OPM August 2013

Oncology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

www.OncPracticeManagement.com

AUGUST 2013

Employment Misclassification and the Practice of Medicine

By Judge Ruth Kraft and Jennifer Kirschenbaum, Esq

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f a medical practice misclassifies employees as in­dependent contractors, it may have significant monetary and tax ramifications. These consequences include noncompliance Judge Ruth Kraft with withholding and employment tax obligations, minimum wage and overtime requirements, wage and hour mandates such as mandatory meal breaks and rest periods, and reallocation of business expenses.

Employers are not responsible for providing workers’ compensation, disabili-

VOLUME 3 • NUMBER 5

Impact of the Medicare Sequester on Community Oncology

By Sydney Abbott, JD, Manager of Provider Economics and Public Policy, Association of Community Cancer Centers

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ncology providers repeatedly face cuts to reimbursement because of policy decisions made by Congress. The sustainable growth rate formula is fundamentally flawed and leaves providers unable to plan for the future; in addition to other policies that constantly threaten provider reimbursement, the

prompt-pay discount prohibits appropriate reimbursement, and not all care that is provided to patients is fully captured by current reimbursement models.

The newest cut to provider reimbursement comes from the 2% across-theboard reduction on Medicare claims.

The “sequester” went into effect on April Continued on page 14

Cancer Care Trends: ACCC’s 2013 Survey of Community Oncology

By Neil Canavan

Washington, DC—The preliminary results of the 2013 Cancer Trends Survey conducted by the Association of Community Cancer Centers (ACCC) were reported at the 2013 ACCC annual meeting by Ron Schlief, RPh, MBA, and Bruce Edelen, of

Oncology Reimbursement Management in Carmel, IN. Survey results show that not all the stars are where they used to be. “In a nutshell,” Mr Edelen said, “it’s not status quo in the marketplace anymore—it’s changing.”

Continued on page 8

Continued on page 21 From the publishers of

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of n it o s D ia ter VI ssocCen 1 O Ar e PR y thence f th ster… a o e D N ou bity C actequ A y T t to mun Impre S N h m e a TIE roug Co Thedic A B

ER

INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM

©2013 Engage Healthcare Communications, LLC

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From the Editor

Contracting Challenges from a New Front

By Dawn Holcombe, MBA, FACMPE, ACHE

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ince the last publication of Oncology Practice Management, I have transitioned to a new position with Florida Cancer Specialists. Like every practice across the country, we are facing new and different contracting challenges.

It is interesting to watch the transitions of contracting. At the same time that we continue to focus on evaluation and management codes and drug codes, payers are merging and expanding their own markets, and contract changes occur as a result, even with no action on our part. A payer contract is no longer a document signed once and put on the shelf for 1 to 3 years.

From the practice perspective, our own changes and addition of new services also lead to amendments, additions to provider rosters, and even new geographic locations for existing providers—all of which reopen the process and can take anywhere from 60 to 90 days to execute.

In the meantime, practices pend their claims and cross their fingers that the negotiations and effective dates will be mutually acceptable.

However, payers do their budgets based upon original contracts, and to their dismay, changes affect their projections as well as the budgets of their customers and self-administered employers. The rapid changes

we now live with in the medical oncology delivery system are often not of our choosing, and yet they cause more administrative overhead and delays in our payment stream while we work through new negotiations with a myriad of payers.

The rapid changes we live with in the medical oncology delivery system are often not of our choosing, and yet they cause more administrative overhead and delays in our payment stream while we work through new negotiations with a myriad of payers.

It is an interesting but reluctant dance between payers and providers, driven by market pressures as varied as drug shortages, deployment of 340B hospital strategies, hospital expansion, and expanded physician employment.

Ronald Barkley, MS, JD President Cancer Center Business Development Group Bedford, NH Peggy Barton, RN Practice Manager Toledo Clinic, OH

Continued on page 6

Editorial Advisory Board

Editor-in-Chief Dawn Holcombe, MBA, FACMPE, ACHE Vice President, Strategic Relationships Florida Cancer Specialists Sarasota, FL

However, there is a new front bringing challenges to specialty practices— primary care physicians.

Primary care physicians are being actively courted by hospitals for both employment and affiliation under new accountable care organization (ACO) development. While oncology as a specialty is not usually a primary or even a secondary focus for these new ACOs, we are dramatically affected when those market changes impact our referral patterns.

In the past month, I have heard from groups about the following challenges: 1. One acquired primary care practice was told that referrals now needed to go to the new organization’s internal oncology group instead of the private oncology group they traditionally used.

2. One oncology group’s key referring physicians suddenly found their own book of business drying up because of the shifts and new affiliations among the major hospital networks in the group’s local market.

3. Primary care physicians are being placed at financial risk

Risë Marie Cleland President Oplinc, Inc Portland, OR

Teri U. Guidi, MBA, FAAMA President & CEO Oncology Management Consulting Group Pipersville, PA

Craig K. Deligdish, MD Hematologist/Oncologist Oncology Resource Networks Orlando, FL

Marianna Lamb, MS Exceutive Director Medical Onocology Association of Southern California Upland, CA

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

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

August 2013

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Bonnie J. Miller, RN, BSN, OCN, FAAMA Administrative Director Women’s Cancer Center Fox Chase Cancer Center Philadelphia, PA Cindy C. Parman, CPC, CPC-H, RCC CSI Coding Strategies, Inc Powder Springs, GA Carla C. Wood, CPC, MS President Altos Solutions, Inc Los Altos, CA

www.OncPracticeManagement.com

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In This Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nick@engagehc.com Vice President, Director of Sales & Marketing Joe Chanley joe@engagehc.com Publisher Cristopher Pires cris@engagehc.com Director, Client Services Lou Lesperance lou@engagehc.com Editorial Director Dalia Buffery dalia@engagehc.com Managing Editor Lisa Neuman lneuman@the-lynx-group.com Associate Editor Lara J. Lorton Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Marie RS Borrelli The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattanonont Ferris Vice President of Finance Andrea Kelly Director, Human Resources Blanche Marchitto Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno

Features

Cancer Care Trends: ACCC’s 2013 Survey of Community Oncology............................................................................................................1

By Neil Canavan

Conference Coverage—Oncology Nursing Society

Reducing Falls in the Outpatient Setting........................................................... 19

By Alice Goodman

Measures to Preserve Fertility............................................................................... 19

By Alice Goodman

Nurse-Led Symptom Management Clinic......................................................... 20

By Alice Goodman

Oral Chemotherapy: What Do Your Oncology Nurses Need to Know?......32

By Alice Goodman

Columns

From the Editor: Contracting Challenges from a New Front............................3

By Dawn Holcombe, MBA, FACMPE, ACHE

News Briefs................................................................................................................ 6 Clinical Trial Update.............................................................................................. 36

Departments

MEDICAL LEGAL UPDATE Employment Misclassification and the Practice of Medicine..........................1

By Judge Ruth Kraft and Jennifer Kirschenbaum, Esq

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

Impact of the Medicare Sequester on Community Oncology….................…1

By Sydney Abbott, JD

DRUG CODING FDA-Approved Medications Used for the Treatment of Leukemia............ 24 PHYSICIAN WEALTH MANAGEMENT 5 Common Estate-Planning Pitfalls and How to Avoid Them.............................40

By Naim Bulbulia, Esq, and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Travean Digital Programmer Michael Amundsen Senior Project Manager Andrea Boylston Project Coordinators Deanna Martinez Jackie Luma Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

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MISSION STATEMENT Oncology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the high-quality care cancer patients deserve, providers must master the ever-changing business of oncology. Oncology Practice Management will offer process solutions for members of the cancer care team—medical, surgical, and radiation oncologists, as well as executives, administrators, and coders/billers—to assist them in reimbursment, staffing, electronic health records, REMS, and compliance with state and federal regulations.

Oncology Practice Management™, ISSN 2164-4403 (print), is published 8 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2013 by Engage Healthcare Communications, LLC. All rights reserved. Oncology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

The ideas and opinions expressed in Oncology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an advertisement or other product mentioned in Oncology Practice Management ™ should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication.

Postmaster: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Oncology Practice Management™, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

ONCOLOGY PRACTICE MANAGEMENT

I August 2013

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From the Editor

Contracting Challenges from…Continued from page 3 for specialty care—and they are driving referrals based upon the costs of treatment in the specialty office.

ACOs and large, clinically integrated network development are adding a significant new twist to contracting challenges. Even having a contract with a payer may not be an absolute guarantee of volume if the market forces are causing referral and market shifts along different alignments that may other-

wise have been neutral in regard to payer relationships.

How do we deal with these new challenges? Keep your eyes and ears wide open and your radar on for new market affiliations and alignment shifts. Visit with your primary care physicians and listen for any indications of trends and potential changes. Analyze your local healthcare market, both upstream and downstream; consider the possible scenarios and changes that could

adversely or positively affect your own business; and create contingency plans as well as backup plans for what you believe are the most likely 2 or 3 looming changes.

Above all, do not stop watching, listening, networking, and reacting—by the time some of these potential market shifts occur, it may already be too late to catch up.

The remainder of 2013 will be a time for careful watchfulness, not complacency. l

the more at risk you are for lung cancer. When deciding who should be screened, clinicians will need to assess the person’s age, overall health, how much the person has smoked, and whether the person is still smoking or how many years it has been since the person quit,” said USPSTF co–vice chair Michael LeFevre, MD, MSPH. “This evaluation will help clinicians decide whether it may be beneficial to screen a given person.”

After reviewing the evidence, the USPSTF determined that a reasonable balance of benefits and harms can be reached by screening people who are 55 to 80 years of age and have a 30–pack-year or greater history of smoking, who are either current smokers or have quit in the past 15 years. A “pack-year” means that someone has smoked an average of 1 pack of cigarettes per day for a year. For example, a person reaches 30 pack-years of smoking history by smoking 1 pack

a day for 30 years or 2 packs a day for 15 years.

“Lung cancer is the leading cause of cancer death in the United States and a devastating diagnosis for more than 200,000 people each year,” said USPSTF chair Virginia Moyer, MD, MPH. “Sadly, nearly 90% of people who develop lung cancer die from the disease, in part because it often is not found until it is at an advanced stage. By screening those at high risk, we can find lung cancer at earlier stages when it is more likely to be treatable.”— Source: US Preventive Services Task Force, July 30, 2013

News Briefs

US Preventive Services Task Force Issues Draft Recommendation Statement on Lung Cancer Screening Washington, DC—The US Preventive Services Task Force (USPSTF) has posted its final evidence report and draft recommendation statement on screening for lung cancer. Based on the available evidence, the USPSTF recommends screening people who are at high risk for lung cancer with annual low-dose computed tomography scans, which can prevent a substantial number of lung cancer– related deaths. This is a grade B draft recommendation.

Smoking is the biggest risk factor for developing lung cancer, resulting in about 85% of lung cancers in the United States. The risk for developing lung cancer also increases with age, with most lung cancers occurring in people aged 55 years or older.

“The more you smoke over time,

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ASCO Urges Administration to Provide Guidance on Protecting Patient Access to Clinical Trials Alexandria, VA—The American Society of Clinical Oncology (ASCO) joined more than 50 other organizations in urging the Obama Continued on page 10

*The VELCADE Reimbursement Assistance Program does not file claims or appeal claims for callers, nor can it guarantee that you will be successful in obtaining reimbursement

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

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

Printed in USA

V-10-0196

11/10

Community Oncology

Cancer Care Trends: ACCC’s 2013…Continued from page 1 He hoped that this initial reporting would give ACCC members a solid footing, providing enough perspective so that they can benchmark their programs against others, in the fol­­­­ lowing vital areas related to cancer care: • Marketplace consolidation • Patients’ ability to afford care • How to establish metrics to measure quality of care—a major component of healthcare reform • The realities of accountable care organizations (ACOs) • The phenomenon of white bagging. White bagging is the practice of having patient-specific medications or supplies delivered directly to the practice setting (ie, outpatient infusion center, physician office, hospital) for use by a specific patient.

A total of 98 cancer care programs and institutions completed the ACCC survey, including 66% community-based cancer programs, 14% outpatient cancer centers, and 5% university-based programs. The vast majority (94%) of respondents were not-for-profit institutions.

Overall Financial Health When asked about the overall financial health of cancer centers, “More than 80% of you who filled out the survey said, ‘I either feel good or very good about my financial status right now,’” Mr Edelen told ACCC attendees. He then suggested that this positive stance is likely attributable to a given program’s ability to manage costs, and may reflect the health of the cancer service line in comparison with other hospital service lines.

Whereas 75% of respondents said that they had enough data on which to base an opinion about overall financial health, respondents “are also saying that they lack the ability to track profit and loss specifically,” observed Mr Edelen, noting that cancer centers do not specifically know what their

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denial rates are, what the collectibles are, and what exactly was billed out or collected. “Many [community cancer centers] are expressing a desire to get better at this,” Mr Edelen said.

Cost management remains a top concern, as was reflected in last year’s survey. “Essentially, what we heard was that there are only so many

“What we heard back loud and clear from hospitals is that virtually every hospital is doing multiple things to try and approach how they measure quality.”

—Ron Schlief, RPh, MBA

strategies you can come up with in order to reduce costs. And there is only so much you can do before you start cutting into the bone that will start to impact your revenues,” Mr Schlief said.

One strategy around revenue production is the increase in the use of technology. “Technology is being a strategy for increasing my revenues throughout the hospital,” Mr Edelen cited survey responses. Investment in technology is increasing in cancer centers.

The Core Issues Consolidation and Mergers/ Acquisitions The survey posed the question, “Over the past year have you acquired, merged, or somehow affiliated yourself with another cancer program?”

Of the respondents, 25% said that

ONCOLOGY PRACTICE MANAGEMENT

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they had. Furthermore, a response to a follow-up question regarding acquisitions of physician practices within the ACCC members’ marketplace showed that 45% of centers and institutions indicated that this is indeed occurring.

“Not surprisingly,” Mr Edelen commented, “sixty percent of you thought this trend would be ongoing; so, the question is, what does this mean for the patient?”

Mr Schlief pondered the implications of shifting sites of care from the employees’ perspective. “For each specialty that is employed, or practicing within a hospital, what kind of employment contract are those employees operating under? Are they operating under an employee contract, or is it a professional service contract, or are they private practice, or is it some type of joint venture?” Mr Schlief asked. Each facet will have an impact on the way a bottom line is calculated.

Cost of Care and the Uninsured “In general,” said Mr Schlief, “what we’re seeing here is that more and more of you have concerns about the uninsured walking into your centers.” Respondents indicated that roughly 66% of current payments are coming from the public sector, “and once you tack on the uninsured, you’re looking at almost 70% of your business coming from other than the commercial payer.”

