march 2012 vol 2, no 2

Unexpected and unwanted over-sight is becoming a more frequentelement of practice, making it

imperative that you understand currentinvestigation and audit initiatives, andhow to prepare and protect your practice.

Understanding the Office ofInspector GeneralThe US Department of Health and

Human Services (HHS) Office of

Inspector General (OIG), which istasked with protecting the in -tegrity of the HHS programsand operations by “de-tecting and preventing

From the publishers of

©2012 Engage Healthcare Communications, LLC

www.OncPracticeManagement.com

ONCOLOGY PRACTICEMANAGEMENT

™

MARCH 2012 VOLUME 2 • NUMBER 2

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

Understanding Office ofInspector General Initiatives andHow to Prepare Your PracticeBy Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

Remember the good old days? I do,and not everything was that good.When I started post-college work,

I had no calculator, no personal comput-er with Excel or word-processing soft-ware, no fax machine, no internet access,and no smartphone. I love technology, soI have been amazed by and embracedadvances that have come along as theyears have passed.Several years ago, I heard a compelling

keynote address by Newt Gingrich at the Medical Group Management Associ -ation (MGMA) national conference. Heshamed us with our slow progress into theelectronic medical record (EMR) arena.Using banking as an example, hereminded us how we use our credit anddebit cards everywhere in this country or

Where Are We Going? Does Anyone Know? By Dawn Holcombe, MBA, FACMPE, ACHE

Continued on page 3

Continued on page 10

PATIE

NT AND PR

OVIDER

ACCES

S

Brought t

o you b

y the A

ssocia

tion o

f

Comm

unity C

ancer Cente

rs

Oral P

arity:

Takin

g It to

the N

ext Le

vel...

.29


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

Technology 2.0 From the Editor

Oncology as a medical specialty is,and always has been, rapidlyevolving. The world in which we

provide care for patients is also rapidlyevolving, and not always in sync with ourchanges. Doctors will be needed to diag-nose and treat patients, but where andhow that happens may look dramaticallydifferent in only 10 years. We still havethe ability to shape that future, but whatwe do today, and every day from now on,

will help to de-fine our role. Moreexternal forces than internal forces havealready shaped our evolution to 2012 fromthe 1970s, as described below.

Physician Offices ReplacedHospital CentersWhen oncology was evolving as a med-

ical specialty, most cancer care was deliv-ered in hospital inpatient units. Side

with dedicated Amgen Reimbursement Counselors

There is A place you can go for user-friendly online tools and reimbursement forms…

…where your coverage questions can be Answered

…where online Access to forms is simple

…where you can talk to A single Amgen Reimbursement Counselor for all your reimbursement activity

www.AmgenAssistOnline.com1-888-4ASSIST (1-888-427-7478)

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

Making Access easier.

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

effects of cancer treatments werealmost as debilitating as the treat-ments themselves. While we werelooking for medical solutions to fightcancer, hospital-based diagnosis-related groups (DRGs) came alongin 1984, and a low price for thechemotherapy DRG encouragedhospitals to shift cancer care into theoutpatient setting of the hospital,where it predominantly remaineduntil the US Food and DrugAdministration (FDA) approveddrugs such as ondansetron (Zofran)starting in 1991. These drugs al-lowed us to manage side effects oftoxic cancer drugs in a far more con-trolled manner, and fueled thegrowth of physician offices withinfusion suites that functioned asacute care medical centers in thecommunity setting. Specially trainedphysicians and nurses streamed awayfrom hospitals into these communityoffices, and pretty soon, about 80%of all cancer care (and clinical

research trials) was being providedin these community settings. Manyhospitals completely closed theiroutpatient infusion centers, andoften made collaborative arrange-ments for community medicaloncology practices to create whatlooked like integrated cancer centersto the general patient.

Physician Rates LaggedBehind Current ModelsDuring the same time period, fed-

eral policy changes regarding health-care reimbursement for all servicesoccurred, which, although notfocused on oncology, had a far-reach-ing effect on cancer care. In the mid-to-late 1980s, the resource-based rel-ative value system (RBRVS) wascreated. After a market review, theRBRVS established physician andpractice work and expense codes foreach medical specialty; these codesand valuations defined a sweepingchange in professional services reim-

bursement by 1989 for all medicalspecialties. The problem for oncolo-gy was that only 2 years after theRBRVS was calculated and put intoprocess, the community oncologyoffice evolved. Consequently, thecare scenario on which the RBRVSrates were based ceased to exist andwas no longer representative of thenew model that had emerged.Professional codes and reimburse-ment rates for oncology servicesnever caught up to the reality of thepracticing model.

Buy and Bill Evolved forEfficiency and Stayed byDefault to Cover PracticeCostsOncology physicians, like the hos-

pitals from which they came, boughtcancer drugs from distributors, treat-ed patients, educated patients onsymptoms and side effects, and thenbilled the insurer for the treatment

From the Editor

3March 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, MDMedical DirectorFlorida ComprehensiveCancer NetworkMelbourne, 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

Where Are We Going?…Continued from the cover

Continued on page 6

4 I ONCOLOGY PRACTICE MANAGEMENT I March 2012

In This Issue

PUBLISHING STAFF

PublisherNicholas [email protected]

Associate PublisherMaurice [email protected]

Associate PublisherCristopher [email protected]

Editorial DirectorDalia [email protected]

Associate EditorLara J. Lorton

Editorial AssistantJennifer [email protected]

Production ManagerMarie R. S. Borelli

Sales AssistantZach Ceretelle

Quality Control DirectorBarbara Marino

Business ManagerBlanche Marchitto

MISSION STATEMENT

Oncology healthcare requires providers tofocus attention on financial concerns andstrategic decisions that affect the bottomline. To continue to provide the high-quality care cancer patients deserve,providers must master the ever-changingbusiness of oncology. Oncology PracticeManagement will offer process solutionsfor members of the cancer care team—medical, surgical, and radiation oncolo-gists, as well as executives, administrators,and coders/billers—to assist them in reim-bursement, staffing, electronic healthrecords, REMS, and compliance withstate and federal regulations.

Oncology Practice Management™, ISSN 2164-4403(print), is published 4 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.

The ideas and opinions expressed in Oncology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher.Publication of an advertisement or other product mentioned in Oncology Practice Management™ should not be construed as an endorsement of the product orthe manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editorsnor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentionedin this publication.

Postmaster: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Oncology PracticeManagement™, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years:$149.00 USD; 3 years: $199.00 USD.

FEATURES

CASE STUDY

The Role of Oncology Pharmacists in the Care Team:Chemotherapy Management and Supportive Care at St. Luke’s Mountain States Tumor Institute......................16By Robert Mancini, PharmD

CANCER CENTER BUSINESS SUMMIT

Compliance with Fair Market Value Critical to Hospital-Oncologist Alignments........................................................28

DRUG CODING

Medications Used for the Treatment of Prostate Cancer..................................................................30

HEALTH POLICYThe End of Health Insurance Companies.... ..................34By Ezekiel J. Emanuel and Jeffrey B. Liebman

DEPARTMENTS

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

Oral Parity: Taking It to the Next Level..................................29By Sydney Abbott, JD

Physician Wealth ManagementWith Lawrence B. Keller, CLU, ChFC, CFP®

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

RxBIN:RxPCN:RxGrp:RxID:Suf:

601341OHCP

OHXXXXXXX000000000000

01

$25 CO-PAY CARD

Novartis offers eligible AFINITOR patients the $25 Co-Pay Card: an assistance program that allows commercial or cash-paying patients to pay a maximum of $25 for their AFINITOR prescription. Novartis will pay the balance of patients’ out-of-pocket expenses, up to a maximum of $1,200 per prescription.* The $25 Co-Pay Card is available at the physician’s office or online at www.AFINITOR.com.

The AFINITOR $25 Co-Pay Card

THE AFINITOR® (everolimus) TABLETS $25 CO-PAY CARD FROM NOVARTIS PHARMACEUTICALS CORPORATION

Designed to help make treatment more affordable for your eligible AFINITOR patients

Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 ©2012 Novartis Printed in USA 2/12 AFI-1036326

Helping make access to AFINITOR easier

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

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

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

This program is available for a limited time.

S

Where Are We Going?…Continued from page 3

actually delivered. Cancer drugswere not readily available from anyother source, and specialized oncolo-gy distributors evolved to serve thegrowing cancer center market. In1993, the federal government recog-nized that the physician codes andrates for oncology were inadequateand that the margin on the averagewholesale price–based drug reim-bursement model was covering theinadequacy, but the governmentdecided not to change the situationbecause of the complexity of enact-ing such a change.

In 2003, the World ShiftedUnder Oncologists, PatientsJust as some wins were being logged

against cancer death rates, and caremanagement and treatment allowedsome cancers to become more chron-ic than fatal, 3 key aspects of the 2003Medicare Modernization and Im -provement Act (MMA) shifted theoncology care model. First, reimbursements for oncology

drugs paid to medical offices werereduced, and now based on an aver-age sales price (ASP). Drug acquisi-tion and inventory costs, even dis-tributor mark-ups for sale tophysicians, were not included in theASP calculation. Despite a couple ofyears of temporary transitionaladjustments, reimbursement ratesand calculations for professionalservices related to oncology care alsocontinued to decline on a net basis.Margins were tightening and prac-tices started to analyze drug costs andreimbursements for both themselvesand the patients. Second, Medicare Advantage

plans were established that offeredPart D drug benefits to Medicarepatients. Initially, premiums, copays,and coinsurances were low andattractive to Medicare patients.Gradually, third and higher tiers werecreated for specialty drugs, and oncol-

ogy drugs tended to be placed on thehighest tiers. This led to increasedcoinsurances and copays for patientswith cancer, and started a chain ofpatient access to care issues and site ofcare shifts based upon patient insur-ance coverage. A majority of Medi -caid and Medicare patients withoutsupplemental insurance were likely toshift to the limited hospital outpa-tient center sites of service, driven bycost burdens for physicians andpatients in the community setting.Third, the Competitive Acqui -

sition Program (CAP) generatedattention on the prospect of a spe-cialty pharmacy delivering drugs (ina practice known as “white bag-ging”) to an oncology practice andbilling the payer directly, thus elimi-nating physician buy and bill. TheCAP program was not successful orattractive to either specialty phar-macies or oncology physicians, andfaded into limbo after its first years ofexistence. The program did, how-ever, spark interest among specialtypharmacies about entering theoncology market for the first time.

Further Change and Interestfrom External PartiesIn 2009, a new wave of federal

healthcare reform created incentivesfor hospital-employed physicianmodels and accountable care organi-zations (ACOs) to evolve. Not onlyspecialty pharmacies, but also anumber of pharmacy benefit man-agers and other companies aggres-sively built programs and proposalsfor private health insurers to use inmanaging oncology drugs, treat-ment, and costs. Words and conceptssuch as pay-for-performance, guide-lines and pathways, preferred treat-ment regimens, evidence-based pay-ments, episode-based payments, andoncology medical homes became hottopics and buzz words for 2010, 2011,and into 2012. Hospitals became

interested again in expanding theironcology services and started buyingpractices that felt financially vulner-able as a result of all of the changessince 2003.

