OPM September 2012, Vol 2, No 5

ONCOLOGY PRACTICE MANAGEMENT ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™ SEPTEMBER 2012

www.OncPracticeManagement.com

Getting More Out of Your Time

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

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am going to start this business article with something personal. Decades ago I read a book that had a very good chapter on personal time management. I have followed one tip in this chapter ever since. In summary: pick the 5 outfits you want to wear Monday through Friday of your workweek during the current season. If there is a jacket, accessorize it with a pin. If there is a necklace, hang it on the outfit hanger. Have your shoes picked as well. After you have worn the outfit, say on Monday, move it to the end of your 5-day row, leaving the accessories in place. This saves you many decision points in the morning on what to put on, as well as what shoes to wear, Continued on page 6

VOLUME 2 • NUMBER 5

Quality Standards 2.0

The Commission on Cancer Genetics Standard: Risk Assessment and Genetic Counseling

By Kristen J. Vogel, MS, CGC, and Scott M. Weissman, MS, CGC Ms Vogel and Mr Weissman are Certified Genetic Counselors, Center for Medical Genetics, NorthShore University HealthSystem, Evanston, IL

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he Commission on Cancer (CoC) of the American College of Surgeons is a consortium of professional organizations with the mission to improve survival and quality of life for patients with cancer through standard setting, prevention, research, education,

and the monitoring of comprehensive quality cancer care.1 Earlier Kristen J. Vogel this year, the CoC released a revised set of standards (www. facs.org/cancer/coc/cocprogramstandards 2012.pdf) with improvements focusing on Continued on page 12

Tough Times for Small Practices How one oncology practice views its challenges

By Caroline Helwick

Houston, TX—Hard times are getting even tougher for small oncology practices, said Leonard Natelson, Chief Executive Officer, Hematology/Oncology Associates, Rockland, NY, at the Second Annual

Conference of the Association for ValueBased Cancer Care.

Hematology/Oncology Associates is an independent practice of 5 physicians, which in the Northeast region is considContinued on page 28

C ght N om t D o m yo M un u PR C ed ity b O om i V c Cy in ar an the O g e c A IDE nc fo C er ss R ol r C uts Ce oc A og o : W n ia y. mm h ter tion CC ... u at s o 41 n ’s ES f

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From the publishers of

©2012 Engage Healthcare Communications, LLC

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Making Access easier.

From the Editor

What Will the Management of Oncology Look Like in 3 Years?

7 Steps to keeping physicians and patients at the forefront Dawn Holcombe, MBA, FACMPE, ACHE

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o many people, the question above may seem simple. But, there are many different answers, depending on the speaker’s perspective, and these are often contradictory. Some people say that physicians are best suited for interpreting and managing the care of patients with cancer. Others say that physicians do not have time to stay on top of new evidence and drug information, so oversight by external agencies and specialty pharmacies is necessary to ensure that appropriate decisions are made across the country.

Yet other people fear that physicians may be making treatment choices based on the ubiquitous term “perverse incentives” rather than on “responsible choices” when given alternatives at a lower cost. Others

say that larger entities are better positioned to mandate quality standards, either externally or by full employment of the physician. Some suggest that every patient is unique, and therefore the care must be tailored to provide the best hope for the individual patient.

Yet others express regret that society can no longer afford to give everyone every possible chance, and that hard choices must be made by physicians, payers, or by someone else (it is harder to pin down who is willing to be that “someone else”).

Among these are some who think that they can “out-evidence” the nationally accepted gold standard for the level of evidence and clinical consensus, the National Comprehensive Cancer Network’s Clin-

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

Dawn Holcombe, MBA, FACMPE, ACHE President DGH Consulting South Windsor, CT

Bruce A. Cutter, MD President Cutter HealthCare Consulting Spokane, WA

Ronald Barkley, MS, JD President Cancer Center Business Development Group Bedford, NH

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

Risë Marie Cleland President Oplinc, Inc Lawton, OK

Continued on page 8

Editorial Advisory Board

Editor-in-Chief

Peggy Barton, RN Practice Manager Toledo Clinic, OH

ical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Compendium.

Others are widely marketing their new ability to “manage” oncology spending from a pharmaceutical standpoint, or even for all costs within the medical benefit (including services and treatments in the physician office). From across the nation, employers, health plans, new collaborative entities, small to large oncology practice groups, hospital systems, and large academic centers bent on cornering the geographic market for cancer treatment are staking their claims to “managing oncology.”

There is dissension even within

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

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

Cindy C. Parman, CPC, CPC-H, RCC CSI Coding Strategies, Inc Powder Springs, GA Jeffrey A. Scott, MD Senior Vice President Cardinal Health Dublin, OH Carla C. Wood, CPC, MS President Altos Solutions, Inc Los Altos, CA

Bonnie J. Miller, RN, BSN, OCN, FAAMA Administrative Director Women’s Cancer Center Fox Chase Cancer Center Philadelphia, PA

September 2012

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In This Issue

PUBLISHING STAFF Publisher Nicholas Englezos nick@engagehc.com 732-992-1884 Editorial Director Dalia Buffery dalia@engagehc.com 732-992-1889 Associate Publisher American Health & Drug Benefits Maurice Nogueira maurice@engagehc.com 732-992-1895 Associate Publisher Cristopher Pires cris@engagehc.com 732-992-1896 Associate Publisher Joe Chanley joe@engagehc.com 732-992-1524 Associate Editor Lara J. Lorton lara@engagehc.com 732-992-1892 Editorial Assistant Jennifer Brandt jbrandt@the-lynx-group.com 732-992-1536 Production Manager Marie R. S. Borelli Sales Assistant Zach Ceretelle Quality Control Director Barbara Marino Business Manager Blanche Marchitto 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 reimbursement, staffing, electronic health records, REMS, and compliance with state and federal regulations.

FROM THE EDITOR What Will the Management of Oncology Look Like in 3 Years?............................................................................3

By Dawn Holcombe, MBA, FACMPE, ACHE

FEATURES TIME MANAGEMENT

Getting More Out of Your Time............................................1

By Ruth Linné Lander, FACMPE

QUALITY STANDARDS 2.0

The Commission on Cancer Genetics Standard: Risk Assessment and Genetic Counseling...........................1

By Kristen J. Vogel, MS, CGC, and Scott M. Weissman, MS, CGC

Tough Times for Small Practices................................................1

By Caroline Helwick

DRUG CODING Medications Used for the Treatment of Breast Cancer .................... ............................................34 DEPARTMENTS MEDICAL LEGAL UPDATE

Accountable Care Organizations: Riding the Wave of the Future ..............................................23

By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

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

Medicare Cuts: What’s Coming for Community Oncology........................................................41

By Sydney Abbott, JD

PHYSICIAN WEALTH MANAGEMENT

Ten Rules for Asset Protection Planning ....................................46

By Jay D. Adkisson, JD, and Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF

Oncology Practice Management™, ISSN 2164-4403(print), is published 6 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2012 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.

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ONCOLOGY PRACTICE MANAGEMENT

I September 2012

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Time Management

Getting More Out of Your Time…Continued from page 1 and if you are female, what jewelry to add. If you are working in an office setting, you usually can get several wearings from an outfit before laundering or dry cleaning temporarily moves it out of the rotation. Let’s face it, you only wear your favorite outfits anyway, so you could declutter your closet and save time every workday morning, and save money and time on shopping for additional clothes, with this approach.

Little did the author know that this tip has piqued my interest in planning and using time well for the past few decades, in my personal life and in my work environment.

Begin with the Big Rocks Time is something we hate and love at the same time. We are often torn by how to spend it. A quote from Jim Rohn (The Treasury of Quotes. Success Books, 1994) puts this topic into perspective well: “We can no more afford to spend major time on minor things than we can to spend minor time on major things.”

We are all bombarded with emails, voicemails, printed information, and interruptions by staff, as well as by our personal issues, every day. With our smartphones we are never really out of touch any more.

Although these advances have brought us incredible benefits, we need to bring some order to their use, or we will all become plagued with what looks like attention deficit disorder and feels like we are the hamster on the spinning wheel on any given day, crashing in bed at night with the feeling that little was accomplished.

When the late Steven Covey’s book First Things First (Simon & Schuster, UK) came out back in 1994, I read it with great interest.

His visual analogy of putting the big rocks into the jar before the little

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rocks made a lasting impact on me. If you start with the little rocks and then add the big rocks, there is no room for all of them to fit in your container. If you reverse the order, putting the big rocks in first, the little rocks fill in around the big rocks and everything fits. Try this for yourself with pebbles and rocks, or a baseball and marbles, and a container—it works.

Plan for the important thing, or it remains a dream, or a hoped-for goal, and you remain discouraged with your lack of time for it.

In other words, you need to focus on what is important, and first make room for that by planning realistic and appropriate blocks of time on your calendar; amazingly, the less important items will then somehow get done around these important items. If you do not block the time for the important “tyranny of the urgent,” smaller items will gobble up your time, leaving that important item “unfunded” in time.

Takeaway: Plan for the important thing, or it remains a dream, or a hoped-for goal, and you remain discouraged with your lack of time for it.

The Communication Deluge I am not antisocial, but I do love the time-savings of electronic communication. If I send a clear e-mail, I have a written record and ideally a timely response, and I have saved myself the lost time of playing telephone tag through voicemails with

ONCOLOGY PRACTICE MANAGEMENT

I September 2012

the other party, or the actual telephone contact, which is filled with extraneous conversation that is not really the best use of time. If you have projects or issues in process with your team, and we all do, proactively updating them by e-mail can also avoid unplanned phone calls, or visits from them that interrupt your day, because they just wanted to know the status of those projects or issues.

As the day progresses, have set times to scan e-mails and deal only with the important e-mails during those times. In my experience this is a small percentage of the total e-mails I get daily. At the end of the day, when you are probably winding down, or at the beginning of the day, when you are trying to get going, scroll through all the remaining e-mails and do not be shy in deleting. Remember that if it is not important, move on. I do the same with voicemails.

Your phone use can be a real time guzzler. We all have contacts who are talkers. If they are not busy, they pick up the phone and call you.

What they do not realize is that you may be very busy doing what is important in your day. If you have caller ID, you can choose to answer now or let the call go to voicemail and return it (or not) during a convenient time.

If it is a persistent problem, I nicely tell the person that he/she may have time at that moment to chat but I simply cannot, because of my busy schedule, and that we need to talk at a time that better fits my personal schedule. If the person is a good friend, that is fine. If the person is just a distracted talker, that person moves on to a more willing listener.

Manage Your Work Environment Coworkers can take your precious time, too. They may just stop by to Continued on page 8

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Time Management

Getting More Out of Your Time…Continued from page 6 talk on their way to another destination in the office, and minutes can go by with unnecessary conversation. I nicely say that I do not have time to talk now and ask whether we can arrange a better time to catch up. If I stand up and move toward my door with something to deliver, it can be a good hint, too.

If you need to be on the move within your work environment, plan your trips around the office in order, and try to do multiple stops in one trip. This saves up-and-down time throughout the day, and these minutes add up. On these trips just say hello to a coworker you encounter along the way; you do not need to stop and talk. By your very walk, a coworker can tell whether you are purposefully going to a destination or are willing to be interrupted for a visit. You need to decide which is true for you.