Based on the survey results, this proportion continues to increase as the number of commercial payers continues to decline. As Mr Schlief noted, “This is not a good picture.”

He further observed that this seemed at odds with the overall sentiment that was expressed earlier that most centers were doing pretty well.

As for Medicare, 33% of respondents indicated that this sector of

Community Oncology

their payer population was increasing, whereas 50% said that the proportion was the same compared with 2011.

Quality-of-Care Metrics Interest in quality-of-care metrics was strong, with 90% of respondents indicating that they were pursuing Commission on Cancer accreditation (there are no trend data about this, because it was the first year this topic was explored).

“What we heard back loud and clear from hospitals is that virtually every hospital is doing multiple things to try and approach how they measure quality,” Mr Schlief said.

“Then the PQRS [Physician Quality Reporting System] with Medicare, certainly there’s an incentive to participate. But what we’ve heard from members is that the incentive is so small—to actually do that for additional reimbursement….What’s driving this trend, I think, is more the hospital at large,” Mr Edelen commented.

When the question of “Would you be interested in collaborating with others as you go on this journey down quality metrics?” was asked, the answer was that nearly all (99%) respondents said that, yes, they would like to participate in peerto-peer groups to better understand quality initiatives. “As we delved into this with follow-up interviews, we saw that the devil’s in the details in terms of how you collaborate, and how you do it in such a way that’s going to be beneficial to all those that are participating,” Mr Edelen suggested.

ACOs “Accountable Care Organizations are certainly at the top of respondents’ minds,” said Mr Schlief.

Everyone is talking about it, yet the data in this survey show that most cancer centers and institutions are not actually doing anything about it: 50% of respondents said that they intended to participate in an ACO, but only 13% actually do at this point. “Hospitals are looking at it, and certainly the cancer programs within those hospitals are trying to

As was expressed by a presenter at the 2012 ACCC meeting, “ACOs are like unicorns—everyone knows what they’re supposed to look like, but no one has ever actually seen one.”

White Bagging “We tend to associate white bagging more with a community practice—a practice that doesn’t have as much clout,” said Mr Edelen.

However, 25% of respondents indicated that white bagging is allowed at their institutions. This percentage represents a growth from 2011, where only 16% of members indicated that white bagging was permitted.

“I think we can expect this upward trend to continue, as payers try and take providers more and more out of the profitability associated with the absolute purchase of chemotherapy,” Mr Schlief noted.

In a follow-up interview concerning this topic, one administrator discussed the relationship that his institution had with a specialty pharmacy, as a way of securing additional business. As Mr Schlief explained, “They were a 340B institution that used the specialty pharmacy to actually capture that business, and they kind of shared in the savings.”

And finally, as it relates to the issue of white bagging, the question “Do you have outpatient pharmacies on site that can administer oral cancer therapies and deliver on the prescriptions that your oncologists are writing?” was asked. Of the respondents, 30% indicated that they did. l

“I think we can expect this upward trend [in white bagging] to continue, as payers try and take providers more and more out of the profitability associated with the absolute purchase of chemotherapy.”

—Ronald Schief, RPh, MBA

figure out what some of their first steps and forays into experimenting in this will be,” Mr Edelen said.

In general, there is a sense that cancer centers are waiting before they make the investment in an ACO, because they are uncertain what that investment will look like.

JOIN THE CONVERSATION!

Oncology Practice Management is now on LinkedIn… see page 23 for details!

August 2013

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News Briefs Continued from page 6

administration to issue regulations or guidance before January 2014 to ensure that health plans implement an important provision of the Patient Protection and Affordable Care Act (PPACA) that would remove a critical obstacle to patients interested in participating in research.

In a jointly signed letter to the US Department of Health and Human Services (HHS) and the US Department of Labor (DOL), ASCO lent its voice to a call for clear federal guidance on coverage of routine medical costs for individuals participating in approved clinical trials, as required under section 2709 of the Public Health Service Act—a provision of the PPACA that goes into effect on January 1, 2014.

A recent HHS and DOL an­ nouncement effectively leaves the implementation details of this pro­ vision up to the individual states, which is likely to produce a patchwork of uneven and unpredictable coverage that will confuse patients and their healthcare providers and impact timely access to potentially life-extending research.

According to the cosigned letter, “Implementation of this provision will be very uneven across the country and many consumers may be denied a new protection they should be guaranteed under the law.”

“While the administration has made it clear that insurance companies must proceed with compliance, it has left important details unaddressed,” said Clifford A. Hudis, MD, FACP, the president of ASCO. “We know that insured patients with coverage for clinical trial participation have faced denials and delays even in those states that require such coverage, a situation that is unacceptable to patients for whom clinical trials of new therapies may represent their best hope for extension of life or a better quality of life. This also unnecessar-

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ily delays the development of better treatments for everyone.”

The letter builds on ASCO’s earlier advocacy efforts with 18 cancer organizations that resulted in submission of recommendations to federal agencies on how to implement the coverage requirement. ASCO is also developing detailed information on the new law for cancer patients, investigators, and research staff, and it will be closely tracking implementation of the law.

Fewer than 5% of patients with cancer and only 6% of patients with severe chronic illness participate in clinical trials. These low participation rates mean that research takes longer, costs more, and ultimately results in delays in the development of new therapies or a lag in evidence about the safety and effectiveness of existing therapies.

Studies have found that patients who are eligible are often denied access to clinical trials. A study published in 2010 found that of 628 eligible patients with cancer denied coverage for their routine clinical trial costs between 2003 and 2008, nearly 80% of those denied had insurance coverage that generally purported to allow coverage for clinical trial participation (Klamerus JF, et al. Clin Cancer Res. 2010;16:5997-6003). In enacting the PPACA provision, Congress sought to remove obstacles to participation in research for patients.

ASCO and the other organizations signing the letter identified 4 key issues that should be addressed through federal rulemaking to ensure that the clinical trials provision of the PPACA is fully implemented: • Prevention, Detection, and Treatment of Complications: Explicit safeguards should ensure that the prevention, detection, and treatment of complications arising from clinical trials are covered under the definition of

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“routine costs.”

• Meaningful Access to Clinical Trials: Regulations should prevent group health plans and insurance issuers from requiring patients to travel unreasonable distances to enroll in a clinical trial with an in-network provider.

• Prevention of Delays and Ad­­ ministrative Barriers: Safeguards should protect patients from delays and administrative barriers that undermine access to clinical trials, including preventing financial incentives arising from new delivery models from inadvertently creating barriers for patients to participate in clinical trials.

• Determining a Life-Threatening Condition: Determination about whether an individual is an appropriate candidate for participation in a trial that qualifies for coverage should be made by the patient’s healthcare professional.­­­— Source: American Society of Clinical Oncology, June 19, 2013 Precyse Awarded Prestigious HFMA Designation for HIM Technology Wayne, PA, and Alpharetta, GA—Precyse, a leader in health information management (HIM) technology and services, announced that, after undergoing the rigorous review process, its Precyse HIM Technology & Services Suite has been awarded the “Peer Reviewed by [Healthcare Financial Management Association] HFMA®” designation.

The comprehensive suite includes the follow features: • Transcription is a combination of transcription technology, processes, and services that accelerates turnaround time, reduces costs, minimizes capital outlay, and transforms dictation into meaningful clinical information.

• Clinical Documentation Im­­ Continued on page 12

Now enrolling Investigating ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Phase II Open-Label Study of the Efficacy and Safety of ABT-199 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion N=100

ABT-199 is an investigational agent that has not been approved by regulatory agencies for the use under investigation in this trial.

Primary Endpoint

Secondary Endpoints

• Overall response rate

• • • • • • • •

Complete remission rate Partial remission rate Duration of response Progression-free survival Time to progression Overall survival Percentage of patients who move on to stem-cell transplant Safety and tolerability of ABT-199

Key Inclusion Criteria • Adult patients ≥18 years of age • Diagnosis of CLL that meets 2008 IWCLL NCI-WG criteria (relapsed/refractory after receiving ≥1 prior line of therapy and 17p deletion) • ECOG performance score of ≤2 • Adequate bone marrow function • Adequate coagulation, renal, and hepatic function, per laboratory reference range

NCT#01889186 Reference: ClinicalTrials.gov.

@ 2013 Genentech USA, Inc. All rights reserved. BIO0001961500 Printed in USA.

To learn more about this study, please visit www.ClinicalTrials.gov.

News Briefs Continued from page 10

provement Services and precyse­ CDI™ evaluates physicians’ current clinical documentation practices, identifies inefficiencies, and offers strategies for improved clinical documentation.

• Coding includes field-tested coding services, either on or off site, delivering code quality and accuracy.

• Coding Audit & Compliance help to identify risk areas and offer specific audit improvements and education for operational improvements and compliance requirements.

• precyseCode ™ ComputerAssisted Coding is an integrated platform that supports multiple HIM roles across an organization driven by natural language processing for embedded intelligence supporting inpatient and outpatient coding and International Classification of Diseases (ICD) needs.

• Precyse University is an on-site, online, and mobile healthcare education solution that is designed to prepare all impacted healthcare populations for the transition to ICD, Tenth Revision.

• HIM Strategic Sourcing is a solution that combines technology and services that can help hospital or physician practice HIM functions optimize their effectiveness and advance their capabilities and functions to successfully operate under a more challenging reimbursement environment.

• HIM Interim Management & Consulting is for a professional HIM department director or manager who takes responsibility for every challenge, large and small, including monitoring, measuring, and reporting on key metrics critical to success.

• Oncology Data Management & Cancer Registry includes

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backlog abstracting and operational assessments, interim management, consulting, software selection, and Commission on Cancer presurvey assessment.

“Precyse is uniquely positioned to help healthcare facilities and providers improve efficiency and deliver tangible outcomes through our advanced, proprietary software and services, and we are very proud to be recognized with the HFMA Peer Review designation,” said Precyse’s president, Chris Powell. “This recognition is a testimony to Precyse’s ongoing commitment to excellence and the exceptional and consistent quality of service provided to our clients.”

HFMA provides the resources that healthcare organizations need to achieve sound fiscal health in order to provide excellent patient care. With more than 40,000 members, HFMA is the nation’s leading membership organization of healthcare finance executives and leaders.

Known as “The Short List,” HFMA’s peer-reviewed products and services provide healthcare financial managers with an objective third-party evaluation. The peer-review status of the product or service and its performance claims are based on effectiveness, quality and usability, price, value, and customer and technical support.

“Precyse is uniquely positioned to help healthcare facilities combat hospital and physician reimbursement cuts,” Powell explained. “As hospitals and healthcare providers begin to face a vast array of reimbursement pressures in 2013, including the 2% Medicare reimbursement cuts that went into effect on April 1 with sequestration, Precyse’s expert staff and customized technology solutions can help many facilities minimize some of the challenges they are facing.”—Source: PRNewswire, June 17, 2013

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Colorado Hospital Earns Joint Commission’s Gold Seal of Approval Englewood, CO—Swedish Med­ ical Center, a Level 1 trauma center and The Joint Commission– accredited Stroke, Cardiology, and Cancer Center that cares for more than 200,000 patients annually with a team of 2000 dedicated employees, 500 volunteers, and more than 1300 physicians, is the first Colorado hospital to earn The Joint Commission’s Gold Seal of Approval for certification in pancreatic and lung cancer care. As the third medical center in the country to be accredited for pancreatic cancer care and the fifth in the country to be accredited for lung cancer care, this certification recognizes dedication to continuous compliance with The Joint Commission’s national standards for quality healthcare.

“This achievement acknowledges the exemplary care we provide to the patients of Colorado and the surrounding region,” said Mary M. White, president and CEO of the Swedish Medical Center. “Our oncology team deserves to be recognized for their outstanding dedication to quality care.”

In February, Swedish underwent a rigorous on-site survey by The Joint Commission that evaluated compliance with standards of care specific to the needs of patients, including infection prevention and control, leadership, and medication management. The Joint Commission is a prestigious national medical accreditation organization that accredits more than 20,000 healthcare organizations and programs in the United States.

Swedish’s pancreatic cancer services are offered as a part of the Center for Diseases of the Liver and Pancreas. As a leader in services offered in Colorado, the center has dedicated physicians and staff

News Briefs

committed to comprehensive care and treatment to all patients with pancreatic cancer. They provide the most advanced treatments and compassionate care to ensure that all of their patients achieve the best possible outcome.

The lung cancer care program’s diverse team of specialists, advanced resources, and full continuum of lung cancer care are important qualities that have helped Swedish earn the trust and confidence of its patients and referring physicians.

Patients are able to work directly with staff to coordinate and manage their treatments, allowing them to devote more time and energy to achieve restoration in their health.

Both pancreatic and lung cancer patients benefit from having personal one-on-one care from the entire staff.

Patients have full access to nurse navigators, multidisciplinary care conferences, state-of-the-art equipment, and expert clinical care.—Source: PRNewswire, June 6, 2013 RCCA and GenPath Oncology Partnership Will Benefit Nearly a Quarter Million NJ Cancer Patients Hackensack, NJ and Elmwood Park, NJ—Regional Cancer Care Associates LLC (RCCA), one of the nation’s largest oncology physician groups, has partnered with GenPath Oncology, a business unit of BioReference Laboratories, to bring advanced diagnostics to the practice’s more than 230,000 cancer patients.

RCCA and GenPath have joined together to create an advanced molecular laboratory on the grounds of the John Theurer Cancer Center in Hackensack, NJ. This initiative expands the group’s offered services

into key diagnostic testing for their patient community. The first step in this multiyear partnership is the development of a physician-owned immunophenotyping service for hematologic malignancies. In addition, GenPath will also be providing a significant amount of esoteric diagnostic testing to RCCA’s network of 92 oncology physicians in 27 locations.

The partnership with GenPath will strengthen RCCA’s mission to raise the standard of cancer care across the state, while remaining competitive in a changing healthcare environment where medical practices increasingly face declining reimbursements and rising administrative costs.

“We recognize that providers are forming larger practices to meet the challenges of a changing market.

BioReference continues to adapt as our clients evolve. RCCA and BioReference both share a commitment to patient care and support scientific innovation for this purpose,” said Marc D. Grodman, MD, the president and CEO of BioReference Laboratories.

“RCCA was established to offer the highest quality and most comprehensive cancer care and our partnership with BioReference expands upon that goal. Through this relationship, RCCA is well positioned to offer the most innovative cancer diagnostics,” said Edward J. Licitra, MD, PhD, the board chairman of RCCA. RCCA is one of the nation’s largest oncology physician networks.

As a group, RCCA is transforming healthcare by providing a broad range of quality cancer services to patients while also controlling the cost of patient care through practice-management consistency, more

competitive contractual rates, and more hospital privileges, resulting in long-term savings for payers.