How Will Cancer CareEvolve Now?Doctors will continue to treat

patients. Drugs will be discoveredand eventually approved by theFDA. All else appears to be up forgrabs. There are at least 6 key vari-ables that could shape what the can-cer care delivery market will looklike in 2022. Your decisions as anindividual physician, administrator,and group may not change any ofthese by themselves, but should asufficient volume of individual deci-sions all go in one direction oranother, the tides could be shiftedfor those who do not take action.

1Site of care. The federal govern-ment is encouraging consolidation

between hospital organizations andprivate physician groups. In somestates (ie, VT, RI, most of MA, andKY for now), there are few privateoncology practices left; the rest havebeen integrated into hospital sys-tems. Private health plans are con-cerned, because many feel that therates they pay hospitals for servicesand drugs are higher than the ratespaid to practices. Some plans are rap-idly changing contractual terms forboth practices and hospitals toaddress those inequalities. There canbe advantages to more integrated sys-tems: multidisciplinary care manage-ment, enhanced supportive servicesthat are not billable in their ownright, enhanced communicationsacross a broad spectrum of depart-ments, and enhanced accreditationand quality designations. There canbe advantages to physician-basedpractices remaining separate but col-

Continued on page 8

From the Editor

I ONCOLOGY PRACTICE MANAGEMENT I March 2012 6

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


laborative with integrated systems:streamlined delivery and cost-effi-ciencies, patient-focused care,enhanced software systems suitedspecifically for oncology, and physi-cian-driven focus on quality andpatient care. Size and business acu-men coupled with technology ad -vances will be essential for any prac-tice seeking to remain independent.

2Oncology management. Numer-ous private entities are building

programs for sale to health plans andthe federal government that addressmanaging oncology care across allsites of care. The current diversity ofcare sites in oncology and the silos inwhich care is delivered can become aliability to those who pay for thecancer care, because of limitationson their ability to collaborate with orinfluence all of the moving parts ofthe care process. Even if the oncolo-gy management focuses solely on theapproval, claims processing, and pos-sibly delivery of drugs, there may beinterest by health plans on suchsolutions if they can be applied uni-versally across all care providers. Themore volatile the financial stabilityof the oncology providers in a mar-ket, the more likely that programs ofthis nature may be considered byhealth plans and the private entities.Once an oncology management pro-gram is established in an individualhealth plan, the harder it will be foreither hospitals or independent prac-tices to negotiate exceptions.

3Evidence-based care, guidelines,and pathways. Successful health

reform in oncology will be driven bydata we do not currently have. Wecannot track the variation in careacross groups, hospitals, and practicestoday in a way that relates to a con-sistent national standard or to help usprove existing treatment standards ofcare. At best, some groups in some

regions have started the process. Inthe near future, we will either cometogether on a single or limited num-ber of platforms we find clinicallyacceptable in the oncology commu-nity, or the decision of which plat-forms are used will be made outside ofthe oncology community. We wantto let evidence support decisions, butto get evidence we have to sharedata. Hospitals, private practices, andpatients will need to become com-fortable quickly with the concept ofcollectively assessing chosen treat-ments for state and stage of patients,and then combining that clinicallyenhanced data with health planclaims data that brings in total cost ofcare for those patients. If we do not,health plans will develop (somealready have started) their ownextrapolated cancer data and use thatfor future oncology coverage policy.

4Medical homes and ACOs.Hospitals and primary care organ-

izations across the country areexploring ACO options. Oncology isnot yet part of that discussion and isnot even addressed in the initialMedicare descriptions of ACOs.What oncology practices do in 2012will likely set the stage for futurenegotiating power in their marketsonce these new structures, howeverthey evolve, become established.Numerous pilots exploring the con-cept of an oncology patient–cen-tered medical home are in playalready across the country (eg, inCA, MA, MI, NM, and PA), butthese are complex processes thatrequire a significant level of sophisti-cation both on the part of the prac-tice and any participating healthplans. One worry is that practicesthat wait and watch will find them-selves unable to catch up fast enoughand will be caught up in the tide ofwhatever becomes the prevalentmodel for their geography. The old

adage, “It takes money to makemoney” could be modified in this sit-uation to, “You can’t win if you don’tplay, and it will take money andtechnology and commitment toplay.” We do not know exactly what model will survive into theyear 2022, but we do know we willbe using technology to track andmove patient care through moredetailed and consistent processesthan have ever been envisioned inthe past.

5Access to care. Some punditshave reported that Medicaid

enrollment may exceed Medicareenrollment in the next few years ashealth insurance exchanges evolve,if they do. Should that happen, andreimbursement levels for large num-bers of patients shift from commer-cial plans to these exchanges, thatalone could drive all independentcare providers to join a system—andthere is little that any one innova-tive group or health plan could doto stem that tide. Shifting medicalcare and reimbursement rates toone level, particularly if it is a lowerlevel comparable to current Medi-caid rates, could become devastat-ing to the war we have recentlyfought with cancer. Lowest com-mon denominator care pricingcould adversely affect access to, andprivate patients’ selection of treat-ment regimens with newer, perhapsmore costly drugs. Medicaid drugformularies for the most part appearto be heavily influenced by netprices and rebates and far less byconventional medical practice orclinical decisions. Ultimately inno-vation in oncology care maybecome stifled, or drugs and med-ical care may become more distinct-ly tiered than today. One wouldhope that this will not be a likelyscenario, but as of now, it is in therealm of possibilities.

From the Editor



American College of Oncology Administrators

Annual Oncology Conference Addresses Oncology Management StrategiesChicago, June 20 – 22, 2012

Developed by and for oncology administrators with networking and exhibiting opportunities

AAMA/ACOA • 701 Lee St., Suite 600 • Des Plaines, IL 60016 • Phone 847-759-8601 • Fax 847-759-8602

ACOA is a national College of the American Academy of Medical Administrators (AAMA)

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

Transform Your Leadership

Work Smarter

Access Solutions

Make Key Contacts

Strengthen Your Skills

Ensure Your Connections. Join Now.www.aameda.org • [email protected]

6Specialty pharmacy, pharmacybenefit management, and oncol-

ogy. There is a strong interest anddrive for health plans, specialty phar-macies, and pharmacy benefit man-agers to define a management role inoncology, through interactions withhealth plans and employers, morethan physicians and hospitals.Although most hospitals now utilizetheir own pharmacies, oncology careis still billed under the medical bene-fit. The medical benefit is underintense scrutiny as to whether a com-plex and costly disease such as cancercan be best tracked through thatprocess, or if an alternative structure,such as the pharmacy benefit (whichis not traditionally billed by physi-cians), would be preferable. Physi-

cians in independent practice tend tobe more vocal about such changesand engaged in discussions withhealth plans and employers about theviability of those and other alterna-tives. Physicians employed by hospi-tals may tend to be less engaged,which could be an asset or a problemfor both the other physicians in thecommunity and the health plansseeking to address oncology issues.Specialty pharmacies seeking toenter the oncology market may findincreasing numbers of markets con-trolled by hospital systems, whichtend to utilize their own pharmacies.

Where are you going? Will youlead the way or be swept along byforces seemingly beyond your con-

trol? The year 2012 is a landmarkyear. There are more opportunitiesthan ever to collaborate, engage,track, evaluate, and move the discus-sion of oncology management for-ward in a positive way for patients,physicians, hospital systems, healthplans, and employers. Knowing what is riding the wave

coming our way is the first step.Deciding to push forward into thecurrent and start paddling is the sec-ond step. Enlarging your platform andadding tools to assist you navigate theturbulent waters is the next. Hope-fully, when this is over, you’ll be oneof the groups that has ridden the waveall the way into the next decade andwill be proudly fighting cancer withyour patients for another decade. l

March 2012 I www.OncPracticeManagement.com I 9

From the Editor

Going Electronic…Continued from the cover

Technology 2.0


worldwide, have online bill pay andaccount access, yet we are satisfiedoperating with paper charts frompractice to practice, with no elec-tronic connectivity—dinosaurs in amodern world. Before and after that speech, I

have attended many talks and lis-tened to early adopters of EMRs,which morphed into electronichealth records (EHRs) during thisextended time span.So, why was our group so slow to

move into this exciting technology?Most of our 9 physicians were satis-fied with paper charts. To me, jump-ing in seemed expensive in moreways than one. Not only was theactual cost high with an exorbitanttime commitment, companies weregoing into business with a splash butwere then bought or were out ofbusiness a few years later. Then therewere the anecdotal stories that per-sisted of a necessary employmentchange after leading a less-than-ideal EHR implementation.No matter what your politics, I

believe the game change came withthe American Recovery and Rein -vestment Act of 2009. Sig nificantmonies became available to eligibleprofessionals to help fund the cost ofan EHR and with this, the hammerof a Medicare penalty if you did notadopt a certified, meaningfully usedEHR by 2015. I saw that this was thetime to push us forward and pursuean EHR.In early 2010, I presented 2 oncol-

ogy-specific “cloud” EHRs to ourphysicians to choose from. Theupfront cost for these choices wassignificantly less than EHRs housedon-site, with practice-owned hard-ware. This also enabled us to keepour current server room intact with-out additional space requirements.Updates would be done automatical-ly in the cloud during off hours, withno interruption to the practice.

Again, learning from others who hadalready implemented an EHR andshared their wisdom, I chose anoncology-specific system, knowing,among other things, that the regi-men library would already be builtfor most protocols and be updated as new drugs entered the market.This would be a huge time-saver. Inthe end, our physicians opted for the iKnowMed EHR offered byMcKesson.

With the decision made and thecontract signed, time moved alongas we went through biweekly phoneimplementation planning meetingsand made necessary decisions alongthe way as we neared a go-live datein January 2012. I was hopeful, yetskeptical, that only a 2-week reducedschedule was indeed needed withthis program. I had heard and read somany times to plan on 6 months or

up to a year of lost productivity. Butwe were assured it would be betterthan that. We are 6 weeks past our go-live

date, and physician-patient produc-tivity was in fact down only a fewweeks. As with all new systems,physicians spend extra hours loadingpatient information for first visits inthe EHRs, but that will end in time.I walked around the office yesterdayand did not see “train wrecks” in thevarious departments but rathersmiles. Our staff is still learning, butthey like the chosen product and seemany benefits versus our paper-onlydays already. The benefits we are see-ing now, or will see in the nearfuture, are:

Efficiency

1Legibility. A huge benefit alreadyenjoyed by most of our staff,

instead of stopping to ask questionsabout what was written, the infor-mation is clearly presented, whichimpacts questions about prescrip-tions or physician and schedulingorders.

2The hunt for charts is over. Thisis self-evident.

3Concurrent record use. Physi -cians, nursing, medical records,

scheduling, or other staff can all bein the same patient chart doing var-ious tasks concurrently. This is anincredible efficiency benefit.

4Physician access 24/7 fromhome and the hospital. A physi-

cian can check patient information,look at his or her queue, sign off onlaboratories or other tests, and dic-tate and write orders from a conven-ient location outside of the office.This is a major improvement frompaper charts confined within a facil-ity or removed from the facility.

We use our credit and debit cardseverywhere in thiscountry or worldwide,have online bill payand account access,yet we are satisfiedoperating with papercharts from practice topractice, with noelectronicconnectivity—dinosaurs in a modern world.

