facts were entered into an

Excel spreadsheet, with the eventsdown the x-axis and the reasons forthe events across the y-axis.

Identifying Breakdowns inthe Process: Improving Care QualityMs Jones then addressed the prob-

lem of chemotherapy waste. “Again,the reporting was there, but therewas no detail about the waste,” shesaid. She asked the pharmacists howthey get through their busy day, toget a clearer picture of what wasgoing on. Once the information wascollected, trends emerged. “Again, I could see communica-

tion breakdowns,” Ms Jones said,outlining the following problems: • Laboratory results were not a -ssessed before the mixing ofchemotherapies

• Orders were mixed before the timethe drugs were needed

Rex Cancer Center: Integrating…Continued from page 1

“The problem was thatthe reporting was notdetailed enough toexplain why anythinghappened.”

— Cynthia Jones,

BSHA, CPHQ

Continued on page 8

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droves, sending formerly com-mercially insured patients intothe streets, seeking health insur-ance exchange coverage that isnot yet defined, priced, or knownif it will be available?

• Even if the health insuranceexchanges materialize as plannedunder the ACA law, what ratesof reimbursement will they offerto physicians and hospitals, andwhich physicians and hospitalswill agree to participate?

• What will the evolving answersto these questions do to access tohealthcare in the United States,

and at what levels of quality?• What will happen to the existingdelivery models of healthcare ifsuddenly the majority of insuredpatients in the United Statesbecome insured as Medicaid orMedicare populations? Currently, Medicare represents

approximately 50% of patients withcancer, with Medicaid running closeto 5%, and commercial and otherinsurance picking up roughly theother 45%. If suddenly the percent-age mix of Medicaid and commercialwere to come close to reversing overthe next 5 years, there would be a sig-

nificant impact (as yet undetermined,but probably very painful) on the cur-rent healthcare delivery system.Practices and hospital centers

already are embroiled in a variety ofproactive and reactive discussionsabout new relationships. Strategicplanning in these organizations willnow need to consider these poten-tial ramifications of the ACA law,in addition to the myriad otherchallenges facing cancer programstoday. We may have received a rul-ing, but we have not yet receivedthe answers we need to face thefuture of oncology. l


From the Editor

• There were port/intravenous prob-lems that the pharmacists did notknow about.“This information helped my

group go from complaining to seeinghow waste could be prevented. This

new insight was not just on the partof the pharmacists, but the nursesand the doctors as well,” she said. The proposed changes were not

monumental. “I would estimate that

we can prevent 75% of these eventsby changing just a few things abouthow we do what we do,” Ms Jonessuggested.She then assessed the radiation

oncology services, using the same

process in gathering data. The maincomplaint from radiology was abouttreatment delays. The assessmentrevealed the main culprits:• The treatment plan was not ap -

proved in either of the oncologymanagement systems softwareprograms (ie, Impac and ADAC)

• Additional information was re -quired by the treating physician

• Miscommunications were com-mon.“I mapped it all out, and then

even broke it down by diagnosis,” MsJones explained. She determinedthat patients with head and neckcancers were experiencing the mostdelays at the center. “We needed torecognize that treating these patientstook more time, involved more vari-ables, and therefore had more delay-causing complexities.”This approach was focused on

understanding the breakdowns inthe process rather than on fingerpointing.This is just one example, and the

story at your institution may be dif-ferent, Ms Jones said, but to tell thestory, and to change how the storyends, you need the qualitative data. l

“This information helped my group go fromcomplaining to seeing how waste could beprevented. This new insight was not just on thepart of the pharmacists, but the nurses and thedoctors as well. I would estimate that we can prevent 75% of these events by changing just a few things.”

— Cynthia Jones, BSHA, CPHQ

Rex Cancer Center: Integrating…Continued from page 6


Supreme Court Wait Is Over…Continued from page 3

perspective on the role they fill intheir cancer treatment. Manypatients may see themselves as vic-tims, buffeted by their circum-stances. If you can help thesepatients to see themselves as poten-tial survivors even more than aspatients, that can turn the treatmentprocess into a more positive force.

2Listen and watch. We all knowthat hearing the diagnosis of can-

cer for the first time can be a “deer inthe headlights” type of moment. Thereality is that most people know very

little about cancer and treatmentoptions until that one momentwhen it becomes a personal diagno-sis. It is human nature to want to notappear stupid and to simply nod andrespond that there are no questions,when inside there may be “a million”questions. Many patients are ner-vous or frightened, and they may notbe hearing or registering what isbeing said. Even if you see thepatient in front of you noddinghis/her head in full agreement,please keep asking if they understandand wait for an answer.

3Keep the information simple. Asmany complicated specialties do,

we have many terms that are uniqueto our oncology world and become somuch a part of our way of speakingthat we often use them with eachother without explanation. How -ever, most, if not all, of our patientshave not been part of our world forlong. Ms Levine urged the audiencemembers to remind their colleaguesto be careful about words and phras-es they use, even terms that theythink everyone knows.

ACOA 2012 Conference


Seeing Cancer Care Through…Continued from page 1


Chicago, IL—Oncology programadministrators from across the coun-try gathered in Chicago on June 21and 22 at the American College ofOncology Administrators (ACOA)2012 annual conference. The atten-dees of this meeting, held in the con-ference center of the AmericanCollege of Surgeons, braved summertemperatures to focus on quality andaccreditation issues in cancer care.The conference was co-hosted by

the American College of Surgeons’Commission on Cancer (COC) andcelebrated the 20th anniversary ofACOA, a specialty group of theAmerican Academy of MedicalAdministrators (www.aameda.org).The keynote and concurrent ses-

sion speakers focused on how cancerprograms can quantify, track, andprove quality in a value-based pur-chasing world. An afternoon pre-conference session with Virtua FoxChase Cancer Center leaders tack-led the thorny issue of demystify-ing quality metrics, illustrating mul-

tiple current measures in place at the center, as well as in other market sources.A moving session from a cancer

care survivor (see article in thisissue) reminded attendees of whythey were there, and how the patientperspective can influence qualityprogram choices in treatment andcare delivery.One of the most prevalent oncolo-

gy quality measurement programs inAmerica today is the Quality Oncol -ogy Practice Initiative (QOPI) pro-gram (see page 11), developed by theAmerican Society of ClinicalOncology (ASCO). The QOPI pro-gram and its new initiatives were pre-sented by an ASCO leader, anddetailed descriptions by 2 activeQOPI participants brought the pro-gram and its contributions to thequality of cancer care to conferenceattendees on a very personal basis. Other keynote programs concen-

trated on recent changes in the COCaccreditation process, how to effec-

tively utilize consultants in times ofrising demands and shrinking re -sources, and preparing for a shift fromvolume to value in cancer services. Some of the concurrent confer-

ence sessions addressed currentupdates regarding drug shortages,growth of patient satisfaction, inte-grated palliative care, healthcarereform, institutional partnershipsand affiliations, and the journey ofthe cancer patient.Networking among the cancer pro-

gram leaders and the thought leadersthroughout the program led to specu-lation about the pending decision bythe US Supreme Court on healthcarereform, but more frequently to specu-lation about the challenges that indi-vidual programs were having in satis-fying their own needs for definingquality and developing appropriatemetrics for discussions of quality. The conference closed with invita-

tions to participate in next year’s pro-gram—to be held April 10-12, 2013,in Las Vegas, NV. l

ACOA Addresses Quality andAccreditation in OncologyBy Dawn Holcombe, MBA, FACMPE, ACHE

4“Read” the patients for theirlevel of engagement. Ms Levine

suggested that not all patients arewilling to take on the burden ofunderstanding their care and makingdecisions. Some may have con-sciously or unconsciously offloadedthe responsibility of knowledge overto the physician or nurses as theexperts—and this could affect howthey hear instructions or informa-tion essential to their treatment.

5Be self-aware. This was a veryimportant issue for Ms Levine.

She pointed out that she and otherpatients note many things going onaround them, and they usually willtry to interpret those (even little)things in terms of their own care.Patients read signs—the little frownas the physician considers theirchart, the serious conversation out-side the waiting room, a sigh as thephysician enters their examinationroom—and they may misinterpretthem as bad signs about their care.They do so even if that frown wasremembering that you have to pickup milk on the way home, the seri-ous conversation outside the roomwas about another person or situa-tion, or perhaps that sigh was a deepbreath to clear your mind and focuson this patient, and none of thoselittle things were ever about thepatient or his/her cancer. Ms Levine observed that patients

with cancer can turn into narcissistsand interpret what goes on aroundthem as being about them; therefore,physicians, nurses, and staff have aresponsibility to recognize that everyfacial gesture, every tone of voice,and every sign can be interpreted assignificant. She remembered clearly how she

would read the technicians’ faces asthey looked at the mammograms—were they intense, or did they takeextra time or repeated tests?—look-

ing for signs of any hint about hercondition.

6Lead with the good news. Onekey point she made was for oncol-

ogy center staff to recognize hownervous patients are and to get to thebottom line quickly if it is goodnews. Ms Levine shared one exam-ple of how misleading poor commu-nication can be: years after her cancer treatment, she had a mam-

mogram that needed further expla-nation. She received a stereotacticbreast biopsy (and noted that theyreally do hurt, no matter what any-one says) and then was told someonewould call her on Friday. Sheexplained that it was all right toleave a message on her answeringmachine, but she was told that thatwas against policy, especially becauseshe did not identify her name on theanswering machine message. She also noted that setting expec-

tations is important. (When apatient hears that the office will getback to her on Friday, she is waitingat 8:01 AM. Therefore, if you usuallyreturn calls at the end of the day, tellthat to the patient up front to reduceanxiety.) Finally, in her case, herphone rang later in the afternoon.The first thing she heard after

answering was a somber voice ask-ing, “Are you alone?” and “Is no onewith you?” (2 immediate bad signs inher mind). She was then told, “Because of

your biopsy, we think we see calcifi-cation” (but she had no idea whatthat meant and it was not ex -plained), and “We would like you tocome back in 6 months, but there isno immediate concern.” The delaybetween the somber voice saying,“Are you alone?” and hearing,“There is no immediate concern”seemed like an eternity. It wouldhave been better for the sombervoice to have led with “This is Dr X.I have good news,” and then explainthe details.Another time Ms Levine’s physi-

cian left a message telling her that atest “looked funny,” but he did notcall back in a timely fashion. Shethen got a recorded message on hercell phone from “Mike”, the physicianassistant, saying that he could notleave a message on her home phonebecause she did not have her name onthe home message machine, and heasked her to call back—the physicianwants to discuss her biopsy. She calledback and after some difficulty, shefinally got Mike. He opened the con-versation noting that the physicianwants to talk with her about her biop-sy, but then proceeded to say that allwas fine. She went through needlesshours of agony and worry, because ofthese communication insensitivities.