The new RCCA testing service will focus on providing timely and clinically relevant results for patient care in a cost-effective manner.

According to Dr Licitra, oncology is at a crossroads—increasing longevity in the population has the unintended effect of raising the incidence of cancer. “Oncology care is advancing, becoming more specialized, and, therefore, getting more expensive. Over time, some cancer care may become unaffordable, and that would be tragic. We need to take steps now that allow us to modulate the growth of the cost of cancer care while maintaining quality,” he explained.

GenPath, headquartered in Elmwood Park, NJ, was selected from among the largest cancer laboratories in the nation, due to its scientific expertise and longstanding relationships with many of RCCA’s physicians. GenPath offers oncology providers a single source for cancer patient management, including bone marrow morphology, solid tumor diagnosis, molecular genetics for personalized medicine, and even routine clinical testing specific for cancer patients. In addition, GenPath offers 2 innovative proprietary testing modalities, OnkoMatch, a tumor genotyping test that covers more than 100 possible mutations in 14 clinically targetable oncogenes, and GenArray, which scans a patient’s entire genome for chromosomal abnormalities, offering superior coverage over conventional methods such as fluorescence in sita hybridization and cytogenetics.—Source: Regional Cancer Care Associates LLC/PRNewswire, June 5, 2013 l

DO YOU HAVE NEWS TO SHARE? Send your press release—and a photograph if you have one—outlining your clinic or center’s news and accomplishments to Lisa Neuman, Managing Editor, at lneuman@the-lynx-group.com.

August 2013

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

Impact of the Medicare Sequester…Continued from page 1 1, 2013 and cancer care providers most likely began seeing reduced payments as early as mid-April.

Because of the way Part B drugs are reimbursed, the 2% sequester disproportionately reduces payments for critSydney Abbott, JD ical cancer drugs.

Provider reimbursement should be at average sales price (ASP) + 6%. However, after accounting for the patient copay component, the sequester actually makes provider reimbursement ASP + 4.3%. While initial discussions indicated that the sequester would be a short-term congressional budget tool, it has become clear that Congress will not reverse it easily.

To get a more complete picture of the impact of the sequester on community oncology, the Association of Community Cancer Centers (ACCC) recently surveyed its membership. ACCC’s survey opened on May 23, 2013, and results were compiled on June 11, 2013, with 200 respondents fairly evenly split between hospital-based cancer centers and private physician oncology practices, with about 50% of all the patients treated being covered by Medicare. The results conclude that the 2% reduction to Medicare payments as a result of

the federally mandated sequester is adversely affecting a majority of cancer patients and providers.

More than 58% of the sites of care surveyed are feeling the sequester’s impact. Of those, 78% have reduced their operating expenses, including reductions in staff, and

64% [of the sites of care surveyed] said that chemotherapy infusion service had been impacted, and frighteningly, 13% responded that patient treatments had been delayed as a direct result of the cut. more than 33% of the facilities have been forced to refer patients to another site of service. In addition, 64% said that chemotherapy infusion service had been impacted, and frighteningly, 13% responded that patient treatments had been delayed as a direct result of the cut.

Other types of services have been affected more greatly; survivorship

and nutrition services as well as clinical trials all have been negatively impacted by 30% or more.

To understand the sequester’s effect on patients, ACCC asked members if their patients had seen any changes in their care. While 32% of respondents in the physician setting have not changed patient care as a result of the across-theboard cuts, 35% reported more inconvenience for patients, including increased travel for treatment, delays in treatment, and less continuity of care. In the hospital outpatient setting, 55% said the sequester has not yet impacted patient care directly, while 7% admit at least some delays in care. In addition, 15% of hospital outpatient departments have seen an increase in patient referrals to their facilities.

The results of this survey confirm that the sequester has already begun to negatively impact patient care in community oncology. To paint a more complete picture of the sequester’s effect on cancer patients and providers, ACCC will conduct a follow-up survey this fall after the cuts have remained in effect.

ACCC will continue to work with its membership to educate members of Congress on the impact that these cuts are having on cancer patients and providers. For more information on the survey, or for information on ACCC’s advocacy efforts, please visit www.accc-cancer.org. l

CALL TO ACTION: Have a Practice Management tip to share?

Submit your success story (in no more than 1,000 words) to Lisa Neuman, Managing Editor, at lneuman@lynx-group.com 14

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ONCOLOGY PRACTICE MANAGEMENT

I August 2013

SHOULDN’T A PATIENT SUPPORT PROGRAM BE EASY TO NAVIGATE?

• REIMBURSEMENT SERVICES

• EDUCATION AND SUPPORT SERVICES

• BENEFIT VERIFICATIONS

• PATIENT ASSISTANCE

• DELIVERY COORDINATION

• CO-PAY ASSISTANCE

An uncommon condition requires a common solution— IncyteCARES IncyteCARES helps connect your patients with intermediate or high-risk myelofibrosis (MF), who qualify for the program, to ongoing support and resources during their treatment with Jakafi® (ruxolitinib).

Indications and Usage Jakafi is indicated for treatment of patients with intermediate or high-risk MF, including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF. Important Safety Information

•Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia, which are

each dose-related effects, with the most frequent being thrombocytopenia and anemia • Monitor CBCs, and in patients with cytopenias, consider dose reductions, temporarily withholding Jakafi, or transfusions, as clinically indicated Please see additional Important Safety Information and the Brief Summary of Full Prescribing Information within this ad.

HELPING PATIENTS RECEIVING JAKAFI (ruxolitinib) STAY CONNECTED TO CARE ®

Patients living with intermediate or high-risk MF face many challenges. IncyteCARES is a program created by Incyte to connect patients who qualify for the program to ongoing support and resources during their treatment with Jakafi.

IncyteCARES HELPS PEOPLE BEING TREATED WITH JAKAFI ACCESS AND REIMBURSEMENT SERVICES

•Benefit verification •Prior authorization •Appeal support • Delivery coordination of Jakafi

•Co-pay assistance •Free medication programs • Referrals and assistance with independent not-for-profit organizations

PATIENT EDUCATION AND SUPPORT

• Access to trained nurses • Educational information to help teach your patients about their condition and Jakafi Patient packet

•

Visit www.IncyteCARES.com or call 1-855-4-JAKAFI (1-855-452-5234), Monday–Friday, 8 AM –8 PM ET, to learn more about how to connect your patients to IncyteCARES.

IncyteCARES: ASSISTING PROVIDERS AND PATIENTS IN OBTAINING ACCESS TO JAKAFI Enrollment sent to

95% of patients had insurance coverage for

Patients without insurance coverage were screened for patient assistance eligibility

94% of prior authorizations were approved for

86% of commercially insured patients had co-pays of less than $100/month

Information is based upon 1421 patients enrolled in IncyteCARES between April 1, 2012 and April 1, 2013.

91% of patients referred to the IncyteCARES commercial co-pay assistance program were eligible for assistance Important Safety Information (continued)

•Risk of Infection: Assess patients for signs and symptoms of infection and initiate

appropriate treatment promptly. Serious infections should have resolved before starting therapy with Jakafi • The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache Please see additional Important Safety Information and the Brief Summary of Full Prescribing Information within this ad.

Jakafi is a registered trademark of Incyte Corporation. © 2013, Incyte Corporation. All rights reserved. RUX-1227f 07/13

Table 2: Worst Hematology Laboratory Abnormalities in the Placebo-controlled Studya Jakafi Placebo (N=155) (N=151) Laboratory All All b Grade 3 Grade 4 Grades Grade 3 Parameter Grades BRIEF SUMMARY: For Full Prescribing Information, see package insert. (%) (%) (%) (%) (%) INDICATIONS AND USAGE Jakafi is indicated for treatment of patients with intermediate or high-risk Thrombocytopenia 69.7 9.0 3.9 30.5 1.3 myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential Anemia 96.1 34.2 11.0 86.8 15.9 thrombocythemia myelofibrosis.

Neutropenia 18.7 5.2 1.9 4.0 0.7 CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia and Neutropenia Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia. [see Dosage and Administration (2.1) in Full Prescribing Information]. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse Reactions]. Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi. Severe neutropenia (ANC less than 0.5 X 109/L) was generally reversible. Withhold Jakafi until recovery [see Adverse Reactions]. Perform a pretreatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse Reactions]. Risk of Infection Serious bacterial, mycobacterial, fungal and viral infections may occur.

Active serious infections should have resolved before starting therapy with Jakafi. Observe patients receiving Jakafi for signs and symptoms of infection and initiate appropriate treatment promptly. PML Progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate. Herpes Zoster Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected [see Adverse Reactions].

ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Myelosuppression [see Warnings and Precautions]; • Risk of Infection [see Warnings and Precautions] 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 practice. The safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 months, 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% of patients treated for more than 6 months and 24.6% treated for more than 12 months. One hundred and eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In a double-blind, randomized, placebo-controlled study of Jakafi, 155 patients were treated with Jakafi. The most 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 reactions were bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless of causality, 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 to pretreatment levels over a period of approximately 1 week. There have been isolated cases of patients discontinuing 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 in these patients. When discontinuing therapy for reasons other than thrombocytopenia, gradual tapering of the dose of Jakafi may be considered [see Dosage and Administration (2.9) 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-controlled Study During Randomized Treatment Jakafi Placebo (N=155) (N=151) Adverse All All Grade 3 Grade 4 Grades Grade 3 Grade 4 Reactions Gradesa (%) (%) (%) (%) (%) (%) Bruisingb 23.2 0.6 0 14.6 0 0 Dizzinessc 18.1 0.6 0 7.3 0 0 Headache 14.8 0 0 5.3 0 0 Urinary Tract Infectionsd 9.0 0 0 5.3 0.7 0.7 Weight Gaine 7.1 0.6 0 1.3 0.7 0 Flatulence 5.2 0 0 0.7 0 0 Herpes Zosterf 1.9 0 0 0.7 0 0 a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 b includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site hematoma, increased tendency to bruise, petechiae, purpura c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis d includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria urine, bacteria urine identified, nitrite urine present e includes weight increased, abnormal weight gain f includes herpes zoster and post-herpetic neuralgia

Description of Selected Adverse Drug Reactions Anemia In the two Phase 3 clinical studies, median time 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 hemoglobin reached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then gradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This pattern was observed in patients regardless of whether they had received transfusions during therapy. In the randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving placebo received red blood cell transfusions during randomized treatment. Among transfused patients, the median number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebo treated patients. Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3 or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was generally reversible with dose reduction or dose interruption. The median time to recovery of platelet counts above 50 X 109/L was 14 days. Platelet transfusions were administered to 4.7% of patients receiving Jakafi and to 4.0% of patients receiving control regimens. Discontinuation of treatment because of thrombocytopenia 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 of Grade 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 Jakafi because of neutropenia. Table 2 provides the frequency and severity of clinical hematology abnormalities reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study.

Grade 4 (%) 0 3.3 1.3

a Presented values are worst Grade values regardless of baseline b National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0

Additional Data from the Placebo-controlled Study 25.2% of patients treated with Jakafi and 7.3% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transaminase (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 treated with 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 or worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was 0.6% for Jakafi with no Grade 3 or 4 cholesterol elevations.

DRUG INTERACTIONS Drugs That Inhibit or Induce Cytochrome P450 Enzymes Ruxolitinib is predominantly metabolized by CYP3A4. Strong CYP3A4 inhibitors: The Cmax and AUC of ruxolitinib increased 33% and 91%, respectively, with Jakafi administration (10 mg single dose) following ketoconazole 200 mg twice daily for four days, compared to receiving Jakafi alone in healthy subjects. The half-life was also prolonged from 3.7 to 6.0 hours with concurrent use of ketoconazole. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding ruxolitinib AUC following concurrent administration with ketoconazole. When administering Jakafi with strong CYP3A4 inhibitors a dose reduction is recommended [see Dosage and Administration (2.7) in Full Prescribing Information]. Patients should be closely 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, pSTAT3 inhibition was consistent with the corresponding exposure information. No dose adjustment is recommended when Jakafi is coadministered with mild or moderate CYP3A4 inhibitors (eg, erythromycin). CYP3A4 inducers: 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 in healthy subjects. In addition, the relative exposure to ruxolitinib’s active metabolites increased approximately 100%. This increase may partially explain the reported disproportionate 10% reduction in the pharmacodynamic marker pSTAT3 inhibition. No dose adjustment is recommended when Jakafi is coadministered with a 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 with ruxolitinib 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 doses of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There was no evidence of teratogenicity. However, decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times the clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest dose 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 its metabolites were excreted in the milk of lactating rats with a concentration that was 13-fold the maternal plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Jakafi, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effectiveness of Jakafi in pediatric patients have not been established. Geriatric Use Of the total number of myelofibrosis patients in clinical studies with Jakafi, 51.9% were 65 years of age and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in healthy 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 pharmacokinetics of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with normal renal function. However, plasma AUC values of ruxolitinib metabolites increased with increasing severity of renal impairment. This was most marked in the subjects with end stage renal disease requiring hemodialysis. 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 removal of some active metabolites by dialysis cannot be ruled out. When administering Jakafi to patients with moderate (CrCl 30-59 mL/min) or severe renal impairment (CrCl 15-29 mL/min) with a platelet count between 100 X 109/L and 150 X 109/L and patients with end stage renal disease on dialysis a dose reduction is recommended [see Dosage and Administration (2.8) in Full Prescribing Information]. Hepatic Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in healthy subjects (N=8) and in subjects with mild [Child-Pugh A (N=8)], moderate [Child-Pugh B (N=8)], or severe 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 patients with normal hepatic function. The terminal elimination half-life was prolonged in patients with hepatic impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours). The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in ruxolitinib exposure except in the severe (Child-Pugh C) hepatic impairment cohort where the pharmacodynamic activity was more 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 (2.8) in Full Prescribing Information].

Jakafi is a registered trademark of Incyte Corporation. All rights reserved.

U.S. Patent No. 7,598,257 © 2011-2013 Incyte Corporation. All rights reserved.

Issued: June 2013 RUX-1216

ONS Conference Highlights

This article originally appeared in its entirety in the June 2013 issue of The Oncology Nurse-APN/ PA®, and the excerpts here are used with permission.

These highlights from the 38th Annual Congress of the Oncology Nursing Society provide valuable information for the oncology practice manager on several aspects of caring for patients with cancer, such as reducing falls in the practice, helping patients preserve their fertility before they begin their treatment, and helping nurses set up programs aimed at helping patients manage their symptoms in the clinic setting.

Reducing Falls in the Outpatient Setting

By Alice Goodman

A

t most hospitals and other inpatient facilities, procedures are in place for identifying patients at risk of falling, and there are guidelines for the prevention of falls. However, such procedures and guidelines are not routinely present in outpatient centers where cancer patients are treated, explained Sara Lantowski, BSN, OCN, of the Smilow Cancer Hospital at Yale-New Haven in Connecticut.

