Oftentimes providers finding them-selves under review comment thatthey wish they had known over-
sight was potentially heading in theirdirection, and that they wish they had
insight into areas of potential areas ofexposure. Such lamenting is, of course,wasted energy, because potential exposureis potential exposure, and having “notknown” of potential exposure is not a
Dallas, TX—We have to control oncolo-gy costs; we think it makes sense to workwith physicians to do so, but we have along way to go in a short time frame.These were the general messages from 4leading payers at the 2012 CancerCenter Business Summit.The panel members expressed worries
about oncology costs rising to the topconcern for many payers, as well as anongoing concern about wide s pread varia-
tion in costs and intreatmentchoicesfor patients withcancer.
WellPointOncology Medical HomeJennifer Malin, MD, PhD, MedicalDirector of On cology, Care Manage -ment, WellPoint, Los Angeles, CA, not -
pidly becoming acore requirement inUS medical practi -ces. Whether medi - cal home models,accountable care
or ganization (ACO) models, HealthInformation Technology for Economicand Clinical Health (HITECH) require-ments, or new Commission on Cancerstandards, all have components of engag-
Health Plans Address the Rising Costs of Cancer CareBy Dawn Holcombe, MBA, FACMPE, ACHE
Cancer Center Business Summit
Preparing for the Office of theInspector General’s 2013 Work Plan By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq
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As practice administrators, wetry to prepare for emergen-cies, but the unexpected
always happens. Hurricane Sandyblew onto the East Coast and hit hardwith rain, wind, and blizzard condi-tions. Many are still digging out; someare still without power more than aweek later. It is not too early to seewhat we can apply from this storm toother storms that can hit here or any-where else in the country.
WaterMany of the affected areas were in
low-lying areas that were vulnerableto both storm surges and drivingrain. Flooding into basements andlower floors was the culprit for manyof the power failures, and even manygenerator failures, for major health-care institutions. To the extent pos-sible, putting vulnerable emergency
equipment in higher elevationscould provide protection. The power outages in southern
Connecticut would have beengreater if one of the major electricalsubstations had been flooded. As itwas, Connecticut Light & Powerbuilt the substation to be higher thanthe 100-year flood maximum plus 1foot. Water rose to within inches ofeven that height. As we renovateoffices, or build new buildings, manyof us do not routinely check 100-yearflood stages in our planning, but wehave seen the relevance of that in -creasing in recent years.
PowerThe question is not, “Where were
you when the lights went out?” butrather, “How isolated are you whenthe lights go out?” Medical officesthat rely on elevators for patient and
staff access are severe-ly affected when thebuilding elevators stopworking. Some health-care facilities keep theiremergency generators onupper floors to avoidflooding, but then find significantchallenges in lugging the fuel neededto power the generators up severalflights of stairs.
CommunicationsWe all have disaster plans for
communications, but when thepower is out and when cell towersare out, even cell phones will notwork. In our area, we have hadlengthy power outages 3 times in thepast 2 years, even before HurricaneSandy. A part of the routine prepara-tions we now make are building lists
From the Editor
3November 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 K. Deligdish, MDHematologist/OncologistOncology Resource NetworksOrlando, FL
Patrick A. Grusenmeyer,ScD, FACHEPresidentChristiana Care HealthInitiativesNewark, DE
Teri U. Guidi, MBA,FAAMAPresident & CEOOncology ManagementConsulting GroupPipersville, PA
MISSION STATEMENTOncology healthcare requires providers tofocus attention on financial concerns andstrategic decisions that affect the bottom line.To continue to provide the high-quality carecancer patients deserve, providers must masterthe ever-changing business of oncology.Oncology Practice Management will offerprocess solutions for members of the cancercare team—medical, surgical, and radiationoncologists, as well as executives, administra-tors, and coders/billers—to assist them inreimbursement, staffing, electronic healthrecords, REMS, and compliance with stateand federal regulations.
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™, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00USD; 3 years: $199.00 USD.
FROM THE EDITOREarly Lessons from Hurricane Sandy........................................3By Dawn Holcombe, MBA, FACMPE, ACHE
FEATURESImplementing a Patient Portal in Your Oncology Practice to Provide Patient-Centered Care.......................1By Gena Cook
Oncology Practices Challenged to Move Forward..........22By Dawn Holcombe, MBA, FACMPE, ACHE
The Oncology Medical Home.................................................26By Gail Thompson
The Nuts and Bolts of Physician and Hospital PracticeArrangements from the Oncology Front Line.....................40By Gail Thompson
DRUG CODINGMedications Used for the Treatment of Multiple Myeloma .................... ......................................36
DEPARTMENTSMEDICAL LEGAL UPDATEPreparing for the Office of the Inspector General’s 2013 Work Plan ........................................................1By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq
PATIENT AND PROVIDER ACCESSBrought to you by the Association of Community Cancer Centers
The Affordable Care Act Will Change Medicare: The Independent Payment Advisory Board......................46By Sydney Abbott, JD
PHYSICIAN WEALTH MANAGEMENTTerm Life Insurance: What You Need to Know Before You Buy ....................................................................................49By Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF
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ing patients in their care. To do thiseffectively and to meet theserequirements, you will be required toinstitute a patient portal in yourpractice. More important, you willneed to not only implement but alsoinstitutionalize new processes andways to care for your patients usingthis technology. If done well, it couldprovide a competitive advantage toyour practice, ease some of theadministrative burdens on you andyour staff, and provide a hugeimprovement in patient satisfactionand well-being as patients take amore active role in their care.
New RequirementsMandate a New Approachto Patient-Centered CareThe following summary discusses
the new models and their require-ments related to a patient-centeredcare approach.
HITECHThe HITECH Act was signed into
law in 2009 by President Obama todigitize medicine and to provideincentives to providers to adopt cer-tified electronic health record(EHR) technology. The majority ofoncology practices have started todigitize their practices and are attest-ing for the stimulus incentives,which peak in 2012. To meet meaningful use criteria,
practices must provide clinical visitsummaries and electronic access toparts of their patient’s health infor-mation. It is easier for a practice toattest for Stage 1, with less adminis-trative burden using a patient portal,but a portal will be required for Stage2 in 2014. One of the primary goalsof the HITECH Act is to “engagepatients and their families toimprove care coordination”; there-fore, it is likely that greater patientengagement will be required in Stage3, which has yet to be finalized.
The patient engagement objec-tives of HITECH include:• Electronic access to health infor-mation
• Patient-specific education, usingcertified EHR technology
• Online secure messaging.Additional objectives are to be de -
termined in Stage 3.
Medical HomeThe medical home model concept
first evolved in primary care; how -ever, for patients with cancer, themedical oncologist becomes theirprimary doctor. Although medicalhome models are new in oncology,pilots are emerging around the coun-try to better define the model, andpayers have been clear that they willpay differentially for oncology prac-tices that provide medical homeservices. Some of the patient engage-ment requirements in the medicalhome model are similar to those ofHITECH; however, the medicalhome model takes them even fur-ther. It is clear that a patient portalwill be needed for most of theserequirements.
The patient engagement require-ments of the patient-centered med-ical home from the NationalCommittee for Quality Assuranceinclude1:• Electronic access to health infor-mation
• Providing continuity of medicalrecord information for care andadvice when the office is not open
• Providing timely clinical adviceusing a secure, interactive elec-tronic system when the office isnot open
• Two-way communication betweenpatients (and their families) andthe practice
• Requests for appointments, pre-scription refills, referrals, or testresults
• Instructions on obtaining care andclinical advice during office hoursand when the office is closed
• The practice functions most effec-tively as a medical home if patientsand their families provide a com-plete medical history and informa-tion about care obtained outside ofthe practice
• The care team gives the patientsand their families access to evi-dence-based care and self-man-agement support
•Uses an EHR to identify patient-specific education resources andprovides educational resources orrefers at least 50% of patients andtheir families to educational re -sources to assist in self-management
• Develops and documents self-man -agement plans and goals in collab-oration with at least 50% ofpatients and their families
• Provides self-management tools torecord self-care results for at least50% of patients and their families.
American College of SurgeonsCommission on Cancer StandardsIn 2015, new Commission on
6 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Oncology Patient Portal
Implementing a Patient Portal…Continued from page 1
Although medicalhome models are newin oncology, pilots areemerging around thecountry to betterdefine the model, andpayers have beenclear that they will paydifferentially foroncology practicesthat provide medicalhome services.
Continued on page 8
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Cancer standards will require moreservices to support patients. To dothis efficiently, and with the bestexperience for your practice, you willneed a combination of people,processes, and technology. The newpatient-centered care requirementsare focused on providing patientsaccess to their health information, aswell as navigation services and sur-vivorship services.The patient engagement require-
ments of the Commission on Cancerinclude:• Patient access to health informa-tion
• Navigation of services• Survivorship services, which in -clude a complete treatment recordsummary at the completion oftreatment.
Accountable Care OrganizationsACOs are groups of healthcare
providers who provide coordinatedcare and disease management toimprove the quality of care thatpatients receive. The organization’spayment is tied to achieving health-care quality goals and outcomes thatwill result in cost-savings. Althoughthere are no direct patient objectivesthat must be met, it will be impera-tive to engage patients to participatein their healthcare to achieve thebest outcomes and cost-savings. For patients with cancer, poorly
managed patients and uneducatedpatients could likely be hospitalizedat rates higher than patients who areactively participating in their care,which could be detrimental tohealthcare professionals in this newmodel. In fact, a recent study thatfocused on the 10 most commontypes of cancer for which chemo -therapy is a key treatment modalityrevealed that 93% of patients hadchemotherapy-related emergencydepartment visits, at an average costof $800 per event.2
Patients Want Access toTheir Health InformationMany studies have shown that
patients want easier access to theirhealth information so they could bemore engaged in their care. A 2012study revealed that 90% of patientswant to self-manage their healthcareonline, with access to health infor-mation and education to help man-age their conditions.3 Another 2012study focusing on patients with can-cer revealed that 74% of the patientswere interested in having secureaccess to their medical recordsonline.4
What patients say they want, andwhat they actually do, can be 2 dif-ferent realities; however, we are start-ing to see that patients are followingthrough on their stated desires. TheOpenNotes project was a year-longstudy that evaluated the effect ondoctors and patients of facilitatingpatient access to visit notes over apatient portal.5 More than 100 doc-tors and more than 13,500 patientsparticipated across 3 different hospi-tal settings that served urban, rural,and poor communities. The resultswere overwhelmingly positive, withthe majority of patients viewing atleast 1 note. Of those, 77% to 87% of patients across the 3 geographical
settings reported that open noteshelped them feel more in control oftheir care, and 60% to 78% ofpatients taking medications reportedincreased adherence. Most impres-sive, nearly 99% of patients wantedopen notes to continue, and no doc-tor elected to stop.5At Navigating Cancer, we are also
starting to see increased patientengagement as a result of givingpatients access to their laboratoryresults and clinic visit summaries. Ofpatients who received a notificationabout a new clinic summary or ahealth update, 63% have logged into their clinic’s patient portal toaccess and view their update.6We are at the very beginning of
being able to track patient engage-ment as a result of giving patientselectronic access to their healthinformation, but the initial results arevery encouraging. We expect that asthe information shared with patientsbecomes more relevant and personal-ized, such as educational resourcesspecific to their diagnosis and securemessaging, patient engagement willcontinue to increase.
Practical Tips toImplementing a Patient PortalDo Your ResearchImplementing a new technology
in your practice is a big decision. Youhave likely been through this processpreviously as you chose your EHRvendor, and you can draw on yourexperiences through that process.What did you do well in selectingyour vendor? What pitfalls did youdiscover through that process thatyou would have done differently?Patient portal vendors have been
around for the past 10 years, so youwill have many options to choosefrom. You will need to decide if youwant a general portal application
At Navigating Cancer,we are also starting tosee increased patientengagement as aresult of giving patientsaccess to theirlaboratory results andclinic visit summaries.
Implementing a Patient Portal…Continued from page 6
Continued on page 10
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that is transaction-based or some-thing that is specific to oncology.Your EHR vendor will likely have asolution to consider. Some EHRvendors have built a modular patientportal into their application that canbe used for your practice, and othershave partnered with patient portalcompanies to provide an indepen -dent solution. The features and functions of
patient portals vary widely, so makesure that you examine several portalsbefore making a decision. Some por-tals are very robust, and others arebasic. Because patient portals are anew requirement, try to understandthe vendor’s motivation for providingthis service. Is it committed to thepatient experience, or did it just cre-ate the basic features and functionsfor HITECH certification? Is the ven-dor actively continuing to developthe product? Requirements are constantly chang -
ing, and many are not yet finalized, so you need to understand if your vendor will be up to the challenge of meeting all of these new require-ments. How quickly does the vendorimplement new features? What kindof customer service does it provide tothe staff and to your patients? If possi-ble, talk to the vendor’s current cus-tomers as well.
Think About the Patient ExperienceThis is not just another technolo-
gy for your practice to use; it is alsoan application that your patients willuse and access on a consistent basis.You need to view the products withthat in mind. Choosing a vendorwith the best patient experience iscrucial. If you do not, you could notonly provide a suboptimal experi-ence for your patients, but you couldalso cause a significant administra-tive burden for your staff. Your portaltechnology should improve your
practice and support your patients,not the opposite.Patient portals will be offered by
your competitors, and referringphysicians and patients will quicklystart to see the differences in prod-ucts. Patients with cancer see manydoctors, and your choices couldeither reflect positively or negative-ly, depending on if you choose a sub-optimal product from the patient’sexperience.
Besides Pricing, Features, andFunctions, Ask Your VendorOther Questions
1How do data flow from my EHRto the patient portal? How isinformation released to the patient?
2How are patients notified that theyhave new health information?
3What features and functions doyou provide for patients? Whatfeatures and functions are availablefor staff? What is your product roadmap for new features?
4How do I handle a password resetfor patients? Who do patients callif they have technical problems?
5What data do you have thatdemonstrate this will save yourpractice time?
6Do you have patient satisfactionsurvey information on your prod-uct? How about staff satisfactioninformation?
7How much does the applicationcost? Do you need additional soft-ware or hardware?
8What browsers do you support?Consumers use a variety of brow sers, so a portal supporting Micr o soft IE 7 is not good enough.This will cause significant problemsfor your patients and headaches for you if you are fielding the phone calls.
A Well-Implemented PortalCan Improve Your PracticeIt is clear that web-based patient
portals are already, and will contin-ue to be, a required tool to enableoncology practices to communicatewith patients and engage them intheir care. Most practices have beenfocused on selecting and imple-menting an EHR vendor to qualifyfor the Stage 1 meaningful useincentives, which peaked this year.Savvy administrators should now belooking beyond meaningful use cri-teria to consider patient portal tech-nology that will be required forStages 2 and 3, but will also be nec-essary to qualify for emerging payerprograms (eg, medical homes andACOs) and new professional stan-dards (eg, the Commission onCancer guidelines). All of theoptions require patient access totheir personal health information toenable more patient engagement,which is at the core of a patient-centered approach to care.Although many practice adminis-
trators are concerned that giving
10 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Oncology Patient Portal
Implementing a Patient Portal…Continued from page 8
The features andfunctions of patientportals vary widely, somake sure that youexamine several portalsbefore making adecision. Some portalsare very robust, andothers are basic.
patients more informationwill result in additionalwork, a well-implementedportal can increase effi-ciency by reducing dataentry and will not add tostaff workload as newprocesses become automat-ed. When evaluating por-tal options, it is importantto keep the big picture inmind—it should addressmultiple needs, make yourpractice more efficient,and increase patient satis-faction so you are betterable to provide patient-centered care. l
References1. National Committee for Quality Assurance.Patient-Centered Medical Home 2011 Standards,Elements and Factors. June 5, 2012. www.ncqa.org/Portals/0/Programs/Recognition/PCMH_2011_Data_Sources_6.6.12.pdf. Accessed October 23, 2012.2. Milliman, Inc. Cancer patients receivingchemotherapy: opportunities for better management.March 30, 2010. http://publications.milliman.com/research/health-rr/pdfs/cancer-patients-receiving-chemothera py.pdf. Accessed October 23, 2012.3. Accenture. Most patients want to self-managehealthcare online, Accenture survey finds. June 20,2012. http://newsroom.accenture.com/article_display.cfm?article_id=5474. Accessed October 23, 2012.4. Smyth B. Patient engagement survey results. Feb ruary27, 2012. www.navigatingcancer.com/blog/patient-engagement-survey-results/. Accessed October 23, 2012.5. Delbanco T, Walker J, Bell SK, et al. Inviting patientsto read their doctors’ notes: a quasi-experimental studyand a look ahead. Ann Intern Med. 2012;157:461-470.6. Cook G. Giving patients access to their health record:does it help patient engagement? October 5, 2012.www.navigatingcancer.com/blog/health-record-access-patient-engagement/. Accessed October 23, 2012.
