OPM November 2013

www.OncPracticeManagement.com

NOVEMBER 2013

VOLUME 3 • NUMBER 7

Oncology Practice Management ™

FOR ONCOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS™

Let the Transition Begin A Sudden Change of Course By Karna W. Morrow, CPC, RCC, CCS-P, PCS

By Teri U. Guidi, MBA, FAAMA President and CEO, Oncology Management Consulting Group

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eflecting the increasing complexity of hospital/private prac­tice relationships, this case study is based on true events, modified to protect the Teri U. Guidi, MBA, innocent. Does your FAAMA practice find itself in a similar situation as our main characters?

The Characters • “Memorial”—A 500-bed community hospital with limited outpatient infusion and a large hospital-owned radiation center.

• “the Practice”—A 12-physician hematology/oncology practice with a large outpatient infusion business.

• “OMC Group”—The Oncology Man­ agement Consulting Group.

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rain the coders: check. Update the software: check. Let the transition begin.

Oh, if it were only that simple.

As many practices move from planning for to actually implementing the new code set for the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), a few things are strikingly apparent. The transition from International Classification of

Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) to ICD10-CM is not about the coders, it is not about ensuring that your software vendor has loaded the new code set, and it is not solely about testing claim submission with your clearinghouse. ICD-10-CM will impact every aspect of the healthcare organization and will need to be given the same due diligence as that last Continued on page 12

Whatever Happened to Thinking?

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

D

rawing closer to the end of my professional career, I have watched the world change dramatically with the onset of the space age, computers, calculators, and much more. But after watching all of these changes for decades, I don’t believe that all of them have given us the best results, for the average human

brain, with respect to thinking.

Especially when I look at some of the younger medical professionals, I often find myself asking, “Can’t we expect more?”

So what is “thinking” anyway? The dictionary defines it as “using thought or rational judgment, intelligent.” Synonyms for thinking include reflecting, reasoning, Continued on page 25

Continued on page 18 From the publishers of

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of n it o s D ia er VI ssoc ent own O A r C td e PR y the nce Shu ang a t -R D N ou bity Cmen ong 20 A y T t to munvern ve L ts…

N h m o a ec TIE roug Co e G ay H Eff A B h

ER

INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM

©2013 Engage Healthcare Communications, LLC

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In This Issue

PUBLISHING STAFF

FEATURES

Senior Vice President/Group Publisher Nicholas Englezos nick@engagehc.com

Case Study: A Sudden Change of Course...........................................................1

Vice President, Director of Sales & Marketing Joe Chanley joe@engagehc.com

Coding Update: Let the Transition Begin ..............................................................1

Publisher Cristopher Pires cris@engagehc.com

Opinion: Whatever Happened to Thinking?….....................................................1

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 Rattananont 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 Director, Production & Manufacturing Alaina Pede

By Teri U. Guidi, MBA, FAAMA

By Karna W. Morrow, CPC, RCC, CCS-P, PCS

By By Ruth Linné Lander, FACMPE

COLUMNS From the Editor: Oncology Through a Fractured Looking Glass: How to Compete?…....................................................................................................6

By Dawn Holcombe, MBA, FACMPE, ACHE

Staffing for Success: Use RNs as Care Coordinators in Your Practice................13

By Sheryl A. Riley, RN, OCN, CMCN

CMS Update: Federal Government Broadens Reimbursement of PET Scans for Cancer Treatment Follow-Up…...............................................................32

By Rosemary Frei, MSc

Best Practices: The Danger Signs of Picking the Wrong Medical Billing Company…......................................................................................................39

By Mary Pat Whaley, FACMPE, CPC

DEPARTMENTS Patient and Provider Access: The Government Shutdown May Have Long-Ranging Effects…................................................................................…20

By Sydney Abbott, JD

Clinical Trial Tracker: Find clinical trials by tumor type and location in order to serve your patient base........................................................26 Drug Coding: FDA-Approved Medications Used for the Treatment of Prostate Cancer.............................................................................................. 34 Medical Legal Update: HIPAA Notice of Privacy Practices: Understanding Required Changes.....................................................................................42

Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean 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 November 2013

A Global Collaboration dedicated to improving the lives of patients with B-Cell Malignancies

Š Pharmacyclics, Inc. 2013 Š Janssen Biotech, Inc. 2013 08/13 K08BR13002C

From the Editor

Oncology Through a Fractured Looking Glass: How to Compete?

By Dawn Holcombe, MBA, FACMPE, ACHE

O

ncology is being actively managed by many entities, and in quite different ways. How will oncology practices and practice managers adapt, compete, and succeed in this fractured world? The first step is to look at the specialty through these many prisms and understand what gaps you might be able to fill.

Category 1: Patients Most patients will seek hope and care. They may be willing to be actively engaged, or they may be completely overwhelmed and unfocused. Someone will provide direction. However, that direction could potentially come from outside of the traditional physician/patient relationship, and that direction may or may not be communicated to the physician. Not only that, the outside direction could possibly conflict with the medical plan. For example, some direction may be financial, because benefit design and

formularies for insurance can and do put parameters on patient choice.

Going forward, patient-reported outcomes will increasingly become part of the evidence for value-based decision-making.

Oncology Practice Manager Plan Review your market. Look for trends in patient benefit structures related to shifting care choices. Are you on the “preferred physician” lists?

How do copayments at your site of care compare with those at others?

Are there case managers or navigators touching the patients? Can you talk to those managers and navigators to build relationships and closer communication for the good of your patients and to maintain referrals?

Assess how you currently measure patient-reported outcomes. What gaps exist? What results can you integrate in a value-based discussion?

Category 2: Health Systems Health systems focus on the community and manage single components much like chess pieces.

Oncology is just one specialty among

Peggy Barton, RN Practice Manager Toledo, OH Risë Marie Cleland President Oplinc, Inc Portland, OR

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Continued on page 8

Editorial Advisory Board

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

many, but one that affects many ancillary elements of the health system, so it is perfectly logical that health systems would seek to integrate oncology back into the fold.

Yes, there are drivers like 340B, but the greater drivers are the need for health systems taking on accountable care and eventual risk—which will require control. Health systems are now at financial risk for several health measures, including readmissions, and are likely to increasingly engage case managers and patient navigators. Health systems are likely to secure as much of the primary care market as possible, and in doing so, control oncology referral patterns. Health systems may not understand all of the issues related to oncology, but they will be more likely to look at the diversity of upstream and downstream patient connections outside of the oncology medical practice. This broad view of the patient will align closely with the goals of payers and the Centers for Medicare & Medicaid Services, and it potentially could conflict

Craig K. Deligdish, MD Hematologist/Oncologist Oncology Resource Networks Orlando, FL Patrick A. Grusenmeyer, ScD, FACHE President Christiana Care Health Initiatives Newark, DE Teri U. Guidi, MBA, FAAMA President & CEO Oncology Management Consulting Group Pipersville, PA Marianna Lamb, MS Exceutive Director Medical Oncology Association of Southern California Upland, CA

ONCOLOGY PRACTICE MANAGEMENT

Ruth Linné Lander, FACMPE Practice Administrator Columbus Oncology & Hematology Associates, Inc Columbus, OH Bonnie J. Miller, RN, BSN, OCN, FAAMA Administrative Director Women’s Cancer Center Fox Chase Cancer Center Philadelphia, PA Karna W. Morrow, CPC, RCC, CCS-P, PCS Senior Consultant CSI Coding Strategies, Inc Powder Springs, GA

I November 2013

Robert D. Orzechowski, MBA, SPHR CEO Lancaster Cancer Center Ltd. Lancaster, PA Mary Pat Whaley, FACMPE, CPC Physician Advocate www.managemypractice.com Durham, NC Carla C. Wood Balch, CPC, MS President Altos Solutions, Inc Los Altos, CA

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From the Editor

Oncology Through a Fractured Looking…Continued from page 6 with—or benefit from—the oncology medical home concept.

Health systems can achieve quality ratings and accreditations that individual practices cannot. Their infrastructure could embrace consistency of process and information sharing/reporting across large databases in a way that individual practices cannot. Conversely, a large infrastructure could be a burden, but the expectations for monitoring, reporting, variation reduction, and patient accountability across all care may be perceived as easier for a health system to manage than an individual practice.

Oncology Practice Manager Plan Watch health system activity in your market, even those with whom you are not affiliated. Seemingly overnight, new affiliations or mergers can happen and, if your primary systems become the underdog, referral patterns could dry up in favor of the dominant system. Engage the C-suite leaders regularly. Become part of their plan and infrastructure for addressing oncology management issues. Remember, practices do not need to be employed by a health system to engage with a health system.

However, developing the needed close infrastructure and informationsharing will require trust and regular communication. Some health systems will find that collaboration with local individual practices is essential for meeting the new requirements for maintaining Commission on Cancer accreditation, and savvy practices are leveraging inclusion in that process.

What accountable care initiatives are progressing in your market? Have you engaged those entities in discussions and planning yet?

What quality accreditation op­ tions are available to your group?

Are there potential partners available? How does your group compare

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in terms of quality assessment and reporting with area competitors? Do you track competitor reporting yet?

Category 3: Payers There is no one description for oncology-related activity that fits all payers, except that oncology is a top concern for them. Some payers are exploring with pilots in some markets and some practices. These pilots include bundled payments, pay-for-performance, partial or full

Engage the C-suite leaders regularly.

Become part of their plan and infrastructure for addressing oncology management issues.

Remember, practices do not need to be employed by a health system to engage with a health system.

risk arrangements, and many variations of shared savings. After several years of pilots, there is still no single solution that has emerged as universal and scalable. Some payers will continue to explore innovative solutions. Others are increasingly looking at internal data collection from prior authorization programs to build their own profile of care and treatments—to be used later as support for narrowing variation through their analysis of evidence-based care.

Still others are using third-party vendors to apply oncology management

ONCOLOGY PRACTICE MANAGEMENT

I November 2013

solutions (albeit still focused primarily on drug choices rather than full-care perspectives), so that all oncology care can be run through one consistent filter, regardless of the site of care. Other payers have not yet made decisions beyond drug approvals and management, but they are seeking other potential solutions.

Oncology Practice Manager Plan Focus internally and externally at the same time. Engage the medical director of each of your top 6 health plans—partner them with one of your physicians. Touch base regularly to understand their current concerns, and to let them know that you are willing to work with them.

When I talk with payer medical directors, I never cease to be amazed at how many say they have never been personally approached by key oncology providers to talk about these issues.

Understand and track what data are being collected by which plans through prior authorization and medical necessity challenges. Pursue and implement internal improvements and oncology medical home precepts, not with the expectation that there will be increased revenue opportunities if you do so, but with the expectation that such improvements will allow for enhanced patient care to make the practice an attractive partner in oncology management or accountable care projects. Additionally, streamlining processes and reducing variation will prepare the group for ultimate bundled-payment arrangements that will come from federal, state, and private payers over the next few years.