“We had a substantial number of reports of falls at our center, but we had no ambulatory fall screening or prevention plan in our outpatient setting. Since this was an unmet need, as well as a nurse-sensitive indicator of quality, we formed a committee to draft proposals for identifying patients at risk for falls and documenting them in our new electronic medical records system. The next steps are to implement prevention strategies and patient and family education,” said Lantowski.

The simple and easy-to-use Fall Risk Screening Tool that the committee developed includes 4 questions for patients: 1. Do you use any assistive device to ambulate?

2. Do you need any physical assistance with standing or walking (ie, walker, cane)?

3. Do you have periods of forgetfulness or don’t know where you are at times?

4. Have you had a fall in the past 6 months?

A “yes” answer to any of these questions indicates high risk of falling, she said.

With the use of this new tool, 80% to 100% of patients at Smilow are screened for risk of falls and are identified in the electronic medical record. The screening effort is led by patient care and medical assistants.

“Falls can result in injury, and providing patients with early education on fall risk and prevention would be expected to minimize falls in ambulatory oncology settings

[and] the home setting and [would] potentially translate to fewer inpatient falls,” she stated.

The committee has developed an educational brochure for patients that includes steps for preventing falls during outpatient visits (wear nonslip footwear, bring assistive walking devices, wear clothes that allow you to walk freely, and wear your eyeglasses). The brochure in­ cludes safety measures for patients to take during outpatient visits, such as asking for help walking if needed, letting the staff know about a recent fall, not using an IV pole as a support, and alerting the staff if there is a slippery floor area or torn carpet.

The brochure also lists fall prevention tips for family members and other visitors who accompany patients on their outpatient visit. l

Reference

Blasiak E, Lantowski S, Bursey C, et al. The ins and outs of fall prevention: improving awareness, providing education, and promoting early fall prevention in the outpatient oncology setting. Presented at: 38th Annual Congress of the Oncology Nursing Society; April 25-28, 2013; Washington, DC. Poster 178.

Measures to Preserve Fertility

By Alice Goodman

C

ancer patients are often at risk for impaired fertility related to their treatments.

A quality improvement initiative at Memorial Sloan-Kettering Cancer

Center (MSKCC) in New York City showed that education, developing an algorithm for discussions with patients, documenting those discussions, and supplying patients and

August 2013

providers with a list of referrals for fertility preservation specialists are an important aspect of oncology nursing that can improve the quality of care provided to patients.

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ONS Conference Highlights

The study included 26 patients with sarcoma or melanoma between the ages of 18 and 45 years treated at MSKCC over a 12-month period.

All patients were eligible for fertility preservation options. Meetings were conducted with physicians and nurses to identify barriers to discussing fertility, which included a lack of knowledge, undefined roles, the absence of a standardized work flow, no documentation system, and the difficulty of discussing fertility with patients with a poor prognosis.

At baseline, 69% of the oncologists discussed fertility risks associated with treatment, 54% explained fertility preservation options, and

54% referred interested patients to fertility specialists. Among the nurses, 0% discussed fertility, 0% discussed fertility preservation options, and 17% referred patients in response to an oncologist’s direction.

The research team provided education for oncologists and nurses regarding the need for discussion of fertility with the patient and options and referrals for interested patients. The team developed an algorithm for oncologists and nurses to use in discussions with patients, a method of data collection, and strategies for implementing improvements, as well as a list of fertility preservation resources

and processes for making referrals and documenting care provided.

After a 3-month evaluation and follow-up of this initiative, dramatic improvement was seen among the nurses: 57% discussed fertility with patients, 71% discussed options, and 80% provided referrals. Among the oncologists, after the education initiative, 60% gave patients referrals for fertility preservation options. l

Reference

Clark R, Baldwin A, Frankel Kelvin J. Fertility preservation: standardizing education and patient referral.

Presented at: 38th Annual Congress of the Oncology Nursing Society; April 25-28, 2013; Washington, DC. Poster 193.

Nurse-Led Symptom Management Clinic

By Alice Goodman

A

nurse-led interdisciplinary symptom management team has been implemented at the Billings Clinic Cancer Center in Montana, part of a top 100 hospital, according to Truven Health Analytics. The team was put together in response to the Commission on Cancer’s mandate for making palliative care services available and suggesting that interdisciplinary symptom management teams be developed. These teams would include a provider and a nurse trained in palliative care and hospice, a pharmacist, a social worker, a mental health clinician, and a chaplain.

“Palliative care is often thought of as end-of-life care, but it really relates to quality of life from the time of diagnosis,” said Alison Weber, RN, BSN, who presented this poster. “Palliative care encompasses psychosocial, spiritual, physical, and advanced care planning.”

Patients undergoing cancer treat-

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ment at the center were screened for distress, and the sources of distress were identified. The top 6 sources of distress were (in descending order) fatigue, pain, sleep, peripheral neuropathy, skin problems, and difficulty concentrating.

Assessment, triage, and protocols were developed for various symptoms. The team held weekly meetings. After the program was put in place, patients attended a weekly symptom management clinic.

Weber’s impression is that patients love the attention and care they get, and that their quality of life is improved.

When symptoms arise, the nurses identify which team members are needed for help in symptom management. For example, if the patient has taste changes, a dietitian might be called in; if the patient is in pain, a pain management staff member will be consulted. If symptoms do not resolve, then a provider is consulted; urgent care and even emer-

ONCOLOGY PRACTICE MANAGEMENT

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gency care are provided if needed.

“This program has been ongoing for the past 4 years. Patients who engage with the nurse-led team seem to love it. They feel their complaints are heard and that they are given attention. The main challenge in implementing this type of interdisciplinary team is to get providers’ buy-ins. We need to convince providers that this effort provides added value,” said Weber.

She said that the information in her poster provides a model for cancer center personnel who want to implement a symptom management team, and she sees this approach gaining favor in the future. “This care is reimbursable for NPs and PAs, and it is billed as a clinic visit,” she said.l l

Reference

1. Weber A, Waitman K, Blaseg K, et al. A nurse-led symptom management clinic: serving cancer patients across the continuum. Presented at: 38th Annual Congress of the Oncology Nursing Society; April 25-28, 2013; Washington, DC. Poster 172.

Medical Legal Update

Employment Misclassification…Continued from page 1 ty, and social security insurance to independent contractors. A putative employer who has misclassified workers will be subject to liability for withholding taxes, interest, and penalties, including liquidated damages of double the calculated tax as well as potential disqualification of an employee benefits plan that excluded such workers.

A multitude of state and federal agencies are involved with the determination of employment status, including the Internal Revenue Service (IRS); the US Department of Labor; the Equal Employment Opportunity Commission; state workers’ compensation, unemployment, and disability benefits agencies; human rights organizations; labor boards; and tax departments.

There is no one definition of an “independent contractor” and, therefore, the determination of whether a worker is an employee or an independent contractor is subject to a facts and circumstances test to assess whether the worker is subject to the control of the recipient of services. However, there is a statutory presumption that workers are employees. An employer–employee relationship generally exists if the person who is contracting for the services has the right to control not only the results but also the means by which the results are accomplished. It is not necessary that the employer actually control the manner in which services are performed but, rather, it is sufficient that the employer have a right to control.1 The factors identified by the IRS since 1987, as determinative of the employer–employee relationship, are as follows, with the degree of importance attributable to each factor being dependent on the occupation and factual context in which the services are performed2:

lenges to employers and has led to the misinterpretation of workplace scenarios. This is particularly applicable to the relationship between doctors and their associates. In a landmark decision, New York’s highest court held that, not- Jennifer Kirschenbaum, Esq withstanding that the professional services of ophthalmologists and optometrists do not lend themselves to control over the results produced and means employed, there was substantial evidence of the existence of control beyond results or means, to wit:

1. Instructions 2. Training 3. Integration into business operations 4. Personally rendered services 5. Hiring, supervision, and payment of assistants 6. Ongoing business relationship 7. Set hours of work 8. Full-time devotion to the enterprise 9. Performance of work takes place on the employer’s premises 10. The order of the work sequence is set by the employer 11. There is an oral or written re­­ porting requirement 12. Payment is by hour, week, or month rather than by job 13. Payment of business expenses 14. Furnishing tools and materials 15. Significant investment in facilities 16. Realization of profit or loss 17. Working for multiple entities at the same time 18. Making services available to the general public 19. Right to discharge 20. Right to terminate.

1. Notwithstanding that the professionals worked part time at the putative employer’s premises, the hours worked were regularly scheduled rather than sporadic or occasional.

2. Appointments were made by the employer’s receptionist.

3. Patients were treated as those of the employer.

4. Fees were fixed by the employer.

5. Services were rendered at the employer’s premises.

6. The employer’s equipment and facilities were utilized.

7. Billings and collections were handled by the employer.

8. Patient records were maintained by the employer.

9. Any applicable insurance forms were prepared by the employer’s staff.4

More recently, the IRS has identified 3 global categories for evaluation: behavioral control, financial control, and relationship of the parties.3 Historically, the courts have recognized that individuals who practice a profession in which services are offered to the public are not employees and that, similarly, they do not require close supervision in the same sense as less skilled workers. However, since the enactment of the Revenue Act of 1978, the IRS has been prohibited from issuing regulations or revenue rulings to clarify the employment status of any individual for the purposes of employment taxes. This lack of guidance has presented chal-

August 2013

Similarly, California courts have held that even where there is an absence of control over work details, an employer–employee relationship will be found if (1) the principal retains pervasive control over the Continued on page 22

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Medical Legal Update

Employment Misclassification…Continued from page 21 operation as a whole; (2) the worker’s duties are an integral part of the operation; and (3) the nature of the work makes detailed control unnecessary.5 In this regard, the existence of a written agreement purporting to establish an independent contractor relationship is not determinative, nor is the fact that a worker is issued a 1099 form rather than a W-2 form material to the assessment of employment status.

Accordingly, under the current state of the case law, doctors who are hired to work in medical offices or clinics would generally be considered employees. The fact that operatory equipment and supplies, as well as support staff, are provided by the medical office establishes a threshold finding which is difficult, but not impossible, to counteract. Critical indicators to the contrary would include an absence of control, not only over the performance of professional services but over important operational aspects as well.

For example, if an independent medical subspecialist was not held to a schedule whatsoever, treated only his own patients, maintained secured patient records to which the putative employer did not have access, set his own fees, hired his own assistants, and managed his own billing, the services rendered would be in support of his own practice and ancillary to the operation of the clinic. Payment of a leasing fee based on the number of patients seen, hours worked, or other variables would not be contrary to such a determination. The ability to designate a substitute in the event of unavailability would be material as well.

Recently, the courts have focused their analyses on whether business development activities—such as business cards or professional websites—have referenced a relationship

22

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between the doctor and the practice.

Significantly, they have minimized the effect of corporate entities established by doctors on the determination of the status of the employer– employee relationship.

The essential terms of a contract between a doctor and a practice

Given the enhanced interagency cooperation and state regulatory initiatives, as well as allocation of significant resources to both the IRS and the Department of Labor to detect and deter misclassifications, ensuring that workers are properly classified should be a leading priority for medical practices in an effort to mitigate exposure.

are, typically, consistent with those in other employment agreements.

On occasion, however, such contracts address the doctor’s potential purchase of an ownership interest in the practice. To the degree that a provision reflects the potential to participate in control decisions for the practice at a later point in time, although appearing neutral, it could be suggestive of integration into the practice as well as of privileges or benefits that are not accorded to an independent con-

ONCOLOGY PRACTICE MANAGEMENT

I August 2013

tractor. Additionally, in the current regulatory environment, it can no longer be said that the fact that a doctor works for multiple practices would determine the relationship of the parties. Governmental agencies could easily find the doctor to be a part-time or per diem employee of each such practice because the existence of an employment relationship with one enterprise would not preclude the existence of multiple such relationships.

It is essential for medical practices to reassess their existing classification determinations right now. An organization should first determine whether independent contractors have been appropriately classified.

If this is not the case, creating a plan for voluntary reclassification or restructuring is essential to mitigate the risk of worker litigation or regulatory audit. Experienced counsel can assist in developing and implementing independent contractor agreements that appropriately recognize the dynamics of the workplace relationship as well as help the practice in preparing employee handbooks and procedures containing standards to ensure conformity with the restructured relationship.

Alternatively, redistribution of a workforce to a staffing company may be contemplated only with stringent legal safeguards.

Given the enhanced interagency cooperation and state regulatory initiatives, as well as allocation of significant resources to both the IRS and the Department of Labor to detect and deter misclassifications, ensuring that workers are properly classified, should be a leading priority for medical practices in an effort to mitigate exposure.6 Taking the time to review your practice’s employment relationships with your accountant and attorney to determine

Medical Legal Update

the right relationship along with ensuring that all of the proper documentation is in order will protect your practice from unwanted exposure from misclassification. l

References

1. Internal Revenue Code, section 3121(d)(2); Treas.

Reg. sec. 31.3401(c)-(1)(b).

2. Rev. Rul. 87-41, 1987-1 C.B. 296 addressing section 530 of the Revenue Act of 1978.

3. Department of the Treasury, Internal Revenue Service. Independent Contractor or Employee?

Training Materials, Training 3320-102 (10-96) TPDS 842381, at 2-7.

4. Matter of Concourse Ophthalmology Associates, P.C., 60 N.Y. 2d 734; 456 N.E. 2d 1201; 469 N.Y.S.

tice. To contact Judge Kraft with an employment question, call her at 516-747-6700 x326 or e-mail her at RKraft@Kirschenbaumesq.com.

2d 78; 1983 N.Y. LEXIS 3431 (1983).

5. Yellow Cab Cooperative v. Workers Compensation Appeals Board, 226 Cal. App. 3d 1288 (1991).

6. Fiscal Year 2013 Budget of the United States, Department of Labor, page 146.

About the Authors Judge Ruth Kraft chairs the Employment Law practice at Kirschenbaum & Kirschenbaum. A graduate of Yale Law School, Judge Kraft brings the experience of 14 years on the bench, notably in the commercial frauds and employment adjudications for the City and State of New York, to her prac-

Jennifer Kirschenbaum manages Kirschenbaum & Kirschenbaum’s healthcare department. To contact Jennifer for assistance with your employment contracts and designations, call her at 516-747-6700 x302 or e-mail her at Jennifer@ Kirschenbaumesq.com.

ONCOLOGY PRACTICE MANAGEMENT ™

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JOIN OUR LinkedIn GROUP TODAY

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Drug Coding Supplied by RJ Health Systems

FDA-Approved Medications Used for the Treatment of Leukemia The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with the treatment of leukemia.