7Good communication is impor-tant at all times. Ms Levine had

just had a biopsy, and although shestill appeared unconscious, herphysician came in to stand by her.He noted repeatedly, “Can you hearme? The nodes were clean, you arefine. I will be back.” He then left toattend to another patient as heexplained, but she, even semicon-scious, had heard him and relaxed.



Seeing Cancer Care Through…Continued from page 9

Physicians, nurses, andstaff have aresponsibility torecognize that everyfacial gesture, everytone of voice, andevery sign can beinterpreted assignificant.

That was just what she needed tohear at that moment. To this day,years later, she still remembers float-ing in and out of consciousness butwith the warmth and comfort of herphysician’s words putting her mindat rest.

8Patients need reassurance. Pa -tients want to know that they are

doing the right things in their treat-ment and may try to exhibit goodbehavior during treatment based onthe belief that if you “like” them, theywill heal better and faster. This meansthat the physicians, staff, and socialworkers need to assure patients thatthere is no “right” way to go throughthis, and that all patients need to dowhat is right for them. The majorityof patients are new at this “cancerthing” and do not know what to do. One other memorable moment

for Ms Levine was when, after herdiagnosis, she met with the physi-cian to discuss her treatment. Shewas trying to be a “perfect patient”and not cry, which of course did not

work. The physician then called inthe nurse and social worker, and theysaid simply to her, “Today and forhowever long you need us, we are

your family.” This made her feel likean individual who was part of thecare team, and that they would support her and do whatever wasnecessary to get her through to theother side of this, and that it was allright to trust her own feelings andher care team.

Quality MeasuresMs Levine’s comments were par-

ticularly illuminating at the ACOAconference that was focused onquality and measurement of qualityin cancer care. Some of the mostvalued moments that can have a sig-nificant impact on the ability andconfidence of the patient to battlecancer are not easily measurable butcome from the heart and the dailyinteractions, gestures, and smilesthat the cancer support team shareswith each patient every day. l



Measuring Oncology Quality throughQOPI: A Growing Industry StandardBy Dawn Holcombe, MBA, FACMPE, ACHE

Chicago, IL—The question of howto define and measure quality inoncology is one of the hottest topicsin oncology care today. At the 2012annual conference of the AmericanCollege of Oncology Administratorsin Chicago this past June, a keynotepanel discussed how they are meet-ing that challenge. Robert Hauser,PharmD, PhD, the new SeniorDirector of Quality and Guidelinesat the American Society of ClinicalOncology (ASCO), joined BethHayden, RN, BSN, MBA, OCN,Director of Oncology Services at the OSF Saint Anthony MedicalCenter, Rockford, IL, and JennaVanGilder, RN, BSN, OCN,Director of Cancer Services at

Edward Hospital, Naperville, IL, indescribing the national ASCOQuality Oncology Practice Initiative(QOPI), and how it is being adaptedacross the country and in their owncenters.

The QOPI ProgramPractices not only have the ability

to voluntarily participate in theQOPI program but also to obtaincertification under the QOPI certifi-cation program. Conference attend-ees very much appreciated thechance to better understand the pro-gram itself and also to listen to 2real-world examples of colleagueinstitutions adapting the programand its processes to their daily

lives—at the OSF Saint AnthonyMedical Center and the EdwardHospital Cancer Services. ASCO launched the QOPI pilot

program in 2002, and expanded theprogram to all members in 2006.After a period of measure and con-tent expansion, the QOPI certifica-tion program was launched in 2010.Practices have the option to partici-pate in 2 chart review programs eachyear, and by spring 2012, more than6700 individual charts have nowbeen reviewed in almost 300 partici-pating practices. More than onethird of participating QOPI practices(approximately 130) have now alsoachieved QOPI certification. More


Physicians, staff, andsocial workers need toassure patients thatthere is no “right” wayto go through this, thatall patients need to dowhat is right for them.

than 100 measures are now activelybeing tracked, and expansion isplanned for measures such as pedi-atric oncology, gynecologic cancer,urology/prostate cancer, cost of care,and efficiency.

Quality Measures In 2012, oncology practices and

payers are struggling to find universal-ly acceptable measures that reflectquality in cancer care. In the absenceof universal measures, it could be tooeasy to focus solely on the cost oftreatment, without enough attentionpaid to how that treatment is beingdelivered. The QOPI program offersnot only universal measures but also away to track and benchmark successagainst those measures in practicesand cancer centers of all sizes andtypes, even though much of the need-ed information is still buried in thepatient’s medical chart. This helps payers and practices to

change their negotiations from aclaims-based discussion to more of aquality initiative–based discussion.ASCO does not release individualpractice information or scores, but itdoes encourage practices and payers

to recognize the value of QOPI par-ticipation and certification.

Program Participation Participation in the QOPI pro-

gram itself is fairly straightforward. Ifa cancer center desires physician-level reporting, it will be necessaryto review and submit findings for aminimum of 24 charts for each of 2or more modules. ASCO offers sig-nificant support through a help desk,training videos, and teleconferencesas practices prepare for the chartreview process. As increasing num-bers of practices implement elec-tronic medical records (EMRs),many are finding it easier to extractQOPI-related data this way ratherthan by manual review.ASCO suggests the following 4-

step process for practices planning toparticipate in the QOPI program:

1Gaining access to the system andsetting up the needed accountsand any restrictions on access forstaff at different locations, depend-ing on patient and program privacyexpectations

2Getting familiar with the toolsand methods of the program,including the forms and the questions

3Getting prepared, that is, defin-ing passwords, training staff, get-ting ready for the 5-week period ofparticipation and submission

4Participating (which entails iden-tifying eligible charts no morethan 1 week before the actual datacollection) and completing submis-sions within the 5-week allotted timeframe for each data collection session.

OSF Saint Anthony Medical CenterTwo participating cancer centers

offered great insight into what par-

ticipation actually entailed for theirprograms. Ms Hayden, from OSF Saint

Anthony Medical Center, reportedthat the key to successful participa-tion and eventual certification underthe QOPI program was to create asolid base of support and visibility forthe program. She and her colleaguesmade participation in QOPI a 2011-2012 oncology service line goal, aswell as a cancer committee program-matic goal. They solicited a physi-cian champion to shepherd the pro-gram through internal discussions, aswell as the support of the oncologymedical director. They also assignedresources to the program in the formof a QOPI resource/audit team.The first time Ms Hayden and her

colleagues tried to participate, theystarted late and were unable to finishwithin the designated 5-week period,but once they became active in latersessions, they found that they lovedthe participation. Ms Hayden notedthat the data collection covers a 2-year window—if the data are relatedto initial visits and you were not fol-lowing those measures at the time,the previous lack of measures will stillbe reflected in lower measure scores.Because active participation in theprogram, with attention to individualmeasures, evolves, the scores willimprove as the data time frame catch-es up with more diligent following ofmeasured data elements over time.Ms Hayden shared the following

strategies that her cancer centerimplemented to improve outcomes,as a result of participating in theQOPI program: • Creating and implementing astandardized physician progressnote

• Incorporating specific questionsinto dictation templates thataddress the areas that needimprovement




Measuring Oncology Quality…Continued from page 11

QOPI Quality MeasuresThe QOPI measures cover 3 significantareas of care:

Core measures• Care documentation• Chemotherapy administration• Pain management• Smoking cessation• Psychological support

Disease-specific modules• Breast cancer• Colorectal cancer• Non-Hodgkin lymphoma• Non–small-cell lung cancer

Additional domain-specific modules• End-of-life care• Symptom/toxicity management

“Quality care iseveryone’s business.”

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• Discussing indicators at weeklyphysician meetings• Incorporating specific QOPI indi-cators into the oncology serviceline scorecard.For illustrative purposes, Ms

Hayden also shared the followingmeasures, for which she and her col-leagues at the center extracted dataand participated:

Core measures module. Underthis module, the cancer center staffextracted data and received bench-marking for several measures,including:1. Pain addressed appropriately 2. Documented plan for chemo -therapy, including doses, route,and time intervals

3. Chemotherapy intent (curative vspalliative) documented

4.Cigarette-smoking status docu-mented by the second office visit

5. Patient emotional well-being as -sessed by the second office visit.

Breast cancer measures module.Under this module, some of the dataextractions covered the following:1. Combination chemotherapy re -ceived within 4 months of diag-nosis by women aged <70 yearswith American Joint Committeeon Cancer (AJCC) stage I (T1c)to stage III estrogen receptor(ER)-negative/progesterone recep -tor (PR)-negative breast cancer

2. Test for HER2/neu gene overexpression

3.Trastuzumab not received whenHER2/neu status is negative orundocumented

4.Trastuzumab received by patientswith AJCC stage I (T1c) to stageIII HER2/neu-positive breastcancer

5.Tamoxifen or aromatase inhib itorreceived within 1 year of diagno-sis of patients with AJCC stage I(T1c) to stage III ER-positive orPR-positive breast cancer.

Colon/rectal cancer measures

module. Under this module, the datacollection included the following:1. Carcinoembryonic antigen testwithin 4 months of curativeresection for colorectal cancer

2. Adjuvant chemotherapy receivedwithin 4 months of diagnosis bypatients with AJCC stage III co-l on cancer

3. Adjuvant chemotherapy receivedwithin 9 months of diagnosis bypatients with AJCC stage II orstage III rectal cancer

4. Colonoscopy before or within 6months of curative colorectalresection or completion of pri-mary adjuvant chemotherapy.Ms Hayden expressed extreme sat-

isfaction with the process and thepotential value of their center’sQOPI certification. She noted thatthe ability to benchmark and focuson quality initiatives that were moreclinically driven and cancer specifichelped with the standardization ofthe process and even with someother certification and accreditationprocesses they needed to follow.