Oncology Patient Portal
11November 2012 I www.OncPracticeManagement.com I
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of “landlines.” Every home and officeshould have old-school phones thatdo not rely on electricity and thatsimply connect directly to the phoneline, which can be done easily with asplit adapter at the wall sending 1wire to the nonelectric phone and 1wire to the electrified base for theremote/answering machine. I keep 2 landline phones perma-
nently attached to the phone linesin my own office and in my house(in addition to the numerous remotephones), and before storms, I remindkey contacts of that number asopposed to my cell number. Key per-sonnel in medical offices would dowell to have such landline connec-tions set up in advance of disasters socommunications can still occur. Doyou ask your patients for their emer-gency numbers, and remind them ofhow useful landline phones can be?
FuelWhen the power is down, fuel
often becomes in short supply,because it needs electricity to bepumped. If you have backup powerplanned, have you also made plansfor sufficient fuel availability to keepthat backup power working?Do you know where your remote
backup servers are? At least 1 remotebackup service was badly affected bythe power outages in New York, aswere all of its clients. Even if youhave not been affected by a storm,identifying the risk of your ownbackups and servers based on theirlocations can be useful.
Backing Up Your BackupsYou may have a backup plan in
your disaster preparedness, but haveyou gone 1 step further to identifywhat the backup may be to yourbackup plan failing? Hospitals pre-pare for natural disasters all of the
time, and yet even major hospitals inNew York had to punt when theirsafety net plans failed. Perhaps evenwith generators, oncology practicesmight find it useful to invest in sim-ple large coolers and fill them withice before an emergency. I myself(having lost 3 freezers full of foodover the past 2 years) bought anoversized cooler for $50 and stuffed itwith 7 large bags of ice (approxi-mately 5 lbs each). It was warrantedto keep ice frozen for at least 5 days.I did not lose power, but 8 days later,more than half of the ice in thatcooler was still intact and frozen. Our hearts go out to all of those
who are still recovering and are fac-ing not just getting power back butalso the rebuilding process. We are a close-knit community in
oncology, and even if we were notdirectly affected, we are all touchedby these events. It is interesting tonote that even as we struggle forgreater efficiency through the won-ders of technology, there are simple,old-school solutions that we stillneed. Good luck to everyone touch -ed by Hurricane Sandy. As youemerge from this, we look forward tohearing from you and learning fromall that you have learned. l
12 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
From the Editor
Early Lessons from Hurricane…Continued from page 3
Hospitals prepare fornatural disasters all ofthe time, and yeteven major hospitals inNew York had to puntwhen their safety netplans failed.
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defense to that exposure. In an effortto encourage provider compliance,and in its efforts to combat health-care fraud, the US Department ofHealth and Human Services (HHS)Office of the Inspector General(OIG) is attempting to offer totaltransparency by telling all providerswhat main areas it will be reviewingin the coming year. It is recommended that providers
pay attention, because the OIG hasthe ability to cripple a provider in itsreview or with penalties and sanc-tions. For those who are unfamiliar,the OIG is tasked with protectingthe integrity of the HHS programsand operations and the well being ofbeneficiaries by “detecting and pre-venting fraud, waste, and abuse;identifying opportunities to improveprogram economy, efficiency, andeffectiveness; and holding account-able those who do not meet programrequirements or who violate federallaws,” and it has taken a leading rolein such investigations and audits(https://oig.hhs.gov/reports-and-publications/archives/workplan/2013/WP00-Intro+Contents.pdf).The OIG maintains a staff of more
than 1700 individuals throughoutthe country to “conduct audits, evalu -ations, and investigations; provideguidance to industry; and, whenappropriate, impose civil monetarypenalties, assessments, and adminis-trative sanctions” (https://oig.hhs.gov/reports-and-publications/archives/workplan/2013/WP00-Intro+Contents.pdf). The OIG investigates awide variety of conduct (42 CFR §1003.102), and may seek civil mon-etary penalties against any personwho, for example, (1) presents orcauses to be presented claims to afederal health program that the per-son knows or should have known isfor an item or service that was not
provided as claimed or is false orfraudulent (42 USC § 1320a-7a[a][1][A] and [B]); (2) violates theantikickback statute by knowingly orwillfully paying or re ceiving remu-neration for referrals of federalhealthcare program beneficiaries (42USC § 1320a-7b[b]); 42 USC §1320a-7a[a][7]); or (3) pre sents orcauses to be presented a claim that aperson knows or should know is for aservice that may not be made underthe physician self-referral or theStark law (42 USC § 1395nn[g][3]).
One need only glance at theOIG’s website to glean that enforce-ment actions are merely ramping up.The OIG has seen incredible successtargeting healthcare providers; avail-able statistics evidence that, as aresult of the OIG’s efforts during fis-cal year (FY) 2010, $3.8 billion ininvestigation receivables that werecourt ordered or agreed to be paidthrough civil settlements had beenrecovered, and $1.1 billion in auditreceivables are to be pursued as aresult of OIG audit disallowance rec-ommendations (http://oig.hhs.gov/reports-and-publications/archives/workplan/2012/WP00-Intro.pdf).The numbers available for 2011show significant increases as theOIG continues to incorporate moresophisticated reviews and to expandthe scope of its investigations. Theavailable statistics for FY 2011 evi-dence that the OIG reported expect-
ed recoveries of approximately $5.2billion, consisting of $627.8 millionin audit receivables and $4.6 billionin investigative receivables (whichincludes $952 million in non-HHSinvestigative receivables resultingfrom our work in areas such as thestates’ share of Medicaid restitution). In addition to projected recover-
ies, the OIG reported exclusions of2662 individuals and entities fromparticipation in federal healthcareprograms; 723 criminal actionsagainst individuals or entities thatengaged in crimes against HHS pro-grams; and 382 civil actions, whichincluded false claims and unjustenrichment lawsuits that were filedin federal district court, civil mone-tary penalty settlements, and admin-istrative recoveries related to provid -er self-disclosure matters (http://oig.hhs.gov/reports-and-publications/archives/workplan/2012/WP00-Intro.pdf).In its FY 2013 work plan, the OIG
sets forth with specificity areas ofreview, allowing practitioners theopportunity to address those areasand to take corrective action now, asopposed to during or after a reviewprocess (https://oig.hhs.gov/reports-and-publications/workplan/index.asp). Examples of a few identifiedareas of potential review include:• Payments for multiuse vials oftrastuzumab (Herceptin): theOIG states it will review claimsto Medicare for trastuzumab,which is used to treat breast can-cer, to determine whether claimswere billed and paid properly.Trastuzumab is a multiuse-vialdrug, and providers are requiredto bill the complete services pro-vided with specificity (ie, theamounts expended; Centers forMedicare & Medicaid Services
Preparing for the Office of the Inspector General’s 2013…Continued from page 1
The OIG has seenincredible successtargeting healthcareproviders.
Continued on page 14
14 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Medical Legal Update
[CMS]. Medicare Claims Pro -cessing Manual. Pub 100-04, ch 1,§§ 70.2.3.1 and 80.3.2.2).Medicare’s single-use vial ruledoes not apply for trastuzumab(CMS. Medicare Claims Pro -cessing Manual. Pub 100-04, ch17, § 40). For certain drug claims,those involving a single-use vialor a package where a providermust discard the remainder of asingle-use vial or package afteradministering a dose or quantityof the drug or biologic, Medicareprovides payment for the amountdiscarded along with the amountadministered, up to the amountof the drug or biologic as indicat-ed on the vial or package label(https://oig.hhs.gov/reports-and-publications/archives/workplan/2013/Work-Plan-2013.pdf)
•Payments for outpatient drugs andfor the administration of thedrugs: the OIG states that it willreview Medicare outpatient pay-ments to providers for certaindrugs and for the administration ofthe drugs (ie, chemotherapydrugs) to determine whetherMedi care overpaid providersbecause of incorrect coding oroverbilling of units. The OIG haspreviously identified chemothera-py drugs as particularly vulnerableto incorrect coding. The OIG willreview whether providers arebilling accurately and completelyfor the services that were provided(CMS. Medicare Claims Pro cessingManual. Pub 100-04, ch 1, §§70.2.3.1 and 80.3.2.2), as well aswhether providers are reportingunits of service as the number oftimes that a service or procedurewas performed (CMS. Medi careClaims Processing Man ual. Pub100-04, ch 5, § 20.2 and ch 26, §10.4; https://oig.hhs.gov/reports-
• Payments for prostate cancerdrugs under the current policy:the OIG states that this year itwill begin to scrutinize the finan-cial impact of rescinding the leastcostly alternative (LCA) policies,
which were in effect from 1995through 2010 and provided aMedicare reimbursement amountfor a group of clinically compara-ble products that was based onthat of the least costly product. InApril 2010, LCA policies forMedicare Part B drugs were dis-continued in response to a courtruling that found that the use ofan LCA policy for certain pre-scription drugs was not author-ized under Medicare (https://oig.hhs.gov/reports-and-publica-tions/archives/workplan/2013/Work-Plan-2013.pdf). The severity of a review by the
OIG cannot be overstated, which iswhy it is imperative for all health-
care providers who are renderingservices to federal healthcare pro-grams to understand areas of poten-tial exposure and to take proactivemeasures to ensure compliance. Before discussing identified areas of
focus for the OIG during FY 2013, itis important to note that the first stepto maintaining compliance is to havea policy governing your practice’scompliance (ie, a compliance plan). The OIG has specified—although
it is not mandatory—that it recom-mends each and every practitionerimplement a specific compliance planthat includes certain areas of compli-ance to protect a practice (www.kirschenbaumesq.com/article/developing-the-right-compliance-plan-for-your-practice). In fact, on review, the OIGwill inquire initially whether the tar-get of any such review has imple-mented a compliance program. Werecommend each and every providerwork with his or her healthcare coun-sel to implement the same and tooperate according to its standards. l
This article is for education and dis-cussion purposes only and does notconstitute legal advice.
Jennifer Kirschenbaum, Esq, managesKirschenbaum & Kirschenbaum, PC’shealthcare department, which specializesin healthcare practitioner compliance,audit defense, licensure and transaction-al matters. Erica Youngerman, Esq, isan associate of the firm. For additionalinformation regarding this topic and forassistance with compliance program cre-ation and implementation, contactJennifer at [email protected], or at (516) 747-6700 ext302. To learn more about complianceoptions, visit www.kirschenbaumesq.com/page/practice-compliance.baumesq.com.
Preparing for the Office of the Inspector General’s 2013…Continued from page 14
The severity of areview by the OIGcannot be overstated,which is why it isimperative for allhealthcare providerswho are renderingservices to federalhealthcare programsto understand areas ofpotential exposure.
Please see brief summary of Full Prescribing Information on adjacent pages, including Boxed WARNING regarding immune-mediated side effects.
IndicationYERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.
Please see detailed Important Safety Information continued on following pages.
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONSYERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs) and thyroid function tests at baseline and before each dose. Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.
The signifi cance of a long-term survival benefi t
Estimated overall survival in the YERVOY pivotal phase 3 study publication The YERVOY overall survival curve separated at approximately 16 weeks and remained separated throughout the study period2
Overall survival rate at 1 year was 46% (95% CI: 37.0, 54.1) in the YERVOY arm vs 25% (95% CI: 18.1, 32.9) in the gp100 arm2,4
Overall survival rate at 2 years was 24% (95% CI: 16.0, 31.5) in the YERVOY arm vs 14% (95% CI: 8.0, 20.0) in the gp100 arm2,4
Median overall survival in the YERVOY + gp100 arm was 10 months (95% CI: 8.5, 11.5), 6 months (95% CI: 5.5, 8.7) in the gp100 arm, and 10 months (95% CI: 8.0, 13.8) in the YERVOY arm
A phase 3, double-blind, double-dummy study that randomized 676 patients with unresectable or metastatic melanoma previously treated with one or more of the following: aldesleukin (IL-2), dacarbazine, temozolomide, fotemustine, or carboplatin. Patients were randomized in a 3:1:1 ratio to receive YERVOY 3 mg/kg in combination with an investigational gp100 peptide vaccine (gp100) (n=403), YERVOY 3 mg/kg (n=137), or gp100 (n=136). The primary endpoint was overall survival in the YERVOY + gp100 arm vs the gp100 arm.3
0 21 21
Please see Important Safety Information, including Boxed WARNING regarding immune-mediated side effects,and brief summary of Full Prescribing Information on adjacent pages.
YERVOY (ipilimumab): The fi rst and only immunotherapy to deliver a signifi cant long-term survival benefi t in metastatic melanoma in a phase 3 study3
Important Safety Information Recommended Dose Modifi cationsWithhold dose for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5 mg prednisone or equivalent per day.Permanently discontinue YERVOY (ipilimumab) for any of the following: Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day Failure to complete full treatment course within 16 weeks from administration of fi rst dose Severe or life-threatening adverse reactions, including any of the following– Colitis with abdominal pain, fever, ileus, or peritoneal signs; increase in stool frequency
( 7 over baseline), stool incontinence, need for intravenous hydration for >24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation
– AST or ALT >5× the upper limit of normal (ULN) or total bilirubin >3× the ULN – Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full-
thickness dermal ulceration or necrotic, bullous, or hemorrhagic manifestations– Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis– Severe immune-mediated reactions involving any organ system– Immune-mediated ocular disease which is unresponsive to topical immunosuppressive therapy
Immune-mediated Enterocolitis: In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening or fatal (diarrhea of 7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) patients Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis Infl iximab was administered to 5 of 62 (8%) patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent)
Immune-mediated Hepatitis: In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5× the ULN or total bilirubin elevations >3× the ULN; Grade 3–5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%
To learn more, visit www.YERVOYinformation.com or call Medical Information at 1-855-YERVOY1(1-855-937-8691).
Important Safety Information continued on following page.
Important Safety Information continued on following page.
Important Safety Information (cont’d)
Immune-mediated Hepatitis (cont’d): 13 (2.5%) additional YERVOY (ipilimumab)-treated patients experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5× but 5× the ULN or total bilirubin elevation >1.5× but 3× the ULN; Grade 2) Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution Permanently discontinue YERVOY in patients with Grade 3-5 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids Withhold YERVOY in patients with Grade 2 hepatotoxicity
Immune-mediated Dermatitis: In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3–5) occurred in 13 (2.5%) patients– 1 (0.2%) patient died as a result of toxic epidermal necrolysis – 1 additional patient required hospitalization for severe dermatitis There were 63 (12%) YERVOY-treated patients with moderate (Grade 2) dermatitis Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. Withhold YERVOY in patients with moderate to severe signs and symptoms Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically. Administer topical or systemic corticosteroids if there is no improvement within 1 week
Immune-mediated Neuropathies: In the pivotal Phase 3 study in YERVOY-treated patients, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-Barré–like syndromes Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities)
Immune-mediated Endocrinopathies: In the pivotal Phase 3 study in YERVOY-treated patients, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients– All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as
adrenal insufficiency, hypogonadism, and hypothyroidism – 6 of the 9 patients were hospitalized for severe endocrinopathiesModerate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) YERVOY-treated patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing’s syndrome
Please see brief summary of Full Prescribing Information on adjacent pages, including Boxed WARNING regarding immune-mediated side effects.