—Ruth Linné Lander, FACMPE



Technology 2.0

5Improved use of staff time.Withpaper charts, nurses and other

staff were often standing outside anexamination room waiting to ask aphysician about a patient for treat-ment, triage, scheduling, or billingissues. With the queue system builtinto the EHR, staff no longer need towaste precious time in the hall.

6Patient portal. We will be goingon the newly available patient

portal as soon as possible. Not onlywill this help us with some meaning-ful-use criteria, but again it will savestaff time (eg, calling patients withnormal results).

7Portability of records. Electron -ically sending encrypted patient

information across town or acrossthe country is another positive EHRbenefit. This saves faxing chartrecords or copying and mailing thisinformation to patients beingreferred for other medical treatmentor for the treatment of mobilepatients spending parts of the yearoutside the area.

8Future area health informationexchange (HIE).We are working

with several larger groups and arehopeful that HIE will be up and run-ning in central Ohio within the nextfew years to exchange patient data,thus avoiding test duplication andmany other safety or cost-savingbenefits to the patient and, ultimate-ly, for total healthcare costs.

Safety

1Privacy of patient records. Paperrecords can be stolen, misplaced,

looked at by improper staff, or gonealtogether as a result of a natural disaster. EHRs are only accessible

by staff at specific and appropriatelevels.

2Offsite backups of records pre-vent the likelihood of a total

destruction of irreplaceable patientinformation.

3Patient drug interactions areflagged. A good electronic sys-

tem will flag drug interactions, sav-ing the patient a potential medicalproblem.

Monetary Savings

1Transcription. Dragon’s medicaltranscription oncology module is

being used by all of our physicianssince our go-live date. This is savingour group more than $125,000 inannual outside transcription costs.We kept our 1 internal transcrip-tionist who edits as needed and con-tinues our practice of electronically

faxing letters and notes to our refer-ring physicians.

2Staff time. Interfaces in place, orsoon to be in place, bring all lab-

oratories and key hospital testingdirectly into the patient’s electronicchart with a queue message for thephysician to sign off on the newinformation. This saves significantamounts of staff time putting paperresults on the physician desk andlater picking up and filing thesigned-off result.

3Supplies. With the EHR, we donot have paper laboratories or

key hospital information coming byfax or mail. In fact, paper use isdown, a dollar savings to the practiceand of trees for the environment.Equipment toners and general wearare also reduced.

4Data mining made easy.We canrun reports by diagnosis, drugs,

age, or almost any data for use by thephysicians as they research and con-tinue to seek improvements inpatient care.

Moving ForwardFinally, I am happy that we are

on this side of our go-live date. Ithas been a positive experience,with only minimal bumps alongthe way. I met with our medicalprotective malpractice agent re -cently, and I found that we will geta 2.5% credit off of each physi-cian’s premium next year and infuture years, because we have thiscertified technology. It took us along time to have an EHR, but itcertainly was the right step for usas a medical practice in the twen-ty-first century. l

I met with our medical protectivemalpractice agentrecently, and I foundthat we will get a 2.5%credit off of eachphysician’s premiumnext year and in futureyears, because wehave this certifiedtechnology.

—Ruth Linné Lander, FACMPE

7% 8%CR

43% 42%

ORRPrimary Endpoint

11% 12%

CR

53% 51%

ORR

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

Subcutaneous VELCADE Demonstrated Efficacy Consistent With IV for the Primary Endpoint

N

RESPONSE RATES† IN RELAPSED MULTIPLE MYELOMA (MM): SUBCUTANEOUS AND IV

P

c

▼ The study met its primary non-inferiority objective that single-agent subcutaneous VELCADE retained at least 60% of the overall response rate after 4 cycles relative to single-agent IV VELCADE

SUBCUTANEOUS VS IV TRIAL: a non-inferiority, phase 3, randomized (2:1), open-label trial compared the efficacy and safety of VELCADE administered subcutaneously (n=148) with VELCADE administered intravenously (n=74) in patients with relapsed MM. The primary endpoint was overall response rate at 4 cycles. Secondary endpoints included response rate at 8 cycles, median TTP and PFS (months), 1-year overall survival (OS), and safety.

* INDICATIONS: VELCADE is indicated for the treatment of patients with multiple myeloma. VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

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

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

WARNINGS, PRECAUTIONS AND DRUG INTERACTIONS ▼ Peripheral neuropathy, including severe cases, may occur – manage with dose modification or discontinuation. Patients

with preexisting severe neuropathy should be treated with VELCADE only after careful risk-benefit assessment ▼ Hypotension can occur. Use caution when treating patients receiving antihypertensives, those with a history of syncope,

and those who are dehydrated▼ Closely monitor patients with risk factors for, or existing heart disease ▼ Acute diffuse infiltrative pulmonary disease has been reported▼ Nausea, diarrhea, constipation, and vomiting have occurred and may require use of antiemetic and antidiarrheal

medications or fluid replacement▼ Thrombocytopenia or neutropenia can occur; complete blood counts should be regularly monitored throughout treatment▼ Tumor Lysis Syndrome, Reversible Posterior Leukoencephalopathy Syndrome, and Acute Hepatic Failure have been reported

c

T m

a less-dose-intense schedule, or discontinuation. Please see full Prescribing Information for dose modification g

C

AT 24 WEEKS (AFTER 8 CYCLES) VELCADE±dexamethasone

AT 12 WEEKS (AFTER 4 CYCLES)Single-agent VELCADE® (bortezomib)

NOW APPROVED FOR SUBCUTANEOUS ADMINISTRATION IN ALL INDICATIONS*

6%16%

GRADE ≥3

38%53%

SC (n=147)

IV (n=74)

ALL GRADES

Difference in Incidence of Peripheral Neuropathy With Subcutaneous VELCADE

PERIPHERAL NEUROPATHY (PN) IN RELAPSED MM: SUBCUTANEOUS AND IVR

Please see Brief Summary for VELCADE on next page.

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

o

w

a

m

▼ Starting VELCADE® (bortezomib) subcutaneously may be considered for patients with preexisting PN or patients at high risk for PN. Patients with preexisting severe neuropathy should be treated with VELCADE only after careful risk-benefit assessment

▼ Treatment with VELCADE may cause PN that is predominantly sensory. However, cases of severe sensory and motor PN have been reported. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain, or weakness

▼ Patients experiencing new or worsening PN during therapy with VELCADE may require a decrease in the dose, a less-dose-intense schedule, or discontinuation. Please see full Prescribing Information for dose modification guidelines for PN

WARNINGS, PRECAUTIONS AND DRUG INTERACTIONS CONTINUED▼ Women should avoid becoming pregnant while being treated with VELCADE. Pregnant women should be apprised of the

potential harm to the fetus▼ Closely monitor patients receiving VELCADE in combination with strong CYP3A4 inhibitors. Concomitant use of strong

CYP3A4 inducers is not recommended

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

IN ALL INDICATIONS*

Brief Summary

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

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

WARNINGS AND PRECAUTIONS:VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE.

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

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

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

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

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

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

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

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

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

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

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

Hepatic Impairment: Bortezomib is metabolized by liver enzymes. Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with VELCADE at reduced starting doses and closely monitored for toxicities.

(continued)

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

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

In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness); (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated); (39%), thrombocytopenia and appetite decreased (including anorexia); (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo); (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of ≥Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).

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

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

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

DRUG INTERACTIONS:Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2. Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Therefore, patients should be closely monitored when given bortezomib in combination with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir). Co-administration of omeprazole, a strong inhibitor of CYP2C19, had no effect on the exposure of bortezomib in 17 patients. Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when VELCADE (bortezomib) is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving VELCADE. St. John’s Wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided. Co-administration of dexamethasone, a weak CYP3A4 inducer, had no effect on the exposure of bortezomib in 7 patients. Co-administration of melphalan-prednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant.

USE IN SPECIFIC POPULATIONS:Nursing Mothers: It is not known whether bortezomib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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

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

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

Patients with Hepatic Impairment: The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment. Starting dose should be reduced in those patients.

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

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

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

Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2012, Millennium Pharmaceuticals, Inc.All rights reserved. Printed in USA V-12-0017 3/12


Case Study

The purpose ofthis article isto outline the

benefits that phar-macists can play incancer care. Eachdiscipline within theinterdisciplinary cancer team has peopletrained in a specificarea of expertise.

With the amount of information,the number of drugs, and the manychanges taking place in oncologythese days, the pharmacist is theexpert best trained in the medica-tions themselves. Physicians areaware of what constitutes the bestregimens for the specific pathology,but when it comes to counselingpatients on medications, includingintravenous and to oral medications,and helping with any side effectsmanagement, pharmacists can pro-vide a lot of benefit in practice. Thisalso includes helping the nononcol-ogy clinical disciplines understandany issues of additional medicationsthat the patient with cancer may betaking for comorbidities.At our cancer institute at St.

Luke’s, when our physicians havequestions about medications—suchas dose adjustment for renal or liverfunctions or dosing based on othermedications or drug interactions—the pharmacist is the one who cananswer those questions. Physicians atcancer practices should be encour-aged to call the pharmacist, who may

not be present at the clinic but maybe at the infusion center or down thehall in the pharmacy; a simple phonecall and a quick conversation withthe pharmacist may promptly resolveany dosing-related questions or con-cerns.

Infusion Therapy/AntiemeticMedication ProtocolThe role of the pharmacist in infu-

sion therapy likely varies by institu-tion. At St. Luke’s, the pharmacist isresponsible for the process once thephysician orders infusion treatmentfor the patient. When we get theorders for the chemotherapy, it is thepharmacist’s role to evaluate that itis the right drug for the right indica-tion, and that any other medicationsthat the patient is taking will notinteract with or interfere with thechemotherapy. The pharmacist dou-ble-checks the laboratory results tomake sure that that particularchemotherapy is appropriate for thatpatient’s blood count, and that thedose is appropriate if the patient hasrenal or hepatic dysfunction. Our role is to check that we are

preparing the medication correctly,that the dose is correct, that it iswhat the patient gets, and it match-es what the physician ordered.According to our antiemetic proto-col, the pharmacists are the oneswho help to determine what anti-nausea medications are given to thepatient before chemotherapy, andany other premedications for a par-

ticular type of chemotherapy, as wellas ensuring that the patient getsthose medications.Individual protocols vary from cen-

ter to center. At St. Luke’s, our proto-col is based on a combination ofguidelines. One of our pharmacistsevaluated the National Com pre-hensive Cancer Network (NCCN),the American Society of ClinicalOncology, and Multinational Associ-ation of Supportive Care in Cancerguidelines to determine what proto-col we would use. The goal was toevaluate the emetogenic potential ofchemotherapy, and to see how thattranslates into what medications weshould be giving the patient.Although this may differ from state tostate, the pharmacists ultimately needto follow the protocol, while takinginto account any patient-specificabnormalities or changes and applythem to the center’s protocol.Our protocol is standardized: if the

emetogenic potential is this, thenthese are the medications we have togive. But there are situations withinthe protocol that say, “Under thesecircumstances, you can add thismedication. Under those circum-stances, you can take away this med-ication.” If it is necessary to seriouslydeviate from the protocol, we discussthis with the physician and makesure that we are on the same pagebefore we move forward with thatdifferent approach.This further highlights the value

The Role of Oncology Pharmacists in theCare Team: Chemotherapy Managementand Supportive Care at St. Luke’sMountain States Tumor Institute By Robert Mancini, PharmDDr Mancini is an Oncology Pharmacist, and Chair of the Pain Comfort Committee, St. Luke’s Mountain States Tumor Institute, Boise, ID


WillWeexhaust all possibilities.