Edward Hospital Cancer CenterMs VanGilder from Edward Hos -

pital stated that the center wasalready accredited by the Com -mission on Cancer, and the center’sleadership decided to seek QOPIcertification as well, after their firstvery successful QOPI participationsession.Ms VanGilder shared much of the

preparation and the process theyinstituted for the certification-relat-ed QOPI site visit. She noted thatmuch of the program seems to residein the responsibilities of the nurses,and that she found it was appropriateto spend much upfront time prepar-ing internally for the certificationprocess and the site visit.The QOPI program has very spe-

cific expectations for a certification

site visit, including: • Introduction/tour of the facility• Observation of 2 to 3 patientsscheduled for chemotherapy(QOPI randomly selected)

• Observation of the pre paration,delivery, and administration ofchemotherapy

• Observation of how ASCO/Oncology Nursing Society safetystandards are implemented

• Review of chart documentationof patients who are observed

• Policy and procedure review• Review of policies related toQOPI selected standards

• Interview of 2 to 3 nurses, 1 phar-macist, 1 administrator, and 1educator

• Exit interview.Ms VanGilder shared the process

that her cancer center created inter-nally to prepare for the site visit.Some of the materials were availablethrough the ASCO resources andhelp desk, and others were createdinternally by Ms VanGilder and herstaff.All of the cancer center staff were

required to attend a QOPI certifica-tion update and a presentation tointroduce them to the QOPI andgive them an overview of the pro-gram. The presentation reviewedwhat the staff could expect duringthe certification visit. All policiesand procedures related to the 17QOPI standards specific to thepreparation and administration ofchemotherapy were organized in abinder, which was made readilyavailable for the nurses to review. The staff was educated on the

QOPI standards, and the evidenceto meet different criteria wasreviewed and shown to them in theEMRs. Demonstrations were alsomade on how they would talk aboutthe evidence, with the surveyor uti-lizing the EMRs. Most important,





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THIRD ANNUAL CONFERENCE

www.AVBCConline.orgFor more information please visit

May 2-5, 2013Westin DiplomatHollywood, Florida

Influencing the Patient-Impact Factor

practice interviews were done withstaff members when they werepreparing to give chemotherapy andduring its administration to makethem more comfortable with thequestions that would most likely beasked by the surveyor. Ms VanGilder noted that no mat-

ter how experienced or skilled thestaff was in delivering cancer care,not everyone was prepared at first toclearly describe what they weredoing and how those actions wereconsistent with the QOPI care stan-dards; therefore, a good deal of timewas spent in adding those skills tothe skill sets of all their staff, inpreparation for the site review. Part of the constant preparation

process for the site visit includedusing a clinical educator to observeclinical practice in action and con-duct mock interviews of staff; safetystandards were also reviewed on aone-on-one basis with the key indi-viduals who would be present in theinfusion clinic during the site visit.By creating an internal binder withall the policies and procedures, MsVanGilder and her staff also foundthat there was a need for, and a valuein, a standardized orientation processfor the staff in general. The centerhas also added a quality coordinatorto follow through with consistencyin the process and training at thecenter, a direct benefit and result ofpreparing for the QOPI certification. Ms VanGilder also shared some of

the recommendations she and herstaff received as a result of their par-ticipation in the QOPI program.One recommendation was to haveall the physicians become certifiedin CPR (cardiopulmonary resuscita-tion). Another was that depression

(ie, the psychosocial effects of treat-ment) was a huge issue that theywere addressing inconsistently. Athird recommendation involved theclarification of cancelled appoint-ments versus “no shows” in theirrecords.The time required to participate

in the data extraction has shrunkmeasurably with ongoing programparticipation, according to MsVanGilder. When she first started,

the process took a while, even whenshe used her EMRs as much as possi-ble; it now takes approximately 15 to20 minutes per patient. There is alearning curve involved with know-ing what the questions are—themore you do it, the easier it becomes.

What Does a QOPICertification Entail?Practices or cancer centers have to

participate in the QOPI program tobecome certified, but certification isa full program on its own. The QOPI certification process

entails abstracting and scoring cer-

tain levels for all modules of QOPIparticipation, as well as attestationto meeting all 17 chemotherapypreparation and administration safe-ty standards, submitting policies anddocumentation for safety standards,and random (personal health infor-mation de-identified) medical re -cords for validation. A majority ofpractices seeking certification willalso participate in an onsite reviewby advanced-degree oncology nurses.Findings and results for the measuresand standards scoring and the onsitevisit are evaluated for qualificationfor a QOPI certification.The certification standards center

on staffing, treatment planning andchart documentation, informed con-sent, chemotherapy orders, drugpreparation, chemotherapy admin-istration, patient monitoring andassessment, and preparedness foremergency situations. Once certifi-cation is awarded, the certification isvalid for a period of 3 years, afterwhich recertification is expected.QOPI certification is one of the

few certification programs availableto private cancer practices, and itfully complements cancer center cer-tifications by the Commission onCancer and other hospital-basedaccreditation programs.Increasingly, payers will be asking

for evidence of such certificationparticipation as a mark of quality,making participation almost a neces-sity for providing cancer services.Another value to such certificationprograms is that they set the bar forcare delivery very high clinically andmay reduce the risk of nonphysician-or hospital-based programs seekingto deliver cancer care services inalternative treatment models. l




Increasingly, payerswill be asking forevidence of suchcertificationparticipation as amark of quality,making participationalmost a necessity forproviding cancerservices.

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

Millennium Pharmaceuticals, Inc., Cambridge, MA 02139

Copyright © 2010, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA V-10-0196 11/10

*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


Practice Management

ogy networks for thepurpose of implement-ing a comprehensiveoncology practice man-agement strategy. Thisstrategy has been de -signed to address thecost of cancer care,while improving treat-ment quality and healthoutcomes. Equipping

physicians with the electronic infra-structure and up-to-date evidence-based pathways needed to delivercost-effective, evidence-based care isone of the aims of this organization.In addition, programs are made avail-able to practices that enable physi-cians to deliver state-of-the-art care,while also assisting patients and theirfamilies at the end of life.

Practice ToolsMoving beyond data and infra-

structure, Oncology Resource Net -works has worked with providers toimplement financial incentives thatput these tools into practice in anexpeditious manner. These toolsinclude assisting practices to networkin a procompetitive manner withother physicians for the purpose ofimplementing pay-for-performanceprograms, shared-savings models,quality initiatives, rational fee sched-ules, and bundled payment models.These approaches enhance practicevalue from the perspective of healthplans and payers and have helpedpractices that have an interest in differentiating themselves in thisincreasingly challenging market-place. The goals of such an approachinclude sustaining community oncol-ogy practices, as well as assisting hos-pital-based and academic practicesthat are facing many of the samechallenges as community practices.

Clinical IntegrationOncology Resource Networks’

core benefit for community practicesis its representation with employersand health plans. The hallmark ofclinical integration, which is thebasis for the concept of ACOs, allowspractices to invest both financial andhuman capital to improve patientcare. Oncology Resource Networkshas created a patient-centric ap -proach by embracing a model thataddresses patient care in a prospec-tive manner. This was done throughthe adoption of a web-based decisionsupport tool that ensures evidence-based care at the point of care. Thisdecision support tool helps physi-cians to take advantage of new diag-nostic tools to include molecular andcompanion diagnostics and, in thenear future, next-generation se -quencing. This approach allowsphysicians to deliver targeted, per-sonalized care and provides cost-effective benefits to patients.

Pathways The development of pathways

that are based on nationally accept-ed treatment guidelines has beendesigned by oncologists to improvepractice profitability and yet reducethe cost of cancer treatment. Thedevelopment of pathways that in -centivize cost-effective approachesto care and the creation of pay-for-performance programs with payershave been designed to reduce theinefficiencies associated with thereimbursement process. The web-based decision support tool madeavailable to Oncology ResourceNetworks’ member practices obviatesthe need for the more inefficientand time-consuming paper-drivenprior ap proval and preauthorizationprograms, while avoiding practicesthat increase payment delays andbad debt. Oncology Resource Networks’

evidence-based practice pathwaysare designed to incentivize physi-

cians to utilize protocols and path-ways that provide cost-effectivetreatment options. The program isdesigned to foster interdependenceamong physician participantsthrough the use of incentives thatreward physicians and practices thatadhere to evidence-based practiceguidelines that re duce cost. Physi -cians are rewarded for the financialinvestments of “human capital” thatare necessary to build this approachto care coordination in an oncologymedical home. The physician’s officestaff is an integral component of thecare coordination team, utilizing thetechnology tools that are providedby Oncology Resource Networks.The uniqueness of this program inthe treatment of patients with cancer—the implementation ofadvanced illness programs and pal-liative care programs—and theincentives that have been created toutilize these programs, as well as the evidence-based guidelines, con-tribute to the network’s representa-tion of practices with payers andhealth plans.

CollaborationOncology Resource Networks’

programs facilitate and ensure col-laboration among physician mem-bers, thereby improving patients’health and potentially reducing thecost of cancer treatment by creatinga comprehensive care managementapproach that also increases thequality of care rendered to patients.The benefits to payers and patientsin clude an integrated set of servicesthat include a web-based technologysystem that monitors adherence toevidence-based practice guidelinesand implements policies and proce-dures related to the program’s utiliza-tion management, case manage-ment, and disease managementactivities.This program is designed to create

Practice Management Strategies…Continued from page 1

Craig Deligdish, MD

Practice Management


substantial integration among itsparticipants and is expected to cre-ate significant efficiencies, includingimproved quality of care and morecost-effective care. The network’srepresentation of its membershipwith payers results in greater coordi-nation of care through the use ofadvanced illness programs that havebeen previously demonstrated toreduce hospital length of stay, emer-gency department visits, and hospi-tal admissions, while also improvingthe quality of care that patients andtheir family members receive.