Important Safety Information (cont’d)
Immune-mediated Endocrinopathies (cont’d): 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 (ipilimumab) Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insuffi ciency (including adrenal crisis), and hyper- or hypothyroidism
– Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecifi c symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identifi ed, signs or symptoms should be considered immune-mediated
– Monitor thyroid function tests and clinical chemistries at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland
Withhold YERVOY in symptomatic patients. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. Long-term hormone replacement therapy may be necessary
Other Immune-mediated Adverse Reactions, Including Ocular Manifestations:In the pivotal Phase 3 study in YERVOY-treated patients, clinically signifi cant immune-mediated adverse reactions seen in <1% were: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia Across the clinical development program for YERVOY, immune-mediated adverse reactions also reported with <1% incidence were: myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, and autoimmune thyroiditisPermanently discontinue YERVOY for clinically signifi cant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactionsAdminister corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy
Pregnancy & Nursing: YERVOY is classifi ed as pregnancy category C. There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefi t justifi es the potential risk to the fetus Human IgG1 is known to cross the placental barrier and YERVOY is an IgG1; therefore, YERVOY has the potential to be transmitted from the mother to the developing fetus It is not known whether YERVOY is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from YERVOY, a decision should be made whether to discontinue nursing or to discontinue YERVOY
Common Adverse Reactions:The most common adverse reactions ( 5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%)
References: 1. YERVOY package insert. Princeton, NJ: Bristol-Myers Squibb Company. 2. Data on fi le. YERV 008. Bristol-Myers Squibb Company. Princeton, NJ. April 2011. 3. Hodi FS, O’Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711-723. 4. Wolchok JD, Weber JS, Hamid O, et al. Ipilimumab effi cacy and safety in patients with advanced melanoma: a retrospective analysis of HLA subtype from four trials. Cancer Immun. 2010;10:9-14.
To learn more, visit www.YERVOYinformation.com or call Medical Information at 1-855-YERVOY1(1-855-937-8691).
To learn more, visit www.YERVOYinformation.com or call Medical Information at 1-855-YERVOY1(1-855-937-8691).
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 (ipilimumab)-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.
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].
[see Warnings and Precautions].
[see Warnings and Precautions].
[see Warnings and Precautions].
[see Warnings and Precautions].
[see Warnings and Precautions].
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
a Including fatal outcome. b Including intestinal perforation. c Underlying etiology not established.
Across clinical studies that utilized YERVOY (ipilimumab) 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.
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
Dallas, TX—The Cancer CenterBusiness Summit grew out of interestin innovative business models for thedelivery of cancer care in communityoncology. The 2012 Summit focusedon oncologist–hospital relationships,changing payer and provider models,and developing market strategies forsuccess in the rapidly changing faceof cancer care and rising costs. Appropriately, the theme of the
Summit this year was Transitioningto Value-Based Oncology: Strategiesto Survive and Thrive. With grow-ing business and federal attentionon rising healthcare costs, the costsof cancer care are often in the spot-light. Public and private payers areexperimenting with new paymentmethodologies and programs totransition from the current volume-based, fee-for-service standard forpayment to a value-based modelthat will increasingly shift risk forsome portion of the cost and thequality of health services to the hos-pitals and physicians who providethose services.Ronald Barkley, MS, JD, President
of the Cancer Center BusinessDevelopment Group, Bedford, NH,presented the Summit’s annualindustry research survey, whichfocused on the rapidly growingaccountable care organizations(ACOs), and how oncology wasbeing addressed in those new mod-els. In addition, research by TheAdvisory Board Company, theAmerican Society for RadiationOncology, and Oncology Metricsshowed a world of oncology that isstruggling to understand its ownmetrics and comparative bench-marks, but that is taking charge and,in key areas, is trying innovative
solutions that may lead to universalapproaches.Several panel discussions ad -
dressed topics directly relevant topractice administrators and pro -viders, focusing on current initia-tives in the delivery of cancer care,especially the recent experiments inoncology medical homes and ACOson the West Coast and on the EastCoast. The participants of the firstpanel discussed what other practices
can learn from their experience withthese innovations in oncology, shar-ing the challenges they have faced,even as they have pioneered some ofthe most visible and innovative pilotprograms with oncologists in thecountry. Several articles provide spe-cific details in this issue.The second panel included physi-
cian and executive leaders fromcommunity oncology who spokefrankly about provider initiativesthey were developing, with andwithout specific payers, at The WestClinic in Tennessee, New MexicoOncology Hematology Consultants,
Regional Cancer Care Associates inNew Jersey, and at Cancer Treat -ment Centers of America.Thomas J. Smith, MD, FACP,
FASCO, Director of PalliativeMedicine at Johns Hopkins MedicalInstitutions, Professor of Oncologyat Sidney Kimmel ComprehensiveCancer Center, and Harry J. DuffeyFamily Professor of PalliativeMedicine, Baltimore, MD, addressesthe opportunities and the challengesof integrating a palliative care focusearly into the treatment process, pro-viding tools that he uses in practice.Ezekiel J. Emanuel, MD, PhD, for-
mer Special Advisor on Health carePolicy, Office of Management andBudget, Executive Office of thePresident, and Chair of the De part -ment of Bioethics at the Nation alInstitutes of Health, delivered theKeynote Address at the Summit,highlighting the journey and futureof the Accountable Care Act and ofhealthcare delivery system reform.The oncology community faces a
very real challenge, for which thereis no easy answer: how will physi-cians continue to fight cancer withand for their patients when theworld is swirling in constant chaosaround them? Community oncology will need to
learn how to manage care and costs,to use data and analytics to monitorquality improvements and cost-sav-ings opportunities, to develop or usecost-effective care protocols thatalso meet their clinical expectationsfor appropriateness and evidence, toreengineer the way they deliver theircare, and to utilize the broad range oftreatment resources that are nowavailable to us. This is not a smallchallenge. l
22 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Cancer Center Business Summit
Oncology Practices Challenged to Move ForwardBy Dawn Holcombe, MBA, FACMPE, ACHE
Community oncologywill need to learn howto manage care andcosts, to use data andanalytics to monitorquality improvementsand cost-savingsopportunities.
Community Cancer Business Center
23November 2012 I www.OncPracticeManagement.com I
ed that the Well Point data for the useof col ony-stimulating factors forbreast cancer, show a variation intreat ment and in cost of 10% to 80%.As in other health plans, Dr Malin isseeing in creasing charges for pa -tients and for the health plan forcare delivered in the hospital outpa-tient setting versus care delivered inthe community practice setting.Fur ther more, some of the oncologycost-management strategies thathave been implemented by Well -Point include fee schedule changesto support community oncology,adjustments to drug payment ratesthat are higher than the averagesales price plus 6%, and raising indi-vidual rates for generic drugs. WellPoint has implemented one
of the few oncology medical homepilots in the country, with theWilshire Oncology Medical Groupserving as a test of the medicalhome concept in oncology. DrMalin said that the overriding con-cern for a health plan that is under-taking such a pilot is the need toconsider how to scale a successfulpilot to the rest of the market. Itwill soon not be enough to have justa few good projects for a plan; ahealth plan will need workabletools to scale such projects to prac-tices of every size across the regionor across the country.
Aetna Addresses Variationin Cancer CareVariation in care was also a con-
cern of Ae tna, said Ira M. Klein, MD,MBA, FACP, Chief of Staff, Officeof the Medical Officer, AetnaOncology Strategy, Hartford, CT.Aetna’s internal data review re -vealed variation of costs and of treat-ments not just across the country instates and cities, but also within spe-cific zip codes. The variations appearin factors such as rates of hospitaliza-tion, hospital costs, choices of drugs,
and lines of therapy for patients withsimilar disease. Based on US Oncology published
data on how its pathways programdemonstrated reduction in costs andvariability, Aetna decided to supportclinical decision-making programsfor oncologists, working with a num-
ber of different pathways programsand individual pilots with communi-ty practices across the country. Sofar, Aetna is surprised to see less ofan impact on drug spending than ithad anticipated, but it has seen solidsavings on the downstream and thetotal cancer spending, includinghospitalizations and emergencydepartment costs. Those findings make sense, be -
cause oncology drug costs constitutea relatively small part of the totalcancer spending, so supporting con-
sistent medical decision-making inthe oncology practice would affectthe more costly aspects of a healthplan’s total cancer spending.Aetna learned that it was most
effective to work closely with thepracticing oncologists, supportingtools and protocols that physiciansneed to reduce the financial burdenof managing cancer as well as to helpbuild care process mechanisms thatcan help health plans and physiciansreduce the current burdens of precer-tification and authorization process-es. Aetna is now investing in tech-nology solutions that practices coulduse to develop multipayer, scalableoperations, according to Dr Klein.
BlueCross BlueShield of FloridaCancer-related costs in Florida
became the major cost driver for allpayers in the state years ago, report-ed Jonathan Gavras, MD, FCCP,Senior Vice President of DeliverySystem and Chief Medical Officer,BlueCross BlueShield of Florida(Florida Blue), Jacksonville. Initially, the health plan focused
on draconian drug reimbursementcontrols and saw small practicesmerge into larger practices, partly inreaction to the financial pressuresthose reimbursement changescaused. More recently, in response toseveral meetings with these largerphysician groups, Florida Blue com-mitted to collaborative programswith the oncologists. Now Florida Blue has developed
the country’s first oncology account-able care organization (ACO) inconcert with Advanced MedicalSpecialties, a 47-physician oncologygroup, and Baptist Health, a leadinghospital system in the area. ThisACO-based program utilizes thepathways that the physician grouphad in place and is focused on the
Health Plans Address the Rising Costs of…Continued from page 1
Aetna is now investingin technology solutionsthat practices coulduse to developmultipayer, scalableoperations.
Ira M. Klein
Continued on page 24
24 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Community Cancer Business Center
total cost of patient care not justoncology-specific care for eachpatient. Early results from the firstquarter of the program are showingpositive impact. In developing thisprogram, the participants havelearned that building trust and fullyengaging leadership in the careprocess are essential.
Priority Health Oncology ProgramsLeadership and trust were al so
themes of the oncology medicalhome pro grams that John L. Fox,MD, MHA, Sen ior Medical Di rector,Priority Health, Grand Rapids, MI.,de veloped with Can cer & Hem a - tology Centers of West ern Mich i ganand several other leading oncologypractices. Although they do not haveall the answers yet, according to DrFox, they do have trust, commonali-ty of purpose, and a shared visionthat has let them move forward, evenin the absence of solid numbers. The Priority Health programs pay
physicians for their professional ser -vices, plus a monthly case-manage-ment fee for every patient in activetreatment. At the end of the year,the practices that have reducedPriority Health’s hospital and emer-gency department costs will receiveshared savings from the health plan.The expectation is that the real sav-ings will come from aspects of themedical decision-making that physi-cians do for these patients, not fromreduced drug costs.
Common Goals, Shared ChallengesAetna tends to outsource some of
the technical solutions, whereasother plans tend to work more close-ly in house with their own and theirphysicians’ solutions. All payersagreed that close collaboration withthe physicians rather than relying onexternal middlemen to intervene
with physicians was their preferencefor achieving best results.
Common key elements of the di -verse programs include:• Pathways• Triage of patient events• Care management• Advanced care planning.Management of adverse events
and hospitalizations tend to yield the most savings. Dr Malin notedthat approximately 33% of patientsreceiving chemotherapy have atleast 1 hospital admission, and morethan 50% of those are admissions forthe management of symptoms andtoxicities. Supporting communityphysicians in better ways to managesymptoms lowers admissions and
total costs of care. Those are thegoals, but the challenge for a healthplan becomes how to do that on anetwork level rather than on anindividual practice-by-practice ap -proach. Pathways are a common toolbut they do not always affect costs asmuch as they lead to predictability of costs. When asked about the rapid site-
of-care shifts being seen in the mar-ket as hospitals acquire private prac-tices, the panelists noted that caredelivered in the community setting isless expensive than care delivered ina hospital setting. They also recog-nized that earlier, traditional ap -proaches to controlling on cologycosts probably achieve the oppositeeffect and contribute to driving themigration of private practices into thehospital settings. Developing innova-tive programs for oncology is moredifficult for health plans to accom-plish with hospitals, because oncolo-gy is merely one of many specialties ata hospital. The panelists noted that bundling
payments will be a huge challenge,given the complexity of oncologycare––even their actuaries are daunt-ed at the thought of the resourcesinvolved; however, bundled pay-ments may be more possible in theradiation oncology environment.One of the biggest challenges that
health plans and the oncology com-munity face relates to data collec-tion. As we move into consideringthe total cost of care rather than thelimited focus on drug costs, the infor-mation needed to accurately evaluatethose costs is spread in different datasilos, so coordination and aggrega-tion of data become a top priority.There are still hurdles to cross in datacoordination and aggregation, whichis why trust is such a key element ofinnovative programs. Sometimes,the innovation needs to begin withtrust, and the data will follow. l
The Priority Healthprograms payphysicians for theirprofessional ser vices,plus a monthly case-management fee forevery patient in activetreatment.
John L. Fox
Health Plans Address the Rising Costs of…Continued from page 23
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Dallas, TX—The American PioneerSpirit is still alive today. At the 2012Cancer Center Business Summit,attendees enjoyed the chance towalk through the challenges andpossibilities of an emerging model incancer care that is quickly becominga buzzword for change—the oncolo-gy medical home. Among the leading pioneers in
the world of the oncology medicalhome are Linda D. Bosserman, MD,President of Wilshire OncologyMedical Group, La Verne, CA, andJohn D. Sprandio, MD, President ofConsultants in Medical Oncology & Hematology and Chairman ofOncology Management Services,Drexel Hill, PA. Susan Tofani, MS, Director of
Network and Payer Relations,Oncology Management Services,joined Dr Sprandio and Dr Bos -serman in discussing their experi-ences involved in establishing thefirst oncology medical homes in thecountry. They offered updates forthose involved in oncology on theirefforts and on the progress of theirinitiatives.
Wilshire Oncology Medical HomeDr Bosserman said that her and
her oncology team’s exploring theoncology medical home was drivenby the need to look, in collaborationwith payers, at how oncology couldbe paid differently for various out-comes. An oncology medical homeabsolutely requires a partnershipbetween the payers, providers, andpatients, she said. The concept of the oncology med-
ical home can be defined as patientcare that delivers “cost-effective careon evidence-based guidelines, with
warranted variations for fullyengaged patients, given wheneverpatients need it, by experienced cli-nician teams led by doctors coordi-nating care with others, inside andoutside of the clinic, that can lower
costs and improve health outcomesfor cancer care from prevention toend of life.”One key difference for providers
transitioning from a more traditionaloncology practice setting to theworld of an oncology medical homeis that their practice and their focusis now patient-centric rather thanphysician- or clinic-centric. To ac -complish this takes a fully engagedand reengineered oncology practicethat involves the entire team. Dr Bosserman’s group reengi-
neered their practice to build a teamof caregivers that is focused onpatients’ needs and preferences in acost-effective manner. The elementsof that reengineering focus on apatient-centric oncology practiceinclude:• The patient’s disease, health, andpreferences
• Engaged practice coordination ofall care
• Active partnership between pro -viders and payers
• Outcome validation and outcomereporting
• Value-based quality and cost• Comprehensive care managementand coordination
• Comprehensive care plan andco ordination.The Wilshire oncology medical
home was the culmination ofapproximately 4 years of develop-ment with Anthem BlueCrossBlueShield of California. Aftermuch discussion regarding practiceand plan capabilities, data collec-tion, comparators, and potentialmodels, an initial pilot was launchedin mid-2011. The first year wasfocused on identifying trackable dataelements and aligning paymentmodeling.
26 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Oncology Medical Home
The Oncology Medical Home: Embodimentof the American Pioneering SpiritBy Gail Thompson
The oncology medicalhome can be definedas patient care thatdelivers “cost-effectivecare on evidence-based guidelines, withwarranted variationsfor fully engagedpatients, givenwhenever patientsneed it, byexperienced clinicianteams led by doctorscoordinating care with others.”