Don’t be afraid to say no. We get asked to be involved with multiple nonessential activities throughout our working life, internally or externally, if we are any good at all. If a task is voluntary, say yes only to the requests you really want to do.

I remember the 1980s ad, “I can

bring home the bacon, fry it up in a pan, and never let you forget you’re a man. Cause I’m a woman.” It was a catchy ad, but not really true. To be really good at something takes focus,

By your very walk, a coworker can tell whether you are purposefully going to a destination or are willing to be interrupted for a visit.

You need to decide which is true for you.

and it is hard to stay focused on too many things, so be more selective, and choose only the best activities that fit with your life goals.

Don’t waste smaller snippets of time. You can usually complete many small tasks or get one more

item crossed off on a project while you wait on hold, or even during lulls in a webinar.

If you really want to dive deeper into time issues, I would suggest visiting Pam Vaccaro’s website (www. designsontime.com). I have heard her talks several times over the years and find her website a rich source of downloadable articles and audios on the use of time. Her approach is practical and refreshing, if you have had bad experiences with time management to date.

Keep Your Perspective Finally, I need to encourage you not to go too far. Don’t become a working machine that never unwinds and uses almost every second. If you need a visual example, think of Scrooge before and after he changed in the well-loved A Christmas Carol

by Charles Dickens. You need to balance your working and personal life, and have breaks during your workday, to remain on an even keel and keep an appropriate perspective.

If you use your time well throughout your day, you will find freed-up time for these needed breaks, at work and in your personal life. l

From the Editor

What Will the Management of Oncology…Continued from page 3 the traditional oncology community.

External pressures for health systems, payers, and providers to collaborate and build new accountable care organizations (ACOs), patient or oncology medical homes, integrated payer provider models, and independent physician associations have worked with consultants, lawyers,

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and meeting organizers, but so far these have proved to have little traction in the real world for oncology (with a few notable exceptions).

Will physicians have the technology to adequately understand what is happening to their patients, and to actually manage the process, quality, scope, and value of care? Will it

ONCOLOGY PRACTICE MANAGEMENT

I September 2012

require the staffing and resources of larger entities? Will it require the additional support and resources of the major payers and even employers in the local area? Do we have the tools, knowledge, information, and sensitivity to the financial cost of treatment options for the patient but Continued on page 10

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Easy-t Easy-to-find o-find reimbursement reimbursement forms forms Schedul e an appointment with or Schedule ccall all a Reimbur sement Specialis Reimbursement Specialistt Updat ed sear ch functionality Updated search Billing and Diagnosis Codes ack yyour our Enr oll and tr Enroll track ases rreimbursement eimbursement ccases

w www.BMSAccessSupport.com ww.BMSAccessSupport.com Bristol-Myers Squibb Oncology is committed to helping appropriate patients get access to our medications by providing reimbursement support services for healthcare professionals.

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From the Editor

What Will the Management of Oncology…Continued from page 8 also for the payer, the employer, and for society as a whole? If not, are we collecting the right information to allow us to make comparative assessments for individuals, populations, and for alternatives to treatment?

The answer to all these questions is yes, and no. This is the dilemma for oncology today, and for those who battle cancer and pay for it. We simply do not know enough, and that response is not acceptable to those who feel financial pressures and are searching for better control and for better answers to this puzzling disease.

There are many challenges. Oncologists know the patient on a personal level. They and their staff of trained professionals make the difficult decisions, fight through the personal struggles, and deal with the physical and emotional tolls of the war on cancer in a way that no other entity seeking to “manage” cancer does. Oncology practices (whether private or hospital based) also have to deal with the financial realities of delivering the care that patients and their families require, in addition to figuring out how to cover their own costs in a timely manner, and how to remain open to provide care for patients.

Our technology systems are still inherently lacking in the ability to track the elements of care and symptom management that we will need to adequately assess comparative effectiveness between different treatments. A physician practice or a hospital system is very capable of regurgitating for analysis what it saw and billed for in its interactions with patients; it is woefully blind to the additional costs and interactions that the payer may see occurring with the same patient. The payer is woefully blind to the clinical outcome of treatments and only sees what was done, not the details of a

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patient’s daily battle or success with cancer.

External entities that seek to make oncology management decisions from outside the provider’s office are themselves blind to the individual patient and to the circumstances or health issues that have a daily impact on the management of a patient’s cancer. The only information that these entities have available is whatever is forwarded to them by the health plan or the practice; this is often not the full picture of medical care but merely a series of isolated snapshots.

With all these blind spots in the perspective of any one of the entities seeking control of the management of oncology, it will be a wonder if we don’t stumble—if we have not already—in our previously steady progress in winning the war on cancer. What can we do in each of our own markets to contain and reshape this battle for the management of cancer? The following are 7 steps to keeping the patient and the physician at the forefront:

1

Look outside your own 4 walls.

Watch and listen to the regional and national markets around you: if lines in the sand are not already being drawn in your market related to management decisions for oncology treatment and payment, look where they are and learn; be prepared.

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Brutal internal assessment. How adept are you at truly managing the oncology patients in your practice, hospital system, and especially in your community? Are you limited by your data sources? Do you only know and track what happens to the patients for whom you care within your own clinic walls? What would it take to integrate a full profile of the care continuum for your patients to include what is done outside your

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walls? With whom do you need to interact and collaborate? What barriers do you need to hurdle? Are you applying and documenting a full care management program for your patients, so that you could review the entire patient population in the future and say, “What happened?

What can I learn? What was effective, what wasn’t, and at what cost?”

Complete care management will of necessity integrate assessments, action, and tracking results. Health plans use care management as a documentation of HEDIS (Health Effectiveness and Data Information Set) and other quality management measures as a critical part of their business model. Are you tracking information that makes you a good partner for them?

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Understand the finances of cancer care. Some care providers believe that financial assessment of cancer treatments may begin and end with the cost of treatments used by their offices. Others counsel patients on the cost of treatments to the patient in terms of out-of-pocket costs under the patient’s benefit structure. Plans and employers, as well as society, consider the cost of treatments to be the total cost of medical services, drugs, and also the cost of hospitalizations, emergency department visits resulting from complications and side effects, comorbidities that may be a complication of one cancer treatment option selected over another, diagnostics, imaging, and other pharmacy and medical costs. Some providers are now working hand in hand with payers to understand those full costs and to identify what they can learn that may affect future choices. Some payers or pharmacy managers are focused solely on management of the cost of a drug at the time of treatment and do not recog-

From the Editor

nize that there are a myriad of other issues that could make it more effective to choose a drug that costs more now to avoid significantly higher costs in the next weeks or months.

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Don’t get caught up in acronyms and the fad of the week. Quality cancer management is a lengthy process and requires a good deal of information. Collaboration outside of your own walls will be essential to closing the knowledge gap. It is entirely probable that many of the ACOs and external entities promising that they can manage oncology from outside the clinical walls will have dissolved in a few years. Linda Bosserman, MD, FACP, medical oncologist and President of Wilshire Oncology Medical Group, California, and her colleagues have focused on a strong data collection effort in their practice for decades, including tracking and evaluating what happens outside of their own care processes. Dr Bosserman has also built strong collaborations with the key health plans in her part of California, and she serves on policy committees for Blue Cross Blue Shield of California. This practice is now actively managing patients under full-capitation, partialcapitation, fee-for-service, and oncology medical home models. Dr Wasserman’s oncology group did not only talk about change, they actually did it. That change has led to documentable enhanced quality in care, and dollars saved, and a new perspective on oncology management between the practice, the patients, and the payers. It is not likely to find any external entities successfully inserting themselves between those physicians and payers; there is no place for them, nor did this oncology group have to rely on creating an acronym to define what they were doing. The Wilshire Oncology Medical Group just did it, and the acronyms caught up with them later.

We have already seen too much

ment or care continuum in a useful way for your own analysis. Effective oncology management cannot be done alone, no matter what role you play in the process.

reliance on the belief that if you build the “fad or acronym of the week” that “they will come,” and we have heard the response back, “it’s nice that you built it, but it’s too bad it isn’t what I wanted.” One team or committee does not speak for an

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Be prepared for dissonance.

Recognize that not everyone you talk to as potential partners, allies, or collaborators may be on the same page as you. You are more likely to run into the different perspectives about oncology management and how to do it as discussed at the beginning of this article than not.

Figure out how you will approach and phrase your outreach, your messages, and your response to each perspective before you encounter it, and know how you will plan to move forward, even in the face of opposition.

So what will the management of oncology look like in 3 years? I know what I would like it to look like, but this will take hard work, digging deep, and taking steps that may be completely unfamiliar to most of us. Many practice physicians and administrators are struggling to tread water in the face of an uncertain future. Patients with cancer will continue to need care, guidance, and treatment. It is up to you to decide whether you want to help shape your future, and in turn the future of patients who need you, or whether you will be content to let others shape it for you.

My father lived by the philosophy, “If not you, than who?” He believed that if you expect others to step forward and take action for you, you are likely to be sadly disappointed, but you will then also deserve whatever you get. Consider the diverse perspectives now circling about how oncology should be managed. Do you have an opinion? Are some of those alternatives not acceptable? Then it is time to take action, and we need to step forward. l

It is up to you to decide whether you want to help shape your future, and in turn the future of patients who need you. entire market or country. Many external entities seeking to control oncology by co-opting subsets of physicians into support of a solution have floundered when it came time to roll out the program, and were surprised to find a lukewarm or negative reception outside the core group.

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Decide what you have to do, do it, and stay the course. Along the way, you may assess new relationships, new uses of technology, and new partnerships. There will be no one right answer; the solutions may end up looking different in various geographic regions of the country. Common sense will ultimately have to prevail. Short-sighted solutions that focus on drug price, creating an entity for the sake of doing what everyone else is doing, acquiring or selling out for reasons other than a well-defined strategic plan with careful positioning, or asking someone else to execute control of oncology choices without understanding what their agenda or value is will all happen, but fail.

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Don’t be afraid to ask for help.

Seek out resources that may understand aspects of the environ-

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Quality Standards 2.0

The Commission on Cancer Genetics…Continued from page 1 the enhancement of patient-centered functions, as well as the provision of performance criteria in quality measurement and outcomes.1 Some examples of patient-centered areas addressed by the updated standards include navigation programs, psychosocial distress screening and intervention, palliative care services, the development of survivorship plans, and genetic risk assessment and counseling services for patients at risk of hereditary cancer syndromes.

The goal of this article is to review CoC Standard 2.3, Risk Assessment and Genetic Counseling, as well as to discuss resources for implementation and to review the benefits of meeting this standard.

The New Genetics Standard CoC Standard 2.3 necessitates that cancer risk assessment, genetic counseling, and genetic testing services be provided to patients, either on site or by referral, by a qualified genetics professional.1 The standard emphasizes that these services are to be performed by a cancer genetics professional who has extensive experience and educational background in cancer genetics and counseling to provide patients with an accurate risk assessment, as well as pretest and posttest genetic counseling to discuss the risks, benefits, and limitations of genetic testing.

The standard outlines the various healthcare professionals who are qualified to provide these services, including:

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A Genetics Clinical Nurse or an Advanced Practice Nurse in Genetics who is credentialed through the Genetics Nursing Credentialing Commission

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A board-certified physician with experience in cancer genetics, providing cancer risk assessment on a regular basis.