Celgene Patient Support® provides free and personalized assistance with patients’ access and reimbursement needs.

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

Benefits investigation

Prior authorization

Appeal support

Medicare

Co-pay assistance – Celgene Commercial Co-pay Program – Co-pay assistance through third-party organizations

Prescription status

Celgene free medication program

Celgene products and restricted distribution programs

To Contact Celgene Patient Support®:

Call: 1-800-931-8691

E-mail: [email protected]

Fax: 1-800-822-2496

Visit: www.CelgenePatientSupport.com

Monday through Friday, 8:00 AM to 7:00 PM ET

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

We will…because patients are our priority.

Celgene Patient Support® is a registered trademark of Celgene Corporation.©2011 Celgene Corporation 11/11 US-CELG110061


Case Study

of the interdisciplinary team, thesesteps are in place to help foster theinteraction between the various dis-ciplines. Our infusion center is justdown the hall from where the physi-cians are seeing their patients. It istherefore very easy for us, the phar-macists, to walk over and chat withthe physicians, or vice versa; physi-cians and mid-level personnel oftencome to the pharmacy to ask ques-tions related to patients, symptoms,or medication side effects, such as“The patient is having this symp-tom. What do you think aboutadding in this medication?” Our physicians see approximately

20 patients daily, so they are verybusy. Sometimes, when the laborato-ry results are not yet available, theyrely on us to double-check theresults when they arrive and talk tothem if there is something abnormal.If the blood count comes backabnormal, we check with them toand see what they want to do. It mayinvolve dose reduction or postpon-ing the chemotherapy.

Oral ChemotherapyProgramIn our oral chemotherapy program

(see December 2011 issue), we havebeen able to vastly improve patientaccess to medications, as well as theunderstanding of medications. St.Luke’s has a unique oral chemother-apy program that includes a full-timepharmacist who is dealing only withoral chemotherapy; this is unique inthe way the program is set up, in theway the pharmacist interacts withthe physicians, the nurses, the socialworkers, our financial advocates, andthe whole system. It has taken us a couple of years to

work out this program, but the resultis very beneficial for our patients, aswell as for the healthcare system as awhole. We may not be the only cen-ter that is involving pharmacists in

the oral chemotherapy program inthis way, but our actual process andthis particular setup may be different. The oral chemotherapy program is

managed by a pharmacist. When thephysician and the patient decide tostart on an oral chemotherapy agent,the prescription is sent to our centralpharmacy in Boise, ID. In Boise, wehave oncology-trained pharmacistswho are running the office, where allthe oral chemotherapy agents arereceived. Once the patient hasreceived the prescription and hasactually received the medication, thepharmacist makes sure to follow upwith the patient on a weekly basisduring their first chemotherapy cycle.We have a scheduled weekly call tothe patient to ensure that everythingis going well, to see how the patient isdoing, and whether the patient hadany problems taking the medication,or if the patient is having any sideeffects or other things of that nature.

Managing Drug CostsOne of the things that we all face

with cancer medications is high cost.On average, these medications rangefrom a couple of hundreds of dollarsmonthly for cheaper generics, suchas oral cyclophosphamide, and up to$10,000 monthly or more for someof the newer oral agents. That can bea major issue, especially for patientswho may be taking such agents untiltheir disease progresses. Spending$10,000 a month for up to 2, 3, or 4years, or longer in the case of some ofpatients with chronic myeloid leu-kemia, is very costly. That is a serious burden for the

center, as well as for the patient andthe healthcare system. For patients,depending on their insurance, someof these medications can be coveredby Medicare Part B or their majormedical plan. However, in manycases, they are still responsible for upto 20% of the drug, and 20% of

$10,000 is still $2000.The other issue is patients who go

through their prescription drug ben-efits, such as Medicare Part D, do notnecessarily have a supplement tohelp them get through the donuthole. In many of these cases, theirfirst fill is going to skyrocket themthrough that donut hole, and theyare going to be responsible for up to$5000 of that first fill. After thatthey will only be responsible forapproximately 5% based on theirPart D plan. But if we cannot getthem through the first fill, they arenot going to make it to their secondor third one.We try to find ways to help with

cost by assisting with prior authoriza-tions and through our financialadvocates at Mountain States TumorInstitute. They are familiar with theprograms for free drugs, copay assis-tance, and other programs that canhelp patients afford these medica-tions. We recently conducted anevaluation that showed that onlyapproximately 1% of our patients do not receive their medicationsbecause of insurance or cost issues.Therefore, we have been able to helpgreatly reduce nonfulfillment rates,compared with the 10% to 20%reported in the literature.

Supportive/Palliative CareClinics Another unique feature at our

center is the involvement of thepharmacists in the multidisciplinarysupportive care clinic or palliativecare clinic. We have been able to dothis thanks to a grant we receivedthrough our National Cancer In -stitute (NCI) Community CancerCenters Program (NCCCP). Thisprogram helps to provide a uniquebenefit to patients, by allowing us tobridge the gap between patients whomay not get to see a pharmacist andthose who now are getting a full

The Role of Oncology Pharmacist…Continued from page 16

Case Study


work-up and a full medication rec-onciliation, with the pharmacistthrough this program.The supportive/palliative care

clinics at St. Luke’s are a part of theNCCCP. Within this NCI program,we have been able to hire a part-time pharmacist to help with theseclinics. Having a pharmacist whocan sit down with these more com-plex patients and do full medicationreconciliation greatly improves can-cer care for our patients. This pro-gram has enabled us to find manyplaces for improvement, such astherapy duplications (eg, patientsusing multiple breakthrough nar-cotics or multiple sleep medicationscausing them to be too drowsy in themorning) or in drug interactions andadverse reactions. This is particularly beneficial for

our patients, because 95% of them(if not more) have multiple pro-viders. Their oncologist is not theirprimary care physician (PCP) sothey are seeing their PCP as well,and possibly even a cardiologist or adiabetes specialist. As a result, thepatient may be seeing many physi-cians from different disciplines whoare all prescribing medications andoften are not talking to each other.That is why it is beneficial for thepharmacist to be involved in thesupportive care clinic and help withthe medication reconciliations. Wecan help every provider know forsure what is going on with thepatient, and we give that patient theupdated medication list.It would be beneficial to have a

pharmacist sit down with everypatient and review the medications,because we have found that evenpatients with cancer are not alwaysreporting all the medications theyare taking. Within this supportive

care clinic, we ask the patients tobring all their medication bottles,not a list but actual bottles, so thatwe can physically look at them andknow for sure what they are taking.The best suggestion I have for

pharmacists is to talk to every pa-tient. You can get a lot out of readingthe progress notes and talking to thephysician, but until you actually talk

to the patient, you do not knowexactly what is going on with thatpatient. We have found that espe-cially in cancer care, patients do notalways reveal everything to theirphysicians, in part because they donot want to disappoint their oncolo-gist. They will sometimes revealthings to a pharmacist or a nurserather than their physician. Theymay also worry that if they tell thetreating physician they are having aside effect, the physician will reducethe dose of the chemotherapy. Theyassociate that dose reduction withless likelihood of success of thechemotherapy. Another reason isthat some patients say they do not

want to bother their doctors, becausethey are so busy. Therefore, a phar-macist can sometimes get informa-tion regarding side effects that he/shecan share back with the physician, tohelp improve the care and symptommanagement of that patient.Symptom management can in-

volve the amount of pain the patienthas, or medication side effects thatthey do not always want to talkabout. Some of those side effects,especially with chemotherapy, canbe easily managed at home, if theyjust let us know. For example, we canhelp to get their nausea under bettercontrol, or control mouth sores ormouth pain by providing rinses orspecial counseling points, such asavoiding alcohol-based mouthwash.Opening that conversation with thepatient can help give the patientpeace of mind about what theyshould and should not be doing, andalso give them a little more controlover their disease itself, and theirsymptoms.

Conclusion The goal of including a pharma-

cist in the care of patients with can-cer is to avoid creating a silo wherethe only focus is oncology. In reality,to treat patients with cancer, wemust be able to treat the wholepatient; this includes knowing,understanding, and reviewing theother comorbidities these patientsmay have. A pharmacist is uniquelytrained to understand all the med-ications a patient may be using andhow those interact with the cancertreatment medications. It is our hopethat pharmacists will continue tohave a key role in the treatment andmanagement of cancer patients aspart of the very important interdisci-plinary team. l

Within this supportivecare clinic, we ask thepatients to bring alltheir medicationbottles, not a list butactual bottles, so thatwe can physically lookat them and know forsure what they aretaking.

fraud, waste, and abuse; identifyingopportunities to improve programeconomy, efficiency, and effective-ness; and holding accountable thosewho do not meet program require-ments or who violate Federal laws,”1has taken a leading role in such inves-tigations and audits. OIG accomplishes its mandate by

deploying its staff of approximately1800 professionals throughout theUnited States to conduct audits, eval-uations, and investigations, as well ascoordinating and overseeing thirdparties conducting audit activities onOIG’s behalf.1 OIG investigates awide variety of conduct,2 and mayseek civil monetary penalties againstany person who, for example: (i) pre-sents or causes to be presented claimsto a Federal health program that theperson knows or should have knownis for an item or service that was notprovided as claimed or is false orfraudulent3; (ii) violates the antikick-back statute by knowingly or willfullypaying or receiving remuneration forreferrals of federal healthcare programbeneficiaries4; or (iii) presents or caus-es to be presented a claim that personknows or should know is for a servicewhich may not be made under thephysician self-referral or Stark law.5In the past several months, OIG

has reported on the following activity:

1On or around January 17, 2012,Buchanan County Health Centerin Iowa agreed to pay $406,030 forallegedly employing an individualthat it knew or should have knownwas excluded from participating infederal healthcare programs, poten-tially violating the Civil MonetaryPenalties Law.6

2On or around November 30,2011, as a result of a self-disclo-sure, Evergreen Health Center, PC,in Lebanon, MO, agreed to pay$83,012.58 for allegedly submitting

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

3On or around October 4, 2011, as a result of a self-disclosure,County of Monterey d/b/a Nativi dadMedical Center of California agreedto pay $174,508.46 for allegedlyentering into a professional medicalservices agreement with a physiciangroup for certain call coverage andclinic services where the compensa-tion terms offered incentives for thephysician group to refer private prac-tice patients to the Center, potential-ly violating the Civil Mon etaryPenalties Law.7

Available statistics show that as aresult of OIG’s efforts during fiscalyear (FY) 2010, OIG reported recov-ering: (i) $3.8 billion in investigationreceivables that were court ordered oragreed to be paid through civil settle-ments; and (ii) $1.1 billion in auditreceivables as a result of OIG auditdisallowance recommendations.1 Be -cause of the many fruits of OIG’slabor, OIG has increased its effortssince FY 2010 to increase recoveriesby incorporating more sophisticatedreviews and expanding the scope ofits investigations.