—Linda D. Bosserman, MD
Anthem and Dr Bosserman’sgroup learned that their organiza-tions could focus on the followingtrackable elements and componentsof patient care:• Therapies: cost-effectiveness bystage, tumor features, evidence-based guidelines, generics, con-sistency with age, comorbidities,and warranted variations, in -cluding clinical trials
• Supportive care that is cost-effec-tive for nausea and vomiting,white and red blood cell growthfactors, and bone metastasis
• Initial and interval symptom man -agement to relieve suffering,lower complication costs, tacklethe common toxicities of therapy(ie, pain, nausea and vomiting,diarrhea, constipation, dehydra-tion, infections, and blood clots),and to encourage therapy com-pliance and adherence
• Optimize the site of care: office,extended office, urgent care ver-sus emergency department, hos-pital, and tertiary care
• End-of-life care.The Wilshire oncology medical
home partnership is now able totrack care progress through the fol-lowing sets of data-based validatedreports that form the basis for thepayments:1. Patients under care: achievablebenchmarks of care (ABC) pre-ferred provider organizationpopulation
2. Patients receiving therapy– Therapy and supportive care:choice, goal, line, and war-ranted variations
– Guideline compliance andwarranted variations
3. Interval care tracking with therapy– Extended office, urgent careversus emergency depart-ment, and hospital
– Cancer therapy and cancersymptoms versus others
4. End-of-life care
– Advanced-care directives– Palliative care only and hos-pice care tracking
– Site of care tracking5. Quality measures: AmericanSociety of Clinical Oncology,meaningful use, ABC
6. Benchmarking.One key element to executing
the program was the issuance of anurgent care card to patients thatcontained explicit information
about who and when to call withquestions during their care. Pro -minently displayed on the card is,“First call your oncology care physi-cian,” along with the appropriatecontact information, which sums upthe focus on the oncology medicalhome concept: the physician is theprimary point of contact and servesas the hub through which all care isdelivered.
Some of the information learnedat the end of the first year of theoncology medical home initiativewith Anthem BlueCross BlueShield,said Dr Bosserman, included the keysteps for the group and the payer thatreflect the ongoing commitment,related to care and reporting, dataexchange and analytics, and dataexport and accountability. Theyhave identified opportunities forcontinued optimization of care—related to transfusions, generic drugs,and after-hours care—as well asplans to enhance the program inyears 2 and 3 through benchmark-ing, cost reviews, and expandedpatient care opportunities.Dr Bosserman noted that her
group and Anthem have learnedthat a patient-centered, value-basedcancer program can benefit anaccountable care organization andcan provide value and positive careenhancement by leveraging deliverysystems, costs, quality, and a strongpayer partnership.
Oncology Patient-CenteredMedical HomeDr Sprandio provided an update
on the initiatives of his Consultantsin Medical Oncology Group relatedto oncology medical homes on theEast Coast. He noted that “everyphysician who treats a patient is apatient-centered medical home,”and that these programs provide away to formalize the process andhopefully get paid for the care that isbeing provided. Dr Sprandio added that “only
those giving the care can improve it.”And a part of that care improvementprocess will, of necessity, include: • Reengineering the processes ofcare, including information tech -nology and support
• Developing a patient-centric ap proach
• Fixing accountability at the pa -tient-physician locus
Oncology Medical Home
27November 2012 I www.OncPracticeManagement.com I
Continued on page 30
“Every physician whotreats a patient is apatient-centeredmedical home. Onlythose giving the carecan improve it.”
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Get grounded in the basics of oncology practice managementand stay current with resourcesthat cover the latest information on practical day-to-day issues
• Communication, coordination,access, and engagement betweenpatients and payers
• Demonstration of value throughmeasured outcomes and costs
• Improving quality of care andreducing utilization (ie, costs).In addition, Dr Sprandio has
developed a branded oncology med-ical home model called the On -cology Patient Centered MedicalHome (OPCMH) and has foundedOncology Management Services,Inc, to help practices that are inter-ested in using his OPCMH modeldevelop oncology medical homes intheir markets.Oncology Management Services
has partnered with InternationalOncology Solutions to bring theOPCMH concept to medical oncol-ogy practices in southeastern Penn -sylvania. The OPCMH model in -corporates:• Clinical and business methodolo-gies for practice and patient effi-ciencies in the community on -cology practice
• The organizational construct anduse of the oncology medicalhome as a neighbor to the pri-mary care patient-centered med-ical home
• Establishment of the model as abridge for oncologists to use forother care initiatives, includingaccountable care organizations,clinically integrated models, etc
• Establishment of a platform for
pricing oncology in a bundled orepisode-of-care payment.Dr Sprandio provided the updated
results and outcomes from the con-tract his group holds with KeystoneMercy Health Plan, noting that theyhave ongoing conversations withother key payers in the area to sup-port his medical home model.Further expansions of the model
and concept are being explored withstate oncology societies and prac-tices across southeastern Penn -
sylvania. Dr Sprandio is also engagedin discussions with the NationalCommittee for Quality Assuranceand the American College ofPhysicians regarding inclusion of theOPCMH model in their specialtypractice recognition programs.Working in association with Dr
Sprandio, Ms Tofani discussed thebasic elements relevant to building
an oncology medical home. Accord -ing to Ms Tofani, implementing anoncology medical home requires: • Fully implement an oncology-specific electronic medical re -cord system
• Define clinical and financial goals• Secure buy-in from physicians viaefficiencies
• Engage payers and commit to newvalue proposition
• Standardize processes of care• Overlay a clinical decision supportsystem
• Improve clinical communicationand coordination
• Integrate horizontally and vertically• Commit to continuous processimprovement.
Accountable CareOrganizationsAll 3 panelists agreed with the
core value proposition that oncologypatient-centered medical homes arein fact accountable care organiza-tions. Dr Bosserman noted thatsometimes it is a challenge to discussthese concepts with payers early incertain markets, but such discussionsare crucial to establishing a medicalhome in oncology. With a nod to the financial chal-
lenges that are facing communityoncology practices of all sizes acrossthe country, Dr Bosserman said, “Ifwe can’t get payers to talk to us andlook at these innovative systems in the next year, we may not be hereto negotiate with them in 12months.” l
30 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Oncology Medical Home
The Oncology Medical Home: Embodiment of theAmerican Pioneering Spirit…Continued from page 27
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On Cycle 1, Day 1, start with Triple Therapy—EMEND® (fosaprepitant dimeglumine) for Injection, a 5-HT3 antagonist, and a corticosteroid—for first-line prevention of CINV.
For appropriate patients receiving highly emetogenic chemotherapy who are at risk of chemotherapy-induced nausea and vomiting (CINV)
EMEND for Injection, in combination with other antiemetic agents, is indicated in adults for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin. EMEND for Injection has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of EMEND for Injection is not recommended.
Selected Important Safety InformationEMEND for Injection is contraindicated in patients who are hypersensitive to EMEND for Injection, aprepitant, polysorbate 80, or any other components of the product. Known hypersensitivity reactions include flushing, erythema, dyspnea, and anaphylactic reactions. Aprepitant, when administered orally, is a moderate cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitor. Because fosaprepitant is rapidly converted to aprepitant, neither drug should be used concurrently with pimozide or cisapride. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions.EMEND for Injection should be used with caution in patients receiving concomitant medications, including chemotherapy agents, that are primarily metabolized through CYP3A4. Inhibition of CYP3A4 by EMEND for Injection could result in elevated plasma concentrations of these concomitant medications. Conversely, when EMEND for Injection is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated. When EMEND for Injection is used concomitantly with medications that induce CYP3A4 activity, aprepitant plasma concentrations could be reduced, and this may result in decreased efficacy of aprepitant.Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine. In clinical studies, EMEND® (aprepitant) was administered commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents were not adjusted to account for potential drug interactions. In separate pharmacokinetic studies, EMEND did not influence the pharmacokinetics of docetaxel or vinorelbine.Because a small number of patients in clinical studies received the CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular caution and careful monitoring are advised in patients receiving these agents or other chemotherapy agents metabolized primarily by CYP3A4 that were not studied.
Selected Important Safety Information (continued)
There have been isolated reports of immediate hypersensitivity reactions including flushing, erythema, dyspnea, and anaphylaxis during infusion of fosaprepitant. These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy. It is not recommended to reinitiate the infusion in patients who have experienced these symptoms during first-time use.Coadministration of EMEND for Injection with warfarin (a CYP2C9 substrate) may result in a clinically significant decrease in international normalized ratio (INR) of prothrombin time. In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of EMEND for Injection with each chemotherapy cycle.The efficacy of hormonal contraceptives may be reduced during coadministration with and for 28 days after the last dose of EMEND for Injection. Alternative or backup methods of contraception should be used during treatment with and for 1 month after the last dose of EMEND for Injection.Chronic continuous use of EMEND for Injection for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profile may change during chronic continuous use. In clinical trials of EMEND® (aprepitant) in patients receiving highly emetogenic chemotherapy, the most common adverse events reported at a frequency greater than with standard therapy, and at an incidence of 1% or greater were hiccups (4.6% EMEND vs 2.9% standard therapy), asthenia/fatigue (2.9% vs 1.6%), increased ALT (2.8% vs 1.5%), increased AST (1.1% vs 0.9%), constipation (2.2% vs 2.0%), dyspepsia (1.5% vs 0.7%), diarrhea (1.1% vs 0.9%), headache (2.2% vs 1.8%), and anorexia (2.0% vs 0.5%).In a clinical trial evaluating safety of the 1-day regimen of EMEND for Injection 150 mg compared with the 3-day regimen of EMEND, the safety profile was generally similar to that seen in prior highly emetogenic chemotherapy studies with aprepitant. However, infusion-site reactions occurred at a higher incidence in patients who received fosaprepitant (3.0%) than in those who received aprepitant (0.5%). Those infusion-site reactions included infusion-site erythema, infusion-site pruritus, infusion-site pain, infusion-site induration, and infusion-site thrombophlebitis.
Please see the adjacent Brief Summary of the Prescribing Information.
In another chemotherapy-induced nausea and vomiting (CINV) study, Stevens-Johnson syndrome was reported as a serious adverse reaction in a patient receiving aprepitant with cancer chemotherapy.
The adverse-experience profiles in the multiple-cycle extensions of HEC studies for up to 6 cycles of chemotherapy were similar to that observed in Cycle 1.
Fosaprepitant: In an active-controlled clinical study in patients receiving HEC, safety was evaluated for 1,143 patients receiving the 1-day regimen of EMEND for Injection 150 mg compared with 1,169 patients receiving the 3-day regimen of EMEND. The safety profile was generally similar to that seen in prior HEC studies with aprepitant. However, infusion-site reactions occurred at a higher incidence in patients in the fosaprepitant group (3.0%) compared with those in the aprepitant group (0.5%). The reported infusion-site reactions included infusion-site erythema, infusion-site pruritus, infusion-site pain, infusion-site induration, and infusion-site thrombophlebitis.
The following additional adverse reactions occurred with fosaprepitant 150 mg and were not reported with the oral aprepitant regimen in the corresponding section above:
General disorders and administration site conditions: infusion-site erythema, infusion-site pruritus, infusion-site induration, infusion-site pain
Other Studies: Angioedema and urticaria were reported as serious adverse reactions in a patient receiving aprepitant in a non-CINV/non-PONV study.
Postmarketing Experience: The following adverse reactions have been identified during postapproval use of fosaprepitant and aprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug.
Immune system disorders: hypersensitivity reactions including anaphylactic reactions
DRUG INTERACTIONS
Drug interactions following administration of fosaprepitant are likely to occur with drugs that interact with oral aprepitant.
Aprepitant is a substrate, a moderate inhibitor, and an inducer of CYP3A4 when administered as a 3-day antiemetic dosing regimen for CINV. Aprepitant is also an inducer of CYP2C9.
Fosaprepitant 150 mg, given as a single dose, is a weak inhibitor of CYP3A4 and does not induce CYP3A4. Fosaprepitant and aprepitant are unlikely to interact with drugs that are substrates for the P-glycoprotein transporter.
The following information was derived from data with oral aprepitant, 2 studies conducted with fosaprepitant and oral midazolam, and 1 study conducted with fosaprepitant and dexamethasone.
Effect of Fosaprepitant/Aprepitant on the Pharmacokinetics of Other Agents: CYP3A4 Substrates: Aprepitant, as a moderate inhibitor of CYP3A4, and fosaprepitant 150 mg, as a weak inhibitor of CYP3A4, can increase plasma concentrations of concomitantly coadministered oral medications that are metabolized through CYP3A4 [see Contraindications].
5-HT3 antagonists: In clinical drug interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).
Corticosteroids: Dexamethasone: Fosaprepitant 150 mg administered as a single intravenous dose on Day 1 increased the AUC0–24hr of dexamethasone, administered as a single 8-mg oral dose on Days 1, 2, and 3, by approximately 2-fold on Days 1 and 2. The oral dexamethasone dose on Days 1 and 2 should be reduced by approximately 50% when coadministered with fosaprepitant 150 mg I.V. on Day 1.
An oral aprepitant regimen of 125 mg on Day 1 and 80 mg/day on Days 2 through 5, coadministered with 20-mg oral dexamethasone on Day 1 and 8-mg oral dexamethasone on Days 2 through 5, increased the AUC of dexamethasone by 2.2-fold on Days 1 and 5. The oral dexamethasone doses should be reduced by approximately 50% when coadministered with a regimen of fosaprepitant 115 mg followed by aprepitant.
Methylprednisolone: An oral aprepitant regimen of 125 mg on Day 1 and 80 mg/day on Days 2 and 3 increased the AUC of methylprednisolone by 1.34-fold on Day 1 and by 2.5-fold on Day 3, when methylprednisolone was coadministered intravenously as 125 mg on Day 1 and orally as 40 mg on Days 2 and 3. The intravenous methylprednisolone dose should be reduced by approximately 25% and the oral methylprednisolone dose should be reduced by approximately 50% when coadministered with a regimen of fosaprepitant 115 mg followed by aprepitant.
Chemotherapeutic agents: Docetaxel: In a pharmacokinetic study, oral aprepitant (CINV regimen) did not influence the pharmacokinetics of docetaxel [see Warnings and Precautions].
Vinorelbine: In a pharmacokinetic study, oral aprepitant (CINV regimen) did not influence the pharmacokinetics of vinorelbine to a clinically significant degree [see Warnings and Precautions].
Oral contraceptives: When oral aprepitant, ondansetron, and dexamethasone were coadministered with an oral contraceptive containing ethinyl estradiol and norethindrone, the trough concentrations of both ethinyl estradiol and norethindrone were reduced by as much as 64% for 3 weeks posttreatment.
The coadministration of fosaprepitant or aprepitant may reduce the efficacy of hormonal contraceptives (these can include birth control pills, skin patches, implants, and certain IUDs) during and for 28 days after administration of the last dose of fosaprepitant or aprepitant. Alternative or backup methods of contraception should be used during treatment with and for 1 month following the last dose of fosaprepitant or aprepitant.
Midazolam: Interactions between aprepitant or fosaprepitant and coadministered midazolam are listed below (increase is indicated as , decrease as , no change as ):
Fosaprepitant 150 mg on Day 1, oral midazolam 2 mg on Days 1 and 4: AUC 1.8-fold on Day 1 and AUC on Day 4
Fosaprepitant 100 mg on Day 1, oral midazolam 2 mg: oral midazolam AUC 1.6-fold
Oral aprepitant 125 mg on Day 1 and 80 mg on Days 2 to 5, oral midazolam 2 mg SD on Days 1 and 5: oral midazolam AUC 2.3-fold on Day 1 and 3.3-fold on Day 5
Oral aprepitant 125 mg on Day 1 and 80 mg on Days 2 and 3, intravenous midazolam 2 mg prior to 3-day
Brief Summary of the Prescribing Information for INDICATIONS AND USAGE EMEND for Injection is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in adults for use in combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
Limitations of Use: EMEND for Injection has not been studied for the treatment of established nausea and vomiting.
Chronic continuous administration is not recommended [see Warnings and Precautions].
CONTRAINDICATIONS
Hypersensitivity: EMEND for Injection is contraindicated in patients who are hypersensitive to EMEND for Injection, aprepitant, polysorbate 80, or any other components of the product. Known hypersensitivity reactions include flushing, erythema, dyspnea, and anaphylactic reactions [see Adverse Reactions].
Concomitant Use With Pimozide or Cisapride: Aprepitant, when administered orally, is a moderate cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitor following the 3-day antiemetic dosing regimen for CINV. Since fosaprepitant is rapidly converted to aprepitant, do not use fosaprepitant concurrently with pimozide or cisapride. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions [see Drug Interactions].