Category 4: Federal and State Insurances Medicare, Medicare Advantage, and the myriad of new federal and

Continued on page 10

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.

From the Editor

Oncology Through a Fractured Looking‌Continued from page 8 state insurance exchanges and managed Medicaid insurance plans will all seek cost reductions. We are now seeing Medicare Advantage plans dropping practices and payment structures of 100% of Medicare in favor of those who will accept percentages less than Medicare. The growing challenges around the insurance exchange programs have not yet begun to sort out in terms of provider networks and payment rates for those provider networks, or in terms of actual care coverage, especially for oncology. Practices are likely to see challenges even from networks where primary care physicians are placed at risk for total costs of care, including oncology costs.

Oncology Practice Manager Plan This category may represent the greatest financial risk to oncology practices over the next 24 months.

Carefully track contracts and comparative payment rates across these types of insurance arrangements.

Actively engage in dialogue with primary care referrers to assess

what changes may be looming for your referral patterns and your own potential contracting issues if those primary care providers start to assume risk. Investigate your groups who are standing against competition in the market regarding utilization, average costs of care, patient satisfaction, admissions, marketing, quality reporting, etc. Watch state exchanges carefully and look at preferred insurance networks. Are you a part of those networks? Have you received contracts and are the payment terms and other limitations/ parameters acceptable?

In addition to these general perspectives, there are many employers starting to contract individually with oncology providers or external vendors to manage oncology. Pharmacy benefit managers and specialty pharmacies are actively developing both medical and specialty pharmacy oncology management strategies.

Conclusion The watch word as we end this chaotic year is: Look.

Look at how your market is

changing; look at how the public and private exchanges will modify your markets in 2014. Look at who is doing what and who is working with whom locally. Look at how you are being perceived and how you stack up against your current and future competitive and collaborative relationships.

We will emerge after the next 2 years looking quite different than we do today—and that will be a reflection of the varied perspectives on oncology that are present now. If we recognize the way oncology management is being viewed and potentially fractured, we can design a workable solution to get to the other side whole and be able to continue to serve our patients.

About the Author Dawn Holcombe is the president of DGH Consulting in South Windsor, Connecticut, and the Editor-in-Chief of Oncology Practice Management.

She can be reached at 860-305-4510 or by e-mailing dawnho@aol.com.

Visit her website at www.dghconsult ing.net. l

CALL FOR SUBMISSIONS! Do you have a practice management solution to share?

An answer to a problem with reimbursement, EMR implementation, medicare audits, or navigating the rules of the ACA? SEND US YOUR SOLUTION! Submit a 1,000-2,000 word original, previously unpublished article to Lisa Neuman, Managing Editor, at lneuman@the-lynx-group.com 10

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ONCOLOGY PRACTICE MANAGEMENT

I November 2013

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Coding Update

Let the Transition…Continued from page 1 new piece of equipment you purchased or when the electronic medical record was brought on board.

This new code set will dramatically highlight the medical necessity or reason(s) behind the services that are performed. Many claims have been paid to date, honestly, because the payers have accepted the unspecified (xxx.x9) codes. It was cost-prohibitive for the payer to manually review each and every case against the medical record when, in many situations, the claim was appropriate. There wasn’t a better code to use. Now, with an exponentially expanded code set, believe me, there is a better code.

Each organization should carefully evaluate the impact on their operational workflow, reimbursement systems, and provider documentation well in advance of the “go live” date of October 1, 2014.

Challenges and Implications Abound Operationally, this new adventure impacts more than the software. The system updates may, in fact, be the simplest piece of the puzzle. The first challenge is to determine each and every pathway for diagnosis codes. Where do they come from, who enters them, into which system are they entered, and then what? How are the codes used within the organization beyond the insurance claim form? Think clinical trials. Think marketing or other nonclinical data-mining project(s).

Think about the process for ordering imaging studies and laboratory work. Think about the conversion of data for patients whose care crosses the implementation date.

In late October you will need to include additional information on that follow-up office visit—past treatments, the specifics related to the location of the primary tumor

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that was treated 5 years ago, and even emergency department status.

Will these data be available on that progress note? How far back into the medical record will you have to dig to find the data? What process is being used to convert old clinical data into the new code set (Hint: using general equivalence mappings is not the correct answer)?

The transition from ICD-9-CM to ICD-10CM is not about the coders, it is not about ensuring that your software vendor has loaded the new code set, and it is not solely about testing claim submission with your clearinghouse. It will impact every aspect of the healthcare organization.

And then there are more practical implications. Every diagnosis code requires keystrokes. Whether coding entails the “clicks” from a physician selecting codes from a drop-down box of favorites or a coder abstracting the new extended level of details, the process still requires time. The time to click/ enter 5 digits—which may occasionally be an alphanumeric format—is completely different from 7 characters that will always be alphanumeric. The time to click/ enter a primary and, occasionally, a secondary diagnosis code is com-

ONCOLOGY PRACTICE MANAGEMENT

I November 2013

pletely different than reporting 3 to 6 or more diagnoses on each claim—even the office visits. That productivity loss is not about a learning curve; it is the “new normal” and every organization will need to brace for the impact. As you think through the impact on productivity, don’t forget about the humans in the system. Employees typically take vacation and benefit time in the fourth quarter. Many organizations have implemented a benefit policy of “use it or lose it.”

It may be necessary to reevaluate that policy and establish a vacation schedule to limit the number of employees needing a significant number of days once the critical implementation stage of this new project is upon us.

It is anticipated that the payers will deny claims that have, as mentioned, previously been paid now that they can more specifically track the reason for the service(s). Most payers will have their local coverage determinations or other coverage guidelines posted with the new code set by the spring of 2014. It will be important to evaluate the websites and ensure that what you think was covered will be. If your organization has negotiated any carve-outs within your managed care contracts, now is the time to evaluate just how those sections will be “crossed” into the new system. Additionally, the reality is that this new process will increase the denials and delay claims processing for at least the first 6 months—if not longer.

Reimbursement—or, more accurately, the entire charge-capture process will be impacted by the implementation of ICD-10-CM. If your organization had to manage an increase in denials that may reach 200%, or had to accept the days in accounts receivable stretching out another 40%, what would be

Coding Update

the results? As this implementation is set for “go live” in the fourth quarter, has the organization thought through its plans for yearend bonus/compensations?

Finally, it is one thing to say that there is a clinical documentation improvement project within your organization and quite another to drill down and evaluate what really needs to “improve.” Unfortunately, up to 60% of our current reports are insufficient for ICD-10-CM guidelines, and probably a large percentage of those really are insufficient for ICD-9-CM guidelines.

But global comments aren’t helpful when training “your” providers.

There must be a strategic, prioritized approach to provider training. And don’t forget the clinical support staff members who are also responsible in many organizations for updating or at least “resolving” acute conditions/side effects that

may occur during treatment. It is also critical to understand that you cannot expect “more specificity” if the system has limited options for free text. The providers may also push back when historical data are expected on every follow-up visit, but systematically pulling data forward is not the answer either. Do not expect appropriate results without appropriate training.

various steps. Today, start with your organizational workflow. Be able to identify where diagnosis information comes from and how it is used within all areas of your organization.

Perhaps start with scheduling, registration, preauthorization, and follow the codes from there. Once you have identified where the initial information comes from and worked to improve the data collection at those points, you will be ready to move on to the next phase in managing your ICD-10-CM transition. Stay tuned to upcoming issues to see where you can look next to be sure your organization is ready when ICD-10-CM “goes live.”

Conclusion The implementation of ICD-10CM is a multifaceted project that will have long-reaching implications to your organization, your staff, and, ultimately, your patients.

Take each step in your plan cautiously and make sure you involve all of the appropriate stakeholders.

Over the next year, Oncology Practice Management will offer additional information at a more granular level to assist you with those

About the Author Karna W. Morrow is a senior consultant at CSI Coding Strategies, Inc, in Powder Springs, Georgia, and an Editorial Advisory Board member of Oncology Practice Management. l Staffing for Success

Use RNs as Care Coordinators in Your Practice

By Sheryl A Riley, RN, OCN, CMCN

T

he healthcare market has begun to redefine or change the qualifications of the care coordinator/manager. This new definition is not being driven by the new care models, service changes, or qualifications. Simply put, it is because of financial reimbursement, government regulation, and subsidies.

For the first time in years, the clinical delivery models are moving in the right direction. They are focused patient-centered care, including the family or caregivers as well as education and wellness. Another benefit of the new models is the support of a strong physician/patient relationship,

which is strategic to driving patients and their families toward self-care and wellness.

Consequently, with all of the focus on the patients, wellness, education, and community-based medicine, why would physician practices move away from using registered nurses (RNs) and transition to social workers or nonclinical staff as the care coordinator/manager for the patients? More than likely it is because of the cost difference between an RN and a social worker and/or nonclinical personnel.

There can be no doubt that both social workers and nonclinical staff members are vital members of the

November 2013

care coordination/management team and serve a significant function; however, neither of those roles can fulfill the clinical responsibilities or have the clinical training and knowledge level of a highly qualified RN. Nor are they qualified to educate the patient on evidence-based medicine, medication compliance, drug interactions and side effects, preventive medicine, exercise, nutrition, and urgent or emergency care.

The Current Landscape The government continues to cut the physician reimbursement yearly Continued on page 16

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Staffing for Success

Use RNs as Care Coordinators…Continued from page 13 but, conversely, increases the requirements and regulations that physicians must follow. In the past 3 to 5 years, the government has poured billions of dollars into new regulations, requirements, and qualifications. The following represents just a sampling of new requirements.

• All physicians need to convert all paper records to an electronic medical record (EMR) by 2015, supported by the federal government.

• All billing for the Centers for Medicare & Medicare Services must be electronic by 2015, supported by the federal government.

• For physicians to qualify for meaningful-use dollars, they must meet 32 standards in regard to software, patient satisfaction, and other quality metrics.

• Transitions of care, care coordination, and community outreach are all supported by money from the federal government.

Because of the lack of any specific requirements in regard to how these improved quality standards are met, and without guidelines recommending the use of highly trained and qualified RNs to support the model, many practices use “other” professionals or even nonclinical professionals in that role.

To put it bluntly, “you get what you pay for.”

The American Nurses Association released a white paper in 2012 with hard and soft data that lends credence to the idea of using RNs for the care coordinator/manager position. Because the recent standards have forced physicians as well as all other fields of healthcare to be more concerned about their “bottom line,” it might be prudent to compare some numbers. Social workers make between $35,000 and $65,000 depending on the region of the country, and nonclinical personnel make between $20,000 and $40,000. This may appear to be a cost-savings at

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first, if you only consider the dollar figure and not the value each brings to the practice. Conversely, highly qualified RNs with a strong clinical and managed care background will cost between $55,000 and $100,000 depending on the region of the country and the role they are required to fulfill.