InnovationOne of the hallmarks of Oncology

Resource Networks’ commitment topatient care is testing these innova-tive approaches.Physicians who participate in the

network agree to use a web-baseddecision support tool, receive en -hanced reimbursement for participa-tion, have the opportunity to receivebonuses that result from the net-work’s shared-savings model, andparticipate in an oncology ACO.The reduction in costs related tohospitalization, radiation therapy,and other cancer-related treatmentexpenditures will be distributedbetween participating physiciansand the health plan, employer, orthe Centers for Medicare &Medicaid Services (CMS). Thismodel of accountable care and clini-cal integration created by OncologyResource Networks also encouragespatients to participate in the treat-ment decision-making process. Aspart of the ACA, CMS has permit-ted Oncology Resource Networks tooperate as an ACO and share withits practices the savings that are gen-erated through programs that reducethe cost of cancer treatment in theMedicare population.Recently, Oncology Resource Net -

works collaborated with a number of

organizations, including the RANDCorporation, led by MireilleJacobson, PhD, Deputy Director ofHealth Economics, Finance andOrganization, for the purpose of fund-ing opportunities. Jalpa Doshi, PhD,Director of Value-Based InsuranceDesign Initiatives at the LeonardDavis Institute’s Center for HealthIncentives and Director of theEconomic Evaluations Unit of theCenter for Evidence-Based Practiceat the University of PennsylvaniaHealth System, and Henry Glick,PhD, at the University of Penn -sylvania also collaborated with thenetworks to provide ongoing out-comes analysis. Other collaborationsinclude the Florida Agency forHealth Care Administration onbehalf of Florida Medicaid, BlueCross Blue Shield of Florida, theFlorida Health Care Coalition,CIGNA, EQ Health, Vital Decisions,and eviti.

New Ways to IncentivizeOncologists to Provide Cost-Effective CareA number of pilot projects have

been developed for the purpose oflooking at innovative strategies torealign the financial incentives asso-ciated with treating patients withcancer. The concept of episode-based payments has been proposedintermittently over the past severaldecades and has received moreprominence as a result of the ACA. In a 2011 article published in

Health Affairs, Peter Bach, MD, andcolleagues discussed the idea ofepisode-based payments for cancercare and proposed a pilot forMedicare. More recently, the April2012 issue of Health Affairs was ded-icated to “Cancer Care: Value,Costs, and Quality.” Lee Newcomer,MD, of UnitedHealthcare, reviewedthe historical context of the “buy-and-bill” reimbursement model and

discussed the potential for a bundledpayment approach as an alternativestrategy for reimbursement. Thisapproach, which has been tested byUnitedHealthcare in a number oflarge practices, is clearly attractive topayers and to providers, who see it asa potential opportunity to reducecosts and improve margins. However, many practices would

be challenged by assessing the risksassociated with providing patientswith chemotherapy drugs, given theever-changing treatments and thenovel treatments that are constantlybeing made available to patientswith cancer. Such an approach,which removes the drug cost fromthe treatment paradigm, potentiallyresults in administrative and patientcare challenges that can prevent itfrom becoming a scalable approachin today’s complex care system. Inaddition, applying this approach to aMedicare population is potentiallyproblematic. The complexities ofvariable patient care settings, includ-ing academic medical centers, hos-pital-based practices, communityoncology practices, and practicesproviding access to 340B drug pric-ing, can potentially further compli-cate this as a scalable approach toreimbursement. Along with traditional forms of

reimbursement and bundled pay-ment approaches, there are a varietyof methods that include rationalreimbursement. In this scenario,physicians are incentivized toreceive higher reimbursements forgeneric alternatives, where cost-effective options are available, sug-gesting those as reasonable choices. Oncology Resource Networks has

pioneered this approach, as well as pay-for-performance strategies, in markets where a rational reim-bursement strategy is a not anoption for physicians or for healthplans. l

Third Annual Navigation andSurvivorship Conference

Friday, September 1412:45 – 1:00pm Welcome

Conference Co-Chairs:Sharon Gentry, RN, MSN, AOCN, CBCNLillie D. Shockney, RN, BS, MAS

1:00 – 2:00pm Pre-Conference Workshops& Beginners Track

2:15 – 3:15pm • Core Principles of NavigationNicole Messier, RN, BSN Pamela J. Vlahakis, RN, MSN, CBCNMembers• Getting Excited about Research – Case Examples Linda Fleisher, PhD, MPH Elaine Sein, RN, BSN, OCN, CBCN

• Panel Discussion: Building Optimal Community Outreach – Lay and CommunityJean B. Sellers, RN, MSN (Moderator)Leah Leilani Beck, BSJessica Denton, MSW

• Implementing a Survivorship Program/ClinicCynthia Waddington, RN, MSN, AOCN

3:15 – 3:30pm Break3:30 – 5:00pm Administrators Track

• Administering a Navigation Program Bonnie J. Miller, RN, BSN, OCN, FAAMAElizabeth Whitley, PhD, RN Navigators Track• How Do Case Managers and Navigators Interface?

Nancy Skinner, RN-BC, CCM5:00 – 6:00pm FREE TIME6:00 – 8:00pm Welcome Reception/Posters in the Exhibit Hall

Saturday, September 157:30 – 8:30am Breakfast/Product Theater:

New Route of Administration for Velcade®

supported by Millennium Pharmaceuticals, Inc.8:30 – 8:45am Welcome & Introductions

Conference Co-Chairs8:45 – 9:45am General Session 1: Navigation Update: 2012

Current Regulations – Navigation & SurvivorshipCare Plan Linda Ferris, PhD

9:45 – 10:00am Break10:00 – 11:30am Disease-Site–Specific Breakouts

Stand-Alone Sessions• Breast Cancer Navigation

Mary Rooney, RN, BSN, OCN • Thoracic Oncology Navigation

Pamela Matten, RN, BSN, OCN• GI Cancer Navigation

Coralyn Martinez, MSN, RN, OCN• Colorectal Cancer Navigation

Maura Kadan, RN, MSN, OCN

PRELIMINARY AGENDA* • GYN Cancer NavigationRobin A. Atkinson, RN, BSN, OCN

• Prostate Cancer NavigationJuli Aistars, RN, MS, APN, AOCNRapid Fire Sessions with Panel• Head, Neck, & Neuro Navigation

Heather Stern, RN, BSN, CNOR, OCNAnd

• Hematology/OncologyTina Scherer, RN, MSN, OCNAdministrators Session • The Role of the Administrator

Lisa Shalkowski, RN, BSN, MSM11:45 – 1:00pm Lunch in the Exhibit Hall1:15 – 2:15pm Advocacy Keynote

TBD2:15 – 3:15pm General Session 2: Best Practices in

Survivorship Care RehabilitationJulie Silver, MD

3:15 – 4:15pm General Session 3: Plenary SessionFinancial and Legal Issues for Our Cancer PatientsDavid S. Landay, JD

4:15 – 5:00pm The Art of Exceptional Professional Performance– Making a Difference in Your Patients’ LivesSelinza Mitchell, RN

5:00 – 7:00pm Poster Award Reception in the Exhibit HallPamela Matten, RN, BSN, OCN

7:00pm Conclusion of Day – Networking FREE TIME

Sunday, September 167:30 – 8:30am Breakfast Symposium/Product Theater8:30 – 9:30am General Session 4: Navigation in the Age of

Personalized Cancer CareSharon Gentry, RN, MSN, AOCN, CBCNLillie D. Shockney, RN, BS, MAS

9:30 – 10:30am General Session 5: Best Practices in AddressingHealth InequitiesLauren Kelley, MSW, MPA Adrienne Lofton, RN, MSN

10:30 – 10:45am Break10:45 – 12:15pm Practice Setting – Panel Discussion with

Moderator• Office-Based

Roxanne Parker, RN, MSN, CPN (Moderator) • Academic

Bonnie J. Miller, RN, BSN, OCN, FAAMA • Community Hospital–Based

Karyl Blaseg, RN, MSN, OCN12:15 – 1:15pm Lunch in the Exhibit Hall1:30 – 2:30pm Clinical Survivorship Guidance

Mandi Pratt-Chapman, MAKatherine Sharpe, MTS

2:30 – 2:45pm Conclusion/Final RemarksConference Co-Chairs

*Preliminary agenda, subject to change.

A

s c

n

Register online: www.regonline.com/aonn2012CONFERENCE REGISTRATION

*Early Bird Rate: $295Includes Membership through September 30, 2013.

Conference Registration: $345Includes Membership through September 30, 2013.

*Early bird expires August 1, 2012.

September 14-16, 2012Phoenix, Arizona Arizona Grand

Medical Learning Institute, Inc.Provider approved by the California Board of Registered Nursing,Provider Number 15106, for up to 12.25 contact hours.

REGISTERED NURSE DESIGNATION

This activity is pending approval from the National Association of SocialWorkers. Contact hours for this continuing social worker education activ-ity have been submitted to the National Association of Social Workers.

SOCIAL WORK DESIGNATION

FACULTY*

AONN’s Third Annual Conference will continue to advance the nav-igation profession by expanding the scope of educational sessions, net-working opportunities, and poster presentations. In addition, this year’sconference will address the evolving challenges of program improve-ment, the role of personalized medicine, and implementing best prac-tices in navigation, survivorship, and psychosocial care.

CONFERENCE OVERVIEW

GoalAONN’s Third Annual Navigation and Survivorship Conferencewill advance the role of navigation and survivorship in cancer careto ultimately improve the quality of patient care.

Objectives• Discuss the evolution of the role of navigation in healthcare• Assess strategies for navigating diverse patient populations by cancer type and environmental factors

• Define methods for providing patient support and guidancein the age of personalized cancer care

• Evaluate best practices regarding survivorship and psychosocial care

CONTINUING EDUCATION INFORMATION

This is an opportunity to share research, programs, and results withyour colleagues. Submit your abstract via e-mail to [email protected] Deadline: August 1, 2012

CALL FOR ABSTRACTS

AONN’s Third Annual Conference is the only meeting that gives youaccess to decision-makers and key practitioners involved in oncologynavigation and survivorship. If your company provides any of the fol-lowing services/products for the oncology healthcare community, thisis the meeting for you.

• Pharmaceutical/Biotech• Genetic Laboratory Services• Navigation Software• Patient Advocacy• Training

TARGET AUDIENCE

• Patient Access• Reimbursement• Publishers• Education• Certification

This educational initiative is directed toward oncology nurse naviga -tors, patient navigators, and social workers.

This activity is jointly sponsored by AONN Foundation for Learning, Inc.,Center of Excellence Media, LLC, and Medical Learning Institute, Inc.