WARNINGS AND PRECAUTIONS
CYP3A4 Interactions: Fosaprepitant is rapidly converted to aprepitant, which is a moderate inhibitor of CYP3A4 when administered as a 3-day antiemetic dosing regimen for CINV. Fosaprepitant should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4. Inhibition of CYP3A4 by aprepitant or fosaprepitant could result in elevated plasma concentrations of these concomitant medications. When fosaprepitant is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated. When aprepitant is used concomitantly with medications that induce CYP3A4 activity, aprepitant plasma concentrations could be reduced, and this may result in decreased efficacy of aprepitant [see Drug Interactions].
Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine. In clinical studies, the oral aprepitant regimen was administered commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents were not adjusted to account for potential drug interactions.
In separate pharmacokinetic studies, no clinically significant change in docetaxel or vinorelbine pharmacokinetics was observed when the oral aprepitant regimen was coadministered. Due to the small number of patients in clinical studies who received the CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular caution and careful monitoring are advised in patients receiving these agents or other chemotherapy agents metabolized primarily by CYP3A4 that were not studied [see Drug Interactions].
Hypersensitivity Reactions: Isolated reports of immediate hypersensitivity reactions including flushing, erythema, dyspnea, and anaphylaxis have occurred during infusion of fosaprepitant. These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy.Reinitiation of the infusion is not recommended in patients who experience these symptoms during first-time use.
Coadministration With Warfarin (a CYP2C9 substrate): Coadministration of fosaprepitant or aprepitant with warfarin may result in a clinically significant decrease in international normalized ratio (INR) of prothrombin time. In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of fosaprepitant with each chemotherapy cycle [see Drug Interactions].
Coadministration With Hormonal Contraceptives: Upon coadministration with fosaprepitant or aprepitant, the efficacy of hormonal contraceptives may be reduced during and for 28 days following the last dose of either fosaprepitant or aprepitant. Alternative or backup methods of contraception should be used during treatment with and for 1 month following the last dose of fosaprepitant or aprepitant [see Drug Interactions].
Chronic Continuous Use: Chronic continuous use of EMEND for Injection for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profile may change during chronic continuous use.
ADVERSE REACTIONS
Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse-reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Since EMEND for Injection is converted to aprepitant, those adverse reactions associated with aprepitant might also be expected to occur with EMEND for Injection.
The overall safety of fosaprepitant was evaluated in approximately 1,100 individuals and the overall safety of aprepitant was evaluated in approximately 6,500 individuals.
Oral Aprepitant: Highly Emetogenic Chemotherapy (HEC): In 2 well-controlled clinical trials in patients receiving highly emetogenic cancer chemotherapy, 544 patients were treated with aprepitant during Cycle 1 of chemotherapy and 413 of these patients continued into the multiple-cycle extension for up to 6 cycles of chemotherapy. Oral aprepitant was given in combination with ondansetron and dexamethasone.
In Cycle 1, adverse reactions were reported in approximately 17% of patients treated with the aprepitant regimen compared with approximately 13% of patients treated with standard therapy. Treatment was discontinued due to adverse reactions in 0.6% of patients treated with the aprepitant regimen compared with 0.4% of patients treated with standard therapy.
The most common adverse reactions reported in patients treated with the aprepitant regimen (n=544) with an incidence of >1% and greater than with standard therapy (n=550), respectively, are listed below:
Respiratory system: hiccups 4.6 vs 2.9
Body as a whole/Site unspecified: asthenia/fatigue 2.9 vs 1.6
Investigations: increased ALT 2.8 vs 1.5, increased AST 1.1 vs 0.9
Digestive system: constipation 2.2 vs 2.0, dyspepsia 1.5 vs 0.7, diarrhea 1.1 vs 0.9
Nervous system: headache 2.2 vs 1.8
Metabolism and nutrition: anorexia 2.0 vs 0.5
A listing of adverse reactions in the aprepitant regimen (incidence <1%) that occurred at a greater incidence than with standard therapy are presented in the Less Common Adverse Reactions subsection below.
In an additional active-controlled clinical study in 1,169 patients receiving aprepitant and HEC, the adverse-experience profile was generally similar to that seen in the other HEC studies with aprepitant.
Less Common Adverse Reactions: Adverse reactions reported in either HEC or moderately emetogenic chemotherapy (MEC) studies in patients treated with the aprepitant regimen with an incidence of <1% and greater than with standard therapy are listed below.
Infection and infestations: candidiasis, staphylococcal infection
Blood and lymphatic system disorders: anemia, febrile neutropenia
Metabolism and nutrition disorders: weight gain, polydipsia
regimen of aprepitant and on Days 4, 8, and 15: intravenous midazolam AUC 25% on Day 4, AUC 19% on Day 8, and AUC 4% on Day 15
Oral aprepitant 125 mg, intravenous midazolam 2 mg given 1 hour after aprepitant: intravenous midazolam AUC 1.5-fold
A difference of less than 2-fold increase of midazolam AUC was not considered clinically important.
The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) should be considered when coadministering these agents with fosaprepitant or aprepitant.
CYP2C9 Substrates (Warfarin, Tolbutamide): Warfarin: A single 125-mg dose of oral aprepitant was administered on Day 1 and 80 mg/day on Days 2 and 3 to healthy subjects who were stabilized on chronic warfarin therapy. Although there was no effect of oral aprepitant on the plasma AUC of R(+) or S(–) warfarin determined on Day 3, there was a 34% decrease in S(–) warfarin trough concentration accompanied by a 14% decrease in the prothrombin time (reported as INR) 5 days after completion of dosing with oral aprepitant. In patients on chronic warfarin therapy, the prothrombin time (INR) should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of fosaprepitant with each chemotherapy cycle.
Tolbutamide: Oral aprepitant, when given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, decreased the AUC of tolbutamide by 23% on Day 4, 28% on Day 8, and 15% on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of the 3-day regimen of oral aprepitant and on Days 4, 8, and 15.
Effect of Other Agents on the Pharmacokinetics of Aprepitant: Aprepitant is a substrate for CYP3A4; therefore, coadministration of fosaprepitant or aprepitant with drugs that inhibit CYP3A4 activity may result in increased plasma concentrations of aprepitant. Consequently, concomitant administration of fosaprepitant or aprepitant with strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir) should be approached with caution. Because moderate CYP3A4 inhibitors (eg, diltiazem) result in a 2-fold increase in plasma concentrations of aprepitant, concomitant administration should also be approached with caution.
Aprepitant is a substrate for CYP3A4; therefore, coadministration of fosaprepitant or aprepitant with drugs that strongly induce CYP3A4 activity (eg, rifampin, carbamazepine, phenytoin) may result in reduced plasma concentrations and decreased efficacy.
Ketoconazole: When a single 125-mg dose of oral aprepitant was administered on Day 5 of a 10-day regimen of 400 mg/day of ketoconazole, a strong CYP3A4 inhibitor, the AUC of aprepitant increased approximately 5-fold and the mean terminal half-life of aprepitant increased approximately 3-fold. Concomitant administration of fosaprepitant or aprepitant with strong CYP3A4 inhibitors should be approached cautiously.
Rifampin: When a single 375-mg dose of oral aprepitant was administered on Day 9 of a 14-day regimen of 600 mg/day of rifampin, a strong CYP3A4 inducer, the AUC of aprepitant decreased approximately 11-fold and the mean terminal half-life decreased approximately 3-fold.
Coadministration of fosaprepitant or aprepitant with drugs that induce CYP3A4 activity may result in reduced plasma concentrations and decreased efficacy.
Additional Interactions: Diltiazem: In a study in 10 patients with mild to moderate hypertension, intravenous infusion of 100 mg of fosaprepitant with diltiazem 120 mg 3 times daily resulted in a 1.5-fold increase of aprepitant AUC and a 1.4-fold increase in diltiazem AUC. It also resulted in a small but clinically meaningful further maximum decrease in diastolic blood pressure (mean [SD] of 24.3 [±10.2] mmHg with fosaprepitant vs 15.6 [±4.1] mmHg without fosaprepitant) and resulted in a small further maximum decrease in systolic blood pressure (mean [SD] of 29.5 [±7.9] mmHg with fosaprepitant vs 23.8 [±4.8] mmHg without fosaprepitant), which may be clinically meaningful, but did not result in a clinically meaningful further change in heart rate or PR interval beyond those changes induced by diltiazem alone.
In the same study, administration of aprepitant once daily as a tablet formulation comparable to 230 mg of the capsule formulation, with diltiazem 120 mg 3 times daily for 5 days, resulted in a 2-fold increase of aprepitant AUC and a simultaneous 1.7-fold increase of diltiazem AUC. These pharmacokinetic effects did not result in clinically meaningful changes in ECG, heart rate, or blood pressure beyond those changes induced by diltiazem alone.
Paroxetine: Coadministration of once-daily doses of aprepitant as a tablet formulation comparable to 85 mg or 170 mg of the capsule formulation, with paroxetine 20 mg once daily, resulted in a decrease in AUC by ap-proximately 25% and Cmax by approximately 20% of both aprepitant and paroxetine.
USE IN SPECIFIC POPULATIONS
Pregnancy: Teratogenic effects: Pregnancy Category B: In the reproduction studies conducted with fosaprepitant and aprepitant, the highest systemic exposures to aprepitant were obtained following oral administration of aprepitant. Reproduction studies performed in rats at oral doses of aprepitant of up to 1000 mg/kg twice daily (plasma AUC0–24hr of 31.3 mcg hr/mL, about 1.6 times the human exposure at the recommended dose) and in rabbits at oral doses of up to 25 mg/kg/day (plasma AUC0–24hr of 26.9 mcg hr/mL, about 1.4 times the human exposure at the recommended dose) revealed no evidence of impaired fertility or harm to the fetus due to aprepitant. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Aprepitant is excreted in the milk of rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for possible serious adverse reactions in nursing infants from aprepitant and because of the potential for tumorigenicity shown for aprepitant in rodent carcinogenicity studies, 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: Safety and effectiveness of EMEND for Injection in pediatric patients have not been established.
Geriatric Use: In 2 well-controlled CINV clinical studies, of the total number of patients (N=544) treated with oral aprepitant, 31% were 65 and over, while 5% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment in the elderly is not necessary.
Patients With Severe Hepatic Impairment: There are no clinical or pharmacokinetic data in patients with severe hepatic impairment (Child-Pugh score >9). Therefore, caution should be exercised when fosaprepitant or aprepitant is administered in these patients.
OVERDOSAGE
There is no specific information on the treatment of overdosage with fosaprepitant or aprepitant.
In the event of overdose, fosaprepitant and/or oral aprepitant should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of aprepitant, drug-induced emesis may not be effective. Aprepitant cannot be removed by hemodialysis.
Thirteen patients in the randomized controlled trial of EMEND for Injection received both fosaprepitant 150 mg and at least one dose of oral aprepitant, 125 mg or 80 mg. Three patients reported adverse reactions that were similar to those experienced by the total study population.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies were conducted in Sprague-Dawley rats and in CD-1 mice for 2 years. In the rat carcinogenicity studies, animals were treated with oral doses ranging from 0.05 to 1000 mg/kg twice daily. The highest dose produced a systemic exposure to aprepitant (plasma AUC0–24hr) of 0.7 to 1.6 times the human exposure (AUC0–24hr=19.6 mcg hr/mL) at the recommended dose of 125 mg/day. Treatment with aprepitant at doses of 5 to 1000 mg/kg twice daily caused an increase in the incidences of thyroid follicular cell adenomas and carcinomas in male rats. In female rats, it produced hepatocellular adenomas at 5 to 1000 mg/kg twice daily and hepatocellular carcinomas and thyroid follicular cell adenomas at 125 to 1000 mg/kg twice daily. In the mouse carcinogenicity studies, the animals
were treated with oral doses ranging from 2.5 to 2000 mg/kg/day. The highest dose produced a systemic exposure of about 2.8 to 3.6 times the human exposure at the recommended dose. Treatment with aprepitant produced skin fibrosarcomas at 125 and 500 mg/kg/day doses in male mice. Carcinogenicity studies were not conducted with fosaprepitant.
Aprepitant and fosaprepitant were not genotoxic in the Ames test, the human lymphoblastoid cell (TK6) mutagenesis test, the rat hepatocyte DNA strand break test, the Chinese hamster ovary (CHO) cell chromosome aberration test and the mouse micronucleus test.
Fosaprepitant, when administered intravenously, is rapidly converted to aprepitant. In the fertility studies conducted with fosaprepitant and aprepitant, the highest systemic exposures to aprepitant were obtained following oral administration of aprepitant. Oral aprepitant did not affect the fertility or general reproductive performance of male or female rats at doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended human dose and exposure in female rats at about 1.6 times the human exposure).
PATIENT COUNSELING INFORMATION
[See FDA-Approved Patient Labeling]: Physicians should instruct their patients to read the patient package insert before starting therapy with EMEND for Injection and to reread it each time the prescription is renewed.
Patients should follow the physician’s instructions for the regimen of EMEND for Injection.
Allergic reactions, which may be sudden and/or serious, and may include hives, rash, itching, redness of the face/skin, and may cause difficulty in breathing or swallowing, have been reported. Physicians should instruct their patients to stop using EMEND and call their doctor right away if they experience an allergic reaction. In addition, severe skin reactions may occur rarely.
Patients who develop an infusion-site reaction such as erythema, edema, pain, or thrombophlebitis should be instructed on how to care for the local reaction and when to seek further evaluation.
EMEND for Injection may interact with some drugs, including chemotherapy; therefore, patients should be advised to report to their doctor the use of any other prescription or nonprescription medication or herbal products.
Patients on chronic warfarin therapy should be instructed to have their clotting status closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of fosaprepitant with each chemotherapy cycle.
Administration of EMEND for Injection may reduce the efficacy of hormonal contraceptives. Patients should be advised to use alternative or backup methods of contraception during treatment with and for 1 month following the last dose of fosaprepitant or aprepitant.
For detailed information, please read the Prescribing Information.
Dallas, TX—Can we create a systemof care that will demonstrate cost-effectiveness and change the wayoncology is being practiced? Thiswas the focus of several provider-driven innovative solutions dis-cussed at the 2012 Cancer CenterBusiness Summit.We have learned that we must
collect and share information, devel-op benchmarks, and make themactionable. The panelists described 4 distinct oncology models that arebeing developed toward effectivecancer management.
Innovative OncologyBusiness Solutions:Oncology Medical HomesBarbara L. McAneny, MD, Chief
Executive Officer, New MexicoOncology Hematology Consultants,Albuquerque, described a 3-year,$19.7-million grant that was recent-ly awarded by the Centers forMedicare & Medicaid Services(CMS) to a new company that shecreated named Innovative OncologyBusiness Solutions. This grant willsupport the infrastructure and soft-ware to develop community oncolo-gy medical homes in New Mexico,Florida, Georgia, Maine, Ohio,Pennsylvania, and Tennessee. “We seem to have learned in
oncology that good practices have to be designed around patient flowand building processes that managepatients and their care. Programsthat focus solely on drugs and cut-ting costs become self-limiting,” DrMcAneny stated.A bundled payment model will be
established to pay the physicians aset amount to manage their patients.In addition, the program will devel-op a personalized medicine program
for Medicare patients with cancerthat will include genetic testing.Another key feature of the pro-
gram is the use of triage processesthat integrate nurse care managerswith the practice. The results from these practices
will be compared with data from CMS
on how patients are being treated atmajor cancer hospitals across thecountry, with the expectation thatthe community practices would showthe same quality of care as CMS, orbetter, but at a lower cost. Dr McAneny observed that “part
of this transitional process is going tobe engaging and teaching patientshow and when to contact their physi-cian to better manage clinical out-comes.” In addition, she noted thatthe oncology community will “alsohave to come up with specific mea -
sures of the patient experience—thewhole experience, not just the clini-cal outcomes and experience. Thetop 2 complaints we hear from pa -tients are ‘we have been waiting toolong for care,’ and ‘no one listened tome, and what I was trying to say.’”