The following sections include: • Associated ICD-9-CM codes used for the classification of leukemia • Drugs that have been FDA-approved for the treatment of leukemia • Drugs that are Compendia listed for off-label use for leukemia based on clinical studies that suggest bene­ ficial use in some cases. Please note: If a check mark appears in the FDA column it will NOT appear in the Compendia off-label use column • Corresponding HCPCS/CPT® codes and code descriptions • Drugs listed in the Compendia section have no FDA-approved uses for leukemia. However, drugs in the FDA-approved section are FDA-approved for at least 1 of the leukemia ICD-9-CM codes but may also have Compendia-listed uses as well.

Associated ICD-9-CM codes for the treatment of leukemia: The following fifth-digit subclassification is for use with category 202: 0 Unspecified site, extranodal and solid organ sites 1 Lymph nodes of head, face, and neck 2 Intrathoracic lymph nodes 3 Intra-abdominal lymph nodes 4 Lymph nodes of axilla and upper limb 5 Lymph nodes of inguinal region and lower limb 6 Intrapelvic lymph nodes 7 Spleen 8 Lymph nodes of multiple sites 202.4 Leukemic reticuloendotheliosis

Hairy-cell leukemia The following fifth-digit subclassification is for use with categories 204-208: 0 Without mention of having achieved remission

>Failed remission< 1 In remission 2 In relapse 204 Lymphoid leukemia

Includes: leukemia Lymphatic Lymphoblastic Lymphocytic Lymphogenous 204.0 Acute Excludes: acute exacerbation of chronic lymphoid leukemia (204.1)

204.1 Chronic 204.2 Subacute

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ONCOLOGY PRACTICE MANAGEMENT

I August 2013

Drug Coding

Associated ICD-9-CM Codes: (continued)

204.8 Other lymphoid leukemia

Aleukemic leukemia: Lymphatic Lymphocytic Lymphoid

204.9 Unspecified lymphoid leukemia 205 Myeloid leukemia Includes: leukemia Granulocytic Myeloblastic Myelocytic Myelogenous Myelomonocytic Myelosclerotic Myelosis 205.0 Acute Acute promyelocytic leukemia Excludes: acute exacerbation of chronic myeloid leukemia (205.1) 205.1 Chronic Eosinophilic leukemia

Neutrophilic leukemia 205.2 Subacute

205.3 Myeloid sarcoma Chloroma

Granulocytic sarcoma

205.8 Other myeloid leukemia Aleukemic leukemia: Granulocytic Myelogenous Myeloid

Aleukemic myelosis

205.9 Unspecified myeloid leukemia 206 Monocytic leukemia Includes: leukemia: Histiocytic Monoblastic Monocytoid 206.0 Acute Excludes: acute exacerbation of chronic monocytic leukemia (206.1) 206.1 Chronic 206.2 Subacute

206.8 Other monocytic leukemia Aleukemic: Monocytic leukemia Monocytoid leukemia

206.9 Unspecified monocytic leukemia 207 Other specified leukemia Excludes: leukemic reticuloendotheliosis (202.4)

plasma cell leukemia (203.1)

August 2013

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Drug Coding

Associated ICD-9-CM Codes: (continued)

207.0 Acute erythremia and erythroleukemia Acute erythremic myelosis

Di Guglielmo’s disease

Erythremic myelosis

207.1 Chronic erythremia Heilmeyer-Schöner disease

207.2 Megakaryocytic leukemia Megakaryocytic myelosis

Thrombocytic leukemia

207.8 Other specified leukemia Lymphosarcoma cell leukemia

208 Leukemia of unspecified cell type

208.0 Acute Acute leukemia NOS

Blast cell leukemia

Stem cell leukemia Excludes: acute exacerbation of chronic unspecified leukemia (208.1)

208.1 Chronic Chronic leukemia NOS

208.2 Subacute Subacute leukemia NOS

208.8 Other leukemia of unspecified cell type

208.9 Unspecified leukemia Leukemia NOS

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HCPCS code: code description

aldesleukin (Proleukin)

J9015: Injection, aldesleukin, per single-use vial

√

96409

amifostine (Ethyol)

J0207: Injection, amifostine, 500 mg

√

96374

arsenic trioxide (Trisenox)

J9017: Injection, arsenic trioxide, 1 mg

√

96413, 96415

asparaginase Erwinia chrysanthemi (Erwinaze)

J9019: Injection, asparaginase (Erwinaze), 1000 IU

√

96401

azacitidine (Vidaza)

J9025: Injection, azacitidine, 1 mg

√

96401, 96409, 96413

bendamustine (Treanda)

J9033: Injection, bendamustine hydrochloride, 1 mg

√

96413

betamethasone acetate and sodium phosphate (Celestone Soluspan)

J0702: Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg

√

11900, 11901, 20600, 20605, 20610, 96372

bosutinib (Bosulif)

*C9399: Unclassified drugs or biological (hospital outpatient use ONLY)

√

N/A

ONCOLOGY PRACTICE MANAGEMENT

I August 2013

FDA-approved for leukemia

Compendia listed off-label uses for Possible CPT ® leukemia administration codes

Generic (brand) name

Drug Coding

FDA-approved for leukemia

Compendia listed off-label uses for Possible CPT ® leukemia administration codes

Generic (brand) name

HCPCS code: code description

bosutinib (Bosulif)

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

√

N/A

busulfan (Busulfex)

J0594: Injection, busulfan, 1 mg

√

96415, 96416

busulfan (Myleran)

J8510: Busulfan, oral, 2 mg

√

N/A

carboplatin (Paraplatin)

J9045: Injection, carboplatin, 50 mg

chlorambucil (Leukeran)

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

√

N/A

chlorambucil (Leukeran)

S0172: Chlorambucil, oral, 2 mg

√

N/A

cladribine (Leustatin)

J9065: Injection, cladribine, per 1 mg

clofarabine (Clolar)

J9027: Injection, clofarabine, 1 mg

√

96413, 96415

cyclophosphamide (Cytoxan)

J9070: Cyclophosphamide, 100 mg

√

96409, 96413, 96415

cyclophosphamide (Cytoxan)

J8530: Cyclophosphamide, oral, 25 mg

√

N/A

Cytarabine (Cytosar-U)

J9100: Injection, cytarabine, 100 mg

√

96409, 96413, 96415, 96450

dasatinib (Sprycel)

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

√

N/A

daunorubicin (Cerubidine)

J9150: Injection, daunorubicin, 10 mg

√

96409, 96413

daunorubicin citrate liposome (DaunoXome)

J9151: Injection, daunorubicin citrate, liposomal formulation, 10 mg

√

96413

decitabine (Dacogen)

J0894: Injection, decitabine, 1 mg

√

96413, 96415

dexamethasone (Decadron)

J8540: Dexamethasone, oral, 0.25 mg

√

N/A

dexamethasone (eg, Decadron)

J1100: Injection, dexamethasone sodium phosphate, 1 mg

√

11900, 11901, 20600, 20605, 20610, 96372, 96374

doxorubicin (Adriamycin)

J9000: Injection, doxorubicin hydrochloride, 10 mg

√

96409

epirubicin (Ellence)

J9178: Injection, epirubicin hydrochloride, 2 mg

√

√

√

August 2013

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96409, 96413, 96415

96413, 96415

96409, 96413

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Drug Coding

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HCPCS code: code description

etoposide (VePesid)

J8560: Etoposide, oral, 50 mg

√

N/A

etoposide (Toposar)

J9181: Injection, etoposide, 10 mg

√

96413, 96415

filgrastim (Neupogen)

J1440: Injection, filgrastim (G-CSF), 300 mcg

√

96365, 96366, 96369, 96370, 96372, 96374

filgrastim (Neupogen)

J1441: Injection, filgrastim (G-CSF), 480 mcg

√

96365, 96366, 96369, 96370, 96372, 96374

fludarabine (Fludara)

J9185: Injection, fludarabine phosphate, 50 mg

√

96413

hydrocortisone (Solu-Cortef)

J1720: Injection, hydrocortisone sodium succinate, up to 100 mg

√

96365, 96366, 96372, 96374

hydroxyurea (Hydrea)

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

√

N/A

hydroxyurea (Hydrea)

S0176: Hydroxyurea, oral, 500 mg

√

N/A

idarubicin (Idamycin)

J9211: Injection, idarubicin hydrochloride, 5 mg

√

96409

ifosfamide (Ifex)

J9208: Injection, ifosfamide, 1g

imatinib (Gleevec)

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

√

N/A

imatinib (Gleevec)

S0088: Imatinib, 100 mg

√

N/A

interferon alfa-2b (Intron A)

J9214: Injection, interferon, alfa-2b, recombinant, 1 million units

√

96372, 96401

irinotecan (Camptosar)

J9206: Injection, irinotecan, 20 mg

√

96413, 96415

mechlorethamine (Mustargen)

J9230: Injection, mechlorethamine hydrochloride (nitrogen mustard), 10 mg

melphalan (Alkeran)

J8600: Melphalan, oral, 2 mg

√

N/A

melphalan (Alkeran)

J9245: Injection, melphalan hydrochloride, 50 mg

√

96409, 96413

mercaptopurine (Purinethol)

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

√

N/A

mercaptopurine (Purinethol)

S0108: Mercaptopurine, oral, 50 mg

√

N/A

methotrexate

J8610: Methotrexate, oral, 2.5 mg

√

N/A

ONCOLOGY PRACTICE MANAGEMENT

FDA-approved for leukemia

Compendia listed off-label uses for Possible CPT ® leukemia administration codes

Generic (brand) name

I August 2013

√

96409

√

96413, 96415

Drug Coding

HCPCS code: code description

methotrexate

J9250: Methotrexate sodium, 5 mg

√

96372, 96374, 96401, 96409, 96450

methotrexate

J9260: Methotrexate sodium, 50 mg

√

96372, 96374, 96401, 96409, 96450

methylprednisolone (Depo-Medrol)

J1030: Injection, methylprednisolone acetate, 40 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Depo-Medrol)

J1040: Injection, methylprednisolone acetate, 80 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Medrol)

J7509: Methylprednisolone, oral, per 4 mg

√

N/A

mitoxantrone (Novantrone)

J9293: Injection, mitoxantrone hydrochloride, per 5 mg

√

96409, 96413

nelarabine (Arranon)

J9261: Injection, nelarabine, 50 mg

√

96413, 96415

nilotinib (Tasigna)

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

√

N/A

ofatumumab (Arzerra)

J9302: Injection, ofatumumab, 10 mg

√

96413, 96415

omacetaxine mepesuccinate (Synribo)

C9297: Injection, omacetaxine mepesuccinate, 0.01 mg

√

96401

omacetaxine mepesuccinate (Synribo)

*J9999: Not otherwise classified, antineoplastic drugs

√

96401

pegaspargase (Oncaspar)

J9266: Injection, pegaspargase, per single-dose vial

√

96401, 96413, 96415

pentostatin (Nipent)

J9268: Injection, pentostatin, per 10 mg

ponatinib (Iclusig)

*C9399: Unclassified drugs or biological (hospital outpatient use ONLY)

√

N/A

ponatinib (Iclusig)

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

√

N/A

prednisolone (eg, Millipred)

J7510: Prednisolone, oral, per 5 mg

√

N/A

prednisone (eg, Deltasone)

J7506: Prednisone, oral, per 5 mg

√

N/A

rituximab (Rituxan)

J9310: Injection, rituximab, 100 mg

√

96413, 96415

sodium phosphate P 32

A9563: Sodium phosphate P 32, therapeutic, per millicurie

√

79101

FDA-approved for leukemia

Compendia listed off-label uses for Possible CPT ® leukemia administration codes

Generic (brand) name

√

August 2013

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96409, 96413

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Drug Coding

FDA-approved for leukemia

Compendia listed off-label uses for Possible CPT ® leukemia administration codes

Generic (brand) name

HCPCS code: code description

temozolomide (Temodar)

J8700: Temozolomide, oral, 5 mg

teniposide (Vumon)

Q2017: Injection, teniposide, 50 mg

thiotepa (Thiotepa)

J9340: Injection, thiotepa, 15 mg

√

51720, 96409

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

√

96413

vincristine (Vincasar PFS)

J9370: Vincristine sulfate, 1 mg

zidovudine (Retrovir)

*J8499: Prescription drug, oral, nonchemotherapeutic, not otherwise specified

√

N/A

zidovudine (Retrovir)

S0104: Zidovudine, oral, 100 mg

√

N/A

√

N/A 96413, 96415

√

96409

√

*When billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code in Column 24D and the drug name, strength, and NDC (National Drug Code) in Box 19 or Column 24A to ensure appropriate reimbursement.

Please note: Check with payer regarding correct placement of medication information.

References HCPCS Level II Expert 2013 • Current Procedural Terminology (CPT ®) 2013 (copyright 2013 American Medical Association. All rights reserved. CPT ® is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Volumes 1, 2, 2013 • 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; G-CSF, granulocytecolony stimulating factor.

This information was supplied by:

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

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ONCOLOGY PRACTICE MANAGEMENT

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RJ Health Systems The Creators of ReimbursementCodes.com

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

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

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

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

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

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Best Practices

Oral Chemotherapy: What Do Your Oncology Nurses Need to Know?

By Alice Goodman This article originally appeared in the June 2013 issue of The Oncology Nurse-APN/PA®, and is used with permission. It contains valuable information for the practice manager on the importance of comprehensive oral chemotherapy protocols in the oncology practice in order to keep both providers and patients safe.

Take-Home Messages • Written treatment plans and chemotherapy orders should be documented • The importance of follow-up visits and laboratory monitoring should be emphasized with every patient receiving oral chemotherapy • A patient calendar should include start and stop dates for therapy, dates for lab testing, and dates for follow-up appointments • Electronic health records can help streamline the communication of changes in orders between providers and prescribers

O

ral chemotherapy presents unique issues, including safety and toxicity, and advance planning is essential, stated Kristine B. LeFebvre, MSN, RN, AOCN, nurse planner and project manager at the Oncology Nursing Society (ONS). She spoke about the nurse’s role in delivering oral chemotherapy at the ONS 38th Annual Congress.

“Oral chemotherapy is not just pills. It is important to give the right drug to the right patient at the right dose and the right time,” she emphasized.

In recognition of the issues particular to oral chemotherapy, the American Society of Clinical Oncology and ONS have recently published administration safety standards for oral chemotherapy (Oncology Nursing Forum, May 2013; Journal of Oncology Practice, March 2013) to optimize care, LeFebvre said.