SPONSORS

Sharon Gentry, RN, MSN, AOCN,CBCNBreast Health NavigatorDerrick L. Davis ForsythRegional Cancer CenterWinston-Salem, NC

Lillie D. Shockney, RN, BS, MASUniversity Distinguished Associate Professor of Breast CancerAdm Director, Johns Hopkins Clinical Breast ProgramsAdm Director, Johns Hopkins Cancer Survivorship ProgramsDepts of Surgery and OncologyAssociate Professor, JHU School of Medicine,Depts of Surgery, Oncology and GynecologyAssociate Professor, JHU School of NursingJohns Hopkins Avon Foundation Breast CenterBaltimore, MD

CONFERENCE CO-CHAIRS

Juli Aistars, RN, MS, APN, AOCNRobin A. Atkinson, RN, BSN, OCNLeah Leilani Beck, BSKaryl Blaseg, RN, MSN, OCNJessica Denton, MSWLinda Ferris, PhDLinda Fleisher, PhD, MPHMaura Kadan, RN, MSN, OCNLauren Kelley, MSW, MPA David S. Landay, JDAdrienne Lofton, RN, MSNCoralyn Martinez, MSN, RN, OCNPamela Matten, RN, BSN, OCNNicole Messier, RN, BSNBonnie J. Miller, RN, BSN, OCN,FAAMA

Roxanne Parker, RN, MSN, CPNMandi Pratt-Chapman, MAMary Rooney, RN, BSN, OCNTina Scherer, RN, MSN, OCNElaine Sein, RN, BSN, OCN, CBCNJean B. Sellers, RN, MSNLisa Shalkowski, RN, BSN, MSMKatherine Sharpe, MTSJulie Silver, MD Nancy Skinner, RN-BC, CCMHeather Stern, RN, BSN, CNOR, OCNPamela J. Vlahakis, RN, MSN, CBCNCynthia Waddington, RN, MSN, AOCNElizabeth Whitley, PhD, RN

*For full information visit www.aonnonline.org

www.regonline.com/aonn2012

��

Every summerand fall, theAssociation of

Community CancerCenters (ACCC)hosts a series ofRegional OncologyEconomic and Man -agement Meetings.These meetings aretargeted for memberswho are in the busi-

ness of delivering cancer care in thehospital or the office setting. Theregional gatherings offer ACCCmembers the opportunity to gettogether with other providers intheir region to receive up-to-dateinformation on the latest trends andthe economics of oncology care. TheACCC has just completed its thirdregional meeting in Berkeley, CA.The recent regional meetings

have highlighted tips and trends onquality reporting and the transitionto the International Classification ofDiseases, Tenth Edition (ICD-10),updates from the new Commissionon Cancer standards, financial coun-seling, payer negotiation in the ageof accountable care organizations,patient navigation education, and alegislative update discussing theimpact of policy measures on cancercare policy.The hot topic at the most recent

ACCC meetings has been thePatient Protection and AffordableCare Act (ACA) and how the USSupreme Court would rule on theconstitutionality of the mandatewithin the ACA. After much antic-ipation, the Supreme Court recentlyupheld the law (with one exception

regarding Medicaid expansion). As expected, the decision on the

constitutionality of the individualmandate in the ACA came down toa vote of 5 to 4, with Chief JusticeJohn Roberts providing the swingvote for the majority. This is a bitsurprising. Most people (includingmyself) believed that Justice Kennedywould be the swing vote. The decision: The ACA, including

the individual mandate that virtual-ly all Americans buy health insur-ance, is constitutional (with theexception of one provision).

An Interesting Conundrum What is interesting in this deci-

sion is the grounds on which the jus-tices determined the law to stand. Asyou may remember, the primaryargument for the upholding of theindividual mandate rested inCongress’s power to regulate com-merce between the states to requireeveryone to buy health insurance(ie, the Commerce Clause). Therewere not 5 votes to uphold the man-date on this ground. However, 5 jus-tices (Roberts, Breyer, Sotomayor,Ginsburg, and Kagan) did agree thatthe penalty a citizen must pay if heor she refuses to buy insurance is akind of tax that Congress can imposeusing its taxing power. What this means: Congress does

not have the power to tell you to buyhealth insurance, but it does holdthe power to tax you if you do not.Because the mandate survives, the

Supreme Court did not need todecide what other parts of the statutewere constitutional, except for a pro-vision in the ACA requiring states to

comply with new eligibility require-ments for Medicaid or risk losing allof their Medicaid funding. On thatquestion, the Court held that theprovision is not constitutional. Stateswill have a choice whether to expandtheir Medicaid programs; those thatdo not comply with this new require-ment will lose additional expandingMedicaid funding moving forward,but they will retain the federal fund-ing they currently receive for theirMedicaid program.

Assessing the Full Impact of the Decision ACCC members can look forward

to hearing a full breakdown of theSupreme Court’s decision on theACA and the impact of the decisionon community cancer care, as well ashow Congress will address unre-solved issues from the 2012 ses-sion—including next steps on a per-manent solution for the sustainablegrowth rate—at the ACCC 29thAnnual National Oncology Con -ference on October 3-6, 2012, inSan Antonio, TX. In addition, to help members bet-

ter manage services, maximize re -sources, engage staff, and promotetransformational change, they willlearn pioneering strategies and prac-tical tools from some of the topachievers in community cancercare—the winners of the 2012Innovator Award. More information about this

meeting and others is available atwww.accc-cancer.org/meetings/. Asalways, the ACCC will keep mem-bers up to date on the most currenttopics in cancer care. l


Patient and Provider Access

Hot Topics in Community Cancer Centers:The Affordable Care Act By Sydney Abbott, JD, Policy Coordinator, Association of Community Cancer Centers

Brought to you by the Association of Community Cancer Centers

Pub:

IndicationYERVOY (ipilimumab) is indicated for the treatmentof unresectable or metastatic melanoma.1

REFERENCES 1. YERVOY (ipilimumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb; March 2011.2. Alpha-numeric HCPCS. Centers for Medicare & Medicaid Services Web site. http://www.cms.gov/HCPCSReleaseCodeSets/Downloads/12anweb.zip. Accessed November 1, 2011.

Please see Important Safety Information, including Boxed WARNING regarding immune-mediated adverse reactions, continued on the following pages.

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY 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.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs) and thyroid function tests at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Important Safety Information

Announcing: J-code for YERVOY™ (ipilimumab) J9228

The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agentsmake no guarantee regarding reimbursement for any service or item. This coding guidance is not intended to provide speci� c directions on requesting prior authorization or submitting claims for YERVOY and does not provide a guarantee of receiving prior authorization or reimbursement. Oncology practices need to make coding decisions based on the diagnosis and treatment of each patient and the speci� c insurer requirements.

aReplaces J9999, J3490, J3590, and C9284.

www.destinationaccess.com1-800-861-0048 (phone) Monday through Friday, 8:00 A M to 8:00 P M ET1-888-776-2370 (fax)

ProductDescription

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

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

NDC Number

10-digit 0003-2327-11 0003-2328-22

11-digit 00003-2327-11 00003-2328-22

Replaces J9999, J3490, J3590, and C9284.

Pub:

Please see brief summary of Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions, on the following spread.

Recommended Dose Modifi cationsWithhold dose for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for any of the following:

Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day

Failure to complete full treatment course within 16 weeks from administration of � rst dose

Severe or life-threatening adverse reactions, including any of the following– Colitis with abdominal pain, fever, ileus, or peritoneal

signs; increase in stool frequency (≥7 over baseline), stool incontinence, need for intravenous hydration for >24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation

– AST or ALT >5 × the upper limit of normal (ULN) or total bilirubin >3 × the ULN

– Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full-thickness dermal ulceration or necrotic, bullous, or hemorrhagic manifestations

– Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis

– Severe immune-mediated reactions involving any organ system

– Immune-mediated ocular disease which is unresponsive to topical immunosuppressive therapy

Immune-mediated Enterocolitis: In the pivotal Phase 3 study in YERVOY-treated patients,

severe, life-threatening or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) patients

Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis

In� iximab was administered to 5 of 62 (8%) patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids

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 (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid

tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients

Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent)

Immune-mediated Hepatitis: In the pivotal Phase 3 study in YERVOY-treated patients,

severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3–5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%

13 (2.5%) additional YERVOY-treated patients experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5x but ≤5x the ULN or total bilirubin elevation >1.5x but ≤3x the ULN; Grade 2)

Monitor LFTs (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 LFT monitoring until resolution

Permanently discontinue YERVOY in patients with Grade 3-5 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids

Withhold YERVOY in patients with Grade 2 hepatotoxicityImmune-mediated Dermatitis: In the pivotal Phase 3 study in YERVOY-treated patients,

severe, life-threatening or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3–5) occurred in 13 (2.5%) patients

– 1 (0.2%) patient died as a result of toxic epidermal necrolysis

– 1 additional patient required hospitalization for severe dermatitis

There were 63 (12%) YERVOY-treated patients with moderate (Grade 2) dermatitis

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

Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 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 in patients with moderate to severe signs and symptoms

Important Safety Information (cont)

731US11AB18316 TRIM 8.125" x 10.875" Pub:

© 2012 Bristol-Myers Squibb 731US11AB18316 01/12 Printed in USA YERVOY is a trademark of Bristol-Myers Squibb.

Please see brief summary of Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions, on the following spread.

Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically. Administer topical or systemic corticosteroids if there is no improvement within 1 week

Immune-mediated Neuropathies: In the pivotal Phase 3 study in YERVOY-treated patients, 1

case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported

Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré 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-Barré–like syndromes

Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities)

Immune-mediated Endocrinopathies: In the pivotal Phase 3 study in YERVOY-treated

patients, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients

– All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insuf� ciency, hypogonadism, and hypothyroidism

– 6 of the 9 patients were hospitalized for severe endocrinopathies

Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) YERVOY-treated patients and consisted of hypothyroidism, adrenal insuf� ciency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing’s syndrome

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

Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insuf� ciency (including adrenal crisis), and hyper- or hypothyroidism

– Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspeci� c symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identi� ed, signs or symptoms 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 in symptomatic patients. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. Long-term hormone replacement therapy may be necessary

Other Immune-mediated Adverse Reactions, Including Ocular Manifestations:

In the pivotal Phase 3 study in YERVOY-treated patients, clinically signi� cant immune-mediated adverse reactions seen in <1% were: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia

Across the clinical development program for YERVOY, immune-mediated adverse reactions also reported with <1% incidence were: 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 signi� cant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions

Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy

Pregnancy & Nursing: YERVOY is classi� ed as pregnancy category C. There are

no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential bene� t justi� es the potential risk to the fetus

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

It is not known whether YERVOY 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

Common Adverse Reactions: The most common adverse reactions (≥5%) in patients

who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%)

Important Safety Information (cont)

YERVOY™ (ipilimumab) Injection, for intravenous infusion

Brief Summary of Prescribing Information. For complete prescribing information consult official package insert.