At first blush it might give you sticker shock, but the return on investment is great when considering that, in the long run, RNs may save you money through more effective and efficient navigation of the health-

RNs have skills and expertise in patient education, care management, coordination of services, and resource and care coaching. care system for your patients. Educated and trained professionals with clinical specialties such as oncology, chronic care, diabetes, heart disease, and mental health will cost more than a social worker or a nonclinical professional, but for good reason.

RNs have skills and expertise in patient education, medication and symptom management, care management, coordination of services, and resource and care coaching. The RN can speak with patients and their families on topics that physicians may not be as comfortable with or do not have the time to discuss because of increased demands under the new system to see more patients in a shorter period of time. Such topics may include medication management, weight loss, and smoking cessation, as well as palliative and end-of-life care. The RN can

ONCOLOGY PRACTICE MANAGEMENT

I November 2013

follow up with the patient after the physician visit and explain the treatments, medications, and laboratory and screening tests. They can make follow-up phone calls, hospital visits, and home visits if warranted. They are, in a sense, “physician extenders” who not only communicate the physician’s plan of care to the patients and their families, they educate and teach the patients how and why they should follow the treatment plan. Nurses can then communicate all of the findings to physicians through the EMR and daily communication.

As a profession, nursing is considered extremely trustworthy and patients may feel more comfortable speaking to nurses rather than physicians about certain aspects of their care. By connecting with patients early in the care management process, it decreases the amount of calls, e-mails, and patient follow-up that physicians have to do themselves.

Nurses continue to come out on top of all professions—as well as physicians and pharmacists—as the most honest, ethical, and trusted of professionals. Nurses give patients a feeling of security and trust that improves patient compliance and satisfaction, decreases emergency department visits and urgent hospitalizations, and improves communication with referrals and transitions to hospitals, home care, and skilled nursing facilities.

In this new world of quality metrics, regulations, and subsidy dollars directed to only the best practices, the question you need to be asking yourself is, can you afford not to hire an RN for the care coordinator/ manager in your practice?

About the Author Sheryl A. Riley is the director of clinical services for SAI Systems, a technology consulting services and solutions company based in Shelton, Connecticut. She can be reached at sriley@saisystems.com or by calling 203-929-0790. l

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Case Study

A Sudden Change of Course Continued from page 1 Once Upon a Time…

Memorial and the Practice were in a rapidly consolidating market.

Nearly 100% of all primary care practices had become employed by one or another of the multiple hospitals and health systems in the region. Over 75% of the specialty practices had also become employed or entered into exclusive relationships as well.

Memorial had its own primary care physician group and employed a handful of other specialists, but the Practice remained independent.

Memorial, like many of its competitors, was opening a variety of satellite locations throughout the market in an effort to capture more primary care patients. But the employed primary care physicians often sent their referrals to oncologists who were affiliated with competing hospitals. When queried, most responded that this was for patient convenience because Memorial’s independent oncologists were located farther away than the competitors. Memorial invited the Practice to a meeting to discuss the situation.

At the meeting, Memorial presented its case and asked the Practice to open their own satellite at one of the most promising hospital satellites. The Practice replied that the volumes would be too low to sustain an additional office. They listed the increasing pressures, which included: • Decreasing reimbursement for chemotherapy drugs, coupled with rising costs of newer drugs

• A decline in prompt-pay discounts and rebates • Rising time lag from billing to collection • Decreasing market share due to market consolidations that were effectively steering referrals to their competitors.

These pressures had already led the Practice to take several steps to survive. They had put a hiring freeze in place several months earlier and had recently announced a reduction in staff benefits and a freeze on pay raises. The physicians all took a pay cut and their bonuses were eliminated. Memorial was sympathetic to the Practice’s plight and asked for suggestions on how they could help so that the Practice would be able to open a satellite office.

The Practice held their own strategy session and brainstormed ideas to generate new revenue streams.

They considered approaching other still-independent physician practices to form a larger multispecialty practice, achieving economies of scale and tightening up some of their referrals. And they discussed approaching Memorial or other hospitals to enter into joint ventures for equipment.

When they had laid out all of the options they could think of, they went back to Memorial and presented the concepts. They assured the hospital that their preference for joint venture partners was Memorial and that they would give Memorial the first right of refusal.

DO YOU HAVE A CASE STUDY TO SHARE? If your practice has a story to tell, we want to hear it. Send your Case Study idea to Lisa Neuman, Managing Editor, at lneuman@the-lynx-group.com 18

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ONCOLOGY PRACTICE MANAGEMENT

I November 2013

Now it was Memorial’s turn to strategize and evaluate the joint ventures suggested by the Practice. In the end, each option was dismissed.

The major reasons for eliminating the joint ventures were (1) Memorial was very conservative and was uncomfortable with the possibility of violating the complicated laws and regulations associated with financial relationships between physicians and hospitals, including concerns about the antikickback statutes; and (2) Memorial was simply not willing in some of the scenarios to share the revenue. Instead, Memorial returned to the Practice and proposed employment. The Practice declined that option and countered with a proposal to explore other alignment options. Both sides agreed to the exploration and engaged OMC Group to facilitate.

The first step in the exploration was to interview each of the stakeholders confidentially to understand their goals, expectations, and any deal breakers. At the same time, OMC Group ran the financials using Memorial’s collection rates and the Practice’s payer mix, collection rates, and billed service volumes. OMC Group determined that, financially, it would be more advantageous to operate the infusion business as a hospital outpatient department. One of the Practice’s deal breakers was a hard insistence that they retain their corporate identity and that they retain substantive control of operations.

Remember, Memorial’s deal breaker was a firm decision that joint ventures would not be accepted.

Thus, all parties agreed that a professional services agreement (PSA) and a comanagement agreement (CMA) was the best combination for the next phase of work (add the options for compensation to the financials, and, through a series of

Case Study

facilitated working sessions, work out the deal points for both of the agreements) the performance expectations on both sides, the delineation of the scope and decision-making structure for the CMA, physician compensation for professional services and for comanagement, transitioning of the infusion business (valuation by a certified public accountant, moving staff to Memorial’s employment, etc), mutual exclusivity, noncompetes, and other details largely associated with ensuring a clear understanding of control. A complete pro forma was developed.

The Plot Twist Just as both parties were handing the deal sheet to their respective attorneys, the senior partners in the Practice called an emergency meeting with Memorial. They were

convinced that with all of the federal scrutiny of financial arrangements between hospitals and physicians, PSAs and, most definitely, CMAs would—probably sooner than later— become disallowed. “By the time we get it all ironed out and implemented, we will probably just have to unwind the thing,” said the managing partner physician. “We wish to have Memorial acquire our entire practice and employ us. Does the offer still stand?” Memorial accepted.

spend time meeting the primary care physicians who would be most likely to refer.

After some months in operations, several payers began to push back on their contracts, noting the increase in costs with the infusion moved to a hospital outpatient structure. This negatively impacted on the pro forma projections, but not enough to make it untenable for any party. Today, the New Practice is as busy as ever.

The satellite is nearing capacity. The potholes in the road over information system integration and staff assimilation have subsided. And emerging efforts around accountable care organizations and bundled payments are now far simpler.

And they lived happily ever after (until Medicare and the Office of Inspector General issues…?) l

Epilogue With additional facilitation, em­­ ployment contracts were negotiated and the transition plan was mapped out. Under the new structure, the New Practice recruited a new oncologist to staff Memorial’s satellite and, while his practice was ramping up, to

ONCOLOGY PRACTICE MANAGEMENT ™

FOR COMMUNITY ONCOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS™

A forum for members of the oncology team to have a discussion on the day-to-day operations of running a business. The goal is to share ideas and best practices, and provide a resource to ultimately help run a more efficient practice and improve patient care.

JOIN OUR LinkedIn GROUP TODAY

www.OncPracticeManagement.com OPMin101713

November 2013

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www.OncPracticeManagement.com

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Patient and Provider Access

The Government Shutdown May Have Long-Ranging Effects

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

W

e all know that the fed­­­ eral government is back in business, but what is less clear is the longterm impact the shutdown may yet have on the oncology community. The House and Senate recently passed a continuing resolution to fund the government through January 15, and raise the debt ceiling until February 7.

It is good news that funding for new clinical trials is restored and the Centers for Medicare & Medicaid Services (CMS) will get back to writing the final rules for the 2014 Physician Fee Schedule and Hospital Outpatient Prospective Payment System. However, Congress passed a continuing resolution, which is legislation to continue funding discretionary spending at the same rate it had been funded, with the only update being for inflation.

This means that funding has been restored at postsequestration levels, and the conversation continues about that impact on community cancer care. Also, CMS will delay release of the final rules until the final week of November, leaving only about a month for implementation of the new policies before January 1. What’s more, because of the timing, CMS may be forced to

hold reimbursement payments for the first 2 weeks of January because Congress will probably address the Medicare cuts resulting from the sustainable growth rate (SGR) formula in combination with the budget.

What does this mean for SGR reform? With 2013 winding down

Congress passed a continuing resolution, which is legislation to continue funding discretionary spending at the same rate it had been funded….This means that funding has been restored at postsequestration levels, and the conversation continues about that impact on community cancer care. and Congress focused on very little besides the budget and debt ceiling, hopes of passing reform this year are slipping away. This means we are looking at the probability of another

“doc fix” to stave off the anticipated 24.4% cut to Medicare reimbursement. Congress has a long history of stepping in at the last minute to avert cuts created by this flawed formula. However, many in the advocacy community believed that this was the year to do away with the SGR, considering the low Congressional Budget Office score and with the House Energy & Commerce, Ways and Means, and Senate Finance committees all drafting legislation.

There is still an outside chance that SGR repeal could get looped into a larger budget deal but, considering that the Senate Finance and House Ways and Means committees’ SGR repeal legislation is still expected to cost about $140 billion over 10 years and no offsets have yet been identified, Congress may wait until another day to take on that fight.

Come January, we may see ourselves in the same situation from which we just emerged—partisanship and political gridlock threatening another shutdown. While the conversation continues to be budget-driven, the Association of Community Cancer Centers (ACCC) will continue to work with members of Congress to preserve provider reimbursement and access to care for patients with cancer. ACCC continues to advocate for SGR reform among other topics of interest to community oncology.

Please stay tuned for updates. l

SUBSCRIBE NOW!

Don’t miss your practice management news… visit www.OncoPracticeManagement.com TODAY!