OIG InitiativesFor many practices devoting their

resources and attention to patientcare, minimal time is spent reviewingoperations and policies in a way thatprotects the practice against an OIGinvestigation or other audit initiative,which puts such practices at a severedisadvantage that is somewhat easilypreventable. Certainly, some prac-tices that are targeted by OIG orother authorities or payers are in thecategory of committing egregiouswrongdoing, whereas others havesimply not taken the time to ensurethat they are operating under the

proper structure. Staying abreast ofthe changes to the numerous docu-mentation requirements while alsotaking care of your patient populationis not an easy task. There are, howev-er, certain steps you may take to placeyourself in a better position to limitexposure. Understanding the OIGWork Plan for Fiscal Year 2012 is onesuch step. OIG’s initiatives are not asecret; in fact, each October, OIGpublishes its initiatives for the comingyear. Reviewing the Work Plan andunderstanding where areas of expo-sure may exist in your practice is asomewhat simple first step to limitingexposure. Two examples of oncology-related initiatives are as follows:

1Payments for off-label anticancerpharmaceuticals and biologicals:OIG states that it will focus a reviewon “Medicare payments for drugs andbiologicals used on an off-label basis…in anticancer chemotherapeuticregimens to determine whetherpatients with particular indicationswere prescribed anticancer drugsapproved by FDA for such indicationsbefore resorting to anticancer drugsnot approved for those indications.”8

2Medicare outpatient payments fordrugs: OIG will review Medicareoutpatient payments to providers forcertain drugs and the administrationof those drugs (eg, chemotherapy) todetermine whether Medicare over-paid providers because of incorrectcoding or overbilling of units.8 OIGexplains that prior reviews have iden-tified certain drugs, particularlychemotherapy drugs, as vulnerable toincorrect coding.

OIG provides additional insightinto the 2 aforementioned initiativesby stating that in calendar year 2007,Medicare payments for anticancerdrugs totaled approximately $2.7 bil-

Understanding Office of Inspector…Continued from the cover


Legal Update


“Quality care iseveryone’s business.”

Value-Based Care in Myeloma !&%0!,-�!2�&/-%0!�%(.!,0%!1-��( �*!,-*!�.%0!-�,!&�.! �.)��)-.��+/�&%.3��( ��!--�%--/!-��*!�%�&�-!�.%)(-�"),��-! ��&%(%�%�(-�� 0�(�! �*,��.%�!�(/,-!-��( �*$�,'��%-.-�1%&&��&-)�")�/-�)(�.$!�/(%+/!��$�&&!(#!-�%(�.$!�'�(�#!'!(.�)"�'/&.%*&!�'3!&)'��

��

Value-Based Care in Myeloma %-��*/�&%��.%)(�)"��(#�#!��!�&.$��,!�)''/(%��.%)(-��'!'�!,�)"��$!��3(2� ,)/*��5��&&�,%#$.-�,!-!,0! �

www.ValueBasedMyeloma.com

��6

��

Beth Faiman, RN, MSN, APRN, BC, AOCNNurse Practitioner, Multiple Myeloma ProgramCleveland Clinic Taussig Cancer InstituteCleveland, OH

��-%4! �

� ��


lion, which as is readily apparent byOIG’s Work Plan, is more money thanOIG believes was proper for reim-bursement. Practices billing for anti-cancer drugs will be targeted this year,as specified in OIG’s Work Plan, andhow those practices will be selectedwill likely be a result of data mining.The initiated investigations will focuson whether those targeted practicesand providers accurately and com-pletely billed for services provided,and also whether such providers havereported units of service as the num-ber of times that a service or proce-dure was performed.8 For those prac-tices targeted for prescribing off-labeldrugs, OIG specified it will be lookingto determine whether there wereimprovements in the patients’ med-ical condition before the use of off-label drugs. The OIG Work Planstates that “if the beneficiaries’ med-ical conditions improved before theuse of off-label drugs, [OIG] willdetermine how much Medicare couldhave saved had the previously admin-istered anticancer drugs continued tobe used,”8 and presumably seek torecoup such amounts from the prac-tice. OIG states as its authority torecoup such monies that “Medicarecovers FDA-approved drugs used foroff-label indications in anticancerchemotherapeutic regimens whensuch uses are supported in authorita-tive compendia identified by theSecretary of HHS.”8

Ramifications of ExposureWhen appropriate, OIG has the

authority to impose civil monetarypenalties assessments and administra-tive sanctions, as well as collaboratingwith the Department of Justice andother government executive branchagencies capable of bringing charges.1OIG is authorized to seek differentamounts of civil monetary penaltiesand assessments based on the type ofviolation at issue.9 For example, in a

case of false or fraudulent claims, theOIG may seek a penalty of up to$10,000 for each item or serviceimproperly claimed, and an assess-ment of up to 3 times the amountimproperly claimed.10 In a kickbackcase, OIG may seek a penalty of up to$50,000 for each improper act anddamages of up to 3 times the amountof remuneration at issue (regardless ofwhether some of the remunerationwas for a lawful purpose).11

Protecting Your PracticeProtecting your practice from an

OIG investigation begins with pre-ventive compliance. This entailsensuring that your practice is properlystructured to comply with numerousrules and regulations, including theself-referral laws. To place your prac-tice in the best position possible, youshould seek the advice of competenthealthcare counsel to either structureyour practice when it is created or toreview your existing structure for com-pliance. In addition to proper structur-ing, your practice should adopt poli-cies and procedures to govern howyour practice operates, including theadoption of a compliance plan thatdetails acceptable billing practices. Also, as part of your practice’s com-

pliance, I strongly recommend work-ing with an external coding andbilling expert, brought in specificallyto examine your practice and diagnoseany areas of exposure. Although youmay have a dynamic team in placehandling the billing operations foryour practice, having a review of yourdocumentation and coding by anexpert specializing in your practicearea who has reviewed documenta-tion and coding of many other prac-tices and is familiar with billingrequirements for your specialty willnot only likely place you in a moreprotected position, but also potential-ly highlight areas where you mayincrease your accounts receivable.

The bottom line with investiga-tions such as OIG’s initiatives is thatwith electronic records and billing,oversight has dramatically changedand it is now much easier to targetpractices potentially overutilizing,upcoding, or abusing the reimburse-ment system. Those practices contin-uing with “business as usual,” andignoring the warning signs that it istime to adapt and modify as the over-sight has, will likely have a muchgreater chance of being targeted. l

References1.US Department of Health & Human Services, Officeof Inspector General Work Plan: Fiscal Year 2012.Introductory message from the Office of InspectorGeneral. http://oig.hhs.gov/reports-and-publications/archives/workplan/2012/WP00-Intro.pdf. AccessedMarch 6, 2012.2. 42 CFR § 1003.102.3. 42 U.S.C. § 1320a-7a(a)(1)(A) and (B).4. 42 U.S.C. § 1320a-7b(b); 42 U.S.C. § 1320a-7a(a)(7).5. 42 U.S.C. § 1395nn(g)(3).6.US Department of Health & Human Services, Officeof Inspector General. False and fraudulent claims.http://oig.hhs.gov/fraud/enforcement/cmp/false_claims.asp. Accessed March 6, 2012.7.US Department of Health & Human Services, Officeof Inspector General. Kickback and physician self-refer-ral. http://oig.hhs.gov/fraud/enforcement/cmp/kickback.asp. Accessed March 6, 2012.8.US Department of Health & Human Services, Officeof Inspector General Work Plan: Fiscal Year 2012 Part I:Medicare Part A and Part B. http://oig.hhs.gov/reports-and-publications/archives/workplan/2012/WP01-Mcare_A+B.pdf. Accessed March 6, 2012.9. HHS OIG Work Plan | FY 2012 IntroductoryMessage: http://oig.hhs.gov/reports-and-publications/archives/workplan/2012/WP00-Intro.pdf. 10. 42 CFR § 1003.103.11. 42 U.S.C. § 1320a-7a.

This article is for education and discus-sion purposes only and does not constitutelegal advice.

Jennifer Kirschenbaum, Esq, managesKirschenbaum & Kirschenbaum’s health -caredepartment, which specializes in representinghealthcare practitioners in regulatory compliance,audit defense, licensure, and transactional mat-ters. Erica Youngerman, Esq, is an associate inKirschenbaum & Kirschenbaum’s healthcarepractice. If you have a question for Jennifer or ifyou would like to discuss ways to protect yourpractice, she can be reached at 516-747-6700x302 or by e-mail at [email protected]. For more information aboutKirschenbaum & Kirschenbaum’s healthcarepractice, visit www.nyhealthcareattorneys.com.

Legal Update

Understanding Office of Inspector…Continued from page 20

Indication

1. 2.

WARNING: IMMUNE-MEDIATED ADVERSE 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 agents make 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)

Product Description

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 J99 a

999, J3490, J3590, and C9284.

Replaces J9999, J3490, J3590, and C9284.

make no guaranteeresponsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agentsThe accurate completion of reimbursement- or coverage-related documentation is the

DescriptionProduct

regarding reimbursement for any service or item. uarantee e responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agentsThe accurate completion of reimbursement- or coverage-related documentation is the

single-use vial of YER50-mg/10 mL (5 mg/mL),

, , ,

This coding guidance regarding reimbursement for any service or item. responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agentsThe accurate completion of reimbursement- or coverage-related documentation is the

single-use vial of YER200-mg/40 mL (5 mg/mL),

VOYsingle-use vial of YER50-mg/10 mL (5 mg/mL),

This coding guidanceresponsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agentsThe accurate completion of reimbursement- or coverage-related documentation is the

VOYsingle-use vial of YER200-mg/40 mL (5 mg/mL),

and treatment of each patient and the speci�c insurer requirements.reimbursement. Oncology practices need to make coding decisions based on the diagnosis

YERclaims for is not intended to provide speci�c directions on requesting prior authorization or submitting


and does not provide a guarantee of receiving prior authorization orVOYYERis not intended to provide speci�c directions on requesting prior authorization or submitting


and does not provide a guarantee of receiving prior authorization oris not intended to provide speci�c directions on requesting prior authorization or submitting

reimbursement. Oncology practices need to make coding decisions based on the diagnosis and does not provide a guarantee of receiving prior authorization or

is not intended to provide speci�c directions on requesting prior authorization or submitting

Recommended Dose Modifications

Immune-mediated Enterocolitis:

Immune-mediated Hepatitis:

Immune-mediated Dermatitis:

Important Safety Information (cont)

Immune-mediated Neuropathies:

Immune-mediated Endocrinopathies:

Other Immune-mediated Adverse Reactions, Including Ocular Manifestations:

Pregnancy & Nursing:

Common Adverse Reactions:

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].