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONSYERVOY (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 3–5) 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 1.6–13.4) and 6.3 weeks (range 0.3–18.9) after the initiation of YERVOY for patients with Grade 3–5 enterocolitis and with Grade 2 enterocolitis, respectively.

Twenty-nine patients (85%) with Grade 3–5 enterocolitis were treated with high-dose (≥40 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 3–5 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 3–5) 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 biopsy-proven hepatitis to characterize the clinical course of this event.

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.

Permanently discontinue YERVOY in patients with Grade 3–5 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]

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 3–5) 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 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-Barré 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-Barré 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-Barré-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 3–4) 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 Cushing’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 immune-mediated adverse reactions.

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]

ADVERSE REACTIONS

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

[see Warnings and Precautions].






Pub:

Clinical Trials Experience

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.

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 (≥5%) 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 3–5 events.

Table 1: Selected Adverse Reactions in Study 1

Percentage (%) of Patientsa

YERVOY 3 mg/kg n=131

YERVOY 3 mg/kg+gp100

n=380

gp100 n=132

System Organ Class/ Preferred Term

Any Grade

Grade3–5

Any Grade

Grade3–5

Any Grade

Grade 3–5

Gastrointestinal Disorders Diarrhea ColitisSkin and Subcutaneous Tissue Disorders Pruritus RashGeneral Disorders and Administration Site Conditions Fatigue

328

3129

41

55

02

7

375

2125

34

43

<12

5

202

118

31

10

00

3

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

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

Table 2: Severe to Fatal Immune-mediated Adverse Reactions in Study 1

Percentage (%) of Patients

YERVOY3 mg/kgn=131

YERVOY3 mg/kg+gp100

n=380

Any Immune-mediated Adverse ReactionEnterocolitisa,b

Hepatotoxicitya

Dermatitisa

Neuropathya

Endocrinopathy Hypopituitarism Adrenal insufficiencyOther Pneumonitis Meningitis Nephritis Eosinophiliac

Pericarditisa,c

157121440

00110

12723

<1111

<1<100

<1

a Including fatal outcome. b Including intestinal perforation. c Underlying etiology not established.

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.

Immunogenicity

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.

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.

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.

DRUG INTERACTIONS

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

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C

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.

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 “knockout mouse”), offspring lacking CTLA-4 were born apparently healthy, but died within 3–4 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

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.

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

1281558A2 IP-B0001A-03-11 Issued: March 2011

7 Pub:


Compendia listed CPT®

Generic (brand) HCPCS code: FDA-approved off-label use for administration

name code description for lung cancer lung cancer codes

amifostine J0207: Injection, amifostine, 500 mg ✓ 96374(Ethyol)

bevacizumab J9035: Injection, bevacizumab, 10 mg ✓ 96413, 96415(Avastin)

bexarotene J8999*: Prescription drug, oral, ✓ N/A(Targretin) chemotherapeutic

Not otherwise specified

bleomycin J9040: Injection, bleomycin sulfate, ✓ 96401, 96409(Blenoxane) 15 units

carboplatin J9045: Injection, carboplatin, 50 mg ✓ 96409, 96413,(Paraplatin) 96415

cetuximab J9055: Injection, cetuximab, 10 mg ✓ 96413, 96415(Erbitux)

cisplatin J9060: Injection, cisplatin, powder or ✓ 96409, 96413, (Platinol AQ) solution, per 10 mg 96415

crizotinib C9399*: Unclassified drugs or biological ✓ N/A(Xalkori) (Hospital outpatient use ONLY)

crizotinib J8999*: Prescription drug, oral, ✓ N/A(Xalkori) chemotherapeutic


cyclophosphamide J8530: Cyclophosphamide, oral, 25 mg ✓ N/A(Cytoxan)

cyclophosphamide J9070: Cyclophosphamide, 100 mg ✓ 96409, 96413, (Cytoxan) 96415

Drug Coding

Supplied by RJ Health Systems

Medications Used for the Treatment of Lung CancerThe following sections will assist healthcareprofessionals and payers by providing appropri-ate coding and billing information associatedwith the management of lung cancer.

The following sections include:• Associated ICD-9-CM codes used forthe classification of lung cancer

• Drugs that have been FDA-approvedin the treatment of lung cancer

• Drugs that are Compendia listed foroff-label use for lung cancer based onclinical studies that suggest beneficialuse in some cases. Please note: If a check mark appears inthe FDA column it will NOT appear inthe Compendia off-label use column

• Corresponding HCPCS/CPT® codesand code descriptions

Associated ICD-9-CM codes for lung cancer:162 Malignant neoplasm of trachea, bronchus, and lung

162.0 TracheaCartilage of tracheaMucosa of trachea

162.2 Main bronchusCarinaHilus of lung

162.3 Upper lobe, bronchus or lung162.4 Middle lobe, bronchus or lung162.5 Lower lobe, bronchus or lung162.8 Other parts of bronchus or lung

Malignant neoplasm of contiguous or overlapping sites of bronchus or lung whose point of origin cannotbe determined

162.9 Bronchus and lung, unspecified


Drug Coding





docetaxel J9171: Injection, docetaxel, 1 mg ✓ 96413(Taxotere)

doxorubicin HCl J9000: Injection, doxorubicin hydrochloride, ✓ 96409(Adriamycin) 10 mg

doxorubicin J9001: Injection, doxorubicin hydrochloride, ✓ 96413(Doxil) all lipid formulations, 10 mg

doxorbicin Q2048: Injection, doxorubicin hydrochloride, ✓ 96413(Doxil) liposomal, Doxil, 10 mg

epirubicin J9178: Injection, epirubicin HCl, 2 mg ✓ 96409, 96413(Ellence)

erlotinib C9399*: Unclassified drugs or biological ✓ N/A(Tarceva) (Hospital outpatient use ONLY)

erlotinib J8999*: Prescription drug, oral, ✓ N/A(Tarceva) chemotherapeutic


etoposide J8560: Etoposide, oral, 50 mg ✓ N/A(Vepesid)

etoposide J9181: Injection, etoposide, 10 mg ✓ 96413, 96415(Etopophus, Toposar)

fluorouracil J9190: Injection, fluorouracil, 500 mg ✓ 96409(Adrucil)

gefitinib J8565: Gefitinib, oral, 250 mg ✓ N/A(Iressa)

gemcitabine J9201: Injection, gemcitabine hydrochloride, ✓ 96413(Gemzar) 200 mg

ifosfamide J9208: Injection, ifosfamide, 1 g ✓ 96413, 96415(Ifex)

irinotecan J9206: Injection, irinotecan, 20 mg ✓ 96413, 96415(Camptosar)

lomustine J8999*: Prescription drug, oral, ✓ N/A(CeeNu) chemotherapeutic


lomustine S0178: Lomustine, oral, 10 mg ✓ N/A(CeeNu)

mechlorethamine HCl J9230: Injection, mechlorethamine ✓ 96409(Mustargen) hydrochloride (nitrogen mustard), 10 mg

methotrexate J8610: Methotrexate, oral, 2.5 mg ✓ N/A

methotrexate J9250: Methotrexate sodium, 5 mg ✓ 96372, 96374,96401, 96409,96450

methotrexate J9260: Methotrexate sodium, 50 mg ✓ 96372, 96374,96401, 96409,96450

mitomycin J9280: Mitomycin, 5 mg ✓ 96409(Mutamycin)


Drug Coding





oxaliplatin J9263: Injection, oxaliplatin, 0.5 mg ✓ 96413, 96415(Eloxatin)

paclitaxel protein-bound J9264: Injection, paclitaxel protein-bound ✓ 96413particles particles, 1 mg(Abraxane)

paclitaxel J9265: Injection, paclitaxel, 30 mg ✓ 96413, 96415(Taxol)

panitumumab J9303: Injection, panitumumab, 10 mg ✓ 96413, 96415(Vectibix)

pemetrexed J9305: Injection, pemetrexed, 10 mg ✓ 96409 (Alimta)

porfimer sodium J9600: Injection, porfimer sodium, 75 mg ✓ 96409(Photofrin)

tamoxifen J8999*: Prescription drug, oral, ✓ N/A(Nolvadex) chemotherapeutic


tamoxifen S0187: Tamoxifen citrate, oral, 10 mg ✓ N/A(Nolvadex)

temozolomide J8700: Temozolomide, oral, 5 mg ✓ N/A(Temodar)

teniposide Q2017: Injection, teniposide, 50 mg ✓ 96413, 96415(Vumon)

topotecan J8705: Topotecan, oral, 0.25 mg ✓ N/A(Hycamtin)

topotecan J9351: Injection, topotecan, 0.1 mg ✓ 96413(Hycamtin)

trastuzumab J9355: Injection, trastuzumab, 10 mg ✓ 96413, 96415(Herceptin)

vinblastine J9360: Injection, vinblastine sulfate, 1 mg ✓ 96409(Velban)

vincristine J9370: Vincristine sulfate, 1 mg ✓ 96409(Vincasar PFS)

vinorelbine J9390: Injection, vinorelbine tartrate, ✓ 96409(Navelbine) per 10 mg

*When billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code (eg, J8999 for Xalkori) in Column24D and the drug name, strength, and NDC (National Drug Code) in Box 19 or 24A to ensure appropriate reimbursement. Please note: check withpayer regarding correct placement of medication information in Box 19 or 24A.

ReferencesHCPCS Level II Expert 2012 • Current Procedural Terminology (CPT®), 2012 (CPT® copyright 2012 American Medical Association. All rightsreserved. 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 byRJ Health Systems International, LLC, Rocky Hill, Connecticut • CMS (Centers for Medicare & Medicaid Services).

CPT indicates Current Procedural Terminology; HCPCS, Healthcare Common Procedure Coding System.

30 Cold Spring Road, Rocky Hill, CT 06067 T: (860) 563-1223 • F: (860) 563-1650 • www.RJHealthSystems.com

This information was supplied by:

RJ Health SystemsThe Creators of ReimbursementCodes.com

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

rjhealthsystems.com

RJ Health Systems — 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 drug’s NDC and brand/generic name.