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ONCOLOGY PRACTICE MANAGEMENT

I November 2013

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

• REIMBURSEMENT SERVICES

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• 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 a Grade 3 Grade 4 Grades Grade 3 Grade 4 Reactions Grades (%) (%) (%) (%) (%) (%) 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 f Herpes Zoster 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

Opinion

Whatever Happened to…Continued from page 1 discerning, pondering, and deliberating.

I believe that our ability to plan and to think has been severely “numbed” over the past several decades growing up in the typical modern household and school system. At home, we often have many electronic devices at our fingertips, from televisions to smartphones. At school, we commonly have laptops, tablets, calculators, and other electronic learning devices in the classrooms. We can now take college classes and get certifications or degrees online without ever leaving our homes. As adults, our TV shows are often dumbed down and unrealistic to actual living, where real thinking is helpful. Our software can be amazing, doing more and more of the grunt work or processing, but it can also have the effect of a drug lulling the brain to sleep. So much is now automatic—just push a button. Look at the writing legibility and spelling of many young people today when they are not on an electronic device to see that problem surface.

I can recall energized math classes in the New York City schools that I attended from sixth grade through high school where we calculated math problems quickly on paper or in our heads. We learned to estimate the value of long lists of numbers quickly in our heads and really learned to understand what we should expect as a near result. Multiplying 10 by 100 doesn’t give you 100, it gives you 1000, and this was understood. When calculators started being accepted in classrooms, understanding what to expect went to sleep for many.

Several years ago a college student buying a $1.25 greeting card with a $10 bill seriously exclaimed to me, “Oh, do I get change?” In the medical field, getting the correct clinical information and calculating any treatment

correctly can literally have “life or death” consequences, and therefore many automated safeguards have been put in place so that errors are minimized. But I have seen well-credentialed medical staff miss mistakes on the units of expensive drugs for billing purposes. Hitting the wrong key on the calculator or computer keyboard

tough time. For the administrative side of medical practice management, it can have less immediately dire consequences and go unnoticed for a while but, over time, it can bring a really bad outcome.

I can remember an Ruth Linné Lander, FACMPE advertising class I took once where, paraphrased, the professor mentioned that 85% of people are just waiting to be told what to do, 12% think a little bit, and only 3% think things through thoroughly when presented with a choice or decision. I remember wondering if people really had been trained like Pavlov’s dogs into this robot-like response 85% of the time. I thought this was a pretty damning overstatement, but I have seen its validity over and over as the years have passed. Medical staff professionals often expect others to do all of the planning and process thinking from day to day, and just wait to be told what to do instead of looking at things in their area for that day or future days and making plans to make it work well with thought and flexibility—in other words, “thinking.”

I do see pockets of hope in some homes and schools. I see the thinking that students acquire when learning something like a musical instrument, gymnastics, or other activity or sport that is not automatic as they grow up. But, many times, we get people in our medical workforce who have never learned how to really think. At this point, we can’t be afraid to bring them back into the classrooms and become their teachers; this time for “thinking” classes. This is a daunting task with adults, but one that will benefit their practices while they are working, and the “students” for the rest of their lives. l

In the medical field, getting the correct clinical information and calculating any treatment correctly can literally have “life or death” consequences, and therefore many automated safeguards have been put in place so that errors are minimized.

But…if the mistake isn’t caught, thousands of dollars go unbilled, bringing the clinic closer to insolvency at a very tough time. can result in a 10 instead of a 100, and not be seen as an absurd or unrealistic answer. Any “thinking” about what the probable result could be is missing.

If the mistake isn’t caught, thousands of dollars go unbilled, bringing the clinic closer to insolvency at a very

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Clincial Trial Tracker

Recruitment Is Open for Several Clinical Trials

A

practice manager is a key point person for relaying information on clinical trials to the physicians, nurses, and navigators in the oncology practice.

Here you will find basic information on several active trials that are currently recruiting patients, including contact information for the study investigators, the clinical trial reference number, and the locations of the study so you can be aware of studies being done near your practice location.

of CLL that meets published 2008 International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute–Work­ing Group criteria. For a list of inclusion/exclusion criteria, contact Cathy Nolan at 847973-2404 or cathy.nolan@abbvie. com. Reference the ClinicalTrials. gov identifier: NCT01889186. This study is sponsored by AbbVie Inc. and Genentech, Inc. The study locations are in Tucson, Arizona, and Harvey, Illinois.

Source: ClinicalTrials.gov

Nab-Paclitaxel/ Gemcitabine or Carboplatin as First-Line Treatment for Triple Negative Metastatic Breast Cancer Celgene is conducting a study in 3 centers in Arkansas, North Carolina, and Virginia to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin with the combination of gemcitabine and carboplatin as a first-line treatment in female subjects with triple-negative metastatic breast cancer.

Debra Barton, MD, the Associate Director of Clinical Trial Disclosure for Celgene and the director of this study, can be contacted at 888-2601599 or clinicaltrialsdisclosure@cel gene.com.

Source: ClinicalTrials.gov

Safety and Efficacy Study of Enzalutamide in Patients with Advanced Androgen Receptor-Positive, Triple– Negative Breast Cancer The purpose of this phase 2 study is to determine if enzalutamide is safe and effective in the treatment of patients 18 years of age and older with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not HER2 amplified. For a list of inclusion/exclusion criteria, contact Amy Peterson, MD, study chair, at 415-543-3470 or amy. peterson@medivation.com. Reference the ClinicalTrials.gov identifier: NCT01889238. The study is sponsored by Medivation, Inc. and Astellas Pharma US, Inc. The study locations are in Lakewood, Colorado; Fort Myers, Florida; Morristown, New Jersey; Greensboro, North Carolina; Cincinnati, Ohio; Greenville, South Carolina; Memphis, Tennessee; Nashville, Tennessee; and Dallas, Texas.

Source: ClinicalTrials.gov

ABT-199 in Relapsed or Refractory Chronic Lymphocytic Leukemia with the 17p Deletion This phase 2, open-label, multicenter study will evaluate the efficacy of ABT-199 in approximately 100 relapsed or refractory subjects with chronic lymphocytic leukemia (CLL) harboring 17p13 (TP53 locus) deletion. Subjects must be 18 years of age or older with a diagnosis

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NovoTTF-100A with Bevacizumab (Avastin) in Patients with Recurrent Glioblastoma NovoTTF-100A is a device and

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bevacizumab is a study drug that have both been approved by the US Food and Drug Administration for use as monotherapy in treating patients with glioblastoma multiforme (GBM). The NovoTTFl00A is a portable, battery-operated device that produces TTFields within the human body using surface electrodes (transducer arrays).

Intermediate frequency electric fields (TTFields) stunt the growth of tumor cells.

The purpose of this open-label, phase 2 trial is to determine the efficacy of the combination of bevacizumab and NovoTTF-100A in bevacizumab-naive adult patients (meaning they have never received bevacizumab), aged 22 years and older, with recurrent GBM as measured by 6-month progression-free survival.

The NovoTTF-100A treatment and bevacizumab will be administered on an outpatient basis; NovoTTF-100A treatment will be initiated in the outpatient clinic.

For a list of inclusion/exclusion criteria, contact Manmeet Ahluwalia, MD, study chair, at 216-444-6145 or ahluwam@ccf.org. Reference the ClinicalTrials.gov identifier: NCT01894061. The study is sponsored by Case Comprehensive Cancer Center, Novocure Limited, and the National Cancer Institute.

The study location is in Cleveland, Ohio, at the Cleveland Clinic Taussig Cancer Institute.

Source: ClinicalTrials.gov

FOLFOX Plus Regorafenib in Patients with Unresectable or Metastatic Esophagogastric Cancer The purpose of this phase 2 study is to evaluate the effects, good and/ or bad, of the drug regorafenib with a Continued on page 29

First- and every-cycle Neulasta achieved: ■

94% relative reduction in febrile neutropenia (17% placebo vs 1% Neulasta; P < .001)1,2

■

93% relative reduction in febrile neutropenia–related hospitalization (14% placebo vs 1% Neulasta; P < .001)1,2

■

80% relative reduction in febrile neutropenia–related IV anti-infective use (10% placebo vs 2% Neulasta; P < .001)1,2

Phase 3 study in patients with breast cancer receiving 100 mg/m2 docetaxel for up to 4 cycles given placebo (n = 465) or Neulasta (n = 463); primary endpoint: incidence of febrile neutropenia.1 Febrile neutropenia = absolute neutrophil count (ANC) < 0.5 × 109/L and temperature ≥ 38.2°C.

Support through every cycle Help reduce the incidence of infection and protect your patients receiving myelosuppressive chemotherapy* from febrile neutropenia.

*Myelosuppressive chemotherapy regimens associated with a clinically significant risk of febrile neutropenia.

Neulasta® (pegfilgrastim) is administered by subcutaneous injection.

Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta for ARDS. Discontinue Neulasta in patients with ARDS. References: 1. Vogel C, et al. J Clin Oncol. 2005;23:1178-1184. 2. Neulasta (pegfilgrastim) Prescribing Information. Thousand Oaks, CA: Amgen; 2011. © 2012 Amgen Inc. All rights reserved.

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Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment.

Permanently discontinue Neulasta in patients with serious allergic reactions.

Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

The granulocyte colony-stimulating factor (G-CSF) receptor, through which pegfilgrastim and filgrastim act, has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.

Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients.

Please see brief summary of Neulasta Prescribing Information on the adjacent page.

Every appropriate patient.

Every cycle.

patients were randomized to receive either 6 mg Neulasta (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% INDICATIONS AND USAGE Hispanic, 2% Black, and < 1% Asian, Native American or other.

Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid Bone pain and pain in extremity occurred at a higher incidence malignancies receiving myelosuppressive anticancer drugs in Neulasta-treated patients as compared with placebo-treated patients. associated with a clinically significant incidence of febrile Table 1. Adverse Reactions With ≥ 5% Higher Incidence neutropenia.

Neulasta is not indicated for the mobilization of peripheral blood in Neulasta Patients Compared to Placebo in Study 3 progenitor cells for hematopoietic stem cell transplantation.

System Organ Class Placebo Neulasta 6 mg CONTRAINDICATIONS Preferred Term (N = 461) SC on Day 2 Do not administer Neulasta to patients with a history of serious (N = 467) allergic reactions to pegfilgrastim or filgrastim.