Engaging the Patient:Cancer Treatment Centersof America Cancer care at the Cancer Treat -
ment Centers of America (CTCA)in Schaumburg, IL, is focused onengaging the oncology consumer,according to Stephen B. Bonner,President and Chief ExecutiveOfficer of CTCA. Patients self-referto CTCA for treatment, and MrBonner described the manner inwhich CTCA engages the oncologyconsumer in making informed choic-es about their care. He believes that oncology patients
are hungry for information abouttheir choices, their treatments, andabout side effects and how to man -age them. CTCA has a widespreaddirect-to-consumer focus, and it pub-lishes self-reported quality results onits website, by cancer type and site.Another CTCA initiative is
transparent pricing. Many of theirpatients travel up to 300 miles oneway for care, and they appreciate thework that CTCA has done to build abundled pricing for the evaluationservices, including guarantees for thetiming of the evaluation and provi-sion of a written care plan. Bundled pricing for treatment is
also in development. CTCA isunderwriting research to allow con-sumers to define quality in oncology,and it is identifying meaningfulfuture metrics for quality measure-ment in oncology. Mr Bonner
34 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Oncology Practice Innovation
Cost-Effective Cancer Care: Thoughts from Leading PhysiciansBy Gail Thompson
“We seem to havelearned in oncologythat good practiceshave to be designedaround patient flowand building processes that managepatients and theircare. Programs thatfocus solely on drugsand cutting costsbecome self-limiting.”—Barbara L. McAneny, MD
expects that “Real-world care mod-els and outcomes and payment mod-els will eventually be more powerfulin determining effective and appro-priate care than clinical trials.”
Value-Based CancerNetwork: John TheurerCancer CenterAndrew L. Pecora, MD, FACP,
CPE, Chief Innovations Officer andProfessor and Vice President ofCancer Services, John TheurerCancer Center at HackensackUniversity Medical Center, NJ, de -scribed an oncology model for clini-cal integration by the establishmentof Value-Based Cancer Network. In New Jersey, 80 like-minded
oncologists (with dozens more soonto join) have designed RegionalCancer Care Associates, with thegoal of oncologists taking action tocoordinate efforts with health plansand drug companies to provide qual-ity cancer care to patients, whilereducing the cost of care. Each prac-tice will retain autonomy (the physi-cians will be able to make specificmedical decisions for their individ-ual patients), but a doctor-dominat-ed board of trustees will standardizethe care and will identify the relativeeffectiveness of chemotherapies orthe number of diagnostic tests thatwill be appropriate. In the face of escalating costs of
cancer care as a result of the growingpopulation and because people areliving longer and are getting cancer,models such as the Value-BasedCancer Network are focused onrational care by providing the treat-ments that offer best survival rates,at a reasonable cost.
Hospital–PhysicianPartnership Model: The West ClinicErich A. Mounce, MHA, Chief
Executive Officer, The West Clinic,Memphis, TN, and Lee Schwart z -berg, MD, FACP, Medical Director,
The West Clinic, and Chief, Divisionof Hematology/Oncology, Universityof Tennessee Health Science Center,Memphis, described how The WestClinic has continued to evolve from a1-stop, quick, efficient, and economi-cal community oncology practice.
The West Clinic has always beenat the center of cancer care innova-tion and quality, including being afounder of the Cancer Clinics ofExcellence and now participating inan episode-of-care payment modelwith UnitedHealthcare. Recognizing that there are limita-
tions to the cost-savings that a singlepractice can achieve without touch-ing on huge cost drivers embeddedelsewhere along the entire spectrumof care delivered outside of its offices,The West Clinic developed a requestfor proposal for possible partnersamong the hospitals that were in itslocal market. One partner was select-ed because of the presence of a sharedvision and willingness to move for-ward with initiatives and a desire totake better care of the community.This partnership is becoming thevehicle to get better access to datacovering the full continuum of care. Dollars are now being saved
through improved drug pricing pro-grams. (The hospital partner partici-pates as a designated-services hospi-tal and receives access to drug pricingprograms that allow the practice andthe hospital partner to serve the un -insured members of the community.)These programs are being used forunfunded services that did not previ-ously exist—patient navigation,physical therapy, and building a mul-tidisciplinary approach to cancercare. The partnership includes inte-gration of research. Part of the reason The West Clinic
decided to expand its services and toinclude a partner was that its referralbase was being captured by a com-peting hospital in the marketplace.A key element of the partnership is amanagement agreement: The WestClinic’s physicians manage theentire service line now. Mr Mounce said that “engaging
senior leadership is imperative. TheChief Executive of Operations andthe Chief Financial Officer of this 7-hospital system sit with us monthlyas we develop programs.” Out of concern for the challenges
that the patients and the payers mayface that arise when private practicesshift to hospital-based programs, the hospital and The West Clinicapproached all payers collaborativelyto figure out how they could bill as a hospital provider, but under thephysician setting contracts. This innovation allowed the
patients’ copays and the patient andhealth plan billings to remain thesame and to not rise as a result of thepartnership. The hospital partnerwalked away from millions of dollarsin potential higher billings by agree-ing to this component of the part-nership, and this then allowed deep-er engagement of patients andpatient management. The next steps will include moving
toward development of quality out-comes and patient outcomes that willfurther drive quality discussions. l
Oncology Practice Innovation
35November 2012 I www.OncPracticeManagement.com I
“Engaging seniorleadership isimperative. The ChiefExecutive ofOperations and theChief Financial Officerof this 7-hospitalsystem sit with usmonthly as wedevelop programs.”
—Erich A. Mounce, MHA
36 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Drug Coding
Supplied by RJ Health Systems
Medications Used for the Treatment of Multiple MyelomaThe following sections will assist healthcareprofessionals and payers by providing appropri-ate coding and billing information associatedwith the management of multiple myeloma.
The following sections include:• Associated ICD-9-CM codes used forthe classification of multiple myelomar
• Drugs that have been FDA-approved inthe treatment of multiple myeloma
• Drugs that are Compendia listed for off-label use for multiple myeloma based onclinical studies that suggest beneficialuse in some cases.Please note: If a check mark appears inthe FDA column it will NOT appear inthe Compendia off-label use column
aWhen billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code in Column 24D and the drug name,strength, and NDC (National Drug Code) in Box 19 to ensure appropriate reimbursement.
ReferencesHCPCS Level II Expert 2012 • Current Procedural Terminology (CPT ®), 2012 (CPT® copyright 2012 American Medical Association. All rightsreserved. CPT® is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Vol 1, 2, 2012 • FDA-approved indication (from product prescribing information) • Compendia references available upon request • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Rocky Hill, Connecticut • CMS (Centers for Medicare & Medicaid Services).
CPT® indicates Current Procedural Terminology; HCPCS, Healthcare Common Procedure Coding System.
30 Cold Spring Road, Rocky Hill, CT 06067 T: (860) 563-1223 • F: (860) 563-1650 • www.RJHealthSystems.com
This information was supplied by:
RJ Health SystemsThe Creators of ReimbursementCodes.com
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
Dallas, TX—Many hospitals andphysician groups are courting now,exploring the possible option ofphysicians going hospital-based.There are many drivers leading tothe dance: financial pressures, anexcess of administrative burden ondoctors who just want to practicemedicine, an aging physician popu-lation, an aging patient populationthat will need more care, and chang-ing policy and reimbursement mod-els that appear daunting to the com-munity oncologist. At the 2012 Cancer Center
Business Summit, 3 oncology prac-tice executives presented some ofthe daily details that can be forgot-ten during the hospital–physicianintegration.
Issues to Consider Beforethe Contract Is Signed Teri U. Guidi, MBA, FAAMA,
President and Chief ExecutiveOfficer of the Oncology ManagementConsulting Group, Pipersville, PA,opened with a discussion of the day-to-day issues listed below that maynot be considered in the heat of con-tract negotiations with a hospital thatmay become unwelcome surprisesonce the deal is done.
Control. The shift in control isoften a surprise, both to the physi-cians and to the staff. Who is makingthe daily operations decisions now,and how much input do the physi-cians have compared with what theywere used to having in private prac-tice? Who will be making the hiringand the firing decisions? Other pres-sure points to watch include labora-
tory and pharmacy turnaroundtimes, check-in and registrationprocesses and timing, scheduling ofvisit lengths, and distribution of newand established visits.
Performance and compensation.There may be unmatched expecta-tions between the hospital and thephysicians that come to light afterthe deal is done, or that may evensurface 2 to 3 years later when the
original contract comes up for re -newal. Is there agreement on produc-tivity targets, management duties,expectations for corporate citizen-ship duties, and other expectations?Has physician compensation beenclearly defined with regard to thebase and basis, the timing of revi-sions, the amounts for ceilings andfloors, and any additional incentives? Compensation issues may arise for
staff as well, regarding pay scales,bonus policies, and seniority statusfor transferred staff. Will there beadditional nononcology duties ex -pected of staff and physicians, andwhat impact will these have on theprocess and flow of normal patientcare in the acquired practice?
Billing and collecting. Practices areoften much more efficient at billingoncology claims than hospital staff,but the transition may not be easy.The oncology practice staff under-stands physician practice claim formsand rules, but hospital billing formsand billing constructs are different. Ms Guidi warns that “payer con-
tracts [for the practice and the hospi-tal] are not likely to be parallel…itmay be a challenge to get cleanclaims out the door and to collect onthem.” That can affect the cash flowfor the new entity.
Technology. There may be chal-lenges related to a different type oftechnology used by either institu-tion, such as when a practice billselectronically and the hospital is stillpaper-based. Or the hospital mayhave a completely new billing sys-
40 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Hospital–Physician Contracting
The Nuts and Bolts of Physician and Hospital Practice Arrangements from the Oncology Front LineBy Gail Thompson
Continued on page 43
“Payer contracts [forthe practice and thehospital] are not likelyto be parallel…it maybe a challenge to getclean claims out the door and to collect on them.”—Teri U. Guidi, MBA, FAAMA
Connecting to Access, Reimbursement, Education, and Support for Jakafi®.
IncyteCARES about you.
Visit www.IncyteCARES.com or call 1-855-4-Jakafi (855-452-5234), Monday−Friday, 8 AM – 8 PM ET, to learn more about Incyte’s patient
support program.
Helping patients with intermediate or high-risk myelofibrosis (MF) stay connected to care
Patients living with MF face many challenges. IncyteCARES is a program created by Incyte to connect patients with MF, who qualify for the program, to continuing support and resources during their treatment with Jakafi®.
Treatment with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia
Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections
The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache
IncyteCARES helps care for patients with MF
Patient education and support
Educational information to help teach patients about MF and Jakafi
a Presented values are worst Grade values regardless of baselineb National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0Additional Data from the Placebo-controlled Study 25.2% of patients treated with Jakafi and 7.3% ofpatients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine trans-aminase (ALT). The incidence of greater than or equal to Grade 2 elevations was 1.9% for Jakafi with 1.3%Grade 3 and no Grade 4 ALT elevations. 17.4% of patients treated with Jakafi and 6.0% of patients treatedwith placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase(AST). The incidence of Grade 2 AST elevations was 0.6% for Jakafi with no Grade 3 or 4 AST elevations.16.8% of patients treated with Jakafi and 0.7% of patients treated with placebo developed newly occurring orworsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was 0.6% forJakafi with no Grade 3 or 4 cholesterol elevations.DRUG INTERACTIONS Drugs That Inhibit or Induce Cytochrome P450 Enzymes Ruxolitinibis predominantly metabolized by CYP3A4. Strong CYP3A4 inhibitors: The Cmax and AUC of ruxolitinibincreased 33% and 91%, respectively, with Jakafi administration (10 mg single dose) following ketoconazole200 mg twice daily for four days, compared to receiving Jakafi alone in healthy subjects. The half-life was alsoprolonged from 3.7 to 6.0 hours with concurrent use of ketoconazole. The change in the pharmacodynamicmarker, pSTAT3 inhibition, was consistent with the corresponding ruxolitinib AUC following concurrent admin-istration with ketoconazole. When administering Jakafi with strong CYP3A4 inhibitors a dose reduction isrecommended [see Dosage and Administration (2.4) in Full Prescribing Information]. Patients should beclosely monitored and the dose titrated based on safety and efficacy. Mild or moderate CYP3A4 inhibitors:There was an 8% and 27% increase in the Cmax and AUC of ruxolitinib, respectively, with Jakafi administration(10 mg single dose) following erythromycin, a moderate CYP3A4 inhibitor, at 500 mg twice daily for 4 days,compared to receiving Jakafi alone in healthy subjects. The change in the pharmacodynamic marker, pSTAT3inhibition was consistent with the corresponding exposure information. No dose adjustment is recommendedwhen Jakafi is coadministered with mild or moderate CYP3A4 inhibitors (eg, erythromycin). CYP3A4inducers: The Cmax and AUC of ruxolitinib decreased 32% and 61%, respectively, with Jakafi administration(50 mg single dose) following rifampin 600 mg once daily for 10 days, compared to receiving Jakafi alone inhealthy subjects. In addition, the relative exposure to ruxolitinib’s active metabolites increased approximately100%. This increase may partially explain the reported disproportionate 10% reduction in the pharmaco-dynamic marker pSTAT3 inhibition. No dose adjustment is recommended when Jakafi is coadministered witha CYP3A4 inducer. Patients should be closely monitored and the dose titrated based on safety and efficacy.USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies of Jakafi in pregnant women. In embryofetal toxicity studies, treatment withruxolitinib resulted in an increase in late resorptions and reduced fetal weights at maternally toxic doses.Jakafi should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at dosesof 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There was no evidence of terato-genicity. However, decreases of approximately 9% in fetal weights were noted in rats at the highest andmaternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 timesthe clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weightsof approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. Ina pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implan-tation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups forfertility indices or for maternal or embryofetal survival, growth and development parameters at the highestdose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily).Nursing Mothers It is not known whether ruxolitinib is excreted in human milk. Ruxolitinib and/or itsmetabolites were excreted in the milk of lactating rats with a concentration that was 13-fold the maternalplasma. Because many drugs are excreted in human milk and because of the potential for serious adversereactions in nursing infants from Jakafi, a decision should be made to discontinue nursing or to discontinuethe drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effec-tiveness of Jakafi in pediatric patients have not been established. Geriatric Use Of the total number ofmyelofibrosis patients in clinical studies with Jakafi, 51.9% were 65 years of age and older. No overall differ-ences in safety or effectiveness of Jakafi were observed between these patients and younger patients. RenalImpairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study inhealthy subjects [CrCl 72-164 mL/min (N=8)] and in subjects with mild [CrCl 53-83 mL/min (N=8)],moderate [CrCl 38-57 mL/min (N=8)], or severe renal impairment [CrCl 15-51 mL/min (N=8)]. Eight (8)additional subjects with end stage renal disease requiring hemodialysis were also enrolled. The pharmaco-kinetics of ruxolitinib was similar in subjects with various degrees of renal impairment and in those withnormal renal function. However, plasma AUC values of ruxolitinib metabolites increased with increasingseverity of renal impairment. This was most marked in the subjects with end stage renal disease requiringhemodialysis. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in metabolite exposure. Ruxolitinib is not removed by dialysis; however, the removalof some active metabolites by dialysis cannot be ruled out. When administering Jakafi to patients withmoderate (CrCl 30-59 mL/min) or severe renal impairment (CrCl 15-29 mL/min) with a platelet countbetween 100 X 109/L and 150 X 109/L and patients with end stage renal disease on dialysis a dose reductionis recommended [see Dosage and Administration (2.5) in Full Prescribing Information]. HepaticImpairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study inhealthy subjects (N=8) and in subjects with mild [Child-Pugh A (N=8)], moderate [Child-Pugh B (N=8)], orsevere hepatic impairment [Child-Pugh C (N=8)]. The mean AUC for ruxolitinib was increased by 87%, 28%and 65%, respectively, in patients with mild, moderate and severe hepatic impairment compared to patientswith normal hepatic function. The terminal elimination half-life was prolonged in patients with hepaticimpairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours). The change in the pharmaco-dynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in ruxolitinib exposureexcept in the severe (Child-Pugh C) hepatic impairment cohort where the pharmacodynamic activity wasmore prolonged in some subjects than expected based on plasma concentrations of ruxolitinib. When administering Jakafi to patients with any degree of hepatic impairment and with a platelet count between 100 X 109/L and 150 X 109/L, a dose reduction is recommended [see Dosage and Administration (2.5) inFull Prescribing Information].