She suggested providing both oral and written instructions to patients undergoing oral chemotherapy. It is essential to document a written treatment plan and chemotherapy

32

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orders and to provide a summary treatment plan at the initial patient encounter. In addition, “verbal orders can only be used for holding/ stopping medications, but any dose

Drugs such as sorafenib, everolimus, capecitabine, erlotinib, pazopanib, gefitinib, and lapatinib have been associated with increased toxicity, including grade 3 and 4 adverse events, compared with the control arm in randomized controlled trials. adjustments must be documented in the patient’s records,” she emphasized. “This is essential with oral

ONCOLOGY PRACTICE MANAGEMENT

I August 2013

chemotherapy.”

“Stress the importance of follow-up visits, and emphasize the need for laboratory monitoring.

Many patients may not realize they will need monitoring when they are taking pills,” she stated.

A patient calendar should include start and stop dates for therapy, dates for lab testing, and dates for follow-up appointments. Issues of insurance coverage and access to the drug should be discussed with the patient.

The nurse also needs to assess the patient’s ability to take the drug, including the ability to swallow, cognitive function, and the need for caregiver or family member assistance. Systems should be in place for managing dose or schedule adjustments. Other needs include triage guidelines or algorithms for changes in patient status and symptoms, and a method for communicating with prescribers. “Electronic medical records should help streamline communication,” LeFebvre stated.

Safe handling is important, she continued. “Many oral antineoplasContinued on page 34

YOUR COMPLIMENTARY SUBSCRIPTION IS ONLY A CLICK AWAY Oncology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT

JUNE 2013

CARE™

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Managed Markets: Payers’ Perspectives on Transforming Care Delivery

By Caroline Helwick

Hollywood, FL—At the Third Annual Conference of the Association for Value-Based Cancer Care, James Lang, PharmD, Vice President of Pharmacy Services at BlueCross BlueShield of Michigan (BCBSM), shared his company’s approach to new managed market challenges.

Dr Lang noted that for each step across the managed market landscape, BCBSM built a “rigorous, intricate infrastructure.”

The company has had incentive programs in place for more than a decade, having rolled out its first Collaborative Quality Initiative in 1997.

In 2004, based on the chronic care model, BCBS implemented its Physician Group Incentive Program (PGIP). The program rewards physicians for improved

VOLUME 3 • NUMBER 4

AACR Issues New Policy on Tobacco Use

Oncology practices asked to educate patients on smoking cessation

By Phoebe Starr

Washington, DC—Tobacco use among patients with cancer is an important, but often overlooked, issue that requires intervention by oncology practices. In recognition of the problem and the gap between the need for intervention and the services delivered, the American

Association for Cancer Research (AACR) issued a policy on tobacco use at its 2013 annual meeting.

The genesis for the policy came from some surprising and disappointing survey results that revealed that many oncology practices do not routinely address tobacco

Receive timely information on the latest developments in oncology practice management to assist you in your daily roles and responsibilities. Sign up now for Oncology Practice Management.

Continued on page 10

Transitioning to ICD-10

By Susanne Talebian, CUA, CPC, CUC, CCS-P, CMOM, PCS, RMM Certified Healthcare Business Consultant, American Health Information Management Association–Certified ICD-10-CM/PCS Trainer

O

n October 1, 2014, the United States will adopt the International Classification of Diseases, Tenth Revision, Clinical Modification/Procedure Coding System (ICD-10-CM/PCS). The reprieve, although welcome to many, is

less than 16 months away, during which several phases of implementation must be completed. The timeline for imple menting the code sets is divided into 4 phases: Phase 1: Impact Assessment, first quarter 2009 through second quar Continued on page 40

Continued on page 8 From the publishers of

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Best Practices

Oral Chemotherapy…Continued from page 32 tic agents are hazardous. The staff and patients require education and training. Personal protective equipment may be required, as well as hand washing and gloves for family members,” she continued.

“Nurses need to know which drugs require safe handling. A list would be helpful, and hazardous drugs should be labeled as such,” she said.

Drugs such as sorafenib, everolimus, capecitabine, erlotinib, pazopanib, gefitinib, and lapatinib have been associated with increased toxicity, including grade 3 and 4 adverse events, compared with the control arm in randomized controlled trials, she noted.

When the nurse administers the drug, independent double-checking of the appropriateness of therapy should be conducted.

“We must monitor clinical status and adherence, manage toxicity, educate patients about drug-drug and drug-food interactions, and ensure that treatment is coordinated in different treatment settings,” she explained.

Assessments should be drug and regimen specific. With oral treat-

ment, document that the patient received the drug. Medication reconciliation is important, as are potential interactions. The orders should incorporate tests that may be needed: for example, with axitinib, orders should automatically include hepatic, thyroid, and urine testing.

“If a patient is admitted to the hospital, you need to know whether the drug should be continued [while there],” LeFebvre noted. A system is needed to notify the emergency department or the hospital that the patient is taking oral chemotherapy when he or she is admitted for other reasons.

At the same session, Kathleen Leifeste, RN, MSN, AOCN, oncology nurse educator at Overlook Medical Center in Summit, New Jersey, discussed additional considerations with oral chemotherapy.

“New oral chemotherapy agents are [continually] being approved. In fact, 25% of all antineoplastic agents are oral now. We need to be concerned with side effects, safe handling, and adherence, and we need to be proactive in following these standards. Serious side effects can occur, including handfoot syndrome,

nausea, vomiting, diarrhea, and skin problems,” Leifeste told the audience.

Barriers to patient adherence include the complexity of regimens, need for behavioral change, fear of side effects (including constipation and weight gain), lack of belief in efficacy, and financial limitations.

Inadequate understanding of directions and difficulty reaching the healthcare provider can also interfere with compliance.

“If a patient is not adhering and you don’t know it, [and] if there is a recurrence or poor response, you may think the drug isn’t working,” she added.

Although some of the principles discussed by both nurses seem self-evident, Leifeste noted that a survey reported that almost half of nurses had no education on oral chemotherapy and more than half did not have patient education materials. This emphasizes the need for better education and attention to this issue.l l

Reference

1. LeFebvre K, Leifeste K. Oral chemo, not just another pill: implications for staff education and practice.

Presented at: 38th Annual Congress of the Oncology Nursing Society; April 26, 2013; Washington, DC.

WEB POLL QUESTION Will your practice or clinic be negatively impacted if sequestration does not end by the end of 2013?

Log onto www.oncpracticemanagement.com to make your voice heard.

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ONCOLOGY PRACTICE MANAGEMENT

I August 2013

Fourth Annual Navigation and Survivorship Conference Memphis, Tennessee â&#x20AC;˘ The Peabody Memphis

NOVEMBER 15-17, 2013 CONFERENCE CO-CHAIRS Lillie D. Shockney, RN, BS, MAS AONN Program Director University Distinguished Service Associate Professor of Breast Cancer Departments of Surgery and Oncology Administrative Director, Johns Hopkins Clinical Breast Programs Administrative Director, Johns Hopkins Cancer Survivorship Programs Department of Surgery and Oncology Associate Professor, JHU School of Medicine Departments of Surgery, Oncology, and Gynecology Associate Professor, JHU School of Nursing Johns Hopkins Avon Foundation Breast Center Baltimore, MD

Sharon Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC

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Clinical Trial Update

OncoGenex’s Spruce Clinical Trial Evaluating OGX-427 Is Open for Enrollment OncoGenex Pharmaceuticals, Inc, has initiated the Spruce clinical trial, an investigator-sponsored, randomized, double-blind, placebo-controlled phase 2 trial evaluating OGX-427, a heat shock protein 27 (HSP27) inhibitor, in patients with previously untreated, advanced, nonsquamous non– small-cell lung cancer (NSCLC).

Spruce will randomize approximately 155 patients with nonsquamous NSCLC to receive either OGX-427 plus carboplatin and pemetrexed therapy, or placebo plus carboplatin and pemetrexed therapy. Patients may also continue maintenance therapy with pemetrexed and/or OGX-427/placebo until disease progression or unacceptable toxicity. The primary objective of the trial is progression-free survival, with additional analyses to evaluate tumor response rates, overall survival, safety, tolerability, and the effect of therapy on HSP27 levels.

“There continues to be an urgent need for a majority of patients with lung cancer who lack specific biomarkers and will receive nontargeted treatments like chemotherapy,” stated David Spigel, MD, Director of the Lung Cancer Research Program at the Sarah Cannon Research Institute (SCRI), in Nashville, TN, and the primary investigator on the trial. “We hope that opening this trial will lead to us better understanding the role of Hsp27 in non-small cell lung cancer, and the ability of OGX-427 to work with chemotherapies in order to delay or prevent treatment resistance and improve survival outcomes for these patients.”

Spruce is sponsored by SCRI and will be conducted at approximately 20 sites within the SCRI network in

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the United States. Visit http://clini caltrials.gov/show/NCT01829113 for more information. Spruce is one of 6 phase 2 clinical trials in the ORCA Program evaluating OGX427 in the treatment of advanced cancers, and the first of 2 randomized phase 2 trials of OGX-427 in NSCLC to open. OncoGenex also recently announced plans to initiate the Cedar clinical trial, an investigator-sponsored, randomized, open-label phase 2 trial evaluating OGX-427 in patients with previously untreated, ad­ vanced, squamous cell lung cancer. Cedar is being conducted in partnership with the UK National Cancer Research Network and the UK Experimental Cancer Medicine Centre Network and is expected to begin enrollment later this year.—Source: OncoGenex, August 1, 2013

Pharmacyclics Submits NDA for Ibrutinib Pharmacyclics, a clinical-stage bio­­ pharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune-mediated diseases, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the investigational oral Bruton’s tyrosine kinase inhibitor, ibrutinib, for 2 relapsed/refractory B-cell malignancy indications: mantle-cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

The submission was based on data from phase 2 studies in patients with relapsed/refractory MCL and in patients with relapsed/refractory CLL/SLL. Pharmacyclics, which is developing ibrutinib with Janssen, also is requesting Priority Review.

The NDA submission follows the receipt of a breakthrough therapy designation from the FDA in

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February for ibrutinib as a monotherapy for the treatment of patients with relapsed/refractory MCL, and receipt of a second breakthrough therapy designation for the treatment of patients with CLL/SLL with deletion of the short arm of chromosome 17 (del 17p).

“This first NDA for ibrutinib was made possible in record time because of the continuous support and consultations we received from the FDA,” said Dr Urte Gayko, Senior Vice President of Global Regulatory Affairs for Pharmacyclics.

“In April we completed enrollment of our first phase III study,” said Bob Duggan, Chief Executive Officer and Chairman of Pharmacyclics. “Thus far, more than 1600 patients have been treated in our studies with ibrutinib, and we are making excellent progress in the development and preparation for commercialization of this investigational drug. As of today, we have initiated 7 phase III studies and have currently registered with the National Institutes of Health 31 clinical trials using ibrutinib.”— Source: CenterWatch, July 16, 2013

Array BioPharma Initiates MILO Study Array BioPharma said a $5-million milestone was achieved after the start of Array’s phase 3 trial in patients with low-grade serous ovarian cancer (LGSOC).

The study, called MILO (MEK Inhibitor in Low Grade Serous Ovarian Cancer), is a multinational, randomized, phase 3 trial and will evaluate MEK162 against the physician’s choice of standard chemotherapy treatments in 300 patients with recurrent or persistent LGSOC following at least 1 prior platinum-based chemotherapy regimen and no more than 3 lines of prior chemotherapy regimens.

Continued on page 38

ANNUAL CONFERENCE

"! !

!

!

Professor Rob Coleman, MBBS, MD, FRCP Yorkshire Cancer Research Professor of Medical Oncology Director, Sheffield Cancer Research Centre Associate Director, National Institute for Health Research Cancer Research Network Department of Oncology, Weston Park Hospital Sheffield, United Kingdom

*

3:00 pm - 7:00 pm

Registration

5:30 pm - 7:30 pm

Welcome Reception and Exhibits

7:00 am - 8:00 am

Symposium/Product Theater

8:15 am - 8:30 am

Welcome to the Second Annual Conference of the Global Biomarkers Consortiumâ&#x20AC;&#x201D;Setting the Stage for the Meeting Professor Rob Coleman, MBBS, MD, FRCP

8:15 am - 11:45 am

General Session I â&#x20AC;˘ Personalized Medicine in Oncology: Evolution of Cancer Therapy from Nonspecific Cytotoxic Drugs to Targeted Therapies â&#x20AC;˘ Taking Stock of Molecular Oncology Biomarkers â&#x20AC;˘ Genomics â&#x20AC;˘ Bioinformatics â&#x20AC;˘ Validating Biomarkers for Clinical Use in Solid Tumors - Professor Rob Coleman, MBBS, MD, FRCP â&#x20AC;˘ Validating Biomarkers for Clinical Use in Hematologic Malignancies Jorge E. Cortes, MD â&#x20AC;˘ The Challenges of Biomarker-Based Clinical Trials â&#x20AC;˘ Keynote Lecture: Understanding Cancer at the Molecular Level

12:00 pm - 1:00 pm

Symposium/Product Theater/Exhibits

1:15 pm - 4:30 pm

This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

General Session II â&#x20AC;˘ Introduction to Case Studies - Jorge E. Cortes, MD â&#x20AC;˘ Case Studies: Optimal, Value-Based Use of Molecular Biomarkers in Oncology: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients, Part I â&#x20AC;˘ Lung Cancer â&#x20AC;˘ Breast Cancer â&#x20AC;˘ Multiple Myeloma â&#x20AC;˘ Prostate Cancer â&#x20AC;˘ Leukemia â&#x20AC;˘ Lymphoma â&#x20AC;˘ Panel Discussion: Management Controversies and Accepted Guidelines for the Personalized Management of Solid Tumors and Hematologic Malignancies â&#x20AC;˘ Keynote Lecture: The Medical-Legal Issues Surrounding the Use of Biomarkers in Oncology

4:30 pm - 6:30 pm

Meet the Experts/Networking/Exhibits

Jorge E. Cortes, MD Chair, CML and AML Sections D.B. Lane Cancer Research Distinguished Professor for Leukemia Research Department of Leukemia, Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX

The only global meeting dedicated to advancing the understanding of value and clinical impact of biomarker research in oncology. Guided by the expertise of leaders in this field, participants will receive a thorough understanding of the current and future landscape of the relevance of tumor biomarkers and how to effectively personalize cancer care in the clinical setting.

This meeting will be directed toward medical oncologists and hematologists, pathologists, geneticists, advanced practice oncology nurses, research nurses, clinical oncology pharmacists, and genetic counselors involved in the management of patients with solid tumors or hematologic malignancies, and interested in the use of molecular tumor biomarkers to help optimize patient care.