In addition, the standard outlines the various components of pretest and posttest counseling required to be provided to patients receiving genetic risk assessment and genetic counseling.

Scott M. Weissman

The standard emphasizes that these services are to be performed by a cancer genetics professional who has extensive experience and educational background in cancer genetics and counseling to provide patients with an accurate risk assessment.

1

An American Board of Genetic Counseling or American Board of Medical Genetics board-certified or board-eligible genetic counselor

2

An American College of Medical Genetics physician who is board certified in medical genetics

(educational seminars offered by commercial laboratories about how to perform genetic testing are not considered adequate training for cancer risk assessment and genetic counseling); certification by the Oncology Nursing Certification Corporation is preferred

The components of the pretest genetic counseling are:

1

A 3- to 4-generation pedigree on maternal and paternal families, including ancestry or ethnicity

2

An assessment of the patient’s risk to carry a heritable cancer susceptibility gene mutation, as well as the patient’s absolute risks to develop various types of cancer, given that patient’s family history

3 4

Psychosocial counseling

assessment

and

Education of the patient regarding the suspected hereditary cancer syndrome (eg, inheritance, penetrance), and the implications of having genetic testing

5

Informed consent before obtaining a sample for genetic testing.

4

An advanced practice oncology nurse who is prepared at the graduate level, with specialized education in cancer genetics and hereditary cancer predisposition syndromes

The components of posttest genetic counseling are:

1

Disclosure of the genetic test results Continued on page 18

12

I

ONCOLOGY PRACTICE MANAGEMENT

I September 2012

THE AFINITOR® (everolimus) TABLETS DUAL BENEFIT CO-PAY CARD FROM NOVARTIS PHARMACEUTICALS CORPORATION Designed to help make treatment more affordable for your eligible AFINITOR patients h The AFINITOR Dual Benefit Co-Pay Card With this co-pay assistance card, most eligible patients will pay $25 per 28-day prescription of AFINITOR® (everolimus) Tablets when they visit their pharmacy. The card also provides up to $50 off their co-pay for generic exemestane when prescribed with AFINITOR.

601341 RxBIN: OHCP RxPCN: RxGrp: [OHXXXXXXX] RxID: [000000000000] 01 Suf:

THE AFINITOR DUAL BENEFIT CO-PAY CARD

Novartis Pharmaceuticals Corporation will pay the balance of your eligible patient’s out-of-pocket expenses, up to a maximum of $1200 per month for the AFINITOR prescription and up to $50 per month for generic exemestane when prescribed with AFINITOR. Not valid for prescriptions for which payment may be made in whole or in part under federal or state healthcare programs, including, but not limited to, Medicare or Medicaid. The exemestane offer is not valid in Michigan. Patients can obtain the co-pay card at their physician’s office or at www.AFINITOR.com. This program will expire on June 30, 2014.

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

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

Please see accompanying Important Safety Information and Brief Summary of Prescribing Information for AFINITOR on the following pages.

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080

© 2012 Novartis

9/12

AFB-1046627

AFINITOR速 (everolimus) Tablets is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole.

Important Safety Information AFINITOR is contraindicated in patients with hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.

Noninfectious Pneumonitis: Noninfectious pneumonitis was reported in up to 19% of patients treated with AFINITOR. The incidence of Common Terminology Criteria (CTC) grade 3 and 4 noninfectious pneumonitis was up to 4.0% and up to 0.2%, respectively.

Fatal outcomes have been observed. If symptoms are moderate, patients should be managed with dose interruption until symptoms improve. The use of corticosteroids may be indicated. For grade 4 cases, discontinue AFINITOR. Corticosteroids may be indicated until symptoms resolve. For grade 3 cases, interrupt AFINITOR until resolution to ) grade 1. AFINITOR may be reintroduced at a daily dose approximately 50% lower than the dose previously administered, depending on the individual clinical circumstances. If toxicity recurs at grade 3, consider discontinuation of AFINITOR. The development of pneumonitis has been reported even at a reduced dose.

Infections: AFINITOR has immunosuppressive properties and may predispose patients to bacterial, fungal, viral, or protozoal infections (including those with opportunistic pathogens). Localized and systemic infections, including pneumonia, mycobacterial infections, other bacterial infections, invasive fungal infections such as aspergillosis or candidiasis, and viral infections, including reactivation of hepatitis B virus, have occurred. Some of these infections have been severe (eg, leading to respiratory or hepatic failure) or fatal. Physicians and patients should be aware of the increased risk of infection with AFINITOR. Treatment of preexisting invasive fungal infections should be completed prior to starting treatment. Be vigilant for signs and symptoms of infection and institute appropriate treatment promptly; interruption or discontinuation of AFINITOR should be considered.

Discontinue AFINITOR if invasive systemic fungal infection is diagnosed and institute appropriate antifungal treatment.

Oral Ulceration: Mouth ulcers, stomatitis, and oral mucositis have occurred in patients treated with AFINITOR at an incidence ranging from 44% to 86% across the clinical trial experience. Grade 3/4 stomatitis was reported in 4% to 9% of patients. In such cases, topical treatments are recommended, but alcohol-, peroxide-, iodine-, or thyme-containing mouthwashes should be avoided. Antifungal agents should not be used unless fungal infection has been diagnosed.

Renal Failure: Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with AFINITOR. Geriatric Patients: In the randomized advanced hormone receptorpositive, HER2-negative breast cancer study, the incidence of deaths due to any cause within 28 days of the last AFINITOR dose was 6% in patients * 65 years of age compared to 2% in patients < 65 years of age. Adverse reactions leading to permanent discontinuation occurred in 33% of patients * 65 years of age compared to 17% in patients < 65 years of age. Careful monitoring and appropriate dose adjustments for adverse reactions are recommended.

Laboratory Tests and Monitoring: Elevations of serum creatinine, proteinuria, glucose, lipids, and triglycerides, and reductions of hemoglobin, lymphocytes, neutrophils, and platelets, have been reported. Renal function (including measurement of blood urea nitrogen, urinary protein, or serum creatinine), blood glucose, lipids,

and hematologic parameters should be evaluated prior to treatment and periodically thereafter. When possible, optimal glucose and lipid control should be achieved before starting a patient on AFINITOR. Drug-Drug Interactions: Avoid coadministration with strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole). Use caution and reduce the AFINITOR dose to 2.5 mg daily if coadministration with a moderate CYP3A4 and/or PgP inhibitor is required (eg, amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem). Avoid coadministration with strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital); however, if coadministration is required, increase the AFINITOR dose from 10 mg daily up to 20 mg daily, using 5-mg increments.

Hepatic Impairment: Exposure of everolimus was increased in patients with hepatic impairment. For patients with severe hepatic impairment (Child-Pugh class C), AFINITOR may be used at a reduced dose if the desired benefit outweighs the risk. For patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, a dose reduction is recommended.

Vaccinations: The use of live vaccines and close contact with those who have received live vaccines should be avoided during treatment with AFINITOR. Embryo-Fetal Toxicity: Fetal harm can occur if AFINITOR is administered to a pregnant woman. Women of childbearing potential should be advised to use a highly effective method of contraception while using AFINITOR and for up to 8 weeks after ending treatment.

Adverse Reactions: The most common adverse reactions (incidence * 30%) were stomatitis (67%), infections (50%), rash (39%), fatigue (36%), diarrhea (33%) and decreased appetite (30%). The most common grade 3/4 adverse reactions (incidence * 2%) were stomatitis (8%), infections (5%), hyperglycemia (5%), fatigue (4%), dyspnea (4%), pneumonitis (4%) and diarrhea (2%).

Laboratory Abnormalities: The most common laboratory abnormalities (incidence * 50%) were hypercholesterolemia (70%), hyperglycemia (69%), increased aspartate transaminase (AST) concentrations (69%), anemia (68%), leukopenia (58%), thrombocytopenia (54%), lymphopenia (54%), increased alanine transaminase (ALT) concentrations (51%), and hypertriglyceridemia (50%). The most common grade 3/4 laboratory abnormalities (incidence * 3%) were lymphopenia (12%), hyperglycemia (9%), anemia (7%), decreased potassium (4%), increased AST (4%), increased ALT (4%), and thrombocytopenia (3%).

Please see accompanying Brief Summary of Prescribing Information for AFINITOR on the following pages.

AFINITOR (everolimus) tablets for oral administration Initial U.S. Approval: 2009 Brief Summary of Prescribing Information. See full prescribing information for complete product information.

1 INDICATIONS AND USAGE AFINITOR® is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole.

4 CONTRAINDICATIONS Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients. Hypersensitivity reactions manifested by symptoms including, but not limited to, anaphylaxis, dyspnea, flushing, chest pain, or angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment) have been observed with everolimus and other rapamycin derivatives.

5 WARNINGS AND PRECAUTIONS Non-infectious Pneumonitis Non-infectious pneumonitis is a class effect of rapamycin derivatives, including AFINITOR. Non-infectious pneumonitis was reported in up to 19% of patients treated with AFINITOR in clinical trials. The incidence of Common Terminology Criteria (CTC) grade 3 and 4 non-infectious pneumonitis was up to 4.0% and up to 0.2%, respectively [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information]. Fatal outcomes have been observed.

Consider a diagnosis of non-infectious pneumonitis in patients presenting with non-specific respiratory signs and symptoms such as hypoxia, pleural effusion, cough, or dyspnea, and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations. Advise patients to report promptly any new or worsening respiratory symptoms.

Patients who develop radiological changes suggestive of non-infectious pneumonitis and have few or no symptoms may continue AFINITOR therapy without dose alteration. Imaging appears to overestimate the incidence of clinical pneumonitis.

If symptoms are moderate, consider interrupting therapy until symptoms improve.

The use of corticosteroids may be indicated. AFINITOR may be reintroduced at a daily dose approximately 50% lower than the dose previously administered [see Table 1 in Dosage and Administration (2.2) in the full prescribing information].

For cases of grade 4 non-infectious pneumonitis, discontinue AFINITOR. Corticosteroids may be indicated until clinical symptoms resolve. For cases of grade 3 non-infectious pneumonitis interrupt AFINITOR until resolution to less than or equal to grade 1. AFINITOR may be re-introduced at a daily dose approximately 50% lower than the dose previously administered depending on the individual clinical circumstances [see Table 1 in Dosage and Administration (2.2) in the full prescribing information]. If toxicity recurs at grade 3, consider discontinuation of AFINITOR. The development of pneumonitis has been reported even at a reduced dose.

Infections AFINITOR has immunosuppressive properties and may predispose patients to bacterial, fungal, viral, or protozoal infections, including infections with opportunistic pathogens [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information]. Localized and systemic infections, including pneumonia, mycobacterial infections, other bacterial infections, invasive fungal infections, such as aspergillosis or candidiasis, and viral infections including reactivation of hepatitis B virus have occurred in patients taking AFINITOR. Some of these infections have been severe (e.g., leading to respiratory or hepatic failure) or fatal. Physicians and patients should be aware of the increased risk of infection with AFINITOR. Complete treatment of pre-existing invasive fungal infections prior to starting treatment with AFINITOR. While taking AFINITOR, be vigilant for signs and symptoms of infection; if a diagnosis of an infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of AFINITOR. If a diagnosis of invasive systemic fungal infection is made, discontinue AFINITOR and treat with appropriate antifungal therapy.