e

[ d

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

Chicago, IL—Compliance with fairmarket value is critical for regulatorycompliance in valuations of oncolo-gist-hospital alignments, whetherthese are professional service agree-ments or comanagement arrange-ments, according to presenters at the 2011 Cancer Center BusinessSummit.“Professional service agreements

comanagement arrangements seemto be where the principal action iscurrently,” said Michael L. Blau, Esq, Chair, Health Care VenturePractice, and Partner at Foley &Lardner, LLP.“For the physician, a professional

service agreement is an economicwin, because when physicians enterinto a relationship with a hospital,the hospital is at least going to holdthem harmless in terms of their cur-rent compensation,” he said.Under professional service agree-

ments, a contract is drawn up inwhich the purchased entity entersinto a contract with the purchasinghospital to staff the hospital’s facili-ties in exchange for fair market com-pensation. Fair market value com-pensation in an arrangement such asthis one can be paid on an aggregatefixed fee or a relative value unit(RVU) basis, Mr Blau pointed out.The risk of reimbursement reduc-

tions would be eliminated if an RVUis locked in over a valuation period of2 or 3 years, he said, and free care andbad debt during this period would berisks taken on by the hospital ratherthan the physician group.The professional service agree-

ments arrangement is also a win forthe hospital, because it has an oppor-tunity to capture an entire service

line of business that it could not pre-viously, he noted. It picks up theentire business, not at the physicianoffice rate, but at the hospital outpa-tient payment rate, which in moststates will be between 120% and180% of what otherwise would bepaid to the physicians,” he said.Under-arrangement transactions,

in which the hospital takes leaseassignment of leases of sites from

landlords of the purchased entityand that entity performs the service,are now prohibited under the StarkLaw, said Mr Blau. “The way to getaround this is to disaggregate fromthe group certain assets, so the groupis in a legally defensible position tosay it is not performing the service,but the hospital is the entity that isperforming the service,” he added.One way to do this is to have

space not provided by the group butby an independent third-party land-lord. “Even if physicians own thespace, they usually have a real estatetrust as an entity that is separatefrom the practice that owns thespace,” he explained.The equipment can be sold to the

hospital for fair market value “so thatthe hospital ends up providing the

equipment,” Mr Blau said. With anunwind clause written into the con-tract, the physicians reserve the rightto get the equipment back at the endof the transaction.The physician group would then

be left as a staffing service, which itcan lease to the hospital. A 2% to3% administrative handling fee paidto the physician group can also beworked into the agreement, he said,as well as a billing fee if the group isresponsible for billing and collection.Hiring an experienced fair market

value appraiser “with an opinion youcan rely on” is strongly advised to re -ceive a proper valuation and thusavoid conflict with the Stark law.Reasonable compensation will also bedetermined by a fair market valueopinion.“A valuation firm is not an advo-

cate for either the physician group orthe hospital,” said Darryl P. Johnson,Managing Partner, HealthCareAppraisers, Inc.One of the misunderstood con-

cepts about certain professional serv-ice agreements transactions is that“notwithstanding the fact that thehospital is getting a tremendouspotential uptick from 340b drugpricing and its ability to bill as afacility-based provider, that valuecannot be shared with the physi-cians,” he said.This ability to bill as a facility-

based provider is still of benefit to thephysician group, he said, because ithelps build the case of a win-winarrangement. “It is beneficial to showthat the arrangement is economicallyviable from the hospital’s standpointand from the physician group’s stand-point,” Mr Blau concluded. l

Cancer Center Business Summit

Compliance with Fair Market Value Criticalto Hospital-Oncologist AlignmentsBy Wayne Kuznar

“A valuation firm is notan advocate for eitherthe physician group orthe hospital.”

—Darryl P. Johnson


Imagine that you are a patientwho has been recently diagnosedwith cancer. While you are still

recovering from a difficult surgery toremove the tumor, your oncologistad vises you it is time to beginchemotherapy. You are relieved tolearn that your doctor has written aprescription for an oral anticancermedication, so you will not have tomake weekly trips to the oncologist’soffice for intravenous (IV) chemo-therapy infusions. You promptly goto the pharmacy to fill the order.But, when it is time to pay for yourprescription, you may not feel sorelieved—especially when you com-pare the out-of-pocket costs for theoral anticancer drug to your copayfor receiving chemotherapy infu-sions in the outpatient setting. The oral medication may cost you

thousands of dollars more per monththan your health insurance plan cov-ers. This disparity between insurancecoverage of oral versus infused med-ications is a dramatic example oftechnology outpacing policy, and, asan increasing number of oral agentsbecome available, more and morepatients across the country are expe-riencing this disparity in out-of-pocket costs.

Out-of-Pocket Costs: IV versus Oral DrugsUntil recently, IV and injected

treatments were the primary meth-ods used in the treatment of cancer.However, oral anticancer treatmentshave become more prevalent, andfor certain types of cancer, oral ther-apies are now the standard of care.Currently, approximately 10% ofchemotherapies are available orally.Furthermore, up to 35% of agents inoncology development are oral med-ications. For some patients with can-

cer, oral anticancer medications arethe only treatment—no IV alterna-tive exists.In addition, studies have shown

overall higher costs associated withIV infusions when considering thephysician and nurse time required for

administration, not to mention theexponential rise in healthcare costs ifthere are complications from theadministration of an IV therapy, suchas an infection at the infusion site.Insurance coverage policies have

not kept up with the pace of cancertreatment technology. With theincreasing numbers of emerging oraltherapies, many health plans are cre-ating inequity and access problems forpatients, by covering infused chemo -therapies at significantly lower out-of-pocket costs for patients than oralagents. Currently, IV treatments are cov-

ered under the medical benefit por-tion of health insurance coverage.This means the patient’s out-of-

pocket cost is limitedto the required copayfor an office visit,which is usually be-tween $20 and $30.By contrast, oralchemotherapy med-ications are coveredunder a health plan’spharmacy benefit,which means thatpatients may be responsible for high-er levels of cost-sharing. Out-of-pocket cost for prescription benefitsis often some percentage of the totalcost of the anticancer medication.Therefore, these copayments canamount to thousands of dollarsmonthly, and in extreme cases, theycan cause patients to forgo necessarytreatment altogether.

State versus FederalLegislation States have recognized the seri-

ousness of this problem, and since2007, 15 state legislatures—Colorado, Connecticut, Hawaii,Idaho, Illinois, Indiana, Iowa,Kansas, Minnesota, New Mexico,New York, Oregon, Texas, Vermont,and Washington—and the Districtof Columbia have passed laws requir-ing health insurance plans to coveroral chemotherapy regimens underterms no less favorable than thoseoffered for IV treatments. As of thepublication date of this article,Maryland, Virginia, Missouri, andothers are also considering similarlegislation. But at the current ratethat legislation is being passed in thestates, it will take more than adecade to reach oral parity for everypatient with cancer in the UnitedStates. Legislation at the nationallevel would ensure equal access to

Patient and Provider Access

Oral Parity: Taking It to the Next Level By Sydney Abbott, JD, Policy Coordinator, Association of Community Cancer Centers

This disparity is adramatic example oftechnology outpacingpolicy, and, asincreasing number oforal agents becomeavailable, more andmore patients acrossthe country areexperiencing thisdisparity in out-of-pocket costs.



Brought to you by the Association of Community Cancer Centers


Drug Coding

Supplied by RJ Health Systems

Medications Used for the Treatment of Prostate CancerThe following sections will assist healthcare pro-fessionals and payers by providing appropriatecoding and billing information associated withthe management of prostate cancer.

The following sections include:• Associated ICD-9-CM codes used for theclassification of prostate cancer

• Drugs that have been FDA-approved inthe treatment of prostate cancer

• Drugs that are Compendia listed for off-label use for prostate cancer based onclinical studies that suggest beneficial usein 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® codes andcode descriptions

Associated ICD-9-CM codes for prostatecancer:185 Malignant neoplasm of prostate

Excludes: seminal vesicles (187.8)

Compendia listed CPT ®

Generic (brand) HCPCS code: FDA-approved off-label use for administrationname code description for prostate cancer prostate cancer codesabiraterone acetate J8999*: Prescription drug, oral, ✓ N/A(Zytiga) chemotherapeutic

Not otherwise specified

abiraterone acetate C9399*: Unclassified drugs or biologics ✓ N/A(Zytiga) (Hospital outpatient use only)

bacillus Calmette-Guerin 90585: Bacillus Calmette-Guerin vaccine ✓ 90471 (Tice BCG) (BCG) for tuberculosis, live,

for percutaneous use

bacillus Calmette-Guerin 90586: Bacillus Calmette-Guerin vaccine ✓ 51720 (Tice BCG, TheraCys) (BCG) for bladder cancer, live,

for intravesical use

bacillus Calmette-Guerin J9031: BCG (intravesical), per installation ✓ 51720 (Tice BCG, TheraCys)

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

bicalutamide J8999*: Prescription drug, oral, ✓ N/A(Casodex) chemotherapeutic


cabazitaxel J9043: Injection, cabazitaxel, 1 mg ✓ 96413(Jevtana)

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

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

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

degarelix J9155: Injection, degarelix, 1 mg ✓ 96402(Firmagon)


Drug Coding



Generic (brand) HCPCS code: FDA-approved off-label use for administrationname code description for prostate cancer prostate cancer codesdexamethasone J8540: Dexamethasone, oral, 0.25 mg ✓ N/A(Decadron)

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

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

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

estradiol valerate J1380: Injection, estradiol valerate, ✓ 96372(Delestrogen) up to 10 mg

estramustine J8999*: Prescription drug, oral, ✓ N/A(Emcyt) chemotherapeutic


estrogens (eg, estradiol, J8499*: Prescription drug, oral, ✓ N/Aconjugated estrogen, nonchemotherapeutic esterified estrogen) Not otherwise specified

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

flutamide J8999*: Prescription drug, oral, ✓ N/A(Eulexin) chemotherapeutic


flutamide S0175: Flutamide, oral, 125 mg ✓ N/A(Eulexin)

goserelin acetate J9202: Goserelin acetate implant, ✓ 96372, 96402(Zoladex) per 3.6 mg

histrelin J9225: Histrelin implant, 50 mg ✓ 11981, 11982,(Vantas) 11983

hydrocortisone J1720: Injection, hydrocortisone sodium ✓ 96365, 96366, (Solu-Cortef) succinate, up to 100 mg 96372, 96374

ixabepilone J9207: Injection, ixabepilone, 1 mg ✓ 96413, 96415(Ixempra)

ketoconazole J8499*: Prescription drug, oral, ✓ N/A(Nizoral) nonchemotherapeutic


leuprolide acetate J9217: Leuprolide acetate ✓ 96402(Eligard, Lupron Depot) (for depot suspension), 7.5 mg

leuprolide acetate J9218: Leuprolide acetate, per 1 mg ✓ 96402(Lupron)

medroxyprogesterone J1051: Injection, medroxyprogesterone ✓ 96402(Depo-Provera) acetate, 50 mg

megestrol J8499*: Prescription drug, oral, ✓ N/A(Megace) nonchemotherapeutic


megestrol S0179: Megestrol acetate, oral 20 mg ✓ N/A(Megace)

melphalan J8600: Melphalan, oral, 2 mg ✓ N/A(Alkeran)

melphalan J9245: Injection, melphalan hydrochloride, ✓ 96409, 96413(Alkeran) 50 mg

Drug Coding


Generic (brand) HCPCS code: FDA-approved off-label use for administrationname code description for prostate cancer prostate cancer codesmethylprednisolone J7509: Methylprednisolone, oral, per 4 mg ✓ N/A(Medrol)

methylprednisolone J1020: Injection, methylprednisolone ✓ 11900, 11901, (Depo-Medrol) acetate, 20 mg 20600, 20605,