Musculoskeletal and connective tissue disorders WARNINGS AND PRECAUTIONS Bone pain 26% 31% Splenic Rupture Pain in extremity 4% 9% Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen Leukocytosis or splenic rupture in patients who report left upper abdominal In clinical studies, leukocytosis (WBC counts > 100 x 109/L) or shoulder pain after receiving Neulasta. was observed in less than 1% of 932 patients with nonmyeloid Acute Respiratory Distress Syndrome malignancies receiving Neulasta. No complications attributable Acute respiratory distress syndrome (ARDS) can occur in patients to leukocytosis were reported in clinical studies. receiving Neulasta. Evaluate patients who develop fever and Immunogenicity lung infiltrates or respiratory distress after receiving Neulasta, for As with all therapeutic proteins, there is a potential for ARDS. Discontinue Neulasta in patients with ARDS. immunogenicity. Binding antibodies to pegfilgrastim were Serious Allergic Reactions detected using a BIAcore assay. The approximate limit of Serious allergic reactions, including anaphylaxis, can occur in detection for this assay is 500 ng/mL. Pre-existing binding patients receiving Neulasta. The majority of reported events antibodies were detected in approximately 6% (51/849) occurred upon initial exposure. Allergic reactions, including of patients with metastatic breast cancer. Four of 521 anaphylaxis, can recur within days after the discontinuation of pegfilgrastim-treated subjects who were negative at baseline initial anti-allergic treatment. Permanently discontinue Neulasta developed binding antibodies to pegfilgrastim following in patients with serious allergic reactions. Do not administer treatment. None of these 4 patients had evidence of Neulasta to patients with a history of serious allergic reactions neutralizing antibodies detected using a cell-based bioassay. to pegfilgrastim or filgrastim.

The detection of antibody formation is highly dependent on Use in Patients With Sickle Cell Disorders the sensitivity and specificity of the assay, and the observed Severe sickle cell crises can occur in patients with sickle cell incidence of antibody positivity in an assay may be influenced disorders receiving Neulasta. Severe and sometimes fatal sickle by several factors, including assay methodology, sample cell crises can occur in patients with sickle cell disorders handling, timing of sample collection, concomitant medications, receiving filgrastim, the parent compound of pegfilgrastim. and underlying disease. For these reasons, comparison of the incidence of antibodies to Neulasta with the incidence Potential for Tumor Growth Stimulatory Effects on of antibodies to other products may be misleading.

Malignant Cells The granulocyte-colony stimulating factor (G-CSF) receptor Postmarketing Experience through which pegfilgrastim and filgrastim act has been found The following adverse reactions have been identified during on tumor cell lines. The possibility that pegfilgrastim acts post approval use of Neulasta. Because these reactions are as a growth factor for any tumor type, including myeloid reported voluntarily from a population of uncertain size, it is not malignancies and myelodysplasia, diseases for which always possible to reliably estimate their frequency or establish pegfilgrastim is not approved, cannot be excluded. a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more ADVERSE REACTIONS of the following factors: (1) seriousness of the reaction, (2) The following serious adverse reactions are discussed in reported frequency of the reaction, or (3) strength of causal greater detail in other sections of the Brief Summary: relationship to Neulasta.

• Splenic Rupture [See Warnings and Precautions] Gastro-intestinal disorders: Splenic rupture [see Warnings • Acute Respiratory Distress Syndrome [See Warnings and Precautions] and Precautions] Blood and lymphatic system disorder: Sickle cell crisis • Serious Allergic Reactions [See Warnings and Precautions] [see Warnings and Precautions] • Use in Patients with Sickle Cell Disorders [See Warnings Hypersensitivity reactions: Allergic reactions/hypersensitivity, and Precautions] including anaphylaxis, skin rash, and urticaria, generalized • Potential for Tumor Growth Stimulatory Effects on Malignant erythema and flushing [see Warnings and Precautions] Cells [See Warnings and Precautions] Respiratory, thoracic, and mediastinal disorder: ARDS The most common adverse reactions occurring in ≥ 5% of [see Warnings and Precautions] patients and with a between-group difference of ≥ 5% higher General disorders and administration site conditions: in the pegfilgrastim arm in placebo controlled clinical trials Injection site reactions are bone pain and pain in extremity.

Skin and subcutaneous tissue disorders: Sweet’s syndrome, Clinical Trials Experience Cutaneous vasculitis Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials DRUG INTERACTIONS of a drug cannot be directly compared with rates in the clinical No formal drug interaction studies between Neulasta and other trials of another drug and may not reflect the rates observed in drugs have been performed. Increased hematopoietic activity of the bone marrow in response to growth factor therapy may clinical practice.

Neulasta clinical trials safety data are based upon 932 patients result in transiently positive bone-imaging changes. Consider these findings when interpreting bone-imaging results. receiving Neulasta in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The USE IN SPECIFIC POPULATIONS ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and Pregnancy 1% Asian. Patients with breast (n = 823), lung and thoracic Pregnancy Category C tumors (n = 53) and lymphoma (n = 56) received Neulasta There are no adequate and well-controlled studies in pregnant after nonmyeloablative cytotoxic chemotherapy. Most patients women. Pegfilgrastim was embryotoxic and increased received a single 100 mcg/kg (n = 259) or a single 6 mg pregnancy loss in pregnant rabbits that received cumulative (n = 546) dose per chemotherapy cycle over 4 cycles. doses approximately 4 times the recommended human dose (based on body surface area). Signs of maternal toxicity The following adverse reaction data in Table 1 are from a randomized, double-blind, placebo-controlled study in patients occurred at these doses. Neulasta should be used during pregnancy only if the potential benefit to the mother justifies with metastatic or non-metastatic breast cancer receiving the potential risk to the fetus. docetaxel 100 mg/m2 every 21 days. (Study 3). A total of 928 BRIEF SUMMARY OF PRESCRIBING INFORMATION Neulasta® (pegfilgrastim) injection, for subcutaneous use

In animal reproduction studies, when pregnant rabbits received pegfilgrastim at cumulative doses approximately 4 times the recommended human dose (based on body surface area), increased embryolethality and spontaneous abortions occurred.

Signs of maternal toxicity (reductions in body weight gain/food consumption) and decreased fetal weights occurred at maternal doses approximately equivalent to the recommended human dose (based on body surface area). There were no structural anomalies observed in rabbit offspring at any dose tested. No evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area).

Women who become pregnant during Neulasta treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Nursing Mothers It is not known whether pegfilgrastim is secreted in human milk.

Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. Caution should be exercised when administered to a nursing woman.

Pediatric Use Safety and effectiveness of Neulasta in pediatric patients have not been established. The adverse reaction profile and pharmacokinetics of pegfilgrastim were studied in 37 pediatric patients with sarcoma. The mean (± standard deviation [SD]) systemic exposure (AUC0-inf ) of pegfilgrastim after subcutaneous administration at 100 mcg/kg was 22.0 (± 13.1) mcg·hr/mL in the 6 to 11 years age group (n = 10), 29.3 (± 23.2) mcg·hr/mL in the 12 to 21 years age group (n = 13), and 47.9 (± 22.5) mcg·hr/mL in the youngest age group (0 to 5 years, n = 11).

The terminal elimination half-lives of the corresponding age groups were 20.2 (± 11.3) hours, 21.2 (± 16.0) hours, and 30.1 (± 38.2) hours, respectively. The most common adverse reaction was bone pain.

Geriatric Use Of the 932 patients with cancer who received Neulasta in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.

Renal Impairment In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim.Therefore, pegfilgrastim dose adjustment in patients with renal dysfunction is not necessary.

DOSAGE AND ADMINISTRATION The recommended dosage of Neulasta is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle in adults. Do not administer Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Neulasta if discoloration or particulates are observed.

NOTE: The needle cover on the single-use prefilled syringe contains dry natural rubber (latex); persons with latex allergies should not administer this product.

This product, its production, and/or its use may be covered by one or more US Patents, including US Patent Nos. 5,824,784; 5,582,823; 5,580,755, as well as other patents or patents pending.

Neulasta® (pegfilgrastim) Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 © 2012 Amgen Inc. All rights reserved. www.neulastaHCP.com 1-800-77-AMGEN (1-800-772-6436) v 13.0

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Clincial Trial Tracker

Recruitment Is Open for…Continued from page 26 chemotherapy regimen (FOLFOX) in patients aged 18 years and older with histologically or cytologically confirmed metastatic or unresectable esophageal, gastroesophageal junction, or gastric adenocarcinoma.

For a list of inclusion/exclusion criteria, contact Yelena Janjigian, MD, principal investigator, at 646-8884186. Reference the ClinicalTrials. gov identifier: NCT01913639. The study is sponsored by Memorial Sloan-Kettering Cancer Center and Bayer Corporation. The study locations are in Basking Ridge, New Jersey; Commack, New York; New York, New York; Rockville Centre, New York; and Sleepy Hollow, New York.

Source: ClinicalTrials.gov

Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients with Relapsed or Refractory Hematologic Malignancies Patients aged 21 years and younger with relapsed or refractory leukemia or lymphoma will be recruited for this phase 1 study to determine whether the addition of a new drug—bendamustine—will be safe and efficacious to give with other chemotherapy drugs. This drug is approved by the US Food and Drug Administration for the treatment of other cancers in adults that are similar to those being studied in the research trial.

The primary objectives of the study are to establish the maximum tolerated dose of bendamustine in combination with clofarabine and etoposide in pediatric participants with hematologic malignancies, and to characterize the safety profile and dose-limiting toxicities of bendamustine in combination with clofarabine and etoposide. The secondary objectives are to estimate

event-free survival at 4 months, to estimate minimal residual disease levels present at the end of each cycle of therapy in patients with leukemia, and to characterize the pharmacokinetic profile of bendamustine in the proposed regimen.

Bendamustine will be combined with clofarabine and etoposide in a 5-day cycle. Dexamethasone will be given to prevent capillary leak syndrome associated with clofarabine.

If the participant does not develop progressive disease or a dose-limiting toxicity during the first cycle, a second cycle may be administered as a bridge to transplant. Each cycle lasts 21 to 28 days (or until count recovery).

Concomitant intrathecal therapy can be given at the investigator’s discretion, but not on the same days as chemotherapy. Recommendations are triple intrathecal therapy (methotrexate, hydrocortisone, cytarabine) weekly for patients with central nervous system (CNS)2 or CNS3 disease, and every 2 weeks for patients with CNS1 disease. Leucovorin may be given according to institutional guidelines.

The intent of this study design is for all patients to receive and complete 1 course of therapy. Patients who exhibit signs of disease progression or experience an unacceptable toxicity will be discontinued from the protocol treatment.

Patients with Hodgkin or non-Hodgkin lymphoma must meet 1 of the following criteria to participate in the trial: relapsing disease in second or greater relapse and measurable disease; or refractory disease failing to achieve complete remission (CR) with >2 induction or reinduction attempts. Patients with acute leukemia must meet 1 of the following criteria to participate in the trial: relapsing acute lymphoblastic leukemia (ALL), acute

November 2013

myeloid leukemia (AML), or acute biphenotypic leukemia in second or greater relapse; or refractory ALL, AML, or acute biphenotypic leukemia failing to achieve CR with ≥2 induction or reinduction attempts.