Oral Ulceration Mouth ulcers, stomatitis, and oral mucositis have occurred in patients treated with AFINITOR at an incidence ranging from 44-86% across the clinical trial experience.

Grade 3 or 4 stomatitis was reported in 4-8% of patients [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information]. In such cases, topical treatments are recommended, but alcohol- or peroxide-containing mouthwashes should be avoided as they may exacerbate the condition. Antifungal agents should not be used unless fungal infection has been diagnosed [see Drug Interactions].

Renal Failure Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with AFINITOR [see Laboratory Tests and Monitoring].

Geriatric Patients In the randomized advanced hormone receptor positive, HER2-negative breast cancer study, the incidence of deaths due to any cause within 28 days of the last AFINITOR dose was 6% in patients ≥ 65 years of age compared to 2% in patients < 65 years of age. Adverse reactions leading to permanent treatment discontinuation occurred in 33% of patients ≥ 65 years of age compared to 17% in patients < 65 years of age. Careful monitoring and appropriate dose adjustments for adverse reactions are recommended [see Dosage and Administration (2.2) in the full prescribing information, Use in Specific Populations].

Laboratory Tests and Monitoring Renal Function Elevations of serum creatinine and proteinuria have been reported in clinical trials [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information].

Monitoring of renal function, including measurement of blood urea nitrogen (BUN), urinary protein, or serum creatinine, is recommended prior to the start of AFINITOR therapy and periodically thereafter.

Blood Glucose and Lipids Hyperglycemia, hyperlipidemia, and hypertriglyceridemia have been reported in clinical trials [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information]. Monitoring of fasting serum glucose and lipid profile is recommended prior to the start of AFINITOR therapy and periodically thereafter. When possible, optimal glucose and lipid control should be achieved before starting a patient on AFINITOR. Hematologic Parameters Decreased hemoglobin, lymphocytes, neutrophils, and platelets have been reported in clinical trials [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information]. Monitoring of complete blood count is recommended prior to the start of AFINITOR therapy and periodically thereafter.

Drug-drug Interactions Due to significant increases in exposure of everolimus, co-administration with strong CYP3A4 inhibitors should be avoided [see Dosage and Administration (2.2, 2.4) in the full prescribing information and Drug Interactions].

A reduction of the AFINITOR dose is recommended when co-administered with a moderate CYP3A4 and/or PgP inhibitor [see Dosage and Administration (2.2, 2.4) in the full prescribing information and Drug Interactions].

An increase in the AFINITOR dose is recommended when co-administered with a strong CYP3A4 inducer [see Dosage and Administration (2.2, 2.4) in the full prescribing information and Drug Interactions].

Hepatic Impairment Exposure to everolimus was increased in patients with hepatic impairment [see Clinical Pharmacology (12.3) in the full prescribing information].

For advanced HR+ BC, advanced PNET, advanced RCC, and renal angiomyolipoma with TSC patients with severe hepatic impairment (Child-Pugh class C), AFINITOR may be used at a reduced dose if the desired benefit outweighs the risk. For patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, a dose reduction is recommended [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) in the full prescribing information].

For SEGA patients with severe hepatic impairment, AFINITOR is not recommended.

For SEGA patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, adjustment to the starting dose may not be needed; however subsequent dosing should be individualized based on therapeutic drug monitoring [see Dosage and Administration (2.4, 2.5) in the full prescribing information].

Vaccinations The use of live vaccines and close contact with those who have received live vaccines should be avoided during treatment with AFINITOR. Examples of live vaccines are: intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines.

The timing of routine vaccinations in pediatric patients with SEGA should be considered prior to the start of everolimus therapy.

Embryo-fetal Toxicity There are no adequate and well-controlled studies of AFINITOR in pregnant women; however, based on the mechanism of action, AFINITOR can cause fetal harm. Everolimus caused embryo-fetal toxicities in animals at maternal exposures that were lower than human exposures. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Women of childbearing potential should be advised to use an effective method of contraception while using AFINITOR and for up to 8 weeks after ending treatment [see Use in Specific Populations].

6 ADVERSE REACTIONS The efficacy and safety of AFINITOR (10 mg/day) plus exemestane (25 mg/day) (n=485) versus placebo plus exemestane (25 mg/day) (n=239) was evaluated in a randomized, controlled trial in patients with advanced or metastatic hormonereceptor-positive, HER2-negative breast cancer. The median age of patients was 61 years (range 28-93), and 75% were Caucasian. Safety results are based on a median follow-up of approximately 13 months.

The most common adverse reactions (incidence ≥ 30%) were stomatitis, infections, rash, fatigue, diarrhea, and decreased appetite. The most common grade 3/4 adverse reactions (incidence ≥ 2%) were stomatitis, infections, hyperglycemia, fatigue, dyspnea, pneumonitis, and diarrhea. The most common laboratory abnormalities (incidence ≥ 50%) were hypercholesterolemia, hyperglycemia, increased AST, anemia, leukopenia, thrombocytopenia, lymphopenia, increased ALT, and hypertriglyceridemia. The most common grade 3/4 laboratory abnormalities (incidence ≥ 3%) were lymphopenia, hyperglycemia, anemia, decreased potassium, increased AST, increased ALT, and thrombocytopenia.

Fatal adverse reactions occurred more frequently in patients who received AFINITOR plus exemestane (2%) compared to patients on the placebo plus exemestane arm (0.4%). The rates of treatment-emergent adverse events resulting in permanent discontinuation were 24% and 5% for the AFINITOR plus exemestane and placebo plus exemestane treatment groups, respectively. Dose adjustments (interruptions or reductions) were more frequent among patients in the AFINITOR plus exemestane arm than in the placebo plus exemestane arm (63% versus 14%).

Table 3 compares the incidence of treatment-emergent adverse reactions reported with an incidence of â&#x2030;Ľ10% for patients receiving AFINITOR 10 mg daily versus placebo.

Table 3: Adverse Reactions Reported â&#x2030;Ľ 10% of Patients with Advanced HR+ BC* AFINITOR (10 mg/day) Placebo + exemestanea + exemestanea N=482 N=238 All All grades Grade 3 Grade 4 grades Grade 3 Grade 4 % % % % % % Any adverse reaction 100 41 9 90 22 5 Gastrointestinal disorders 67 8 0 11 0.8 0 Stomatitisb Diarrhea 33 2 0.2 18 0.8 0 Nausea 29 0.2 0.2 28 1 0 Vomiting 17 0.8 0.2 12 0.8 0 Constipation 14 0.4 0 13 0.4 0 Dry mouth 11 0 0 7 0 0 General disorders and administration site conditions Fatigue 36 4 0.4 27 1 0 Edema peripheral 19 1 0 6 0.4 0 Pyrexia 15 0.2 0 7 0.4 0 Asthenia 13 2 0.2 4 0 0 Infections and infestations 50 4 1 25 2 0 Infectionsc Investigations Weight decreased 25 1 0 6 0 0 Metabolism and nutrition disorders Decreased appetite 30 1 0 12 0.4 0 Hyperglycemia 14 5 0.4 2 0.4 0 Musculoskeletal and connective tissue disorders Arthralgia 20 0.8 0 17 0 0 Back pain 14 0.2 0 10 0.8 0 Pain in extremity 9 0.4 0 11 2 0 Nervous system disorders Dysgeusia 22 0.2 0 6 0 0 Headache 21 0.4 0 14 0 0 Psychiatric disorders Insomnia 13 0.2 0 8 0 0 Respiratory, thoracic and mediastinal disorders Cough 24 0.6 0 12 0 0 Dyspnea 21 4 0.2 11 0.8 0.4 Epistaxis 17 0 0 1 0 0 19 4 0.2 0.4 0 0 Pneumonitisd Skin and subcutaneous tissue disorders Rash 39 1 0 6 0 0 Pruritus 13 0.2 0 5 0 0 Alopecia 10 0 0 5 0 0 Vascular disorders Hot flush 6 0 0 14 0 0 Median Duration of Treatmente 23.9 weeks 13.4 weeks CTCAE Version 3.0 *160 patients (33.2%) were exposed to AFINITOR therapy for a period of â&#x2030;Ľ 32 weeks) a Exemestane (25 mg/day) b Includes stomatitis, mouth ulceration, aphthous stomatitis, glossodynia, gingival pain, glossitis and lip ulceration c Includes all preferred terms within the â&#x20AC;&#x2DC;infections and infestationsâ&#x20AC;&#x2122; system organ class, the most common being nasopharyngitis (10%), urinary tract infection (10%), upper respiratory tract infection (5%), pneumonia (4%), bronchitis (4%), cystitis (3%), sinusitis (3%), and also including candidiasis (<1%), and sepsis (<1%), and hepatitis C (<1%). d Includes pneumonitis, interstitial lung disease, lung infiltration, and pulmonary fibrosis e Exposure to AFINITOR or placebo

Key observed laboratory abnormalities are presented in Table 4.

Table 4: Key Laboratory Abnormalities Reported in â&#x2030;Ľ 10% of Patients with Advanced HR+ BC Laboratory parameter AFINITOR (10 mg/day) Placebo + exemestanea + exemestanea N=482 N=238 All All grades Grade 3 Grade 4 grades Grade 3 Grade 4 % % % % % % Hematologyb Hemoglobin decreased 68 6 0.6 40 0.8 0.4 WBC decreased 58 1 0 28 5 0.8 Platelets decreased 54 3 0.2 5 0 0.4 Lymphocytes decreased 54 11 0.6 37 5 0.8 Neutrophils decreased 31 2 0 11 0.8 0.8 Clinical Chemistry Glucose increased 69 9 0.4 44 0.8 0.4 Cholesterol increased 70 0.6 0.2 38 0.8 0.8 Aspartate transaminase (AST) increased 69 4 0.2 45 3 0.4 Alanine transaminase (ALT) increased 51 4 0.2 29 5 0 Triglycerides increased 50 0.8 0 26 0 0 Albumin decreased 33 0.8 0 16 0.8 0 Potassium decreased 29 4 0.2 7 1 0 Creatinine increased 24 2 0.2 13 0 0 CTCAE Version 3.0 a Exemestane (25 mg/day) b Reflects corresponding adverse drug reaction reports of anemia, leukopenia, lymphopenia, neutropenia, and thrombocytopenia (collectively as pancytopenia), which occurred at lower frequency.

7 DRUG INTERACTIONS Everolimus is a substrate of CYP3A4, and also a substrate and moderate inhibitor of the multidrug efflux pump PgP. In vitro, everolimus is a competitive inhibitor of CYP3A4 and a mixed inhibitor of CYP2D6.

Agents that may Increase Everolimus Blood Concentrations CYP3A4 Inhibitors and PgP Inhibitors In healthy subjects, compared to AFINITOR treatment alone there were significant increases in everolimus exposure when AFINITOR was coadministered with: O >8GB6BA4MB?8 4 FGEBA: 0) <A;<5<GBE 4A7 4 ):) <A;<5<GBE max and AUC increased by 3.9- and 15.0-fold, respectively.