20610, 96372

methylprednisolone J1030: Injection, methylprednisolone ✓ 11900, 11901,(Depo-Medrol) acetate, 40 mg 20600, 20605,

20610, 96372

methylprednisolone J1040: Injection, methylprednisolone ✓ 11900, 11901, (Depo-Medrol) acetate, 80 mg 20600, 20605,

20610, 96372

methylprednisolone J2920: Injection, methylprednisolone ✓ 96365, 96366, (Solu-Medrol) sodium succinate, up to 40 mg 96372, 96374

methylprednisolone J2930: Injection, methylprednisolone ✓ 96365, 96366,(Solu-Medrol) sodium succinate, up to 125 mg 96372, 96374

mitoxantrone J9293: Injection, mitoxantrone ✓ 96409, 96413(Novantrone) hydrochloride, per 5 mg

nilutamide J8999*: Prescription drug, oral, ✓ N/A(Nilandron) chemotherapeutic


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

prednisone J7506: Prednisone, oral, per 5 mg ✓ N/A(Deltasone)

prednisolone J7510: Prednisolone, oral, per 5 mg ✓ N/A (eg, Orapred, Millipred)

sipuleucel-T Q2043: Sipuleucel-T, minimum of ✓ 96413, 96415 (Provenge) 50 million autologous CD54+ cells

activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion (Code price is per 250 mL)

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

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

triptorelin J3315: Injection, triptorelin pamoate, ✓ 96372, 96402(Trelstar Depot, 3.75 mgTrelstar LA)

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

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

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

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



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


Health Policy

Here’s a bold prediction forthe new year. By 2020, theAmerican health insurance

industry will be extinct. Insurancecompanies will be replaced by ac-countable care organizations (ACOs)—groups of doctors, hospitals andother health care providers who cometogether to provide the full range ofmedical care for patients.Already, most insurance compa-

nies barely function as insurers. Mostnon-elderly Americans—or 60 per-cent of Americans with employer-provided health insurance—workfor companies that are self-insured.In these cases it is the employer, notthe insurance company, that assumesmost of the risk of paying for themedical care of employees and theirfamilies. All that insurance compa-nies do is process billing claims.For individuals and small busi-

nesses, health insurance companiesusually do provide insurance; theytake a premium and assume finan-cial responsibility for paying thebills. But the amount of risk sharingthat is accomplished is limitedbecause the insurers charge premi-ums that vary, depending on thehealth of an individual or a group ofemployees, and use their data andmarket power to identify healthypeople to cover and unhealthy peo-ple to exclude from coverage. (Thehealth care law’s total ban on exclu-sions for preexisting conditions willbegin in 2014.)

A new system is on its way, onethat will make insurance companiesunnecessary. Many health insurance compa-

nies also impose barriers—likerequiring prior authorization fortests and treatments and denyingpayment for covered services,which forces patients to appeal—todiscourage patients from using themedical services for which they areinsured and to attempt to avoidpaying for those services. Whilethese barriers can reduce waste bypreventing unnecessary care, theycan also discourage patients fromreceiving care they need, as well asimpose administrative burdens ondoctors and patients.But thanks to the ACOs provid-

ed for by the health care reform act,a new system is on its way, one thatwill make insurance companiesunnecessary. ACOs will increasecoordination of patient’s care andshift the focus of medicine awayfrom treating sickness and towardkeeping people healthy.Because most physicians and hos-

pitals today are paid on a fee-for-service basis, medical care is organ-ized around treating a specificepisode of illness rather than thewhole patient. This system encour-ages overtreatment and leads to mis-takes and miscommunication whenpatients are sent between their pri-mary care doctors, specialists andhospitals. Indeed, under today’s pay-ment system, investments in provid-ing better care are doubly penalized.If a hospital hires a nurse to followup with patients after they are dis-charged in order to reduce readmis-sions—for example, to help patientswith diabetes improve blood sugarcontrol—it must pay for the nurse,which is typically not reimbursed by

insurance companies or Medicare,and it loses revenue by preventingthe readmission.In contrast, ACOs will typically

be paid a fixed amount per patient,along with bonuses for achievingquality targets. The organizationswill make money by keeping theirpatients healthy and out of the hos-pital and by avoiding unnecessarytests, drugs and procedures. Thus,they will actually have a financialincentive to hire that nurse for follow-ups.In addition to providing better

and more efficient care, ACOs willalso make health insurers superflu-ous. Because they will each beresponsible for a large group ofpatients (typically more than15,000), they will pool the risk ofpatients who have higher-than-average costs with those with lowercosts. And with the end of fee-for-service payments, insurance compa-nies will no longer be needed tohandle complicated billing andclaims processing, nor will theyneed to be paid a fee for doing so.Payments can flow directly from an employer, Medicare or Medicaidto the ACOs. ACOs will requireenhanced information systems totrack patients and figure out how todeliver more effective care, but thisanalytic capacity will be directed atimproving health outcomes, not atimposing barriers to those seekingtreatment.ACOs are not simply a return to

the health maintenance organ-izations (HMOs) of the 1990s.Although in both models patientsare members of a provider networkwith a specific group of doctors andhospitals, and both are paid prima-rily per member rather than per

The End of Health Insurance CompaniesBy Ezekiel J. Emanuel and Jeffrey B. Liebman

Ezekiel J. Emanuel is a contributingopinion writer for The New YorkTimes. Jeffrey B. Liebman is a professorof public policy at Harvard. Both wereadvisers in the Obama administration.Reprinted with permission from TheNew York Times, January 30, 2012. Continued on page 35


procedure or test, there are big dif-ferences between them. HMOswere often large national corpora-tions far removed from their mem-bers. In contrast, ACOs will consistof local health care providers work-ing as a team to take care ofpatients who are likely to be mem-bers for years at a time. HMOsoften cut costs not by keeping peo-ple healthy but by denying patientsservices and by forcing doctors andhospitals to take lower payments.In the 1990s, we lacked the infor-mation technology and provenmodels of integrated care deliverythat we have now. These advanceswill allow ACOs to simultaneouslyimprove health outcomes and re -duce costs.A final bonus of ACOs is that

they will lead to a better form ofcompetition in health care markets.Today, consumers have to chooseamong insurance plans with abewildering array of copayments,deductibles and annual out of pock-et maximums—choices that few ofus are any good at making. In theACO model, consumers will choosea primary care physician and theteam of doctors and hospitals thatare in the same group. Choosing adoctor and provider group is aresponsibility that consumers wantto have and are likely to be muchbetter at.A few health insurers see this

asteroid coming. WellPoint, forexample, bought the clinic operatorCareMore for $800 million lastsummer to make the transition into

the ACO business. Others, like the Optum unit of UnitedHealthGroup, are developing data analysisservices to provide to future ACOs.If they don’t want to go the way ofthe dinosaurs, insurance companieswill have to find a new business tobe in, one that is useful in the newworld of coordinated care. l

Health Policy

The End of Health…Continued from page 34

Share your response tothis article with your

colleagues on the pages ofOncology Practice

Management.Send your comments to: [email protected]

the most appropriate treatment regi-men for all patients. It is time forCongress to take action.Medicare has already fixed this

problem. Under Medicare Part D,any oral chemotherapy drug that isidentical to an IV chemotherapydrug is covered under Medicare PartB’s medical benefits. Only privatepayers are not yet required to updateinsurance policies to keep pace withthe changing landscape of qualitycancer care.Last fall, Congressman Brian

Higgins (NY-27) introduced theCancer Drug Coverage Parity Act of2011 (H.R. 2746). This bill, which is still making its way throughCongress, has many supporters buthas faced opposition from those whoare concerned that this is a mandate.However, H.R. 2746 does not pro-pose to require plans to coverchemotherapy. Rather, it requiresinsurers that already cover chemo-therapy treatments to provide forcoverage of oral anticancer drugs onterms no less favorable than the cov-

erage provided for intravenouslyadministered medications.The Association of Community

Cancer Centers (ACCC) wants tosee access to oral chemotherapyoptions protected for all cancerpatients in the United States. Wewill continue to fight to preserve ourmembers’ ability to prescribe themost appropriate treatment for theirpatients. The ACCC will monitorthis issue and will notify members of state and federal efforts in thisarea. l

Oral Parity: Taking It to the Next Level…Continued from page 29

Patient and Provider Access

Brought to you by the Association of Community Cancer Centers

Alt h o u g hmost physi-cians are

aware that one of thegreatest risks theyface is becoming dis-abled and unable toperform the “materi-al and substantial”duties of their med-ical specialty, mostare unaware that

myriad types of disability insurancepolicies exist to protect their medicalpractices. These types of policies canassure that ongoing business expensescan be met, that creditors can be paid,and that the medical practice or valueof their business interest(s) will bepreserved in the event that he or sheis unable to return to the practice ofmedicine. My first article in this seriesis focused on the benefits of “key per-son replacement insurance.”

Key Person ReplacementInsuranceAs a business owner, you probably

rely on one or more key peoplethroughout the day to keep yourpractice running effectively. A “keyemployee” is someone who con-tributes significantly to the financialsuccess of a business. This personmay be an office manager, a physi-cian’s assistant, an employee physi-cian, or even another physicianowner. If any of these key peopledied or became disabled, what wouldthat mean to the future of your prac-tice? How would cash flow, revenues,profitability, and morale be affected?What would patients and creditorsthink? The loss of revenue could bedevastating.Key person insurance is an effec-

tive way to provide a small- to medi-um-sized business with funds to han-

dle the loss of a key employee as aresult of disability or death. Theemployer pays the premium and is theowner of the policy insuring the keyemployee in the event of a total dis-ability. If the key employee becomes

totally disabled, the employer re -ceives benefits from the policy to off-set costs such as recruitment andtraining, temporary staffing needs,and short-term revenue replacement.As mentioned, often a similar type ofpolicy can be purchased to protectthe practice in the event of a key per-son’s premature death.Perhaps one of the best applica-

tions of key person disability insur-ance is in the case of a medical prac-tice that is owned by a husband anda wife. In these situations, tradition-al disability buy-out insurance wouldnormally be unavailable. However,with key person disability insurance,as long as a nonmajority insured(owns ≤50% of the practice) meetsthe definition of total disability, theowner of the policy receives either alump-sum payment or a combina-tion of monthly and lump-sum pay-ments, depending on how the policyis structured.

Premium RatesPremium rates are dependent on

many factors, including, but not lim-ited to, age, gender, occupationalclassification, smoking status, benefitamount, elimination period, and rid-ers selected. However, when multiplebusiness owners and/or employeespurchase a combination of disabilityincome and business protection poli-cies from the same insurance compa-ny, large discounts can typically beobtained. Addi tionally, these samediscounts can be made available toemployees interested in purchasingindividual coverage. For these rea-sons, physicians and other businessowners should consider working withthe same insurance agent to design aplan to meet the individual needs ofthemselves and their businesses andto make sure that the policies pur-chased are integrated and coordinat-ed, and that they take advantage ofany available discounts.