Upon completion of this activity, the participant will be able to: â&#x20AC;˘ Assess emerging data and recent advances in the discovery of molecular biomarkers and their impact on the treatment of patients with solid tumors or hematologic malignancies â&#x20AC;˘ Discuss the role of molecular biomarkers in designing personalized therapy for patients with solid tumors or hematologic malignancies â&#x20AC;˘ Outline the practical aspects of integrating molecular biomarkers into everyday clinical practice in the treatment of patients with cancer

Grant requests are currently being reviewed by numerous supporters. Support will be acknowledged prior to the start of the educational activities.

7:00 am - 8:00 am

Symposium/Product Theater

8:15 am - 11:45 am

General Session III â&#x20AC;˘ Review of Saturdayâ&#x20AC;&#x2122;s Presentations and Preview of Today - Jorge E. Cortes, MD â&#x20AC;˘ Case Studies: Optimal, Value-Based Use of Molecular Biomarkers in Oncology: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients, Part II â&#x20AC;˘ Melanoma â&#x20AC;˘ Colorectal Cancer and Other GI Malignancies â&#x20AC;˘ MDS â&#x20AC;˘ Myeloproliferative Neoplasms â&#x20AC;˘ Keynote Lecture: Promises and Challenges of Personalized Medicine in Improving Cancer Care â&#x20AC;˘ Tumor Board: Challenging Cases in the Use of Biomarkers in Managing Solid Tumors (attendee-contributed cases) â&#x20AC;˘ Tumor Board: Challenging Cases in the Use of Biomarkers in Managing Hematologic Malignancies (attendee-contributed cases)

12:00 pm - 1:00 pm

Symposium/Product Theater/Exhibits

1:15 pm - 3:00 pm

General Session IV â&#x20AC;˘ Keynote Lecture: Making Personalized Medicine a Reality: The Realization of Genomic Medicine â&#x20AC;˘ The Future of Personalized Medicine: Measuring Clinical Outcomes â&#x20AC;˘ Cost-Effective Technologies That Can Drive Therapeutic Decision Making â&#x20AC;˘ Regulatory Perspectives on PMO â&#x20AC;˘ PMO: The Payerâ&#x20AC;&#x2122;s Perspective â&#x20AC;˘ Panel Discussion: Can We Afford PMO? A Value-Based Analysis â&#x20AC;˘ Practical Considerations in Incorporating PMO into Everyday Cinical Management â&#x20AC;˘ Reimbursement Challenges

â&#x20AC;˘ Closing Remarks

3:00 pm

Departures

The Medical Learning Institute Inc designates this live activity for a maximum of 12.5 AMA PRA Category 1 Creditsâ&#x201E;˘. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Medical Learning Institute Inc and the Center of Excellence Media, LLC. The Medical Learning Institute Inc is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Medical Learning Institute Inc Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 12.5 contact hours.

The Medical Learning Institute Inc is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Completion of this knowledge-based activity provides for 12.5 contact hours (1.25 CEUs) of continuing pharmacy education credit.

The Universal Activity Number for this activity is (To be determined).

CONFERENCE REGISTRATION

EARLY BIRD REGISTRATION NOW OPEN! $175.00 until June 30, 2013

www.globalbiomarkersconsortium.com

*Agenda is subject to change.

P O

PERSONALIZED MMEDICINE IN ONCOLOGY

Clinical Trial Update Continued from page 36

The primary end point is progression-free survival, and the key secondary end point is overall survival.

“Array is pleased to initiate its first phase III trial with the goal of helping women with low-grade serous ovarian cancer who have progressed on cytotoxics and have no other proven therapeutic options,” said Ron Squarer, Chief Executive Officer of Array BioPharma. “We also look forward to Novartis initiating both the NRAS- and BRAFmutant melanoma pivotal studies later this year.”

Array invented MEK162 and licensed worldwide rights to develop and commercialize the drug to Novartis in April 2010. Novartis recently detailed plans to initiate phase 3 trials of MEK162 in both NRAS- and BRAF-mutant melanoma. All 3 trials will be conducted as part of the Novartis/Array codevelopment agreement, under which costs are capped annually and in total for Array.

There are 10 active or completed oncology clinical trials of MEK162, with plans to initiate at least 6 trials in 2013, including 3 phase 3 trials, one each planned in LGSOC, NRAS-mutant melanoma and BRAF-mutant melanoma.—Source: CenterWatch, July 9, 2013

Morphotek Announces Initiation of Phase 1 Study for MORAb-066 Biopharmaceutical Morphotek, a subsidiary of Eisai, has announced that the Sarah Cannon Research Institute in Nashville, TN, has opened enrollment in a phase 1 clinical study with MORAb-066 in patients with advanced or metastatic breast, pancreatic, colorectal, or non– small-cell lung cancer (adenocarcinoma) malignancies. The open-label, phase 1 study will assess the safety, tolerability, and pharmacokinetics of MORAb-066 administered with

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weekly intravenous infusions.

MORAb-066 is a humanized monoclonal antibody that targets tissue factor (TF), a protein whose role under normal conditions is to support blood coagulation. In cancer, it has been shown that TF is a membrane-bound antigen expressed by tumor endothelial cells that is hypothesized to play a role in promoting tumor angiogenesis and growth. Morphotek obtained exclusive worldwide rights to develop and commercialize this antibody from Janssen Biotech.

“New agents are needed for cancer treatment and our strategy of using collaborations with leading research institutions provides us opportunities to develop novel medicines that target disease-specific pathways,” said Nicholas Nicolaides, PhD, President and Chief Executive Officer of Morphotek.—Source: CenterWatch, July 3, 2013

FDA Approves 2 GSK Oral Oncology Treatments GlaxoSmithKline (GSK), a re­ search-based pharmaceutical and healthcare company, announced that the US Food and Drug Administration (FDA) has approved both Tafinlar (dabrafenib) and Mekinist (trametinib).

Tafinlar is indicated as a singleagent oral treatment for unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma that has spread to other parts of the body) in adult patients with BRAF V600E mutation. Tafinlar is not indicated for the treatment of patients with wildtype BRAF melanoma.

Mekinist is indicated as a singleagent oral treatment for unresectable or metastatic melanoma in adult patients with BRAF V600E or V600K mutations. Mekinist is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy. These

ONCOLOGY PRACTICE MANAGEMENT

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mutations must be detected by an FDA-approved test, such as the companion diagnostic assay from bioMérieux SA, THxID-BRAF. “With today’s FDA approvals, GSK can now offer 2 new single-agent therapies to selected patients who have metastatic melanoma, a devastating disease with very low survival rates and few treatment options,” said Paolo Paoletti, MD, President of GSK Oncology.

Among those with metastatic melanoma, approximately half have a BRAF mutation, which is an abnormal change in a gene that can enable some melanoma tumors to grow and spread. Tafinlar and Mekinist are each approved for patients with the BRAF V600E mutation, which accounts for approximately 85% of all BRAF V600 mutations in metastatic melanoma. Mekinist is also approved for patients with the V600K mutation, which makes up approximately 10% of all BRAF V600 mutations in metastatic melanoma.

“MEK has been pursued as a therapeutic target in cancer for more than a decade,” said Keith Flaherty, MD, Director of Developmental Therapeutics, Massachusetts General Hospital Cancer Center, Boston, and Principal Investigator of the phase 3 METRIC trial. “Based on the clear improvement versus chemotherapy in progression-free survival, trametinib represents the first validated MEK inhibitor.”

In 2010, GSK entered a collaboration with bioMérieux to develop a companion diagnostic test to detect BRAF V600 (V600E and V600K) gene mutations found in several cancers, including melanoma. bioMérieux has received FDA premarket approval of THxIDBRAF. Currently, it is the only FDA-approved test that detects the V600K mutation.—Source: CenterWatch, May 31, 2013 l

VISIT THE NEW ONLINE RESOURCE FOR NURSES AND THE ENTIRE MULTIPLE MYELOMA CARE TEAM

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Value-Based Care in Myeloma delivers exclusive interviews and perspectives related to cost, quality, and access issues.

Special sections for VA-based clinicians, advanced practice nurses, and pharmacists will also focus on the unique challenges in the management of multiple myeloma.

www.ValueBasedMyeloma.com Value-Based Care in Myeloma is a publication of Engage Healthcare Communications, a member of The Lynx Group. © 2012 All rights reserved.

VBCC0112_VBMAsizeGH

Wealth Management With Lawrence B. Keller

5 Common Estate-Planning Pitfalls and How to Avoid Them

By Naim Bulbulia, Esq, and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

E Lawrence B. Keller

state planning is a process de­signed to help you manage and pre­­ serve your assets while you are alive, and to conserve and control their distribution after your death pursuant to your goals and objectives. This article will provide a brief overview of 5 common estate- planning pitfalls and how to avoid them.

Life Insurance Policies Are Included as Part of Your Estate You may not realize that your taxable Naim Bulbulia, Esq estate includes any life insurance policies that you own or control. The total value of any such policies increases the value of your taxable estate dollar for dollar—including term life insurance policies.

Action Step One of the most basic tenets of a tax-efficient estate plan is that all life insurance policies should be owned, not by the insured, and not by the insured’s spouse, but rather by an irrevocable life insurance trust (ILIT). The purpose of holding all life insurance in ILITs is to avoid having any death benefit subject to taxation as a part of the insured’s estate. An additional benefit for physicians, many of whom are extremely aware of creditor risk, is that the ILIT will also protect the

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value of any life insurance policy from any creditors of the insured, as well as any creditors of his or her beneficiaries.

If you have existing policies, you can transfer the ownership to an ILIT for the benefit of your loved ones, because as long as you survive 3 years after the transfer, the value of the life insurance proceeds will be removed from your taxable estate, thereby making the insurance proceeds fully available to your spouse and/or children without requiring them to pay any taxes on the policy.

However, if your health is still good and premium rates are similar to what you are currently paying, you can avoid the 3-year rule by replacing your current insurance policy or policies. The ILIT can apply for a new policy on your life.

The trustee is the applicant and the trust is the owner and beneficiary of the policy. This guarantees that you have no “incidents of ownership” in the policy that would cause it to become part of your taxable estate.

Know Your State’s Estate Tax Exemptions, Estate Taxes, and Marital Deductions Estate tax exemptions vary widely from state to state. For example, New Jersey’s exemption from estate tax is only $675,000, while neighboring New York’s exemption from estate tax is $1 million. If you die with an estate worth in excess of your state’s exemption (that does not pass to your spouse or to certain qualifying trusts for his or her benefit), these states will collect estate taxes at rates between 4% and 16%, respectively.

Furthermore, spouses who are not

ONCOLOGY PRACTICE MANAGEMENT

I August 2013

US citizens will not receive a full estate tax exemption for property.

In addition, there is a $5.25-million exemption from federal estate tax (the “applicable exclusion amount”). Once your estate exceeds $5.25 million, the combined federal and state estate tax rates rise steeply, peaking at 40%.

Furthermore, a married person may leave an unlimited amount of assets to his or her spouse (provided that both spouses are US citizens) free of estate taxes and without using any of the estate tax exemption.

Unfortunately, when thinking about their estate plan, too many married couples see the unlimited marital deduction as their solution. This strategy can cost one’s children and/ or other beneficiaries hundreds of thousands of dollars in unnecessary state and federal estate taxes if the surviving spouse’s estate is worth more than the estate tax exemption.

Action Step Simply including what is often referred to as a “credit shelter trust” in your will, or drafting your will to permit your surviving spouse to disclaim property into a credit shelter trust (or “disclaimer trust”) for his or her own benefit (and often also for your children’s benefit) safeguards the decedent spouse’s applicable exclusion amount. This enables both your exemption and your spouse’s exemption to pass estate tax–free to the next generation, effectively doubling the amount of assets that pass to your children estate tax–free. The surviving spouse can still have access to the property in the credit shelter trust, but upon that spouse’s death,

Wealth Management

the property will not be included in his or her estate, and such property will pass estate tax–free to your descendants or to the other beneficiaries of the trust.

By giving your spouse the power to disclaim assets into a credit shelter trust, you preserve maximum flexibility in deciding whether to fully fund the credit shelter trust with the applicable exclusion amount, or whether to partially fund the trust with only the maximum state exemption from estate taxes (eg, either $1 million or $675,000 in New York and New Jersey, respectively).

Of course, this same tax savings can be achieved by leaving the applicable exclusion amount directly to your descendants or other beneficiaries who are not your spouse.

This is generally advisable when your spouse will have sufficient assets to live on after your death.

The Necessity of Retitling Assets Often, credit shelter trusts are included in wills but assets are not retitled in a manner that enables the credit shelter trust to be funded upon death. Are your and your spouse’s assets titled such that a credit shelter trust can be funded?

Action Step To achieve the maximum tax savings when the first spouse dies, you and your spouse should have sufficient assets in each of your own individual names to fund a credit shelter trust ($5.25 million in each of your own names, if assets are sufficient to do so, or if assets are not sufficient to do so, the assets should be split such that each of you own half of them). This is because jointly owned property, retirement accounts (with designated beneficiaries), and insurance proceeds (that are not payable to your estate) typically cannot be used to fund a credit shelter trust because such

Periodically Update Your Estate-Planning Documents Many people fail to update estate-planning documents to reflect life-changing events such as a divorce, remarriage, or the birth of a child or additional children.

It is important for you to ensure that your current estate-planning documents (including life insurance beneficiary designations and 401(k) and IRA beneficiary designations) still embody your present wishes.

assets pass outside of your will.

Therefore, adjustments with respect to how your assets are titled (eg, splitting of brokerage accounts or retitling a home) may be advisable to ensure that a credit shelter trust or a disclaimer trust can be funded upon you or your spouse’s death.

Don’t Wait—Create Trusts for Your Children It is important to protect assets for your children after your death.

If trusts are not set up, you risk an immature child wasting his or her inheritance, potential creditors gaining access to these funds, and future ex-spouses taking your family’s assets.

Action Step Every 3 to 5 years, you should review your documents to ensure that they still match your wishes.

Conclusion By working with an attorney who specializes in estate planning as well as a financial planner, you can ensure that your wishes regarding property distribution are respected and honored. In addition to legal documents, your attorney might also incorporate other legal instruments and/or strategies to take advantage of further estate tax savings opportunities and/or to protect your assets from the claims of creditors. l

It is important to protect assets for your children after your death.

Action Step We generally steer our clients toward fully discretionary trusts.

These trusts grant the trustee(s) flexibility to distribute trust property for a child’s health, education, support, and maintenance, or for any other reason that the trustee deems appropriate. Trustees are forbidden from making any discretionary distributions to themselves and are bound to carry out the provisions of the trust, only making distributions for the trust’s beneficiaries pursuant to the trust’s authority, which grants broad discretion to the trustee. In addition, in the event that your children or other heirs are successful enough that they never need to use the inheritance, certain assets can pass to their children free from estate tax (by reason of the generation-skipping tax exemption).