O 8ELG;EB@L6<A 4 @B78E4G8 0) <A;<5<GBE 4A7 4 ):) <A;<5<GBE max and AUC increased by 2.0- and 4.4-fold, respectively.

O I8E4C4@<? 4 @B78E4G8 0) <A;<5<GBE 4A7 4 ):) <A;<5<GBE max and AUC increased by 2.3- and 3.5-fold, respectively.

Concomitant strong inhibitors of CYP3A4 should not be used [see Dosage and Administration (2.2, 2.4) in the full prescribing information and Warnings and Precautions].

Use caution when AFINITOR is used in combination with moderate CYP3A4 and/or PgP inhibitors. If alternative treatment cannot be administered reduce the AFINITOR dose [see Dosage and Administration (2.2, 2.4) in the full prescribing information and Warnings and Precautions].

Agents that may Decrease Everolimus Blood Concentrations CYP3A4 Inducers In healthy subjects, co-administration of AFINITOR with rifampin, a strong inducer of CYP3A4, decreased everolimus AUC and Cmax by 63% and 58% respectively, compared to everolimus treatment alone. Consider a dose increase of AFINITOR when co-administered with strong CYP3A4 inducers if alternative treatment cannot be administered. St. Johnâ&#x20AC;&#x2122;s Wort may decrease everolimus exposure unpredictably and should be avoided [see Dosage and Administration (2.2, 2.4) in the full prescribing information].

Agents whose Plasma Concentrations may be Altered by Everolimus Studies in healthy subjects indicate that there are no clinically significant pharmacokinetic interactions between AFINITOR and the HMG-CoA reductase inhibitors atorvastatin (a CYP3A4 substrate) and pravastatin (a non-CYP3A4 substrate) and population pharmacokinetic analyses also detected no influence of simvastatin (a CYP3A4 substrate) on the clearance of AFINITOR. A study in healthy subjects demonstrated that co-administration of an oral dose B9 @<7 4MB?4@ F8AF<G<I8 0) FH5FGE4G8 J<G; 8I8EB?<@HF E8FH?G87 <A 4 <A6E84F8 <A @<7 4MB?4@ max 4A7 4 <A6E84F8 <A @<74MB?4@ - (0-inf).

Coadministration of everolimus and exemestane increased exemestane Cmin by 45% and C2h by 64%. However, the corresponding estradiol levels at steady state (4 weeks) were not different between the two treatment arms. No increase in adverse events related to exemestane was observed in patients with hormone receptorpositive, HER2-negative advanced breast cancer receiving the combination.

Coadministration of everolimus and depot octreotide increased octreotide Cmin by approximately 50%.

8 USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category D [see Warnings and Precautions].

There are no adequate and well-controlled studies of AFINITOR in pregnant women; however, based on the mechanism of action, AFINITOR can cause fetal harm when administered to a pregnant woman. Everolimus caused embryo-fetal toxicities in animals at maternal exposures that were lower than human exposures.

If this drug is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be apprised of the potential hazard to a fetus.

Women of childbearing potential should be advised to use an effective method of contraception while receiving AFINITOR and for up to 8 weeks after ending treatment.

In animal reproductive studies, oral administration of everolimus to female rats before mating and through organogenesis induced embryo-fetal toxicities, including increased resorption, pre-implantation and post-implantation loss, decreased numbers of live fetuses, malformation (e.g., sternal cleft), and retarded skeletal development. These effects occurred in the absence of maternal toxicities. Embryofetal toxicities in rats occurred at doses ≥ 0.1 mg/kg (0.6 mg/m2) with resulting exposures of approximately 4% of the exposure (AUC0-24h) achieved in patients receiving the 10 mg daily dose of everolimus. In rabbits, embryotoxicity evident as an increase in resorptions occurred at an oral dose of 0.8 mg/kg (9.6 mg/m2), approximately 1.6 times either the 10 mg daily dose or the median dose administered to SEGA patients on a body surface area basis. The effect in rabbits occurred in the presence of maternal toxicities.

In a pre- and post-natal development study in rats, animals were dosed from implantation through lactation. At the dose of 0.1 mg/kg (0.6 mg/m2), there were no adverse effects on delivery and lactation or signs of maternal toxicity; however, there were reductions in body weight (up to 9% reduction from the control) and in survival of offspring (~5% died or missing). There were no drug-related effects on the developmental parameters (morphological development, motor activity, learning, or fertility assessment) in the offspring.

Nursing Mothers It is not known whether everolimus is excreted in human milk. Everolimus and/or its metabolites passed into the milk of lactating rats at a concentration 3.5 times higher than in maternal serum. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from everolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use AFINITOR is recommended for use only in patients with SEGA who are aged ≥ 3 years.

A prospective, open-label, single-arm trial was conducted to evaluate the safety and efficacy of AFINITOR in patients with SEGA associated with TSC. In total, 28 patients received treatment with AFINITOR; median age was 11 years (range 3-34).

AFINITOR has not been studied in patients with SEGA < 3 years of age.

Geriatric Use In the randomized advanced hormone receptor positive, HER2-negative breast cancer study, 40% of AFINITOR-treated patients were ≥ 65 years of age, while 15% were 75 and over. No overall differences in effectiveness were observed between elderly and younger subjects. The incidence of deaths due to any cause within 28 days of the last AFINITOR dose was 6% in patients ≥ 65 years of age compared to 2% in patients < 65 years of age. Adverse reactions leading to permanent treatment discontinuation occurred in 33% of patients ≥ 65 years of age compared to 17% in patients < 65 years of age [see Warnings and Precautions].

In two other randomized trials (advanced renal cell carcinoma and advanced neuroendocrine tumors of pancreatic origin), no overall differences in safety or effectiveness were observed between elderly and younger subjects. In the randomized advanced RCC study, 41% of AFINITOR treated patients were ≥ 65 years of age, while 7% were 75 and over. In the randomized advanced PNET study, 30% of AFINITOR-treated patients were ≥ 65 years of age, while 7% were 75 and over.

Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3) in the full prescribing information].

No dosage adjustment in initial dosing is required in elderly patients, but close monitoring and appropriate dose adjustments for adverse reactions is recommended. [see Dosage and Administration (2.2), Clinical Pharmacology (12.3) in the full prescribing information].

Renal Impairment No clinical studies were conducted with AFINITOR in patients with decreased renal function. Renal impairment is not expected to influence drug exposure and no dosage adjustment of everolimus is recommended in patients with renal impairment [see Clinical Pharmacology (12.3) in the full prescribing information].

Hepatic Impairment The safety, tolerability and pharmacokinetics of AFINITOR were evaluated in a 34 subject single oral dose study of everolimus in subjects with impaired hepatic function relative to subjects with normal hepatic function. Exposure was increased in patients with mild (Child-Pugh class A), moderate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment [see Clinical Pharmacology (12.3) in the full prescribing information].

For advanced HR+ BC, advanced PNET, advanced RCC, and renal angiomyolipoma with TSC patients with severe hepatic impairment, AFINITOR may be used at a reduced dose if the desired benefit outweighs the risk. For patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, a dose reduction is recommended [see Dosage and Administration (2.2) in the full prescribing information].

For SEGA patients with severe hepatic impairment (Child-Pugh class C), AFINITOR is not recommended. For SEGA patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, adjustment to the starting dose may not be needed; however, subsequent dosing should be individualized based on therapeutic drug monitoring [see Dosage and Administration (2.4, 2.5) in the full prescribing information].

10 OVERDOSAGE In animal studies, everolimus showed a low acute toxic potential. No lethality or severe toxicity were observed in either mice or rats given single oral doses of 2000 mg/kg (limit test).

Reported experience with overdose in humans is very limited. Single doses of up to 70 mg have been administered. The acute toxicity profile observed with the 70 mg dose was consistent with that for the 10 mg dose.

Manufactured by: Novartis Pharma Stein AG Stein, Switzerland Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis T2012-132 July 2012

Quality Standards 2.0

The Commission on Cancer Genetics…Continued from page 12

2 3 4 5

Significance of the test results with regard to cancer risk Medical management options, based on the estimated cancer risk Implications of the test results for family members

Identification of resources for psychosocial support and future decision-making related to medical management.

Why Was the Genetics Standard Developed?

Genetic testing for inherited cancer susceptibility syndromes has become a routine component of cancer care. This testing allows for the identification of patients and families who are at increased risk to develop future malignancy, with the hope of tailoring management to promote early detection and, at times, cancer prevention.

Various national cancer organizations have outlined when to offer genetic testing, as well as the need for pretest and posttest genetic counseling. For example, the American Society of Clinical Oncology (ASCO) has published policy statements on genetic testing, recommending that genetic testing be offered when (1) the individual being tested has a personal or family history suggestive of genetic cancer susceptibility, (2) the genetic test can be adequately interpreted, and (3) the test results have accepted clinical utility.2,3 In addition, ASCO’s policy statement recommends that genetic testing be conducted only in the setting of pretest and posttest genetic counseling; the policy statement outlines the important components of genetic counseling, as well as proper informed consent, in the setting of genetic testing

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for cancer susceptibility.2,3 The US Preventive Services Task Force has similar recommendations, emphasizing the importance of appropriate genetic counseling by healthcare providers with appropriate training.4 To assist providers in the identification of patients eligible for risk assessment and genetic counseling, the National Comprehensive Cancer Network has published guidelines that include personal and family history criteria that warrant referral.5

If your institution does not currently meet the standard, several options are available to make your institution compliant.

One strategy would be to hire a genetics professional.

Given the widespread recognition of the importance of cancer risk assessment, it is fitting that the CoC would develop a standard to address the appropriate delivery of genetics services at CoC-accredited sites, particularly because the CoC has taken on a patient-focused model.

The CoC genetics standard is designed to ensure that risk assessment and genetic counseling or testing services are available, and to ensure that professionals with genetics expertise are providing these services.

Our understanding of the genetic basis of cancer is ever-changing with the continual discovery of new cancer susceptibility genes, making

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cancer risk assessment a complex science. In addition, genetic testing technology is quickly evolving, more so now than ever before.

In light of these complexities, the CoC recognized the importance of involving specialized genetics professionals in the genetic risk assessment and counseling process to ensure that patients are receiving accurate risk assessment, undergoing testing in a cost-effective manner that includes ensuring that the correct genetic test is being ordered, and receiving accurate interpretation of genetic test results so that medical management can be individually tailored using genetic test results and/or family history information.

Meeting the Standard: How to Implement Genetic Services at Your Institution Healthcare professionals trained in genetics are skilled at providing risk assessment and genetic counseling and, ideally, are the type of professionals your institution should strive to have on staff or refer to.

If your institution already has a genetics professional (as defined by the standard), it is important that you contact this individual to make sure that he/she is meeting the minimum essential elements outlined in the new CoC genetics standard and is involved with your cancer committee and cancer conferences.

If your institution does not currently meet the standard, several options are available to make your institution compliant. One strategy would be to hire a genetics professional. Recognizing the budgetary pressure that many organizations face, genetics and genomic medicine are quickly making their way into routine care in many areas of medicine beyond oncology, and it is possible that a genetics professional can be a “shared cost” across multi-

Quality Standards 2.0

ple departments, such as cardiology, neurology, pediatrics, and prenatal obstetrics and gynecology. Specifically, most medical geneticists or genetic counselors receive multifaceted training and can provide genetic risk assessment across specialties.