SummaryAlthough most physicians are keen-

ly aware of the need to purchase indi-vidual disability insurance coverage,few are cognizant of the variety of dis-ability insurance policies designed tohelp meet the needs of self-employedphysicians and/or the shareholders of amedical practice. These include, butare not limited to disability businessoverhead expense insurance, key per-son replacement insurance, and dis-ability buy-out insurance. l

Lawrence B. Keller, CLU, ChFC,CFP®, is the founder of Physician Finan -cial Services, a New York–based firmspecializing in income protection andwealth accumulation strategies for physi-cians. He can be reached at 516-677-6211 or [email protected] for comments or questions.

Physician Wealth Management

Business Disability Insurance and YourMedical Practice

Key person insurance isan effective way toprovide a small- tomedium-sized businesswith funds to handlethe loss of a keyemployee as a result ofdisability or death.


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

ZYTIGA® (abiraterone acetate) TabletsBrief Summary of Prescribing Information.INDICATIONS AND USAGEZYTIGA in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel.CONTRAINDICATIONSPregnancy: ZYTIGA may cause fetal harm when administered to a pregnant woman. ZYTIGA is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: Use ZYTIGA with caution in patients with a history of cardiovascular disease. ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Adverse Reactions and Clinical Pharmacology (12.1) in full Prescribing Information]. Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in the incidence and severity of these adverse reactions. Use caution when treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, e.g., those with heart failure, recent myocardial infarction or ventricular arrhythmia. The safety of ZYTIGA in patients with left ventricular ejection fraction <50% or NYHA Class III or IV heart failure has not been established because these patients were excluded from the randomized clinical trial. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with ZYTIGA. Adrenocortical Insufficiency: Adrenocortical insufficiency has been reported in clinical trials in patients receiving ZYTIGA in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations [see Warnings and Precautions].Hepatotoxicity: Marked increases in liver enzymes leading to drug discontinuation or dosage modification have occurred [see Adverse Reactions]. Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced ZYTIGA dose of 250 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt ZYTIGA treatment and closely monitor liver function. Re-treatment with ZYTIGA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [see Dosage and Administration (2.2) in full Prescribing Information].The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown.Food Effect: ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. The safety of these increased exposures when multiple doses of abiraterone acetate are taken with food has not been assessed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].ADVERSE REACTIONSThe following are discussed in more detail in other sections of the labeling:Hypertension, hypokalemia, and fluid retention due to mineralocorticoid excess [see Warnings and Precautions].Adrenocortical insufficiency [see Warnings and Precautions].Hepatotoxicity [see Warnings and Precautions].Food effect [see Warnings and Precautions].Clinical Trial ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be

directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.In a placebo-controlled, multicenter phase 3 clinical trial of patients with metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy, ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arm (N = 791). Placebo plus prednisone 5 mg twice daily was given to control patients (N = 394). The median duration of treatment with ZYTIGA was 8 months.The most common adverse drug reactions (≥5%) reported in clinical studies were joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection.The most common adverse drug reactions that resulted in drug discontinuation were aspartate aminotransferase increased, alanine aminotransferase increased, urosepsis and cardiac failure (each in <1% of patients taking ZYTIGA). Adverse reactions and laboratory abnormalities related to mineralocorticoid effects were reported more commonly in patients treated with ZYTIGA than in patients treated with placebo: hypokalemia 28% versus 20%, hypertension 9% versus 7% and fluid retention (edema) 27% versus 18%, respectively (see Table 1). In patients treated with ZYTIGA, grades 3 to 4 hypokalemia occurred in 5% of patients and grades 3 to 4 hypertension was reported in 1% of patients [see Warnings and Precautions].Table 1 shows adverse reactions due to ZYTIGA that occurred with either a ≥ 2% absolute increase in frequency compared to placebo, or were events of special interest (mineralocorticoid excess, cardiac adverse reactions, and liver toxicities).Table 1: Adverse Reactions due to ZYTIGA in a Placebo-Controlled Phase 3

Trial ZYTIGA with Placebo with Prednisone Prednisone (N=791) (N=394)System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % %Musculoskeletal and connective tissue disorders Joint swelling/discomfort2 29.5 4.2 23.4 4.1 Muscle discomfort3 26.2 3.0 23.1 2.3General disorders Edema4 26.7 1.9 18.3 0.8Vascular disorders Hot flush 19.0 0.3 16.8 0.3 Hypertension 8.5 1.3 6.9 0.3Gastrointestinal disorders Diarrhea 17.6 0.6 13.5 1.3 Dyspepsia 6.1 0 3.3 0Infections and infestations Urinary tract infection 11.5 2.1 7.1 0.5 Upper respiratory

tract infection 5.4 0 2.5 0Respiratory, thoracic and mediastinal disorders Cough 10.6 0 7.6 0Renal and urinary disorders Urinary frequency 7.2 0.3 5.1 0.3 Nocturia 6.2 0 4.1 0Injury, poisoning and procedural complications Fractures5 5.9 1.4 2.3 0Cardiac disorders Arrhythmia6 7.2 1.1 4.6 1.0 Chest pain or

chest discomfort7 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.31 Adverse events graded according to CTCAE version 3.02 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 3 Includes terms Muscle spasms, Musculoskeletal pain, Myalgia,

Musculoskeletal discomfort, and Musculoskeletal stiffness4 Includes terms Edema, Edema peripheral, Pitting edema, and Generalized

edema5 Includes all fractures with the exception of pathological fracture6 Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular

tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia

ZYTIGA® (abiraterone acetate) Tablets

7 Includes terms Angina pectoris, Chest pain, and Angina unstable. Myocardial infarction or ischemia occurred more commonly in the placebo arm than in the ZYTIGA arm (1.3% vs. 1.1% respectively).

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

Cardiovascular Adverse Reactions: Cardiovascular adverse reactions in the phase 3 trial are shown in Table 1. The majority of arrhythmias were grade 1 or 2. Grade 3-4 arrhythmias occurred at similar rates in the two arms. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arm. No patients had sudden death or arrhythmia associated with death in the placebo arm. Cardiac ischemia or myocardial infarction led to death in 2 patients in the placebo arm and 1 death in the ZYTIGA arm. Cardiac failure resulting in death occurred in 1 patient on both arms. Hepatotoxicity: Drug-associated hepatotoxicity with elevated ALT, AST, and total bilirubin has been reported in patients treated with ZYTIGA. Across all clinical trials, liver function test elevations (ALT or AST increases of > 5X ULN) were reported in 2.3% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. In the phase 3 trial, patients whose baseline ALT or AST were elevated were more likely to experience liver function test elevations than those beginning with normal values. When elevations of either ALT or AST > 5X ULN, or elevations in bilirubin > 3X ULN were observed, ZYTIGA was withheld or discontinued. In two instances marked increases in liver function tests occurred [see Warnings and Precautions]. These two patients with normal baseline hepatic function, experienced ALT or AST elevations 15 to 40X ULN and bilirubin elevations 2 to 6 X ULN. Upon discontinuation of ZYTIGA, both patients had normalization of their liver function tests and one patient was re-treated with ZYTIGA without recurrence of the elevations. In clinical trials, the following patients were excluded: patients with active hepatitis, patients with baseline ALT and/or AST ≥ 2.5X ULN in the absence of liver metastases, and patients with ALT and/or AST > 5X ULN in the presence of liver metastases. Abnormal liver function tests developing in patients participating in clinical trials were managed by treatment interruption, dose modification and/or discontinuation [see Dosage and Administration (2.2) in full Prescribing Information and Warnings and Precautions]. Patients with elevations of ALT or AST > 20X ULN were not re-treated. Other Adverse Reactions: Adrenal insufficiency occurred in two patients on the abiraterone arm of the phase 3 clinical trial (< 1%). Laboratory Abnormalities of Interest: Table 2 shows laboratory values of interest from the phase 3 placebo-controlled clinical trial. Grade 3-4 low serum phosphate (7.2%) and potassium (5.3%) occurred more frequently in the ZYTIGA arm.

Table 2: Laboratory Abnormalities of Interest in a Phase 3 Placebo-Controlled Clinical Trial

Abiraterone (N=791) Placebo (N=394) All Grades Grade 3-4 All Grades Grade 3-4 Laboratory Abnormality (%) (%) (%) (%)High Triglyceride 62.5 0.4 53.0 0High AST 30.6 2.1 36.3 1.5Low Potassium 28.3 5.3 19.8 1.0Low Phosphorus 23.8 7.2 15.7 5.8High ALT 11.1 1.4 10.4 0.8High Total Bilirubin 6.6 0.1 4.6 0

DRUG INTERACTIONSEffects of Abiraterone on Drug Metabolizing Enzymes: ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) in full Prescribing Information].Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Avoid or use with caution, strong inhibitors and inducers of CYP3A4 during ZYTIGA treatment [see Clinical Pharmacology (12.3) in full Prescribing Information].

USE IN SPECIFIC POPULATIONSPregnancy: Pregnancy Category X [see Contraindications]. ZYTIGA is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the potential risk for pregnancy loss. Women of childbearing potential should be advised to avoid becoming pregnant during treatment with ZYTIGA. Nursing Mothers: ZYTIGA is not indicated for use in women. It is not known if abiraterone acetate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ZYTIGA, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.Pediatric Use: ZYTIGA is not indicated in children.Geriatric Use: Of the total number of patients in a phase 3 trial of ZYTIGA, 71% of patients were 65 years and over and 28% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients.Patients with Hepatic Impairment: The pharmacokinetics of abiraterone were examined in subjects with baseline mild (n = 8) or moderate (n = 8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone after a single oral 1,000 mg dose of ZYTIGA increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function. No dosage adjustment is necessary for patients with baseline mild hepatic impairment. In patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the recommended dose of ZYTIGA to 250 mg once daily. If elevations in ALT or AST >5X ULN or total bilirubin >3X ULN occur in patients with baseline moderate hepatic impairment, discontinue ZYTIGA treatment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information]. The safety of ZYTIGA in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA. For patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Clinical Pharmacology (12.3) in full Prescribing Information].Patients with Renal Impairment: In a dedicated renal impairment trial, the mean PK parameters were comparable between healthy subjects with normal renal function (N=8) and those with end stage renal disease (ESRD) on hemodialysis (N=8) after a single oral 1,000 mg dose of ZYTIGA. No dosage adjustment is necessary for patients with renal impairment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].OVERDOSAGE: There have been no reports of overdose of ZYTIGA during clinical studies. There is no specific antidote. In the event of an overdose, stop ZYTIGA, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function.Storage and Handling: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Based on its mechanism of action, ZYTIGA may harm a developing fetus. Therefore, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves [see Use in Specific Populations].

Manufactured by:Patheon Inc.Mississauga, Canada

Manufactured for:Janssen Biotech, Inc.Horsham, PA 19044

Issued: December 2011

08Z11205B

ZYTIGA® (abiraterone acetate) Tablets ZYTIGA® (abiraterone acetate) Tablets

2/12 08Z12026

I

A

I

o

6

© 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.

08Z

1112

1R3

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 accesssimple, convenient, and easy.

8

march 2012 vol 2, no 2

Documents

reimbursement formswhere

reimbursement activitywww

amgen assist

medical specialty

answeredwhere online

cancer care

internet access

practice administrator