Please visit www.rjhealthsystems.com to learn more about our

products and services listed below:

10:36 PM

More so than ever, regulatorsare using a provider’s prac-tice structure as the tool to

investigate or deny reimbursement,and convict providers of improperconduct. Doing so has proved fairlysimple from the regulator’s standpoint,mainly because many physicians enterand exit medical school, residency,and fellowship programs without hav-ing been subjected to educationregarding the laws, and regulationsthat govern appropriate practice struc-ture. As such, many practices arestructured and operate in violation ofthe many healthcare laws.Although our current educational

system is arguably the best for thepatient, a gaping hole is left in manyphysicians’ knowledge base aboutthe requirements of operating theirown medical practices. The lack ofknow-how or understanding ofallowable practice structures or con-straints is by no means the physi-cian’s fault; in fact, physicians likelydid not come across many opportu-nities to expose themselves to “busi-ness of medicine” topics, and whenthey were exposed, likely such expo-sure was not more than a glazing ofpreliminary topics. For instance, aphysician may have attended anhour seminar on HIPAA or heardmention of times when a physician isnot authorized to make a referral tooneself. Some physicians opt to go italone, “open up shop,” and see whathappens, whereas others elect towork with a knowledgeable attorneyto assist in practice structure orpotentially with a practice consult-ant, of whom there are many. In fact, an entire industry of con-

sultants has arisen to fill the physician“business of medicine” knowledge

gap, about which we caution, caveatemptor (buyer beware): a consultantwho is not a physician, not a lawyer,not an accountant, and not a finan-cial planner has no formal specialty,so be sure to check credentials,including referrals by a healthcareattorney, before paying a retainer. The purpose of this article is to

highlight the need for each physi-cian and practice manager to understand the importance of theirpractice structure to ensurereim -bursement for services rendered, andto ensure compliance in operationsto protect from potential exposure.In addition to potential criminalexposure for improper structure,many practices are at risk of financialexposure. In most cases, practices are not in

compliance because the practiceowners and managers are unaware ofthe compliance requirements; how-ever, being unaware is not an excuse,should the practice come underscrutiny by a payer (ie, Medicare) ora government regulator (ie, theOffice of Inspector General). Failureto comply with applicable structuralrequirements is a strict liabilityoffense in some instances. If you arenot in compliance, then you maynot be entitled to payment for a par-ticular claim for Designated HealthServices (DHS) or any claim sub-mitted while the practice was not incompliance; this is called “disal-lowance.”DHS includes most ancil-lary testing, imaging, durable med-ical equipment, and physicaltherapy, as well as other critical serv-ices needed by many patients.Whether a service constitutes DHSis not subjective; Medicare has a listof DHS services, by CPT® (Current

Procedural Terminology) code, on its web- site (www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelf Referral/List_of_Codes.html).The concept of disallowance is set

forth in the Stark Law, as follows (42CFR § 411.353):(1) Except as provided in para-

graph (e) of this section, no Medi -care payment may be made for a designated health service that is fur-nished pursuant to a prohibitedreferral. The period during whichreferrals are prohibited is the periodof disallowance. For purposes of thissection, with respect to the followingtypes of noncompliance, the periodof disallowance begins at the timethe financial relationship fails tosatisfy the requirements of an appli-cable exception and ends no laterthan—(i) Where the noncompliance is

unrelated to compensation, the datethat the financial relationship satis-fies all of the requirements of anapplicable exception;(ii) Where the noncompliance is

due to the payment of excess com-pensation, the date on which allexcess compensation is returned bythe party that received it to theparty that paid it and the financialrelationship satisfies all of therequirements of an applicableexception; or(iii) Where the noncompliance is

due to the payment of compensationthat is of an amount insufficient tosatisfy the requirements of an appli-cable exception, the date on whichall additional required compensa-tion is paid by the party that owes itto the party to which it is owed andthe financial relationship satisfiesall of the requirements of an appli-


Legal Update

Protecting Against Disallowance throughPractice StructureBy Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

cable exception [emphasis added]. Below are examples of hypotheti-

cal situations that may arise underthe 3 subparts of the statute refer-enced above.First, subpart (i) of 42 CFR §

411.353(c)(1) defines the period ofdisallowance from the date the finan-cial relationship fails to meet therequirements of an exception untilsuch time that the practice is nolonger structured improperly. Anexample of how simple it is for apractice to be structured improperlymay be evinced by a simple StarkLaw hypothetical. The Stark Law(one of the main statutes applicableto medical practices when ensuringstructural compliance) prohibits self-referring for DHS unless the practiceis structured in accordance with cer-tain requirements and meets appli-cable exceptions (see 42 U.S.C.§1395nn). Under the Stark Law, apractice with more than 1 physicianmust meet the definition of a grouppractice to potentially qualify for a Stark Law exception, which isrequired to enable the practice toself-refer to DHS. One of the “grouppractice” requirements of the StarkLaw is that the majority (75%) of allof the patient care services (75%) ofthe physicians who are members ofthe group must be furnished throughthe group (see 42 CFR § 411.351).Smaller group practices with part-time physicians who are ordering andconducting their own imaging servic-es may not be in compliance and,therefore, the analysis as to whetherthe practice is in compliance neednot continue. That practice may bein a period of disallowance. Second, subpart (ii) of 42 CFR §

411.353(c)(1) defines the period ofdisallowance from the date the finan-cial relationship fails to meet therequirements of an exception untilsuch time that the identified over-payment is returned to the payer andthe financial relationship meets therequirements of an exception. This

definition is utilized when the non-compliance is a result of payment ofexcess compensation. An example ofwhen a practice may be in a period ofdisallowance for excess compensa-tion is during such period as a prac-tice has received compensation inexcess of what it has been entitled tofor services rendered, which, forexample, may be a result of inten-tional upcoding. This period of disal-lowance would continue until suchtime as the practice returns excessfunds to Medicare and all practicestructural requirements are met. Third, subpart (iii) of 42 CFR §

411.353(c)(1) defines the period ofdisallowance from the date the finan-cial relationship fails to meet therequirements of an exception untilthe date when additional requiredcompensation is paid and the finan-cial relationship meets the require-ments of an exception. This defini-tion may apply where a practice failsto meet an exception due to insuffi-cient compensation. By way of exam-ple, where an oncology practiceagrees to rent equipment from a ven-dor and for one reason or another thevendor agrees to offer the equipmentat well below the fair market value,the fair market value is a requirementthat must be met to qualify for anexception under rental of equipment,should such equipment be used forDHS. Under subpart (iii), until suchtime as the practice is paying fairmarket value for the equipmentrental, and has paid back-owed rentfor underpayments, the period of dis-allowance would continue and thepractice would not be authorized toreceive reimbursement for servicesrendered to Medicare beneficiaries,reimbursable by Medicare for thatperiod of disallowance. These examples are provided as an

explanatory tool, so that practiceowners and managers may betterunderstand the definitions of disal-lowance and how the same may beapplicable to a potential practice

arrangement. This does not consti-tute a complete analysis, nor shouldit be utilized to evaluate an individ-ual practice arrangement. To under-stand the nuances and intricacies ofthe applicable laws referenced hereinwould require a level of masteryabove and beyond reviewing an indi-vidual article. Equally as important asunderstanding appropriate practicestructure issues is to ensure that youare working with professionals bestable to guide you and assist in appro-priate practice structure matters. The intricate laws governing

structure and prohibiting certainfinancial relationships and referralscreate strict liability offenses if cer-tain structure parameters are notmet. “I didn’t know” is not a tenabledefense. The good news is that thereis still time to ensure you are operat-ing compliantly. Regulators are con-ducting more reviews of practicestructures, but those reviews are justramping up, and if you have not yetbeen targeted, there is still time totake preventive action. l

This article is for education and discussionpurposes only and does not constitute legaladvice.

Jennifer Kirschenbaum, Esq, managesKirschenbaum & Kirschenbaum’shealthcare department, which special-izes in representing healthcare practi-tioners in regulatory compliance, auditdefense, licensure, and transactionalmatters. She may be reached at 516-747-6700 x302 or by e-mail [email protected]. Forupdates on changes in documentationrequirements and general healthcareupdates, visit www.nyhealthcareattorneys.com. Erica Youngerman, Esq, an associate

in Kirschenbaum & Kirschenbaum’shealthcare department, assisted in thepreparation of this article and may bereached at 516-747-6700 x308 or by e-mail at [email protected].

Legal Update



In today’s turbulent economictimes, physicians are looking for solutions that provide tax de -

ductions and the opportunity tosave efficiently for their retirement.No matter whether you are self-employed, run a small medical prac-tice, own shares in a large surgicalcenter, or are directly involved inrunning a corporation/tax-exemptorganization, you have the ability toestablish a qualified retirement pro-gram for you and for your employees. However, how do you create a

retirement program to maximizeyour tax-deductible contributionswithout “breaking the bank” on em -ployee costs? This article presentsplan design concepts successfullyused by others in the medical com-munity, to help you better under-stand the elements that go into awell-designed and well-executedretirement program.

What Is a QualifiedRetirement Plan?The term “qualified” generally

indicates that the plan must meetstatutory requirements under theEmployee Retirement IncomeSecurity Act of 1974 (ERISA),regarding issues such as participanteligibility, benefit coverage, vesting,funding requirements, and employeecommunication. Qualified plans aresubject to the most stringent regula-

tion, but, as a result, receive the mostfavorable tax treatment. Two of thebiggest benefits are (1) immediateincome tax deductions, and (2)creditor protection.

Defined Contribution versusDefined Benefit PlansAs with any project, there is usu-

ally more than one way to accom-plish your objective. The same holdstrue for retirement plans. Most peo-ple have heard about 401(k) plans,where you can defer a portion ofyour salary and the employer makesa discretionary contribution as amatch or as a percentage of yourcompensation. These plans arecalled Defined Contribution Plansand function as a savings accountthat is affected by investment gainsand losses. The contribution goinginto such a plan is “defined,” but notthe end benefit. The reverse of this isthe Defined Benefit/Cash BalancePlan, in which an actuary deter-mines the annual employer contri-bution that will provide a specificbenefit payable at retirement.Participants who begin saving

later in life are at a distinct disad-vantage in Defined ContributionPlans, because they have fewer yearsto accumulate funds for retirement.Conversely, Defined Benefit/CashBalance Plans, for these same em -ployees, allow them to accumulateconsiderable retirement assets in arelatively short period, because theend benefit has been predetermined.