Once hired, most genetics professionals have the skill set to initiate a cancer risk assessment program; this skill set generally includes:

1

Working with hospital administrators and physician leads in determining the logistics for where to see patients (eg, in a shared multidisciplinary clinic with other oncology staff or a separate clinic specifically dedicated to genetics), depending on the institution’s space availability and workflow

2

Developing billing and reimbursement protocols with hospital administrators and finance staff

3

Setting up meetings with staff from different oncology subdivisions (eg, breast, gastroenterology, gynecology, and endocrine) to discuss strategies for referral and communication before and after consultations; if house staff are not familiar with what a genetics professional has to offer or who to refer for a cancer risk assessment, the genetics professional may provide educational in-services for the staff

4

Developing documentation (eg, pedigree, consult notes) protocols, which in turn may require communicating with the medical records and/or the legal department to determine whether there are specific statutes in state genetics legislation that have certain requirements for the documentation or the release of genetic information; for institutions with an electronic medical record, a meeting with information technology staff may be needed

5

Establishing relationships with physicians who refer to your cancer center to promote the cancer genetic risk assessment program

test results, with follow-up recommendations to your institution, or the genetics professional from the outside institution could come to your institution (eg, 1 or 2 days weekly) and provide the risk assessment and counseling on site, which would also allow the input of documentation directly into your own medical record system. The expense of this second approach would be lower than the expense associated with hiring a full-time genetics professional and may be a more feasible option for institutions with budgetary restrictions.

A third choice for implementing the genetics standard is to refer patients to a third-party over-thephone genetic counseling company.

This option may be ideal for centers that cannot afford to hire a genetics professional or that are in a rural area in which either recruiting a genetics professional is difficult or a truly local (eg, a drive less than 60-90 minutes) professional referral is not available.

Currently, there are 2 companies—DNADirect (www.dnadirect. com/dnaweb/home.html) and Informed Medical Decisions (www. informeddna.com)—that employ certified and/or licensed genetic counselors who provide cancer risk assessment over the telephone.

If genetic testing is indicated, the company will coordinate sample collection with the referring provider.

Once complete, the company will send the patient and referring provider a summary of the consultation, which generally includes a pedigree, the consult notes, and genetic test results (if performed), which can be added to the patient’s chart. These companies often work directly with a patient’s insurer on the billing associated with the consultation and testing.

There are varied benefits and limitations to each of these options

6

Meeting with public relations staff to assess how to best promote the program to the community, which would likely require the genetics professional going into the community to give talks to a lay audience about cancer genetics

7

Working with the laboratory administration to develop genetic testing protocols that facilitate efficiency in ordering testing, while minimizing costs to the institution

The expense of this second approach would be lower than the expense associated with hiring a full-time genetics professional and may be a more feasible option.

8

Instituting a database of patients seen that may be able to be completed in conjunction with current registries.

If hiring a genetics professional is not feasible, consider the option to contract with another local institution that has a genetics professional on site. With this model, either your institution could refer patients to the contracted site and, in turn, the genetics professional would send back formal documentation with the risk assessment and/or the genetic

September 2012

Continued on page 20

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Quality Standards 2.0

The Commission on Cancer Genetics…Continued from page 19 Table 1 Options for Implementing the Genetics Standard On-site genetics services

Referral to outside genetics services

Advantages Provide comprehensive services to patients in-house

Potentially no additional costs to start a program

Have genetics involvement with cancer committees and tumor boards

Foster relationships with other institutions or companies

Increase opportunities for internal genetics educational seminars for staff

If referrals are local, may be able to have genetics representation at cancer committees and tumor boards

Can use the genetics services providers from other departments (eg, cardiology, prenatal)

For over-the-phone genetic counseling companies, can provide patient services on nights and weekends, as well as to the patient’s home for a patient who lives a long distance from the institution

Reduce risk of losing patients to competitors May be able to generate additional revenue with both billing for genetics service and downstream revenue from additional tests or procedures

Do not need additional space for the program

Genetics professional can represent your institution at the local and national level May decrease referral laboratory costs for genetic testing Disadvantages Costs associated with genetics professional and additional personnel (ie, administrative support), if needed Need space to house personnel and program

Referring patients out increases risk of losing patients to competitors May not have genetics representation on cancer committees and tumor boards Potentially do not have genetics personnel to interact and educate in-house staff May lose out on additional revenue Referring out may suggest to patients that the institution is not a comprehensive cancer center

(Table 1), all of which should be considered when your cancer center is making its plan for how to meet the CoC genetics standard.

The Benefits of Meeting the Genetics Standard The most important point in trying to meet the CoC genetics standard is to understand that the standard promotes cancer risk assessment and genetic counseling, not necessarily genetic testing. By following the elements outlined in the stan-

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dard and having a trained genetics professional provide a risk assessment, your cancer center can pride itself on the identification of patients who face an elevated risk of a future cancer. Once high-risk patients are identified, cancer surveillance and risk reduction options can be offered, which have been shown to lead to reduction of cancer-related morbidity and mortality.

Furthermore, patients will have an understanding of the benefits, risks, and limitations of genetic testing,

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allowing them to make an informed choice about whether they or their family want the information that genetic testing can provide.

Ultimately, your center will provide the high level of care that is consistent with a multitude of medical societies’ and organizations’ professional guidelines.

In addition to improving patient care and allowing patients to be fully informed of the implications of genetic testing, the CoC genetics Continued on page 22

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

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

Printed in USA

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Quality Standards 2.0

The Commission on Cancer Genetics…Continued from page 20 Table 2 Resources for Genetics Counselors Organization

Functions

National Society of Genetic Counselors (NSGC) www.nsgc.org

Find a local genetic counselor Post an employment opportunity via NSGC’s job connection services Review NSGC practice guidelines and position statements

American College of Medical Genetics (ACMG) www.acmg.net

Find a local medical geneticist Post an employment opportunity via ACMG’s employment resource center Review ACMG practice guidelines and policy statements

Genetic Nursing Credentialing Commission (GNCC) www.geneticnurse.org

Find information on the credentialing process for a nurse to become a Genetics Clinical Nurse (GCN) or an Advanced Practice Nurse in Genetics (APNG)

International Society of Nurses in Genetics (ISONG) www.isong.org

Review ISONG’s practice standards and position statements Learn more about nursing master’s and doctorate programs that involve a genetics specialization

standard can help minimize inappropriate genetic testing. Historically, commercial laboratories have provided assistance to nonspecialized healthcare professionals on how to order genetic testing. However, this can lead to “one-size-fits-all” testing, absent a true cancer risk assessment, where patients are all offered the same genetic test for only 1 cancer syndrome.

Although this type of testing may identify some individuals with a hereditary cancer syndrome, patients who have a pattern of cancer that fits a different syndrome may never be tested for the correct syndrome. As a result, patients will not know what cancers they and their families may be at risk for, leading to improper medical management,

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and the ordering physician may be at risk of being accused of malpractice if the true cancer syndrome would have been obvious to a genetics specialist. Another result of a nongenetics professional ordering testing is that inappropriate individuals may be offered unnecessary (and expensive) tests, putting further financial strain on the healthcare system.

Genetic Counseling Resources Table 2 lists a number of organizations that can provide assistance when you are looking to identify a local genetics professional who can assist your institution in meeting the CoC genetics standard. These resources can be valuable when

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I September 2012

looking to hire for a new position, when locating a nearby provider who may accept referrals, or in researching the process of credentialing a professional you may already have on staff. l

References 1. American College of Surgeons Commission on Cancer. Cancer program standards 2012: ensuring patient-centered care. www.facs.org/cancer/coc/cocpro gramstandards2012.pdf. Accessed August 27, 2012.

2. Robson ME, Storm CD, Weitzel J, et al. American Society of Clinical Oncology policy statement update: genetic and genomic testing for cancer susceptibility. J Clin Oncol. 2010;28:893-901.

3. American Society of Clinical Oncology. American Society of Clinical Oncology policy statement update: genetic testing for cancer susceptibility. J Clin Oncol. 2003;21:2397-2406.

4. US Preventive Services Task Force. Genetic risk assessment and BRCA mutation testing for breast and ovarian cancer susceptibility: recommendation statement. Ann Intern Med. 2005;143:355-361.

5. National Comprehensive Cancer Network (NCCN). NCCN guidelines. NCCN Website. www.nccn.org/professionals/physician_gls/f_guide lines.asp#detection. Accessed August 27, 2012.

Medical Legal Update

Accountable Care Organizations: Riding the Wave of the Future

By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

A

s healthcare reform changes the face of medical practice as we know it, certain initiatives are likely to play a prominent role in emerging practice structures.

Among the programs predicted to take center stage are those offered by Medicare’s Shared Savings Program, in particular, accountable care organizations (ACOs).

Understanding the ACO Concept An ACO is defined by the Centers for Medicare & Medicaid Services (CMS) as “an organization of healthcare providers that agrees to be accountable for the quality, cost, and overall care of the Medicare beneficiaries who are enrolled in the traditional fee-for-service program who are assigned to it.”

A stated goal of the ACO model is one that “promotes accountability for a patient population and coordinates items and services under parts A and B [of Medicare] and encourages investment in infrastructure and redesigned care processes for high quality and efficient service delivery” (42 USC § 1395jjj[a][1]).

With the combined aims of reducing cost while increasing the quality of care, the model seems to be an efficient mechanism to navigate the changing healthcare landscape.

The ACO model has existed for several years as a test program administered by CMS, and rapid growth of this model is anticipated.

Of course, the concept of accountable care is not new, because the idea of coordinated care, increased quality, and decreased cost has been a shared goal of many different aspects of the healthcare industry for

decades. If you are wondering what authority is out there to indicate this developing trend, look no further than healthcare reform itself. The Patient Protection and Affordable Care Act has identified ACOs as one of the waves of the future that will improve quality of care by encouraging physicians to collaborate with one another.

physician owned, owned by a hospital employing physicians, owned by a network of individual practices of physicians, or owned by others, as specified by the Secretary of Health and Human Services (42 USC § 1395jjj[b][1]).

For specialists, membership may be a no-brainer, because specialists may join as many ACOs as will have them. Any such membership would likely be cemented by a contract defining the relationship.

A barrier to the ACO model has been start-up cost. Because an ACO relies on, at its core, integration of data and patient care, all participants should be operable on collaborative electronic medical record (EMR) systems. Reading the previous statement may leave little to the imagination as to why large hospital systems and large practice groups are better suited to ACO formation than individual, smaller groups coming together and forming an ACO. The large hospital systems and large medical practices are presumably integrated and presumably better suited to absorbing the cost for hardware, software, training, and lag time, with the EMR integration required for the ACO model.

Also, the start-up cost makes an ACO creation less desirable for specialists, such as oncologists, who arguably may have less to gain from this structure than primary care providers, the intended core of the model—each ACO is required to have primary care providers, accounting for more than 5000 Medicare beneficiaries at any given time.

Although start-up costs may require a significant financial invest-

For specialists, membership may be a no-brainer, because specialists may join as many ACOs as will have them.