BRIEF SUMMARY: For Full Prescribing Information, see package insert.INDICATIONS AND USAGE Jakafi is indicated for treatment of patients with intermediate or high-riskmyelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essentialthrombocythemia myelofibrosis.CONTRAINDICATIONS None.WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia and Neutropenia Treatmentwith Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia.A complete blood count must be performed before initiating therapy with Jakafi [see Dosage andAdministration (2.1) in Full Prescribing Information]. Patients with platelet counts of less than 200 X 109/Lat the start of therapy are more likely to develop thrombocytopenia during treatment. Thrombocytopenia wasgenerally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If clinically indicated, platelet transfusions may be administered [see Dosage and Administration (2.2) in FullPrescribing Information, and Adverse Reactions]. Patients developing anemia may require blood trans-fusions. Dose modifications of Jakafi for patients developing anemia may also be considered. Neutropenia(ANC less than 0.5 X 109/L) was generally reversible and was managed by temporarily withholding Jakafi[see Adverse Reactions]. Complete blood counts should be monitored as clinically indicated and dosingadjusted as required [see Dosage and Administration (2.2) in Full Prescribing Information, and AdverseReactions]. Infections Patients should be assessed for the risk of developing serious bacterial, mycobac-terial, fungal and viral infections. Active serious infections should have resolved before starting therapy withJakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection andinitiate appropriate treatment promptly. Herpes Zoster Physicians should inform patients about early signsand symptoms of herpes zoster and advise patients to seek treatment as early as possible [see AdverseReactions].ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted underwidely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directlycompared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Thesafety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9months, including 301 patients with myelofibrosis in two Phase 3 studies. In these two Phase 3 studies,patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 88.7% ofpatients treated for more than 6 months and 24.6% treated for more than 12 months. One hundred andeleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. Ina double-blind, randomized, placebo-controlled study of Jakafi, 155 patients were treated with Jakafi. Themost frequent adverse drug reactions were thrombocytopenia and anemia [see Table 2]. Thrombocytopenia,anemia and neutropenia are dose related effects. The three most frequent non-hematologic adverse reactionswere bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless ofcausality, was observed in 11.0% of patients treated with Jakafi and 10.6% of patients treated with placebo.Following interruption or discontinuation of Jakafi, symptoms of myelofibrosis generally return topretreatment levels over a period of approximately 1 week. There have been isolated cases of patients discon-tinuing Jakafi during acute intercurrent illnesses after which the patient’s clinical course continued to worsen;however, it has not been established whether discontinuation of therapy contributed to the clinical course inthese patients. When discontinuing therapy for reasons other than thrombocytopenia, gradual tapering of thedose of Jakafi may be considered [see Dosage and Administration (2.6) in Full Prescribing Information].Table 1 presents the most common adverse reactions occurring in patients who received Jakafi in the double-blind, placebo-controlled study during randomized treatment.Table 1: Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlledStudy During Randomized Treatment
a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0b includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site
urine, bacteria urine identified, nitrite urine presente includes weight increased, abnormal weight gainf includes herpes zoster and post-herpetic neuralgiaDescription of Selected Adverse Drug Reactions Anemia In the two Phase 3 clinical studies, mediantime to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks. One patient (0.3%)discontinued treatment because of anemia. In patients receiving Jakafi, mean decreases in hemoglobinreached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and thengradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This patternwas observed in patients regardless of whether they had received transfusions during therapy. In therandomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receivingplacebo received red blood cell transfusions during randomized treatment. Among transfused patients, themedian number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebotreated patients. Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia wasgenerally reversible with dose reduction or dose interruption. The median time to recovery of platelet countsabove 50 X 109/L was 14 days. Platelet transfusions were administered to 4.7% of patients receiving Jakafiand to 4.0% of patients receiving control regimens. Discontinuation of treatment because of thrombo-cytopenia occurred in 0.7% of patients receiving Jakafi and 0.9% of patients receiving control regimens.Patients with a platelet count of 100 X 109/L to 200 X 109/L before starting Jakafi had a higher frequency ofGrade 3 or 4 thrombocytopenia compared to patients with a platelet count greater than 200 X 109/L (16.5%versus 7.2%). Neutropenia In the two Phase 3 clinical studies, 1.0% of patients reduced or stopped Jakafibecause of neutropenia. Table 2 provides the frequency and severity of clinical hematology abnormalitiesreported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study.
tem that will present a learningcurve for the practice staff members.Is it possible for the billing systems tobe integrated or merged? Have plansbeen made for the “transitional eon,”as Ms Guidi calls it?
Outsourcing to SpecialtyPharmaciesBurt Zweigenhaft, BS, Chief
Executive Officer of OncoMedOnco360 in Great Neck, NY, spokeabout some of the considerationsthat a hospital may encounter whendeciding whether to outsource to an oncology pharmacy. With con -tinuing Medi care and com mercialpayer drug reimbursement reduc-tions, some hospitals are evaluatingthe option of outsourcing the acqui-sition and the mixing of oncologydrugs to specialty pharmacies.Access to oncology drugs is no
longer as simple as using a sole drugdistributor. Many pharmaceuticalmanufacturers now choose to namespecific channels for new drug dis-tribution, and drugs may have to be acquired from multiple sources,thereby requiring dedicated re -sources for inventory acquisition andfor management.The population of patients with
cancer is growing exponentially asAmerica ages, and it is likely to runright up against a concurrent reduc-tion in the number of treating oncol-ogists. Oncology pharmacists can be avalued asset to the oncology careteam in providing drug managementsupport to oncologists in the comingyears, Mr Zweigenhaft suggests.Mr Zweigenhaft anticipates an
increase in payer imposition of priorauthorization processes, formularies,and selected pathways. Part of thatincreased payer oversight is also verylikely to include payer network con-tracting with pharmacy benefitsmanagers and with specialty phar-macies. He suggests that hospitals
that outsource the management ofcancer drugs to specialty pharmacieswould benefit from:• Medication treatment manage-ment interventions
• Support of a board-certifiedoncology pharmacist
• Increased focus on pathwaysand concordance with evidencein treatment decisions
• Increased focus on care and min -imizing side effect management
• Pharmacists who would followthe physician care plan andmanage to quality end points
• Increased focus on the manage-ment of patient adherence for
oral formulations of cancertherapies
• Inclusion of advanced caredirectives
• Stronger reporting and measure-ment of data.
Pharmacy regulations in the hos-pital setting are different from thosein the physician office setting, butthey may also differ from those in thecommercial pharmacy setting. Mr Zweigenhaft suggests that
recent state Board of Pharmacychanges, such as in Georgia, may setforth dispensing expectations thathospital pharmacies will find diffi-cult to meet. He also noted thatsome facility accreditation expecta-tions may be a challenge for physi-cian-based or hospital-based phar-macies and for the new models inwhich hospitals now manage physi-cian practice–based pharmacy needs.
Operating Officer, The MedicalOncology Group, PA, Gulfport, MS,discussed the process of integratinghis practice physicians with the localhospital. His practice began the nego-tiations with the hospital in January2009 and completed the deal byDecember 2009 that was based on aprovider services arrangement. Mr Shenk outlined the following
7 tips for practice managers, basedon his experience with this hospi-tal–practice integration process.
1Beware of promises made in thecourtship phase. The longest partof the process was determining thevaluation of the practice. The hospi-tal had initially offered substantialsalaries, with fine print noting thatthe offer was subject to fair marketvalue. One of the most difficult chal-
Hospital–Physician Contracting
43November 2012 I www.OncPracticeManagement.com I
Continued on page 44
The Nuts and Bolts of Physician and Hospital…Continued from page 40
Mr Zweigenhaftsuggests that recentstate Board ofPharmacy changes,such as in Georgia,may set forthdispensingexpectations thathospital pharmacies willfind difficult to meet.
lenges for the practice and the physi-cians was coming to grips with howvaluations are developed. The strategic value of the practice
as an acquired asset for a hospital isnot quantifiable; in fact, it does notenter into the valuation process atall. The postvaluation compensationwas considerably lower than theoriginal offer. Mr Shenk also commented that
the current compensation was basedon Current Procedural Terminology®code volumes, and that, so far, thereis no provision for what would hap-pen should care payment move to abundled rate, which could happen inoncology—specifically with certainpayers or on a national scale withaccountable care organizations—and in payment reform.
2Understand where the powerreally lies in the hospital organi-zation. During the negotiationprocess, Mr Shenk’s practice learnedquickly how to distinguish betweenthose who said they had the powerto make decisions and those whoactually did have the power. If some-one in the room says he or she needsto check with someone else, perhapsthat person is not the right person tobe in the room for this negotiation. The Medical Oncology Group was
glad that it maintained employmentof its own staff as opposed to leasingthe staff members back to the hospi-tal, so that the hiring and firingprocess was not as difficult as it couldhave been had they had to workwithin the hospital infrastructure. Mr Shenk also noted a concern
that current strong relationships aregrounded with existing hospitalleadership, and he wondered whatmight happen should those leadersmove away from the hospital.
3Watch the clinic’s design and lay-out. Hospitals often have severe
space limitations and many frag-mented services (eg, registration inone area, laboratories and imaging incentralized locations) that createvery different patient and staff work-flow situations from those seen inprivate practice. Mr Shenk warnedabout the unanticipated impact onthe historical practice workflow andon staff and patient expectations.
4Understand EMR complications.Many hospitals have multispecial-ty EMRs electronic medical recordsthat may not have a strong oncologymodule and that may not integratewell with the systems you already use.Understand the challenges, andnegotiate for an arrangement thatworks best for you, your physicians,and your staff. An oncology-specificEMR is absolutely essential.
5Understand the challenges of340B pricing. Make sure youunderstand what 340B pricingmeans to hospitals. Mr Shenkwarned that “340B prices are not afloor—they are a ceiling—whichmakes a difference when the hospitalintegrates inpatient and outpatientvolume.” He also warned that prac-tices need to be aware that 340Bpricing may not be applied to a com-ponent of an eligible hospital until
that component (ie, division) of thehospital has appeared on the hospi-tal cost report. This can take as longas 16 months, which can be anunpleasant surprise for hospitals andpractices who entered negotiationsand new arrangements without fullyunderstanding that timing delay.
6Understand the impact of yourown referrals. Before the negotia-tions go too far, measure your prac-tice’s volume of referrals to the radi-ation oncology, radiology, andsurgical specialties that are affiliatedwith the hospital. In many cases,your clinic may refer more than 50%of the hospital’s positron emissiontomography and computed tomogra-phy scans. It will be important forboth parties to understand that inthe negotiation processes.
7Keep your physicians focused onpatient care. Both during andafter the negotiations, it will be easyfor physicians to get drawn into hos-pital and administration issues. Ifyou work with them and supportthem to stay focused on patient care,it will help keep the practice on aneven keel. After the negotiations aredone, this will protect the physiciansfrom being burdened down with hos-pital administration tasks.
Conclusion Then Ms Guidi, Mr Zweigenhaft,
and Mr Shenk reminded the attend -ees that there is much more in-volved in hospital–physician negoti-ations than often meets the eye.They shared these process detailswith the hope that these pointswould make it easier for oncologypractices to come out on the otherside of the negotiation process betterequipped to handle the new reality ofhospital–physician relationships incancer care, no matter how the nego-tiations end. l
44 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Hospital–Physician Contracting
The Nuts and Bolts of Physician and Hospital…Continued from page 43
“340B prices are not afloor—they are aceiling—which makesa difference when thehospital integratesinpatient andoutpatient volume.”
—Martin Shenk, CMPE
“Quality care iseveryone’s business.”
Value-Based Care in Myeloma !&%0!,-�!2�&/-%0!�%(.!,0%!1-��( �*!,-*!�.%0!-�,!&�.! �.)��)-.��+/�&%.3���( ����!--�%--/!-���*!�%�&�-!�.%)(-�"),������-! ��&%(%�%�(-��� 0�(�! �*,��.%�!�(/,-!-���( �*$�,'��%-.-�1%&&��&-)�")�/-�)(�.$!�/(%+/!��$�&&!(#!-�%(�.$!�'�(�#!'!(.�)"�'/&.%*&!�'3!&)'��
Care Act (ACA) of2010 created manyimportant reforms inhealthcare. Many ofthe ACA’s provisionsare very popular,such as the ability ofparents to keep chil-
dren on their health insurance plansuntil age 26 years and the elimina-tion of insurance denials for pre-existing conditions. Other provi-sions are not as popular. The Independent Payment Ad -
visory Board (IPAB), slated to beginin 2013, is one of the more contro-versial provisions. Created by sec-tions 3403 and 10320 of the ACA,the IPAB has the explicit task ofachieving specified savings in Medi -care without affecting coverage orquality. Under current law, the Medi -care Payment Advisory Council(MedPAC) reviews payment policiesand makes recommendations to Con - gress about ways to reduce spending.Congress must then debate and voteon these recommendations for themto become law.
What Is IPAB?The IPAB is a 15-member panel
appointed by the president and con-firmed by the Senate, similar to theUS Supreme Court appointmentprocess. Unlike Supreme CourtJustices, however, IPAB memberswill serve in 6-year staggered terms.The panel will replace the decision-making power of MedPAC, butMedPAC will remain an advisory
body for Congress. Beginning nextyear, if the chief Medicare actuarydetermines that the projected 5-yearaverage growth rate spending perMedicare beneficiary is projected tooutpace the target growth rate, theIPAB must submit a proposal to Con -gress to reduce spending on Medi -care by a specified amount.
Through 2017, the target growthrate is the 5-year projected averageof the Consumer Price Index (CPI)for all consumers and the CPI formedical care. For 2018 and beyond,the target growth rate is the 5-yearprojected average percentage in -crease in the per-capita gross domes-tic product plus 1%. If spendingexceeds these targets, the IPAB mustsubmit a proposal to Congress thatreduces spending on Medicare downto the target spending rate per bene-ficiary. Congress must then acceptthe proposal without amendments orcome up with its own plan thatachieves at least the same amount ofsavings. Congress has a poor track record
of compromise and agreement, andit is likely that identification of more
than $3 billion in savings (theexpected savings necessary toachieve targets for Medicare in2015) will be no different. If theIPAB does not submit a proposal,and if Congress is unable to developa plan, the Secretary of the USDepartment of Health and HumanServices (HHS) must act unilateral-ly to achieve the target spendingrates in Medicare. Ultimately, it willbe the job of the HHS Secretary toimplement the final savings plan. The IPAB significantly changes
the current Medicare policy devel-opment structure. Once appointed,the Board will be essentially “un -checked,” because there is no over-sight by Congress or voters. Thismeans that an unpopular proposal bythe IPAB will have no recourse atthe polls. In addition, it is stillunknown who will serve on theBoard and how, and how well com-munity oncology will be represented.
Authority of the IPABAchieving $3 billion in savings
starting in 2015 could mean signifi-cant changes for providers and forbeneficiaries. The following 2 ques-tions are just examples of the manyquestions about IPAB’s ability tochange healthcare:
1What exactly can the IPAB do?The IPAB’s power is limited to
Medicare. Medicaid and other pro-grams are exempt.
2What kind of changes can theIPAB make to Medicare? The
IPAB’s authority is limited to
The Affordable Care Act Will ChangeMedicare: The Independent PaymentAdvisory BoardBy Sydney Abbott, JD, Policy Coordinator, Association of Community Cancer Centers
Continued on page 48
The IPAB significantlychanges the currentMedicare policydevelopment structure.Once appointed, theBoard will be essentially“un checked.”