Participants with leukemia must have M2 or M3 marrow at the time of enrollment. Participants with M2 marrow must have definite cytogenetic, molecular, or immunophenotypic evidence of recurrent/refractory disease. Participants must not yet have reached their 22nd birthday.

For a list of inclusion/exclusion criteria, contact Deepa Bhojwani, MD, principal investigator, at 866-2785833 or info@stjude.org. Reference the ClinicalTrials.gov identifier: NCT01900509. The study is sponsored by St. Jude Children’s Research Hospital and Teva Pharmaceuticals USA. The study location is in Memphis, Tennessee.

Source: ClinicalTrials.gov

Assessing CUDC-427 When Given Twice Daily to Patients with Advanced and Refractory Solid Tumors or Lymphoma This is a phase 1, open-label, dose-escalation study of CUDC-427 in patients aged 18 years or older with advanced or refractory solid tumors or lymphoma. CUDC-427 is a drug that is designed to antagonize proteins that prevent or interfere with cell death. The study is de­signed to assess the safety, including the maximum tolerated dose (MTD), the pharmacokinetics, and the anticancer activity of CUDC-427.

Sequential dose-escalation co­­ horts of oral CUDC-427 are planned. Subject enrollment and dose escalation will proceed according to a standard 3+3 design. In the absence of intolerable toxicity, each subject will receive a minimum of 1 Continued on page 30

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Clincial Trial Tracker

Recruitment Is Open for…Continued from page 29 cycle (21 days) of study treatment, and may continue to receive additional cycles until disease progression has been documented or other treatment discontinuation criteria have been met.

No intrasubject dose escalation will be allowed. During the doseescalation phase, up to 3 additional subjects may be enrolled at previously cleared dose levels to better define the safety, tolerability, and activity of the study treatment. Similarly, an MTD expansion cohort of up to 12 evaluable subjects may also be enrolled; enrollment into this expansion cohort may be limited to a particular cancer type.

Safety and tolerability will be assessed by the incidence and severity of adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4.03).

A Safety Review Committee comprised of the medical monitor, principal investigators, and sponsor representatives will be convened to review safety information and to decide on dose escalation and further subject enrollment.

The antitumor activity of study treatment will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or the Revised Response Criteria for Malignant Lymphoma as appropriate for each subject’s tumor type.

Exploratory biologic markers of CUDC-427 activity will be assessed in tumor samples (where available), peripheral blood mononuclear cells, and plasma.

For a list of inclusion/exclusion criteria, contact Lorrie Patterson at 877-691-7274 or asksarah@scre search.net; or Isabel Jimenez, RN, MSN at 210-593-5265 or isabel. jimenez@start.stoh.com. Reference the ClinicalTrials.gov identifier: NCT01908413. The study is sponsored by Curis, Inc. The study locations are in Nashville, Tennessee; and San Antonio, Texas.

Source: ClinicalTrials.gov

Bortezomib for Low or Intermediate-1 Myelodysplastic Syndrome with p65 Activation The goal of this phase 2 clinical research study is to learn if

bortezomib can help to control myelodysplastic syndrome (MDS).

Bortezomib is designed to block a protein that causes cells to grow, which may cause cancer cells to die. The safety of the drug will also be studied. Those found to be eligible to take part in this study will receive bortezomib as a subcutaneous injection on days 1, 4, 8, and 11 of each 21-day cycle.

This is an investigational study.

Bortezomib is approved by the US Food and Drug Administration and commercially available to treat multiple myeloma and mantle cell lymphoma. Giving it to patients with MDS is investigational. Up to 40 participants, aged 18 years and older, will be enrolled in this study.

For a list of inclusion/exclusion criteria, contact Guillermo Garcia-Manero, principal investigator, at 713-745-3428. Reference the ClinicalTrials.gov identifier: NCT01891968. The study is sponsored by Millennium Pharmaceuticals, Inc. The study location is in Houston, Texas at the MD Anderson Cancer Center at The University of Texas.

Source: ClinicalTrials.gov l

WEB POLL QUESTION Have your cancer patients experienced any “side effects” from the Afforadable Care Act yet? What are you and your patients concerned about as the ACA goes into effect?

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

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*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

CMS Update

Federal Government Broadens Reimbursement of PET Scans for Cancer Treatment Follow-Up

By Rosemary Frei, MSc

T

he recent decision by the Centers for Medicare & Medicaid Services (CMS) to broaden coverage of fluorine-18 fluo­­rodeoxyglucose positron emission tomography (FDG-PET) imaging in patients who have been treated for tumors has been welcomed by many in the oncology community, although the decision is not without its critics.

CMS stated in the June 11, 2013, Decision Memo that the agency will cover 3 FDG-PET scans for guiding antitumor treatment strategy after the initial anticancer therapy has been completed, to determine whether there are any distant metastases that were not found in initial staging studies. This includes patients with all forms of cancer, including prostate cancer, breast cancer, and testicular cancer. The CMS deemed that it is up to local Medicare administrative contractors (MACs) to decide whether they will cover any additional FDGPET scans on these patients.

The CMS will also cover FDGPET scanning for the determination of initial treatment strategy for most types of solid tumors, with the sole exceptions being prostate cancer, the initial diagnosis of cervical cancer, the initial diagnosis and/ or staging of axillary lymph nodes in women with breast cancer, and the initial staging of regional lymph nodes in people with melanoma.

All of this is in line with what officials at the National Oncologic PET Registry (NOPR), which previously had been tasked with collecting data on PET imaging of cancers, had requested.

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“One of the arguments from day 1 has been that by drilling down to the level of each tumor type and each tumor indication, you reach a point where you make it impossible to reach a decision about use of the tool unless the overarching goal is not to pay for it,” Barry Siegel, MD, cochair of the NOPR, told Oncology Practice Management. “But at the same time, the fact that something is covered doesn’t mean we should assume that

All of this is in line with what officials at the National Oncologic PET Registry (NOPR), which previously had been tasked with collecting data on PET imaging of cancers, had requested.

doctors will foolishly use it in cases where it’s not useful…. What the CMS has done is set a policy that allows doctors to use their discretion and to use the tool intelligently to answer clinical questions.”

Walter J. Curran, Jr, MD, Executive Director of the Winship Cancer Institute and Associate Vice President, Woodruff Health Sciences Center, Emory University, Atlanta, Georgia, has a different point of view.

“While I believe that PET is an integral part of the initial staging of patients with most solid tumors, the data don’t necessarily support that

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it makes a difference in second-line and subsequent therapy with what would be at that point patients with incurable solid tumors,” Dr Curran said. “And at a time when there are increasing constraints for healthcare spending, the cost implications of the CMS’ decision could be significant.”

Details of the June 11 Decision Memo Part of the purpose of the Decision Memo was to help determine ways to curb PET use, which increased from 35.9% to 53.6% between 1999 and 2006, and which exposes patients to significant amounts of radiation.

The lead author of the Decision Memo was Louis B. Jacques, MD, Director, Coverage and Analysis Group, CMS. Other authors included Tamara Syrek Jensen, JD, Deputy Director, Coverage and Analysis Group, CMS, and James Rollins, MD, PhD, Director, Division of Items and Devices, CMS. They ended the requirement that had been in place since 2006 for PET scans of solid tumors to be included in the NOPR. They concurred with Dr Siegel and his colleagues at the NOPR that the existing database provides sufficient information on PET studies’ effects on intended clinical management. None of the comments received by the CMS during the initial and second comment periods on their proposed Decision Memo opposed ending the gathering of this information.

In contrast, the CMS received 175 comments that opposed the portion of its March 2013 proposed Decision Memo suggesting coverage be granted only to 1 postcancer treatment FDG-

CMS Update

PET scan. This included opposition from the NOPR, with Dr Siegel and his colleagues opining that the 1-scan limit is not evidence-based.

The authors of the CMS Decision Memo gave significant weight to the information gleaned from data in the NOPR while also examining other studies published before January 2013 and taking into consideration reviews of the utility of FDG-PET by Blue Cross and Blue Shield Association’s Technology Evaluation Center and by a team in the United Kingdom.

The reviewers concluded that PET should not be used for surveillance and that the jury is out on whether PET improves health outcomes— other than, the UK review authors concluded, for non–small-cell lung cancer, restaging Hodgkin’s lymphoma, staging/restaging colorectal cancer, and the detection of solitary pulmonary nodules.

Data from the NOPR show that FDG-PET changes doctors’ self-reported management in 35% to 40% of patients, the CMS authors concluded.

It has not been demonstrated to lead to actual changes in management or outcomes. “Nevertheless, NOPR-derived re­sults have informed our considera­ tion of the evidence base for covering FDG-PET imaging for this oncologic indication,” they wrote in the Decision Memo. “…In the setting of anticancer treatment, we believe that the choices made by treating physicians, in many instances, change the patient’s experience of illness. Therefore, we have largely accepted the persuasiveness of the NOPR report [delivered to the CMS committee in April 2013], except where we believe there is other evidence available to better support an alternative conclusion.”

The authors of the Decision Memo also discuss each form of solid tumor separately, and give the nod to coverage of FDG-PET for every type, both for initial treatment strategy (formerly diagnosis and staging) and for subsequent treatment strat-

egy (formerly restaging and monitoring response to treatment) with a few exceptions, including noncoverage of PET for the initial treatment strategy in prostate cancer.

The most controversial area was whether CMS should cover FDGPET for subsequent antitumor treatment strategy of prostate cancer, with 7 of 30 comments on this particular indication requesting noncoverage.

Despite the comments to the contrary, the authors of the Decision Memo were “convinced that FDGPET/CT imaging’s selective use in assessing progression of prostate cancer does provide valuable additional information for managing treatment decisions,” and that physicians use appropriate judgment in determining when to use FDG-PET for treatment-planning purposes.

The CMS team also acknowledged that some patients and their physicians might wish to have more than 3 FDG-PET scans after initial treatment to help determine whether their second-line or further therapies have been successful.

Therefore, they decided to permit local MACs to make autonomous decisions about further coverage.

Director, Division of Medical Oncology, calls for well-designed clinical trials to define the role of FDG-PET in posttreatment surveillance. “[But] I’m concerned that the present decision by CMS could make the conduct of such studies very difficult. [And as a result] our patients could [continue to] be exposed to unnecessary stress and anxiety from abnormal results that might not make a difference in their overall outcome,” Dr Ramalingam told Oncology Practice Management. “Results from FDG-PET also can lead to abandoning effective therapies prematurely. I see a lot of patients referred from the community that have been told a certain standard therapy has stopped working solely based on the results of FDG uptake without any change in tumor size.

This concerns me deeply—we don’t know if an increase in FDG uptake represents treatment resistance when the tumor size is unchanged.”