At its core, an ACO is an entity formed to tabulate patient care data in a way that Medicare may then determine cost-savings, which the ACO would be eligible to share in.

By way of a simplified example, if an ACO were able to evidence a lower rate of hospital admissions as a result of preventive care initiatives, the ACO would allegedly be entitled to a portion of the shared savings.

The beauty of the ACO model is that this structure does not require a practitioner to lose ownership or control over his/her practice. Instead, a practitioner may elect to participate with an ACO, sharing patient care data with the ACO, and to participate with shared savings. The ACO would be a separate entity, apart from your practice. ACOs may be physician owned, hospital and

September 2012

Continued on page 24

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Medical Legal Update

Accountable Care Organizations…Continued from page 23 ment, there are financial advantages to the ACO model. The current payment structure, as practitioners are well aware, is untenable and is bankrupting Medicare. Medicare has had to find ways to incentivize physicians to keep costs down, and the ACO model is one of the answers to this dilemma. Under the Shared Savings Program, the model includes reimbursement for fee-forservice, plus a percentage of shared savings. The intended impact of this model is to provide for a model that enables reimbursement to shift from quantity to quality, with the ultimate aim of reducing costs to the healthcare system.

Choosing “Accountable” Care For betting individuals, a safe bet is that our current care delivery system is not sustainable, and changes will be coming. We are headed toward a modified system, where quality over quantity and preventive over reactive are valued. To ensure your practice keeps pace with anticipated changes in our healthcare delivery system, regardless of whether you intend to participate in an ACO or similar model, you may wish to consider the concepts set forth herein and better position your practice for accountability, including adopting EMRs and understanding new initiatives such as ACOs. ACO creation takes a village— ACO creation begins with doctors, lawyers, managers, billers, EMR companies, chief executive officers, accountants, and consultants, and requires significant start-up capital, as discussed above. For those interested in the ACO model, ACO participants must make a 3-year commitment to the program when they sign on; a structure must be implemented for receiving and distributing shared savings; processes must be in

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place to coordinate care, such as having remote patient monitoring; and the ACO must have at least 5000 beneficiaries who will all receive their primary care coverage through the ACO (42 USC § 1395jjj[b][2]).

In order to receive financial incentives, quality-of-care measures must be in place, such as those for clinical processes and outcomes, and experience of care, and, in addition, there

Providers who fail to ready their practices now and leaders in the industry who do not get on board will fall to the back of the pack in the marathon that is healthcare today.

are numerous other requirements that must be in place in order to be eligible to participate in an ACO (42 USC § 1395jjj[b][2]).

It is also relevant to note that ACOs must be formed and operated in compliance with antitrust requirements. Those looking to participate in an ACO need to be wary of the fact that ACOs may be considered harmful to consumers by reducing competition. To assist ACOs, the Department of Justice and the Federal Trade Commission have created a procedure for voluntary expedited review. Before being admitted into the Shared Savings Program, newly formed ACOs may apply to both agencies for an antitrust analysis (www.justice.gov/ atr/public/health_care/aco.html). It is advisable to consult with your

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healthcare counsel to ensure compliance with relevant antitrust laws and policies and to offer your ACO the best protection possible.

Although the climb for an ACO creation is certainly uphill, it is not unhikable. And, with rolling admissions for ACO participants by CMS, the next application period being for a 2014 start date, the number of Notice of Intent to Apply letters is predicted to increase dramatically over the coming years. It is not being suggested that this system is going to be perfect and be the solution to all things wrong with our healthcare system as it stands today. In fact, a lot of information is still unavailable, and it appears that the Secretary of Health and Human Services is going to have a lot of authority over what payments are made. What is clear moving forward is that providers who fail to ready their practices now and leaders in the industry who do not get on board will fall to the back of the pack in the marathon that is healthcare today. l This article is for education and discussion purposes only and does not constitute legal advice.

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

Erica Youngerman, Esq, is an associate in Kirschenbaum & Kirschenbaum’s healthcare practice. If you have a question for Jennifer or if you would like to discuss accountable care organizations, Jennifer may be reached at 516-7476700 x302 or by e-mail at Jennifer@ kirschenbaumesq.com. For more information about Kirschenbaum & Kirschenbaum’s healthcare practice visit www.nyhealth careattorneys.com.

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Practice Management

Tough Times for Small Practices…Continued from page 1 ered “large,” Mr Natelson said. He cited 5 main challenges facing community oncologists today: • The gridlock in Washington, DC, and the lack of progress in fixing the sustainable growth rate (SGR)

this would be problematic,” he said.

Nor is hospital-based cancer care the answer. “Does Congress really believe that pushing physicians to a hospital setting will cut costs for Medicare? Costs are 34% higher in

“Two hospitals are after me, as is another large consortium.

I do not want to be owned by a hospital. This will only drive up cost, not improve the quality of care I give.”

—Leonard Natelson

• Drug shortages • Implementation of HIPAA (Health Insurance Portability and Accountability Act of 1996) 5010 and ICD-10 (International Classification of Diseases, Tenth Revision) • Reduced reimbursements • Leadership in the transformation of cancer care.

The inability to settle the SGR continues to plague practices such as Mr Natelson’s. With a “lame duck” Congress around the bend, progress this year seems doubtful, he said. In addition, should the SGR not be “patched” again, providers will be hit with a 30% cut in reimbursement in January 2013, and this, compounded by other potential economic difficulties, will worsen the payment delays that continually threaten the fiscal viability of oncology community practices.

Mr Natelson suggests that using bundled payments is not the solution to the current fiscal unpredictability, because this approach eliminates flexibility. “With the patients we see,

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the hospital for the same type of patient visit,” Mr Natelson said.

“This was tried 15 years ago, and it did not work” so care was pushed back into the community. “This time, there would be fewer community practices to push back out to.”

Further driving practice inefficiency of community practice is the drug shortage crisis. In 2005, 61 drugs were in short supply; this number now approaches 250. The causes include low profit margins for generic drugs, few manufacturers, and poor quality control. “I am chasing my tail all the time,” Mr Natelson said.

Conversion difficulties with HIPAA 5010 compliance and the future ICD-10 coding system create additional work, without increasing revenue. “My practice spent $30,000 on information technology infrastructure upgrades, and this does not generate more revenue for me, but it does generate expense. I am also hearing that practices that have converted to 5010 are getting erroneous

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I September 2012

denials of claims, which is delaying payments,” he said. “Some practices are still waiting for payments from November.”

A decrease in reimbursement is an obvious challenge. Of Mr Natelson’s practice’s drugs, 46% are “under water,” and this makes it “much more challenging to provide the kind of care we want to provide,” he said. “We need wiggle room so that our physicians can spend time with patients.”

His practice is also experiencing more denials caused by medically unlikely edits. “Any time we have to pay for a drug up front, and we do not get reimbursed in time to pay that bill, these denials put us further behind,” he added.

The last of the 5 issues considered most critical by Mr Natelson pertains to leadership in the transformation of cancer care. The question is whether community-based oncology will continue to be relevant in the delivery of cancer care, he said.

“Two hospitals are after me, as is another large consortium. I do not want to be owned by a hospital.

This will only drive up cost, not improve the quality of care I give,” he maintained.

Ironically, community oncology is in the best position to operate efficiently and “bend the cost curve,” Mr Natelson said. “We are a small business. It is more real time in community practice. We have to watch what we spend, what we take in, make sure people pay us. We do not have deep pockets like the large institutions that get by if they are not paid for 6 weeks. I would hate to see all oncology practices move to the hospital setting, and then we figure out that it costs more —which is something we already know.” l

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Important Safety Information WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

1.

2.

Important Safety Information (cont) Recommended Dose Modifications t

t

Immune-mediated Hepatitis: t

t t

t

t

t

Immune-mediated Enterocolitis: t

t Immune-mediated Dermatitis: t

t

t t t

t

t t

Important Safety Information (cont) t

Immune-mediated Neuropathies: t t t t

Other Immune-mediated Adverse Reactions, Including Ocular Manifestations: t

t t Immune-mediated Endocrinopathies: t t

t

t

t t

Pregnancy & Nursing: t

t t

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YERVOYâ&#x201E;˘ (ipilimumab) Injection, for intravenous infusion Brief Summary of Prescribing Information. For complete prescribing information consult official package insert.

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY (ipilimumab) can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. [See Dosage and Administration (2.2) in Full Prescribing Information] Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose. [See Warnings and Precautions] INDICATIONS AND USAGE YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.

CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS YERVOY can result in severe and fatal immune-mediated reactions due to T-cell activation and proliferation.

[See Boxed Warning] Immune-mediated Enterocolitis In Study 1, severe, life-threatening, or fatal (diarrhea of 7 or more stools above baseline, fever, ileus, peritoneal signs; Grade 3â&#x20AC;&#x201C;5) immune-mediated enterocolitis occurred in 34 (7%) YERVOY-treated patients, and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) YERVOY-treated patients. Across all YERVOY-treated patients (n=511), 5 (1%) patients developed intestinal perforation, 4 (0.8%) patients died as a result of complications, and 26 (5%) patients were hospitalized for severe enterocolitis.

The median time to onset was 7.4 weeks (range 1.6â&#x20AC;&#x201C;13.4) and 6.3 weeks (range 0.3â&#x20AC;&#x201C;18.9) after the initiation of YERVOY for patients with Grade 3â&#x20AC;&#x201C;5 enterocolitis and with Grade 2 enterocolitis, respectively.

Twenty-nine patients (85%) with Grade 3â&#x20AC;&#x201C;5 enterocolitis were treated with high-dose (â&#x2030;Ľ40 mg prednisone equivalent per day) corticosteroids, with a median dose of 80 mg/day of prednisone or equivalent; the median duration of treatment was 2.3 weeks (ranging up to 13.9 weeks) followed by corticosteroid taper.

Of the 28 patients with moderate enterocolitis, 46% were not treated with systemic corticosteroids, 29% were treated with <40 mg prednisone or equivalent per day for a median duration of 5.1 weeks, and 25% were treated with high-dose corticosteroids for a median duration of 10 days prior to corticosteroid taper. Infliximab was administered to 5 of the 62 patients (8%) with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids.

Of the 34 patients with Grade 3â&#x20AC;&#x201C;5 enterocolitis, 74% experienced complete resolution, 3% experienced improvement to Grade 2 severity, and 24% did not improve. Among the 28 patients with Grade 2 enterocolitis, 79% experienced complete resolution, 11% improved, and 11% did not improve.

Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms.

Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least one month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients.

Withhold YERVOY dosing for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for more than one week, initiate systemic corticosteroids at a dose of 0.5 mg/kg/day prednisone or equivalent. [See Dosage and Administration (2.2) in Full Prescribing Information] Immune-mediated Hepatitis In Study 1, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations of more than 5 times the upper limit of normal or total bilirubin elevations more than 3 times the upper limit of normal; Grade 3â&#x20AC;&#x201C;5) occurred in 8 (2%) YERVOY-treated patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4% of YERVOY-treated patients. An additional 13 (2.5%) patients experienced moderate hepatotoxicity manifested by liver function test abnormalities (AST or ALT elevations of more than 2.5 times but not more than 5 times the upper limit of normal or total bilirubin elevation of more than 1.5 times but not more than 3 times the upper limit of normal; Grade 2). The underlying pathology was not ascertained in all patients but in some instances included immune-mediated hepatitis. There were insufficient numbers of patients with biopsyproven hepatitis to characterize the clinical course of this event.