401(k)/Profit-Sharing PlansIt is common for a medical prac-

tice to combine a 401(k) plan with a profit-sharing component. The401(k) plans have become one ofthe most popular types of employer-sponsored retirement plans. Thepurpose is to permit you to defer a

portion of your salary, up to $17,000($22,500 for those aged 50 years orolder) annually, on a pretax or post-tax (ie, Roth) basis. In addition,when there are ample funds, theemployer can make a discretionarycontribution that could increase the business owner up to $50,000($55,500 if aged 50 or older) inannual contributions. As yourmoney grows in these plans, allincome taxes are deferred until youtake distributions at retirement.This all sounds good, but is there a

catch? The catch is that if you haveemployees, you must also providethem with a benefit and prove to theIRS that your plan encourages andbenefits those rank-and-file employ-ees. Although every organization’sdemographics are different, some ofthe best design tools include the fol-lowing features:• The Safe Harbor 401(k) plan is a401(k) plan that eliminates allcompliance testing. With thistype of plan, employers with low-to-very-poor 401(k) participa-tion by staff can safely defer theirfull $17,000 ($22,500 for thoseaged 50 or older) contribution,without fear that the plan willfail nondiscrimination testingand that part of their deferral willbe refunded at the end of theyear, creating a taxable event.Based on the design chosen, theemployer will provide either amatching benefit (ie, 100% onthe first 3% deferred, plus 50%on the next 2% deferred) or anonelective benefit (ie, 3% ofsalary) for all participants. The“cost” for using this plan design isthat all employer contributionsare immediately vested.

• When additional benefits are de -sired, many business owners aug-ment their 401(k) plan with a

Physician Wealth Management

Retirement Plans and Your Medical PracticeBy Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF, and Peter M. Coleman, ASA, EA, FCA, MAAA, MBA

With Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF

Peter M. ColemanLawrence B. Keller



Table. The M

edical Practice Traditional 401(k) P

lan with

New

Com

parability Profit-Sh

aring and Cash Balance Com

ponents

Objective: Provide M

axim

um Benefit for Partners/M

inim

ize Ov

erall C

osts

(A)

Projected

(B)

(C)

Maximum

voluntary

Employer

Employer

(B) + (C)(A) + (B) + (C)

Profit-

Cash

salary for

employee

profit-

defined

Total

Total

Allocation

sharing

balance

benefit

401(k)

sharing

benefit

employer

partner

of total

Age,

contribution, contribution,

purposes,

deferral,

contribution,contribution, contribution,

benefits,

benefits,

Participants

yr%

%$

$$

$$

$%

Group 1: Owner physicians

Physician 1

6013.2

Max

250,000

22,500

33,000

238,462

271,462

293,962

26.7

Physician 2

5813.2

Max

250,000

22,500

33,000

217,949

250,949

273,449

24.9

Physician 3

5513.2

Max

250,000

22,500

33,000

187,179

220,179

242,679

22.1

Physician 4

5313.2

Max

250,000

22,500

33,000

169,231

202,231

224,731

20.4

Subtotal: Group 1

1,000,000

90,000

132,000

812,820

944,820

1,034,820

94.1

Group 2: Registered nurses (RNs)

RN 1

403.0

0.0

112,000

4480

3360

0 3360

0.4

RN 2

523.0

0.0

130,000

5200

3900

0 3900

0.4

Subtotal: Group 2

242,000

9680

7260

0 7260

0.8

Group 3: Staff

Staff 1

337.5

2.5

80,000

3200

6000

1385

7385

0.7

Staff 2

327.5

2.5

75,000

3000

5625

1281

6906

0.6

Staff 3

287.5

2.5

65,000

2600

4875

1051

5926

0.5

Staff 4

357.5

2.5

65,000

2600

4875

1157

6032

0.4

Staff 5

277.5

2.5

35,000

1400

2625

558

3183

0.3

Staff 6

257.5

2.5

35,000

1400

2625

543

3168

0.3

Staff 7

357.5

2.5

40,000

1600

3000

712

3712

0.3

Staff 8

427.5

2.5

37,000

1480

2775

726

3501

0.3

Staff 9

287.5

2.5

50,000

2000

3750

808

4558

0.4

Staff 10

357.5

2.5

60,000

2400

4500

1068

5568

0.5

Staff 11

477.5

2.5

55,000

2200

4125

1265

5390

0.5

Staff 12

217.5

2.5

32,000

1280

2400

470

2870

0.2

Subtotal: Group 3

629,000

25,160

47,175

11,024

58,199

5.1

Total

1,871,000

124,840

186,435

823,844

1,010,279

100

Estimated tax savings for partners/firm

36,000

74,600

329,500

404,100

440,100



profit-sharing feature. Offeringsuch a plan helps to attract quali-ty employees and reduces employ-ee turnover. The best part aboutthe profit-sharing contribution isthat it is discretionary in nature,and you are not required to makea set contribution (or any contri-bution) in any given year. Thisflexible standard allows medicalpractices considerable latitude inbudgeting, especially for thosewith varying or uncertain profits.And with a properly designed pro-gram, the majority of the contri-butions will be allocated to thekey employees in your practice.

A Properly Designed ProgramWhat is a properly designed pro-

gram? This is typically a plan inwhich the key staff members, inclu-sive of the owner(s), receive morethan 60% of the total dollars goinginto the plan. One of the best wayswe have accomplished this goal is byusing a New Comparability Profit-Sharing (NCPS) design. An NCPSplan will allow you to place all partic-ipants in the appropriate group and toprovide them with different contribu-tion percentages, as long as you passdiscrimination tests. For example, aprofit-sharing allocation for the fol-lowing participants could include:• Senior physician (owner): 20% ofcompensation

• Junior physician (owner): 10%• Office manager: 7%• Remaining staff: 5%.The employer contributions are

usually made after the end of the planyear (but before filing your taxes),and when you have determined yourability to make the contribution.Each year, working with your retire-ment consultant, you determine thepercentages to allocate to eachgroup. If your demographics do notwork well with this type of design,there are many other variations to

choose from, including pro rata, agebased, service based, and integrationwith Social Security wage base.However, regardless of the designchosen, the maximum contributionany one person can receive, inclusiveof the 401(k) component, is $50,000($55,500 for those aged 50 or older)per employee.

Combination ProgramFor some business owners, the ben-

efits provided through a 401(k)/prof-it-sharing plan are just not enough.They are looking for programs thatwill provide tax-deductible contribu-tions for themselves in excess of$100,000. In these cases, the solutionis the combination of a 401(k)/ Profit-Sharing and Defined Benefit/CashBalance Program. Like an NCPS, theDefined Benefit Plan can be struc-tured to provide greater benefits forthe key employees and minimize over-all costs for the staff. With a De finedBenefit Plan, after 10 years of partici-pation and retirement at age 62, youcould amass an account balance ofapproximately $2.5 million in addi-tion to the account balance in your401(k) profit-sharing plan. Pleasenote that unlike the profit-sharingplan, the contribution to the DefinedBenefit Plan is not discretionary andmust be made for at least 3 to 5 years.

Multiple Plans: An ExampleIn this hypothetical medical prac-

tice listed in the Table, there are 4high wage earners looking for waysto defer additional sums of money in excess of the $50,000 permittedunder a 401(k)/profit-sharing plan.The solution was to use theCombination Program, including a401(k)/profit-sharing plan and aDefined Benefit/Cash Balance com-ponent. By adding on the CashBalance Plan, the physicians’ tax-deductible contributions increasedby more than $150,000 each, while

still maintaining a reasonable costfor the staff. As a result, the ownersare able to collectively contributemore than $1 million for themselvesand receive more than 93% of alldollars going into the plan. In addi-tion, if any of the physicians did notwant such a large benefit, this couldeasily be modified.

ConclusionWhen it comes to choosing an

appropriate retirement program,there are many choices available,often too many. What we say to allour clients is, “Pretend there are norules and regulations, and you can dowhatever you would like. Now tell ushow you would like to design yourspecific program.” You should neverbe presented a solution before youhave been able to communicateexactly what you would like fromyour plan. More often than not, acustomized retirement program canvery closely mirror the objectives ofyour practice. Working with anexperienced third-party administra-tor and financial advisor, you will beable to craft the right tax-efficientprogram for your practice. l

Lawrence B. Keller, CFP®, CLU,ChFC, RHU, LUTCF, is the founderof Physician Financial Services, a NewYork–based firm specializing in incomeprotection and wealth accumulationstrategies for physicians. He can bereached at (516) 677-6211 or [email protected] for com-ments or questions.

Peter M. Coleman, ASA, EA, FCA,MAAA, MBA, is the ManagingPartner of The Benefit Practice, a firmspecializing in pension consulting,administration, and related actuarialservices to clients nationwide. He canbe reached at (203) 517-3502 [email protected] forcomments or questions.


Retirement Plans and Your…Continued from page 35

Quality Assessment 2.0

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Quality Assessment 2.0

© Janssen Biotech, Inc. 2012 2/12 08Z12026

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

ContraindicationsZYTIGA® (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 ExcessUse 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 retentionat 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.

HepatotoxicityIncreases 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 EffectZYTIGA® 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 afasted state.

Adverse ReactionsThe 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 InteractionsZYTIGA® 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 PopulationsThe safety of ZYTIGA® in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA®.

Please see brief summary of Prescribing Information on adjacent pages.

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Support for you:

Benefit InvestigationSupport for your patients:

Care Coordination• Rapid assessment of patient eligibility/coverage

• Prior authorization support

• Concise benefit summary

• Identification of specialty pharmacy provider

• Access to the ZytigaOne™ Instant Savings Program

• Referral to a patient assistance program

• Coordination with SPP for processing/delivery of medication

• Educational materials and prescription reminders

Take advantage of ZytigaOne™ Support today.

Also available online at janssenaccessone.com

Single-Source Support for Access to ZYTIGA®

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

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

© Janssen Biotech, Inc. 2012 2/12 08Z12026

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

Our goal is to make access to ZYTIGA®(abiraterone acetate)

simple, convenient, and easy.

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OPM July 2012, Vol 2, No 4

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Transcript of OPM July 2012, Vol 2, No 4