The Chief Medical Officer of the American Society of Clinical Oncology (ASCO), Richard L. Schilsky, MD, said ASCO and Dr Curran have a similar point of view in terms of wanting evidence-based decisions and wise resource use— “we [just] have a different emphasis.”

“ASCO felt the original position of the CMS—that only 1 posttreatment scan would be covered—was too limiting. We can certainly conceive of many clinical scenarios in which more than 1 PET scan would be helpful for a physician in determining the best subsequent course of treatment for a patient,” Dr Schilsky said. “At the same time, ASCO has come out quite strongly in other venues, including the Choosing Wisely campaign of the American Board of Internal Medicine Foundation, in advocating against routine posttreatment surveillance scans unless they are going to be used to influence key treatment decisions.” l

Potential Problems with the Decision Dr Curran noted that while FDG-PET scanning at the time of a locoregional-only recurrence could help physicians determine whether surgical or radiotherapeutic salvage would be indicated, that there are many scenarios in which CT is more appropriate than FDG-PET. “If a patient has several metastatic sites from a commonly occurring tumor such as colorectal cancer, breast, or lung cancer, CT scanning is probably sufficient to help the oncologist determine if the treatment is working or not,” Dr Curran said.

His colleague at the Winship Cancer Institute, Suresh S. Ramalingam, MD, Professor and

November 2013

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Drug Coding Supplied by RJ Health Systems

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

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

Associated ICD-9-CM codes for the treatment of prostate cancer: 185 Malignant neoplasm of prostate

Excludes: seminal vesicles (187.8)

Generic (brand) name

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HCPCS code: code description

FDA approved for prostate cancer

Compendia listed off-label uses for prostate cancer

Possible CPT ® administration codes

abiraterone acetate (Zytiga) J8999*: Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

abiraterone acetate (Zytiga) C9399*: Unclassified drugs or biologicals (hospital outpatient use ONLY)

√

N/A

bacillus Calmette-Guerin (Tice BCG)

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

√

90471

bacillus Calmette-Guerin (Tice BCG, TheraCys)

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

√

51720

bacillus Calmette-Guerin (Tice BCG, TheraCys)

J9031: bCG (intravesical), per installation

√

51720

bevacizumab (Avastin)

J9035: Injection, bevacizumab, 10 mg

√

96413, 96415

bicalutamide (Casodex)

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

√

N/A

cabazitaxel (Jevtana)

J9043: Injection, cabazitaxel, 1 mg

√

96413

ONCOLOGY PRACTICE MANAGEMENT

I November 2013

Drug Coding

FDA approved Compendia listed for prostate off-label uses for cancer prostate cancer

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: code description

cisplatin (Platinol AQ)

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

√

96409, 96413, 96415

cyclophosphamide (Cytoxan)

J8530: Cyclophosphamide, oral, 25 mg

√

N/A

cyclophosphamide (Cytoxan)

J9070: Cyclophosphamide, 100 mg

√

96409, 96413, 96415

degarelix (Firmagon)

J9155: Injection, degarelix, 1 mg

dexamethasone (Decadron)

J8540: Dexamethasone, oral, 0.25 mg

docetaxel (Taxotere, Docefrez)

J9171: Injection, docetaxel, 1 mg

doxorubicin (Adriamycin)

J9000: Injection, doxorubicin hydrochloride, 10 mg

enzalutamide (Xtandi)

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

√

N/A

enzalutamide (Xtandi)

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

√

N/A

epirubicin (Ellence)

J9178: Injection, epirubicin hydrochloride (HCI), 2 mg

estradiol valerate (Delestrogen)

J1380: Injection, estradiol valerate, up to 10 mg

√

96372

estramustine (Emcyt)

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

√

N/A

estrogens (eg, estradiol, conjugated estrogen, esterified estrogen)

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

√

N/A

fluorouracil (Adrucil)

J9190: Injection, fluorouracil, 500 mg

flutamide (Eulexin)

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

√

N/A

flutamide (Eulexin)

S0175: Flutamide, oral, 125 mg

√

N/A

goserelin acetate (Zoladex)

J9202: Goserelin acetate implant, per 3.6 mg

√

96372, 96402

histrelin (Vantas)

J9225: Histrelin implant (Vantas), 50 mg

√

11981, 11982, 11983

hydrocortisone (Solu-Cortef)

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

96402

√ √

96413

√ √

√

√

√

November 2013

N/A

I

96409

96409, 96413

96409

96365, 96366, 96372, 96374

www.OncPracticeManagement.com

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Drug Coding

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FDA approved Compendia listed for prostate off-label uses for cancer prostate cancer

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: code description

ixabepilone (Ixempra)

J9207: Injection, ixabepilone, 1 mg

√

96413, 96415

ketoconazole (Nizoral)

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

√

N/A

leuprolide acetate (Eligard, Lupron Depot)

J9217: Leuprolide acetate (for depot suspension), 7.5 mg

√

96402

leuprolide acetate (Lupron)

J9218: Leuprolide acetate, per 1 mg

√

96402

medroxyprogesterone (Depo-Provera)

J1050: Injection, medroxyprogesterone acetate, 1 mg

√

96402

megestrol (Megace)

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

√

N/A

megestrol (Megace)

S0179: Megestrol acetate, oral 20 mg

√

N/A

melphalan (Alkeran)

J8600: Melphalan, oral, 2 mg

√

N/A

melphalan (Alkeran)

J9245: Injection, melphalan hydrochloride, 50 mg

√

96409, 96413

methylprednisolone (Medrol)

J7509: Methylprednisolone, oral, per 4 mg

√

N/A

methylprednisolone (Depo-Medrol)

J1020: Injection, methylprednisolone acetate, 20 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Depo-Medrol)

J1030: Injection, methylprednisolone acetate, 40 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Depo-Medrol)

J1040: Injection, methylprednisolone acetate, 80 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Solu-Medrol)

J2920: Injection, methylpredniso­ lone sodium succinate, up to 40 mg

√

96365, 96366, 96372, 96374

methylprednisolone (Solu-Medrol)

J2930: Injection, methylpredniso­ lone sodium succinate, up to 125 mg

√

96365, 96366, 96372, 96374

mitoxantrone (Novantrone)

J9293: Injection, mitoxantrone hydrochloride, per 5 mg

√

96409, 96413

nilutamide (Nilandron)

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

√

N/A

paclitaxel (Taxol)

J9265: Injection, paclitaxel, 30 mg

√

96413, 96415

prednisolone (eg, Orapred, Millipred)

J7510: Prednisolone, oral, per 5 mg

√

N/A

ONCOLOGY PRACTICE MANAGEMENT

I November 2013

Drug Coding

FDA approved Compendia listed for prostate off-label uses for cancer prostate cancer

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: code description

prednisone (Deltasone)

J7506: Prednisone, oral, per 5 mg

radium 223 dichloride (Xofigo)

A9699: Radiopharmaceutical, therapeutic, not otherwise classified

√

79101

radium 223 dichloride (Xofigo)

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

√

79101

sipuleucel-T (Provenge)

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

√

96413, 96415

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

√

96413

trastuzumab (Herceptin)

J9355: Injection, trastuzumab, 10 mg

√

96413, 96415

triptorelin (Trelstar Depot, Trelstar LA)

J3315: Injection, triptorelin pamoate, 3.75 mg

vinblastine (Velban)

J9360: Injection, vinblastine sulfate, 1 mg

√

96409

vinorelbine (Navelbine)

J9390: Injection, vinorelbine tartrate, per 10 mg

√

96409

√

N/A

96372, 96402

√

*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 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; GM-CSF, granulocyte-macophage colony-stimulating factor; HCPCS, Healthcare Common Procedure Coding System; PAP, prostatic acid phosphatase.

This information was supplied by:

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

November 2013

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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:

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

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

rjhealthsystems.com

Best Practices

The Danger Signs of Picking the Wrong Medical Billing Company

By Mary Pat Whaley, FACMPE, CPC

O

utsourcing your billing can be a great decision.

Practices typically outsource billing when they feel they don’t have the people, space, resources, bandwidth, or finances to keep billing in-house. There is a strong difference of opinion as to which model is less expensive.

Most billing companies will charge 4% to 8% of net revenue, which is medical revenue minus any payer and patient refunds. Most medical billing companies charge on the lower side of the range for surgical groups and other high-dollar specialties and on the higher side of the range for primary care and other medicine specialties. Some states require billing companies to charge a flat fee as opposed to a percentage, as it is felt that paying a percentage of revenue incentivizes billing companies to “game” the system in trying to maximize revenue.

We work with many practices that either want to bring their billing back in-house again or want to outsource their billing again. For those wanting to outsource their billing, we offer a list of the danger signs to watch for when choosing a medical billing company you’ll be tied to in the years (contracts are usually 3 years) to come.

Danger Sign #1 They have no existing clients in your specialty. It’s true that most physician coders and billers are trained on all specialties, but coding This article originally appeared on Mary Pat Whaley’s blog at www.managmypractice.com. Used with permission.

and billing rules change annually, and if the billing company isn’t up to speed on the nuances of your specialty, how long will it take them to get there?

Danger Sign #2 They will not give you any references except the ones on their preprinted list. You know that saying—a company is not going to put any name on their reference list that won’t give them a glowing ref-

can look at everything.

Why wouldn’t you expect to have 100% access to your own data?

Recently I heard of a billing company that would not give their practices access to their system because it was “proprietary.” What is proprietary about a billing system and what are they afraid you will see?

The most dangerous time is in the early days when you are in transition from one system to another.

Have a timeline for the switchover with very specific goals and penalties if the goals are not met.

Danger Sign #4 They do not allow you to run your own reports. This is similar to #3, but I have had billing companies provide me with reports that are not system-generated. In other words, they took the data from the system reports and entered it into a spreadsheet. So I don’t know if the numbers are real or not. I insist that all reports given me by a billing company be system-generated.

They can give me a snapshot report that simplifies the information, but I want the system-generated reports as well.

Danger Sign #5 They do not allow you to have an interview with the lead biller on your account. I want to know who will have this crucial role in my client’s financial well-being and who the staff will be communicating with over the coming years. I also want to know if the biller is a data entry person or a real thinker.

erence. Some companies give you their entire list of clients—they’re not afraid! If they only give you 10 names and you know they have 100 clients, you have to ask: what’s wrong with the other 90?

Danger Sign #3 They do not give you access to their system to look up patient accounts. This is where a system on the cloud makes everything so easy—the vendor assigns you a login and initial password and you

November 2013

Mary Pat Whaley, FACMPE, CPC

Danger Sign #6 You’ve never heard of the billing software they use. There are hundreds of billing systems out there, Continued on page 40

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Best Practices

The Danger Signs of Picking the Wrong…Continued from page 39 and I am sure I haven’t heard of all of them. If I’ve never heard of this billing software, I’d like to know more about it. How long has it been around? How often is it updated?