Brought to you by the Association of Community Cancer Centers
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CONFERENCE CO-CHAIRS
May 2-5, 2013 • Westin Diplomat • Hollywood, Florida
Craig K. Deligdish, MDChief Medical OfficerOncology Resource Networks
Gary M. Owens, MDPresidentGary Owens Associates
Burt Zweigenhaft, BSPresident and CEOOncoMed
THURSDAY, MAY 2, 20138:00 am - 5:00 pm Registration
FRIDAY, MAY 3, 20137:00 am - 8:00 am Simultaneous Symposia/Product Theaters
8:15 am - 9:15 am Session 1: Welcome, Introductions, and Opening RemarksConference Co-Chairs - Craig K. Deligdish, MD; Gary M. Owens, MD; Burt Zweigenhaft, BS
9:15 am - 10:15 am Keynote Address
10:15 am - 10:30 am Break
10:30 am - 11:45 am Session 2: Trends in Treatment Decision-Making: Pathways and Stakeholder CollaborationsRoy A. Beveridge, MD; Michael Kolodziej, MD
3:00 pm - 3:45 pm Session 13: Personalized Medicine, Companion Diagnostics, Molecular Profiling,Genome Sequencing—The Impact on Cost, Treatment, and the Value PropositionMark S. Boguski, MD, PhD
3:45 pm - 4:15 pm Summary/Wrap-Up of Day 2
4:30 pm - 6:30 pm Cocktail Reception in the Exhibit Hall
SUNDAY, MAY 5, 20137:00 am - 8:00 am Simultaneous Symposia/Product Theaters
8:15 am - 8:30 am Opening Remarks
8:30 am - 9:15 am Session 14: Cancer Rehabilitation: The Next Frontier in Survivorship CareJulie Silver, MD
9:15 am - 10:00 am Session 15: Current and Future Considerations for the Oncology Practice ManagerDawn Holcombe, MBA, FACMPE, ACHE; Leonard Natelson
10:00 am - 10:15 am Break
10:15 am - 11:00 am Session 16: Access to Drugs—Shortages, BiosimilarsDouglas Burgoyne, PharmD; James T. Kenney, Jr., RPh, MBA
11:00 am - 11:45 am Session 17: Perspectives from Large Oncology Group Practices—Successes, Issues, and Challenges
11:45 am - 12:00 pm Summary and Conclusion of Conference
*Agenda is subject to change.
PROGRAM OVERVIEWFollowing on the success of our Second Annual Conference, AVBCC will be comingto Hollywood, Florida, on May 2-5, 2013. We continue to be guided by the expertise ofleaders in these fields providing at tendees with a thorough understanding of the evo-lution of the value equation as it relates to cancer therapies. Our goal is to be able toassist them in implementing, improving, and sustaining their organizations and institu-tions, while improving access for patients and ultimately quality patient care.
TARGET AUDIENCEThis conference is intended for medical oncologists, practice managers/administrators,and managed care professionals. Stakeholders in a position to impact cancer patientcare, such as advanced practice nurses, pharmacists, and medical directors, are alsoinvited to join this exciting forum.
SPONSORSThis activity is jointly sponsored by Medical Learning Institute Inc, the Association forValue-Based Cancer Care, Inc., Center of Excellence Media, LLC, and Core PrincipleSolutions, LLC.
COMMERCIAL SUPPORT ACKNOWLEDGMENTGrant requests are currently being reviewed by numerous supporters. Support will beacknowledged prior to the start of the educational activities.
REGISTERED NURSE DESIGNATIONMedical Learning Institute Inc. Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 17.25 contact hours.
REGISTERED PHARMACY DESIGNATIONThe Medical Learning Institute Inc is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Comple-tion of this knowledge-based activity provides for 17.25 contact hours (1.725 CEUs)
of continuing pharmacy education credit. The Universal Activity Number for this activityis (To be determined).
PHYSICIAN CREDIT DESIGNATIONThe Medical Learning Institute Inc designates this live activity for a maximum of 17.25AMA PRA Category 1 Credits™. Physicians should claim only the credit commensuratewith the extent of their participation in the activity. This activity has been planned andimplemented in accordance with the Essential Areas and policies of the AccreditationCouncil for Continuing Medical Education through the joint sponsorship of the MedicalLearning Institute Inc and the Center of Excellence Media, LLC. The Medical LearningInstitute Inc is accredited by the Accreditation Council for Continuing Medical Educa-tion to provide continuing medical education for physicians.
DESIGNATION OF CREDIT STATEMENTS
LEARNING OBJECTIVESUpon completion of this activity, the participant will be able to:• Discuss the current trends and challenges facing all stakeholders in optimizing valuein cancer care delivery.
• Define the barriers associated with cost, quality, and access as they relate to health-care reform and what solutions are currently being considered.
• Compare and contrast the different approaches/tools providers and payers are utilizing to manage and deliver care collaboratively.
• Examine the current trends in personalized care and companion diagnostics.• Analyze the patient issues around cost, quality, and access to care.
$375.00 until January 15, 2013$475.00 until March 15, 2013$675.00 after March 15, 2013
Influencing the Patient-Impact Factor
THIRD ANNUALAssociation for Value-Based Cancer Care Conference
www.regonline.com/avbcc2013REGISTER TODAY AT
AGENDA*
48 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Patient and Provider Access
changes in reimbursement only. It isthe intent of the ACA that patientsnot be impacted by the Medicaresavings that must be achieved. Therefore, the IPAB may consider
reimbursement rates, payment mod-els, and other mechanisms forachieving these goals; however,patient benefits, such as Medicarerosters and beneficiary composition,cannot be altered. Although the aimof the ACA is to achieve savingswithout impacting access, those inthe provider community understandthat you cannot dramatically reducereimbursement without impact-ing access to care on some level.Continued squeezing of reimburse-ment rates—particularly in light ofthe broken sustainable growth rateformula and sequestration—willonly make it increasingly difficult forproviders to continue to give themost fitting care at the most appro-priate time to all of their patientswith Medicare.
The Future of the IPABBecause of the concern that the
IPAB will not report directly to thevoting public, many in Congress wantto repeal the IPAB. In fact, a number
of efforts have already been made. Todate, however, there has not been sufficient agreement between bothchambers to pass the measure; how-ever, that does not mean legislationwill not pass in the future. As elements of the IPAB become
more visible, we may see a resur-gence of repeal efforts in the House
or in the Senate. It is increasinglyimportant for the oncology commu-nity to work together to educate ourelected officials and our regulatorybodies on the issues that impact
community cancer care. The Associ -a tion of Community Cancer Centers(ACCC) continues to stay on theforefront of this issue and on otherissues to educate members of Con -gress about community oncology. Asalways, the ACCC will keep itsmembers up to date on the most cur-rent topics in cancer care. l
The Affordable Care Act Will Change…Continued from page 46
The IPAB could remove reimbursement policydecision-making from the legislature and placethe power to make these important decisionswith an independent body—a body withoutcongressional oversight.
Influencing the Patient-Impact Factor TM
REGISTER TODAY AT www.AVBCConline.org
May 2-5, 2013 Westin Diplomat • Hollywood, Florida
THIRD ANNUAL CONFERENCE
Physician Wealth Management
49November 2012 I www.OncPracticeManagement.com I
Over their ca reers, physiciansgenerally purchase largeamounts of term life insur-
ance. Term life insurance, for themost part, is a commodity, so thepricing is very competitive and com-parison shopping is easy. So, why is it that so many physi-
cians have the wrong type of termlife insurance and/or are paying sig-nificantly higher premiums thanthey should be for their policies?This article will serve as a guide tohelp you purchase the right type ofterm life insurance at the lowestcost to meet your individual needsand goals.
What Is Term Life Insurance?Term life insurance provides pure
insurance protection and does notbuild cash value. It allows you topurchase the largest death benefitwhile minimizing your (initial) pre-mium outlay. When you purchase aterm life insurance policy, you arebuying coverage for a specified peri-od of time. If you die within the termof the policy, the insurance companywill pay the death benefit to yourbeneficiary or beneficiaries.
Annual Renewable Term Life InsuranceAnnual renewable term life insur-
ance, also known as yearly renewableterm life insurance, provides coveragefor a period of 1 year and then auto-matically renews at an increased pre-mium. This type of policy providesyou with 2 sets of premium rates: a current or scheduled premium and a guaranteed maximum premium. In general, after the first policy
year, the annual premium payablemay be equal to or higher than thescheduled renewal premium, but it
will never be more than the guaran-teed maximum renewal premium. Because of its low initial cost, this
type of term life insurance is reallyonly ideal for those individualslooking for short-term life insur-ance protection, or for those whodesire to convert their coverage to apermanent or “cash value” lifeinsurance policy shortly after theinitial purchase.
Level Premium Term Life InsuranceIn general, level premium term
life insurance policies provide cost-effective financial protection forperiods of 5, 10, 15, 20, 25, or 30years. This is the time in which pre-mium rates are guaranteed to remainthe same. However, after the levelpremium period expires, most poli-cies become annually renewable.Therefore, in the same way asdescribed above, premium rates willultimately become cost-prohibitiveand will limit the options availablein the future. Therefore, it makesmore sense to purchase a policy witha longer guarantee period comparedwith one with a shorter guaranteedperiod to lower your overall costs.That being said, if budget is an issue,you might want to opt for a policywith a larger death benefit and ashorter guarantee period (eg, 20years) instead of one with a smallerdeath benefit and a longer guaranteeperiod (eg, 30 years) if the premiumamount is similar. After all, if thingsgo well, you will most likely outliveboth anyhow.
Return of Premium Term Life InsuranceReturn of premium is term life
insurance that guarantees that all of
the premiums paidduring the level pre-mium period will bereturned, on an in -come tax–free basis,if the insured doesnot surrender thepolicy and lives tothe end of the guar-antee period selected.Although this may
sound very appealing, few companiesoffer this type of policy, the premi-ums are much more expensive com-pared with a basic level premiumterm life insurance policy, and thistype of policy does not provide theinsured with the ability to “refi-nance” the policy should premiumrates decrease.For example, assuming a 35-year-
old male physician in New Yorkqualified for Prudential’s best under-writing classification, the annualpremium for a 30-year level premiumterm life insurance policy would be$885.00. The same policy, but including
the return of premium feature, wouldcost $1747.90 annually (a differenceof $862.90). If the doctor kept thepolicy for the full 30 years, then$52,437.00 would be returned, pro-viding him with a return of 4.23% by electing the return of premiumoption—a return which, in my opin-ion, is less than adequate over thattime horizon compared with otherinvestments.Because websites such as www.term
4sale.com compare the premiumrates of several insurance companies,as well as the pricing for varioustypes of term life insurance, deathbenefit amounts, and guarantee peri-ods, it is easy to determine if the
Term Life Insurance: What You Need toKnow Before You BuyBy Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF
With Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF
Continued on page 52
Your source for reimbursement information related to Halaven®
Patient Assistance ProgramCoverage ScenariosFAQFDA Approval Letter
Prescribing InformationEisai Assistance ProgramEnrollment FormInsurance Veri3cation Form
CODING & BILLING
Coding & PricingHCPCS Level II CodesCPT Drug AdministrationCodeICD-9-CM Diagnosis CodesNational Drug CodesRevenue CodesBilling for WastageMedicare Reimbursement Rate
Annotated CMS 1500(08/05) FormAnnotated UB-04 FormChecklist for Claims SubmissionCMS 1500 (08/05) FormUB-04 Form
Full-time pharmacists on duty during hours of operation (Monday through Friday,8AM to 8PM ET)
Dedicated EAP team with an average of morethan 9 years of healthcare, reimbursement,and/or call center experience
On-staff Certi9ed Professional Coders (CPCs)provide an additional level of expertise
Region ally aligned EAP hotline agents arewell-versed in local payor and plan knowledge
Insurance veri9cation and coverage optionswith an approximate 24- to 48-hour turnaroundfor all queries
52 I ONCOLOGY PRACTICE MANAGEMENT I November 2012
Physician Wealth Management
agent or financial planner that youare working with is providing youwith the lowest cost options for thecoverage that you want to purchase.
Term Life InsuranceUnderwritingIt is important to note that various
insurance companies may use a dif-ferent set of guidelines to qualify forthe best underwriting classification.For example, if you are being treatedfor hypertension, certain companieswill allow you to qualify for their bestunderwriting classification whereasothers will not. The same may betrue if you have an immediate familyhistory of a cardiac disorder or can-cer, even if you are currently healthy.Finally, height and weight are alsotaken into consideration, and somecarriers are more liberal than others.For these reasons, you should
employ the services of an experi-enced insurance agent who repre-sents several companies to help youget the best rates, especially if yourhealth is less than perfect. The agentwill know which carriers are likely to provide you with a better under-writing classification, based on thespecifics of your situation, to allowyou to secure a lower premium rate.After all, using an agent or applyingfor the product online will not costyou any additional money.
Conversion OptionMost term life insurance policies
contain a conversion option. Thisoption allows you to convert yourterm insurance policy into a perma-nent or “cash value” policy, regardlessof your future health. The majoradvantage of this feature is that youmaintain the underwriting classifica-tion in which your policy was origi-nally issued. Therefore, assuming that you qual-
ified for the best underwriting classifi-cation when your policy was pur-
chased, but would not qualify for ittoday based on your health, the newpolicy would also be issued in the bestunderwriting classification.Although most life insurance
companies will allow you to convertfor the entire guaranteed period inthe policy, others may limit the con-version option to a specified periodof time, such as the first 5 or 10 pol-icy years.
If your goal is to ultimately con-vert some or all of your term insur-ance to permanent insurance, youshould only purchase your policyfrom a company that has a reputa-tion for offering a broad array ofthose types of policies. Otherwise,you will most likely be better off witha company that specializes in low-cost term life insurance. Either way,it is important that you understandthe conversion options available forthe policies that you are consideringbefore making your final decision.
Waiver of Premium RiderAnother important aspect of a life
insurance policy is the waiver of apremium rider. This rider enables
you to have the premiums of thepolicy paid for by the insurancecompany in the event of your dis-ability. Again, if your goal is to ulti-mately convert some or all of yourterm life insurance to permanent lifeinsurance, it is important that thisrider be included in your term lifeinsurance policy. This way, whenyou convert to a permanent insur-ance policy, it will allow the pre -miums—which are substantiallyhigher compared with term lifeinsurance—to be waived. Other -wise, if you plan on sticking withterm insurance, you will want toforego this rider, because it is rela-tively expensive and will only waivethe premiums associated with your(inexpensive) term life insurancepolicy.
ConclusionFor the most part, term life insur-
ance is a commodity, so the pricing is very competitive and comparisonshopping is easy. The type of termlife insurance that should be pur-chased depends on factors such asyour age, health, budget, and yourlong-term financial plans. If you areconsidering the purchase of a newlife insurance policy, or if you arereplacing an existing policy, it is bestto consult with a knowledgeableinsurance agent who represents sev-eral companies. He or she can reviewyour situation and can then help youmake intelligent and informedchoices regarding your life insuranceprotection. l
Lawrence B. Keller, CFP®, CLU,ChFC, RHU, LUTCF, is the founderof Physician Financial Services, a NewYork–based firm specializing in incomeprotection and wealth accumulationstrategies for physicians. He can bereached for comments or questions at516-677-6211, or by e-mail at [email protected].
Most term life insurancepolicies contain aconversion option. Thisoption allows you toconvert your terminsurance policy into apermanent or “cashvalue” policy,regardless of your future health.
Term Life Insurance: What You Need…Continued from page 49
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.
Patient insurance benefit investigation is provided as a service by TheraCom, LLC and The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, TheraCom, LLC, and The Lash Group, Inc., assist healthcare professionals in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer and patient information provided by the healthcare provider under appropriate authorization following the provider’s exclusive determination of medical necessity. Importantly, insurance verification is the ultimate responsibility of the provider. Third-party reimbursement is affected by many factors. Therefore, TheraCom, LLC, The Lash Group, Inc., and Janssen Biotech make no representation or guarantee that full or partial insurance reimbursement or any other payment will be available. This information is provided as an information service only. While TheraCom, LLC, and The Lash Group, Inc., try to provide correct information, they and Janssen Biotech make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall TheraCom, LLC, The Lash Group, Inc., or Janssen Biotech or its employees or agents be liable for any damages resulting from or relating to the services. All providers and other users of this information agree that they accept responsibility for the use of this service.Janssen Biotech assumes no responsibility for, and does not guarantee the quality, scope, or availability of the services including but not limited to reimbursement support services, patient education, and other support services. Each provider, not Janssen Biotech, is responsible for the services they provide. These support services have no independent value to providers apart from the product and are included within the cost of the product.
Our goal is to make access to ZYTIGA®(abiraterone acetate)