August 2013

About the Authors Naim Bulbulia, Esq, is a partner in the law firm Hartman, Doherty, Rosa, Berman, & Bulbulia LLC, where he practices in the area of Trusts and Estates. He can be reached at 201-441-9056 or by e-mail to nbulbulia@hdrbb.com with comments or questions.

Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF is the founder of Physician Financial Services, a New York­–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 516-677-6211 or by e-mail to Lkeller@physicianfinan cialservices.com with comments or questions.

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

INDICATIONS AND USAGE ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

CONTRAINDICATIONS Pregnancy: ZYTIGA can cause fetal harm when administered to a pregnant woman. ZYTIGA is not indicated for use in women. ZYTIGA is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss [see Use in Specific Populations].

WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1) in full Prescribing Information]. In the two randomized clinical trials, grade 3 to 4 hypertension occurred in 2% of patients, grade 3 to 4 hypokalemia in 4% of patients, and grade 3 to 4 edema in 1% of patients treated with ZYTIGA [see Adverse Reactions].

Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in the incidence and severity of these adverse reactions. Use caution when treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, e.g., those with heart failure, recent myocardial infarction or ventricular arrhythmia. Use ZYTIGA with caution in patients with a history of cardiovascular disease. The safety of ZYTIGA in patients with left ventricular ejection fraction < 50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials [see Clinical Studies (14) in full Prescribing Information]. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with ZYTIGA. Adrenocortical Insufficiency: Adrenal insufficiency occurred in the two randomized clinical studies in 0.5% of patients taking ZYTIGA and in 0.2% of patients taking placebo. Adrenocortical insufficiency was reported in patients receiving ZYTIGA in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations [see Warnings and Precautions].

Hepatotoxicity: In the two randomized clinical trials, grade 3 or 4 ALT or AST increases (at least 5X ULN) were reported in 4% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. Patients whose baseline ALT or AST were elevated were more likely to experience liver test elevation than those beginning with normal values. Treatment discontinuation due to liver enzyme increases occurred in 1% of patients taking ZYTIGA. No deaths clearly related to ZYTIGA were reported due to hepatotoxicity events.

Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced ZYTIGA dose of 250 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt ZYTIGA treatment and closely monitor liver function.

Re-treatment with ZYTIGA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [see Dosage and Administration (2.2) in full Prescribing Information].

The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown.

Increased ZYTIGA Exposures with Food: ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. The safety of these increased exposures when multiple doses of abiraterone acetate are taken with food has not been assessed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

ZYTIGA® (abiraterone acetate) Tablets ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Hypertension, Hypokalemia, and Fluid Retention due to Mineralocorticoid Excess [see Warnings and Precautions].

• Adrenocortical Insufficiency [see Warnings and Precautions].

• Hepatotoxicity [see Warnings and Precautions].

• Increased ZYTIGA Exposures with Food [see Warnings and Precautions].

Clinical Trial Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Two randomized placebo-controlled, multicenter clinical trials enrolled patients who had metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy. In both Study 1 and Study 2 ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arms. Placebo plus prednisone 5 mg twice daily was given to control patients.

The most common adverse drug reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) reported in the two randomized clinical trials that occurred more commonly (≥2%) in the abiraterone acetate arm were anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Study 1: Metastatic CRPC Following Chemotherapy: Study 1 enrolled 1195 patients with metastatic CRPC who had received prior docetaxel chemotherapy. Patients were not eligible if AST and/or ALT ≥ 2.5X ULN in the absence of liver metastases. Patients with liver metastases were excluded if AST and/or ALT > 5X ULN. Table 1 shows adverse reactions on the ZYTIGA arm in Study 1 that occurred with a ≥2% absolute increase in frequency compared to placebo or were events of special interest. The median duration of treatment with ZYTIGA was 8 months.

Table 1: Adverse Reactions due to ZYTIGA in Study 1 ZYTIGA with Placebo with Prednisone (N=791) Prednisone (N=394) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % Musculoskeletal and connective tissue disorders Joint swelling/discomfort2 29.5 4.2 23.4 4.1 Muscle discomfort3 26.2 3.0 23.1 2.3 General disorders Edema4 26.7 1.9 18.3 0.8 Vascular disorders Hot flush 19.0 0.3 16.8 0.3 Hypertension 8.5 1.3 6.9 0.3 Gastrointestinal disorders Diarrhea 17.6 0.6 13.5 1.3 Dyspepsia 6.1 0 3.3 0 Infections and infestations Urinary tract infection 11.5 2.1 7.1 0.5 Upper respiratory tract infection 5.4 0 2.5 0 Respiratory, thoracic and mediastinal disorders Cough 10.6 0 7.6 0 Renal and urinary disorders Urinary frequency 7.2 0.3 5.1 0.3 Nocturia 6.2 0 4.1 0 Injury, poisoning and procedural complications Fractures5 5.9 1.4 2.3 0 Cardiac disorders Arrhythmia6 7.2 1.1 4.6 1.0 Chest pain or chest discomfort7 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.3 1 Adverse

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

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

4 Includes

1 Adverse

terms Edema, Edema peripheral, Pitting edema, and Generalized edema 5 Includes all fractures with the exception of pathological fracture 6 Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia 7 Includes terms Angina pectoris, Chest pain, and Angina unstable.

Myocardial infarction or ischemia occurred more commonly in the placebo arm than in the ZYTIGA arm (1.3% vs. 1.1% respectively).

8 Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction, Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased Table 2 shows laboratory abnormalities of interest from Study 1. Grade 3-4 low serum phosphorus (7%) and low potassium (5%) occurred at a greater than or equal to 5% rate in the ZYTIGA arm.

Table 2: Laboratory Abnormalities of Interest in Study 1 Abiraterone (N=791) Placebo (N=394) Laboratory All Grades Grade 3-4 All Grades Grade 3-4 Abnormality (%) (%) (%) (%) Hypertriglyceridemia 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Hypokalemia 28.3 5.3 19.8 1.0 Hypophosphatemia 23.8 7.2 15.7 5.8 High ALT 11.1 1.4 10.4 0.8 High Total Bilirubin 6.6 0.1 4.6 0 Study 2: Metastatic CRPC Prior to Chemotherapy Study 2 enrolled 1088 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥ 2.5X ULN and patients were excluded if they had liver metastases.

Table 3 shows adverse reactions on the ZYTIGA arm in Study 2 that occurred with a ≥ 2% absolute increase in frequency compared to placebo.

The median duration of treatment with ZYTIGA was 13.8 months.

Table 3: Adverse Reactions in ≥5% of Patients on the ZYTIGA Arm in Study 2 ZYTIGA with Placebo with Prednisone (N=542) Prednisone (N=540) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % General disorders Fatigue 39.1 2.2 34.3 1.7 Edema2 25.1 0.4 20.7 1.1 Pyrexia 8.7 0.6 5.9 0.2 Musculoskeletal and connective tissue disorders Joint swelling/ discomfort3 30.3 2.0 25.2 2.0 Groin pain 6.6 0.4 4.1 0.7 Gastrointestinal disorders Constipation 23.1 0.4 19.1 0.6 Diarrhea 21.6 0.9 17.8 0.9 Dyspepsia 11.1 0.0 5.0 0.2 Vascular disorders Hot flush 22.3 0.2 18.1 0.0 Hypertension 21.6 3.9 13.1 3.0 Respiratory, thoracic and mediastinal disorders Cough 17.3 0.0 13.5 0.2 Dyspnea 11.8 2.4 9.6 0.9 Psychiatric disorders Insomnia 13.5 0.2 11.3 0.0 Injury, poisoning and procedural complications Contusion 13.3 0.0 9.1 0.0 Falls 5.9 0.0 3.3 0.0 Infections and infestations Upper respiratory tract infection 12.7 0.0 8.0 0.0 Nasopharyngitis 10.7 0.0 8.1 0.0 Renal and urinary disorders Hematuria 10.3 1.3 5.6 0.6 Skin and subcutaneous tissue disorders Rash 8.1 0.0 3.7 0.0

events graded according to CTCAE version 3.0 terms Edema peripheral, Pitting edema, and Generalized edema 3 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 2 Includes

Table 4 shows laboratory abnormalities that occurred in greater than 15% of patients, and more frequently (>5%) in the ZYTIGA arm compared to placebo in Study 2. Grade 3-4 lymphopenia (9%), hyperglycemia (7%) and high alanine aminotransferase (6%) occurred at a greater than 5% rate in the ZYTIGA arm.

Table 4: Laboratory Abnormalities in > 15% of Patients in the ZYTIGA Arm of Study 2 Abiraterone (N = 542) Placebo (N = 540) 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Laboratory Abnormality Grade % % % % Hematology Lymphopenia 38.2 8.7 31.7 7.4 Chemistry Hyperglycemia1 56.6 6.5 50.9 5.2 High ALT 41.9 6.1 29.1 0.7 High AST 37.3 3.1 28.7 1.1 Hypernatremia 32.8 0.4 25.0 0.2 Hypokalemia 17.2 2.8 10.2 1.7 1Based on non-fasting blood draws Cardiovascular Adverse Reactions: In the combined data for studies 1 and 2, cardiac failure occurred more commonly in patients treated with ZYTIGA compared to patients on the placebo arm (2.1% versus 0.7%). Grade 3-4 cardiac failure occurred in 1.6% of patients taking ZYTIGA and led to 5 treatment discontinuations and 2 deaths. Grade 3-4 cardiac failure occurred in 0.2% of patients taking placebo. There were no treatment discontinuations and one death due to cardiac failure in the placebo group.

In Study 1 and 2, the majority of arrhythmias were grade 1 or 2. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arms and no deaths in the placebo arms. There were 7 (0.5%) deaths due to cardiorespiratory arrest in the ZYTIGA arms and 3 (0.3%) deaths in the placebo arms. Myocardial ischemia or myocardial infarction led to death in 3 patients in the placebo arms and 2 deaths in the ZYTIGA arms.

DRUG INTERACTIONS Effects of Abiraterone on Drug Metabolizing Enzymes: ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) in full Prescribing Information].

In vitro, ZYTIGA inhibits CYP2C8. There are no clinical data on the use of ZYTIGA with drugs that are substrates of CYP2C8. However, patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

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

USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications].: ZYTIGA can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. While there are no adequate and well-controlled studies with ZYTIGA in pregnant women and ZYTIGA is not indicated for use in women, it is important to know that maternal use of a CYP17 inhibitor could affect development of the fetus. Abiraterone acetate caused developmental toxicity in pregnant rats at exposures that were lower than in patients receiving the recommended dose. ZYTIGA is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with ZYTIGA.

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

In an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6-17). Findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/ day. Doses ≥10 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 0.03, 0.1 and 0.3 times, respectively, the AUC in patients.

Nursing Mothers: ZYTIGA is not indicated for use in women. It is not known if abiraterone acetate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ZYTIGA, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

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

Geriatric Use: Of the total number of patients receiving ZYTIGA in phase 3 trials, 73% of patients were 65 years and over and 30% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Patients with Hepatic Impairment: The pharmacokinetics of abiraterone were examined in subjects with baseline mild (n = 8) or moderate (n = 8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone after a single oral 1,000 mg dose of ZYTIGA increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function.

No dosage adjustment is necessary for patients with baseline mild hepatic impairment. In patients with baseline moderate hepatic impairment (ChildPugh Class B), reduce the recommended dose of ZYTIGA to 250 mg once daily. If elevations in ALT or AST >5X ULN or total bilirubin >3X ULN occur in patients with baseline moderate hepatic impairment, discontinue ZYTIGA treatment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

The safety of ZYTIGA in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA. For patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Clinical Pharmacology (12.3) in full Prescribing Information].

Patients with Renal Impairment: In a dedicated renal impairment trial, the mean PK parameters were comparable between healthy subjects with normal renal function (N=8) and those with end stage renal disease (ESRD) on hemodialysis (N=8) after a single oral 1,000 mg dose of ZYTIGA. No dosage adjustment is necessary for patients with renal impairment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

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

There is no specific antidote. In the event of an overdose, stop ZYTIGA, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function.

Storage and Handling: Store at 20oC to 25oC (68oF to 77oF); excursions permitted in the range from 15oC to 30oC (59oF to 86°F) [see USP controlled room temperature].

Based on its mechanism of action, ZYTIGA may harm a developing fetus.

Therefore, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves [see Use in Specific Populations].

• Patients receiving GnRH agonists should be informed that they need to maintain this treatment during the course of treatment with ZYTIGA and prednisone.

• Patients should be informed that ZYTIGA must not be taken with food and that no food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. They should be informed that the tablets should be swallowed whole with water without crushing or chewing. Patients should be informed that taking ZYTIGA with food causes increased exposure and this may result in adverse reactions.

• Patients should be informed that ZYTIGA is taken once daily and prednisone is taken twice daily according to their physician’s instructions.

• Patients should be informed that in the event of a missed daily dose of ZYTIGA or prednisone, they should take their normal dose the following day. If more than one daily dose is skipped, patients should be told to inform their physician.

• Patients should be apprised of the common side effects associated with ZYTIGA, including peripheral edema, hypokalemia, hypertension, elevated liver function tests, and urinary tract infection. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. • Patients should be advised that their liver function will be monitored using blood tests.

• Patients should be informed that ZYTIGA may harm a developing fetus; thus, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves. Patients should also be informed that it is not known whether abiraterone or its metabolites are present in semen and they should use a condom if having sex with a pregnant woman. The patient should use a condom and another effective method of birth control if he is having sex with a woman of child-bearing potential. These measures are required during and for one week after treatment with ZYTIGA.

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) • Patients should be informed that ZYTIGA and prednisone are used together and that they should not interrupt or stop either of these medications without consulting their physician.

Manufactured by: Patheon Inc. Mississauga, Canada Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044 © Janssen Biotech, Inc. 2012 Revised: December 2012 2000005445 K08Z121174A

INDICATION and IMPORTANT SAFETY INFORMATION about ZYTIGA® (abiraterone acetate) INDICATION ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

IMPORTANT SAFETY INFORMATION

K08Z121176

Contraindications ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant.

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition.

Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.

Adrenocortical Insufficiency (AI) AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®.

Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function.

Increased ZYTIGA® Exposures with Food ZYTIGA® must be taken on an empty stomach. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.

Adverse Reactions The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Drug Interactions ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on its use with drugs that are substrates of CYP2C8. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors or inducers on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution during treatment with ZYTIGA®.

Use in Specific Populations Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).

Please see Brief Summary of Prescribing Information on adjacent pages.

© Janssen Biotech, Inc. 2013

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

Patient insurance benefit investigation is provided as a service by 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. © Janssen Biotech, Inc. 2013

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