How many practices are using the software? What do you mean the billing company owner’s wife wrote the software and you are the only ones using it? Is the company big enough to put enough resources into ICD-10 or will they be one that will fall by the wayside before the big switchover?

Danger Sign #7 They will not give you a daily report of their work completed.

You need a daily report on charges, adjustments, and payments. If you have access to their system, or they are working on your system, you’ll be able to generate this report yourself, but otherwise, you don’t know what they are doing until monthend. Think of what could potentially happen (or not happen) in 4 weeks.

Danger Sign #8 They do not give service turnaround guarantees (charges entered 24 hours after receipt, claims processed daily, etc). A service guarantee is one of the biggest reasons you outsource your billing. If they don’t have the bench-depth to cover staff losses or unexpected staff shortages, why are you even considering them?

Danger Sign #9 They will not agree to do your billing on your software—they insist on using theirs. A lot of billing companies will only use one brand of billing software. Take it or leave it. Their profit is dependent on the efficiency and duplication of the same process over and over again. I understand that. But what if you have a system you like, and it is loaded with years of data, but for whatever reason you want someone else to staff it? You can outsource your billing, but don’t commit to losing your system when you’re happy with it.

Danger Sign #10 They cannot integrate electronically and accept your charges from your electronic medical records (EMRs). Providers are taking the place of superbills (encounter forms, charge slips, etc) by having their EMR orders translated into CPT codes. If you are doing this in your EMR (and you should if you’re not!) and you can’t feed that info into a billing system, you’ll have to go back to a paper system, such as a superbill. Ask the billing company if you will have to print out anything on your side for them to do their work and use the answer to gauge the additional work outsourcing billing might be for your practice.

The Contract If you do sign a contract with a billing company, make sure the contract language is very clear on how problems will be resolved.

What happens if they don’t meet the service guarantee? What happens if they don’t have adequate backup and your claims aren’t sent for a week while someone is on vacation? The most dangerous time is in the early days when you are in transition from one system to another. Have a timeline for the switchover with very specific goals and penalties if the goals are not met. It’s always good to have a line of credit or a little padding to draw on during a billing switchover—you never know how smoothly things will go. Make sure the termination clause or end of contract term has language on when and how you will receive your data if the billing company is not using your software, and what the cost will be.

About the Author Mary Pat Whaley is a physician advocate and consultant who blogs at Manage My Practice (www.manage mypractice. com), and hosts her own LinkedIn group by the same name for those interested in healthcare management. She is also a regular contributor to Oncology Practice Management’s LinkedIn group. You can contact Ms Whaley at marypat@man agemypractice.com. l

JOIN THE CONVERSATION!

Oncology Practice Management is now on LinkedIn… see page 19 for details!

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ONCOLOGY PRACTICE MANAGEMENT

I November 2013

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

“Quality care is everyone’s business.”

Beth Faiman, PhD(c), MSN, APRN-BC, AOCN Nurse Practitioner, Multiple Myeloma Program Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Value-BasedCare IN Myeloma

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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.

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Medical Legal Update

HIPAA Notice of Privacy Practices, Understanding Required Changes

By Jennifer Kirschenbaum, Esq

E

ffective Septem­­ ber 23, 2013, your practice (whether hospitalbased or private) is now required to have adopted changes to your current Health Insurance Portability and Accountability Act (HIPAA) policies and procedures. The required changes, when reviewed objectively, are arguably geared to follow the trend of moving to a patient-centered, transparent healthcare delivery system. The purpose of this article is to highlight the most relevant requirements for practitioners, and to serve as a checklist of compliance. We will also briefly discuss the ramifications of noncompliance.

Before delving further, be advised that the required changes for many practices are far from onerous; however, compliance may easily be confirmed and noncompliance putatively punished.

The most overt change to the HIPAA rules is the requirement that each and every “Notice of Privacy Practices” nationwide be updated to include several new concepts that notify patients of how their protected health information may be used. The Notice of Privacy Practices is already a required document for every “covered entity,” which is inclusive of physician practices (whether hospital-based or private). The Notice of Privacy Practices details how a practitioner or practice may use or disclose protected health information, including disclosures for treatment, payment, and operation purposes, as well as disclosures to the patient

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and third parties, such as the government. The Final Omnibus Rule, published in January 2013 and effective September 23, 2013, requires the addition of several concepts to every Notice of Privacy Practices.

The changes may not appear significant or even relevant to your practice, but as will be discussed below, noncompliance may result in significant liability and an unnecessary

The stakes for HIPAA compliance are high, and the likelihood of potential discovery for noncompliance is now even higher. and inconvenient administrative process. Operating under the presumption that your practice’s Notice of Privacy Practices complies with previous requirements of delineated uses and disclosures mandated for such a policy, the following topics are now required for inclusion: (1) marketing; (2) sale; 3) fundraising; and (4) psychotherapy notes, and each of these shall be addressed in turn.

The 4 Topics for Notice of Privacy Practices Marketing Every Notice of Privacy Practices must have a provision explaining that the medical practice is required to obtain an authorization for any use or disclosure of protected health information for marketing purposes: except if the communication is: (1)

ONCOLOGY PRACTICE MANAGEMENT

I November 2013

face to face; or (2) a promotional gift of nominal value. The Omnibus Rule explains marketing to mean a communication about: (1) a product or service that encourages recipients of the communication to purchase or use the product or service (except refill reminders or other communications about drugs or prescriptions the patient is on) where the covered entity, in exchange for making the communication, is reasonably related to the practitioner’s cost of making the communication; and (2) treatment purposes, case management, or care. In addition, if the marketing involves financial remuneration to the practitioner from a third party, the subsequent authorization must disclose that such remuneration is involved.

Sale Notice of Privacy Practices must have a provision that the practitioner must obtain an authorization should the practitioner sell patient-protected health information and gain from such a sale.

Under the new HIPAA rules, a practitioner may sell patient-protected health information without getting authorization if that information is used for research, and the only remuneration is a reasonable cost-based fee to cover the cost to prepare and transmit, and where transmitted for the sale, transfer, merger, or consolidation of all or part of the practice and for related due diligence.

Fundraising Notice of Privacy Practices must contain a provision addressing that patient-protected health information may be used or disclosed for fundraising, and that during each

Medical Legal Update

fundraising communication the patient shall have an opportunity to opt out of future requests.

Psychotherapy Notes Notice of Privacy Practices must have a statement regarding the use and disclosure of psychotherapy notes, regardless of whether you the practitioner are creating such notes or you are a practitioner practicing psychotherapy. Every practitioner in any active practice is required to incorporate statutorily mandated language addressing permitted uses without additional authorization of psychotherapy notes, as any patient may have such notes transferred to any practitioner as part of their medical record.

Next Steps It is important to understand each of these required inclusions in your Notice of Privacy Practices, because each requirement may trigger an additional obligation for a separate authorization prior to the use of patient-protected health information for a particular purpose.

Once your Notice of Privacy Practices has been updated—either through your own efforts or by working with a qualified healthcare attorney or consultant—a crucial step is proper implementation. The updated Notice of Privacy Practices is required to be posted in a clear and prominent location where it is reasonable to expect that patients will be able to view it. The new Notice of Privacy Practices also must be available upon request on or after the effective date of any revision.

For practitioners with websites, it is recommended that you post your Notice of Privacy Practices to your website so that patients may access it. It is also advisable to have printed versions available in your waiting room for patient distribution.

Patients are not required to sign your Notice of Privacy Practices, but it is certainly advisable that you

require your patients to indicate in the paperwork you distribute that they have had an opportunity to review the Notice of Privacy Practices and that they acknowledge such opportunity or receipt of the notice. Typically, our office incorporates this consent into the document used to confirm appropriate contact points for the patient— ie, whether the practitioner may contact the patient via e-mail and/ or phone, and whether the patient authorizes such messages.

For many practitioners, the challenge of the new HIPAA requirements is recognizing an instance where additional protections are necessary for patient-protected health information, because previously such vigilance was not standard practice. That challenge may be best met by not only implementing a modified Notice of Privacy Practices at your office, but by providing education and training to your staff so that they understand the practice’s obligation to identify those instances when an additional authorization may be required, and also know in what form that authorization must be obtained.

The stakes for HIPAA compliance are high, and the likelihood of potential discovery for noncompliance is now even higher. The Office for Civil Rights (OCR), the arm of the federal government responsible for HIPAA oversight, is now required to impose monetary penalties for HIPAA noncompliance; the potential penalties incurred may vary based on the extent of the noncompliance and the intent of any breach. As of September 23, 2013, OCR is also mandated to begin auditing to confirm that practitioners are in compliance. Prior to the new HIPAA rules, OCR would only initiate an inquiry when it received a complaint, minimizing audit exposure for many. Now, OCR is tasked with actively policing HIPAA compliance.

November 2013

Also disconcerting is that OCR is now authorized to participate in “agency share,” meaning if OCR believes there is an improper procedure taken by the practitioner with regard to HIPAA and suspects that other areas of the practice may not be in compliance, OCR may now refer the practitioner to the Office of Inspector General for Medicare fraud issues, or, potentially, even to the Department of Justice.

The Bottom Line HIPAA compliance, while previously more of an afterthought requiring little more than basic patient cooperation and certain forms to be maintained on file, should now— with these updated requirements and increased scrutiny by OCR— be considered a major priority. It is imperative for each practitioner nationwide to abide by the new HIPAA rules and to take measures in their practices to conform and to ensure that their employees conform as well. Importantly, while it does mean an additional administrative process, the changes to the HIPAA laws are not overly burdensome, and they begin with a proper Notice of Privacy Practices being implemented correctly and followed accordingly.

This article summarizes the new requirements for Notice of Privacy Practices; however, it does not ex­haust HIPAA compliance requirements. To view a free HIPAA webinar discussing the required changes, visit www.practicewebinars.com.

About the Author Jennifer Kirschenbaum manages Kirschenbaum & Kirschenbaum’s healthcare department, which specializes in representing healthcare practitioners in regulatory compliance, audit defense, licensure, and transactional matters.

To discuss your practice’s compliance needs, contact Jennifer at 516-7476700 x302, or e-mail her at Jennifer@ Kirschenbaumesq.com. l

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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 29.5 4.2 23.4 4.1 Joint swelling/discomfort2 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 terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness

2 Includes 3 Includes

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

4 Includes

1 Adverse

edema

terms Edema, Edema peripheral, Pitting edema, and Generalized

5 Includes 6 Includes

all fractures with the exception of pathological fracture 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) Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Laboratory Abnormality % % % % 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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Our goal is to make access to ZYTIGA®(abiraterone acetate) simple, convenient, and easy.

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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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