The median time to onset of moderate, severe, or life-threatening immune-mediated dermatitis was 3.1 weeks and ranged up to 17.3 weeks from the initiation of YERVOY (ipilimumab).

Seven (54%) YERVOY-treated patients with severe dermatitis received high-dose corticosteroids (median dose 60 mg prednisone/day or equivalent) for up to 14.9 weeks followed by corticosteroid taper. Of these 7 patients, 6 had complete resolution; time to resolution ranged up to 15.6 weeks.

Of the 63 patients with moderate dermatitis, 25 (40%) were treated with systemic corticosteroids (median of 60 mg/day of prednisone or equivalent) for a median of 2.1 weeks, 7 (11%) were treated with only topical corticosteroids, and 31 (49%) did not receive systemic or topical corticosteroids. Forty-four (70%) patients with moderate dermatitis were reported to have complete resolution, 7 (11%) improved to mild (Grade 1) severity, and 12 (19%) had no reported improvement.

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

Permanently discontinue YERVOY in patients with Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations.

Administer systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent. When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. Withhold YERVOY dosing in patients with moderate to severe signs and symptoms. [See Dosage and Administration (2.2) in Full Prescribing Information] For mild to moderate dermatitis, such as localized rash and pruritus, treat symptomatically. Administer topical or systemic corticosteroids if there is no improvement of symptoms within 1 week.

Immune-mediated Neuropathies In Study 1, one case of fatal Guillain-BarrĂŠ syndrome and one case of severe (Grade 3) peripheral motor neuropathy were reported. Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-BarrĂŠ syndrome have been reported.

Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-BarrĂŠ-like syndromes. Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids at a dose of 1 to 2 mg/kg/day prednisone or equivalent for severe neuropathies. Withhold YERVOY dosing in patients with moderate neuropathy (not interfering with daily activities). [See Dosage and Administration (2.2) in Full Prescribing Information] Immune-mediated Endocrinopathies In Study 1, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3â&#x20AC;&#x201C;4) occurred in 9 (1.8%) YERVOY-treated patients. All 9 patients had hypopituitarism and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies. Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and one case each of hyperthyroidism and Cushingâ&#x20AC;&#x2122;s syndrome. The median time to onset of moderate to severe immune-mediated endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the initiation of YERVOY. Of the 21 patients with moderate to life-threatening endocrinopathy, 17 patients required long-term hormone replacement therapy including, most commonly, adrenal hormones (n=10) and thyroid hormones (n=13).

Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism. Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms of endocrinopathies should be considered immune-mediated.

Monitor thyroid function tests and clinical chemistries at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland.

Withhold YERVOY dosing in symptomatic patients. Initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent, and initiate appropriate hormone replacement therapy. [See Dosage and Administration (2.2) in Full Prescribing Information] Other Immune-mediated Adverse Reactions, Including Ocular Manifestations The following clinically significant immune-mediated adverse reactions were seen in less than 1% of YERVOY-treated patients in Study 1: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia.

Across the clinical development program for YERVOY, the following likely immune-mediated adverse reactions were also reported with less than 1% incidence: myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, and autoimmune thyroiditis.

Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions.

Initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day prednisone or equivalent for severe immunemediated adverse reactions.

Monitor liver function tests (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of liver function test monitoring until resolution.

Administer corticosteroid eye drops to patients who develop uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease that is unresponsive to local immunosuppressive therapy. [See Dosage and Administration (2.2) in Full Prescribing Information]

Permanently discontinue YERVOY in patients with Grade 3â&#x20AC;&#x201C;5 hepatotoxicity and administer systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent. When liver function tests show sustained improvement or return to baseline, initiate corticosteroid tapering and continue to taper over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients who have persistent severe hepatitis despite high-dose corticosteroids. Withhold YERVOY in patients with Grade 2 hepatotoxicity. [See Dosage and Administration (2.2) in Full Prescribing Information]

ADVERSE REACTIONS

Immune-mediated Dermatitis In Study 1, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3â&#x20AC;&#x201C;5) occurred in 13 (2.5%) YERVOY-treated patients. One (0.2%) patient died as a result of toxic epidermal necrolysis and one additional patient required hospitalization for severe dermatitis. There were 63 (12%) patients with moderate (Grade 2) dermatitis.

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

t *NNVOF NFEJBUFE FOUFSPDPMJUJT [see Warnings and Precautions].

t *NNVOF NFEJBUFE IFQBUJUJT [see Warnings and Precautions].

t *NNVOF NFEJBUFE EFSNBUJUJT [see Warnings and Precautions].

t *NNVOF NFEJBUFE OFVSPQBUIJFT [see Warnings and Precautions].

t *NNVOF NFEJBUFE FOEPDSJOPQBUIJFT [see Warnings and Precautions].

t 0 UIFS JNNVOF NFEJBUFE BEWFSTF SFBDUJPOT JODMVEJOH PDVMBS NBOJGFTUBUJPOT [see Warnings and Precautions].

Clinical Trials Experience

Immunogenicity

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared with rates in other clinical trials or experience with therapeutics in the same class and may not reflect the rates observed in clinical practice.

In clinical studies, 1.1% of 1024 evaluable patients tested positive for binding antibodies against ipilimumab in an electrochemiluminescent (ECL) based assay. This assay has substantial limitations in detecting anti-ipilimumab antibodies in the presence of ipilimumab. Infusion-related or peri-infusional reactions consistent with hypersensitivity or anaphylaxis were not reported in these 11 patients nor were neutralizing antibodies against ipilimumab detected.

The clinical development program excluded patients with active autoimmune disease or those receiving systemic immunosuppression for organ transplantation. Exposure to YERVOY (ipilimumab) 3 mg/kg for four doses given by intravenous infusion in previously treated patients with unresectable or metastatic melanoma was assessed in a randomized, double-blind clinical study (Study 1). [See Clinical Studies (14) in Full Prescribing Information] One hundred thirty-one patients (median age 57 years, 60% male) received YERVOY as a single agent, 380 patients (median age 56 years, 61% male) received YERVOY with an investigational gp100 peptide vaccine (gp100), and 132 patients (median age 57 years, 54% male) received gp100 peptide vaccine alone. Patients in the study received a median of 4 doses (range 1 to 4 doses). YERVOY was discontinued for adverse reactions in 10% of patients.

The most common adverse reactions (â&#x2030;Ľ5%) in patients who received YERVOY at 3 mg/kg were fatigue, diarrhea, pruritus, rash, and colitis.

Table 1 presents selected adverse reactions from Study 1, which occurred in at least 5% of patients in the YERVOY-containing arms and with at least 5% increased incidence over the control gp100 arm for all-grade events and at least 1% incidence over the control group for Grade 3â&#x20AC;&#x201C;5 events.

Table 1:

Percentage (%) of

a

gp100 n=132

Any Grade

Grade 3â&#x20AC;&#x201C;5

Any Grade

Grade 3â&#x20AC;&#x201C;5

Any Grade

Grade 3â&#x20AC;&#x201C;5

32 8

5 5

37 5

4 3

20 2

1 0

31 29

0 2

21 25

<1 2

11 8

0 0

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

USE IN SPECIFIC POPULATIONS Pregnancy

41

7

34

5

31

3

In a combined study of embryo-fetal and peri-postnatal development, severe toxicities including increased incidences of third-trimester abortion, stillbirth, premature delivery, low birth weight, and infant mortality occurred following intravenous administration of ipilimumab to pregnant cynomolgus monkeys every 21 days from the onset of organogenesis through parturition at doses of 2.6 or 7.2 times the recommended human dose of 3 mg/kg (by AUC). [See Nonclinical Toxicology (13.2) in Full Prescribing Information] In genetically engineered mice in which the gene for CTLA-4 has been deleted (a â&#x20AC;&#x153;knockout mouseâ&#x20AC;?), offspring lacking CTLA-4 were born apparently healthy, but died within 3â&#x20AC;&#x201C;4 weeks due to multi-organ infiltration and damage by lymphocytes.

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

Nursing Mothers

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

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

Table 2:

DRUG INTERACTIONS

There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Patientsa

YERVOY 3 mg/kg+gp100 n=380

YERVOY 3 mg/kg n=131

Gastrointestinal Disorders Diarrhea Colitis Skin and Subcutaneous Tissue Disorders Pruritus Rash General Disorders and Administration Site Conditions Fatigue

Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to YERVOY with the incidences of antibodies to other products may be misleading.

Pregnancy Category C

Selected Adverse Reactions in Study 1

System Organ Class/ Preferred Term

Because trough levels of ipilimumab interfere with the ECL assay results, a subset analysis was performed in the dose cohort with the lowest trough levels. In this analysis, 6.9% of 58 evaluable patients, who were treated with 0.3 mg/kg dose, tested positive for binding antibodies against ipilimumab.

Severe to Fatal Immune-mediated Adverse Reactions in Study 1 Percentage (%) of Patients

Any Immune-mediated Adverse Reaction Enterocolitisa,b Hepatotoxicitya Dermatitisa Neuropathya Endocrinopathy Hypopituitarism Adrenal insufficiency Other Pneumonitis Meningitis Nephritis Eosinophiliac Pericarditisa,c

YERVOY 3 mg/kg n=131

YERVOY 3 mg/kg+gp100 n=380

15 7 1 2 1 4 4 0

12 7 2 3 <1 1 1 1

0 0 1 1 0

<1 <1 0 0 <1

It is not known whether ipilimumab is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from YERVOY, a decision should be made whether to discontinue nursing or to discontinue YERVOY, taking into account the importance of YERVOY to the mother.

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

Geriatric Use Of the 511 patients treated with YERVOY at 3 mg/kg, 28% were 65 years and over. No overall differences in safety or efficacy were reported between the elderly patients (65 years and over) and younger patients (less than 65 years).

Renal Impairment No formal studies of YERVOY in patients with renal impairment have been conducted. [See Clinical Pharmacology (12.3) in Full Prescribing Information] Hepatic Impairment No formal studies of YERVOY in patients with hepatic impairment have been conducted. [See Clinical Pharmacology (12.3) in Full Prescribing Information] OVERDOSAGE There is no information on overdosage with YERVOY. PATIENT COUNSELING INFORMATION See MEDICATION GUIDE in Full Prescribing Information. t *OGPSN QBUJFOUT PG UIF QPUFOUJBM SJTL PG JNNVOF NFEJBUFE BEWFSTF SFBDUJPOT t "EWJTF QBUJFOUT UP SFBE UIF :&370: .FEJDBUJPO (VJEF CFGPSF FBDI :&370: JOGVTJPO t "EWJTF XPNFO UIBU :&370: NBZ DBVTF GFUBM IBSN t "EWJTF OVSTJOH NPUIFST OPU UP CSFBTU GFFE XIJMF UBLJOH :&370:

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

a

Including fatal outcome.

Including intestinal perforation. c Underlying etiology not established. b

Across clinical studies that utilized YERVOY doses ranging from 0.3 to 10 mg/kg, the following adverse reactions were also reported (incidence less than 1% unless otherwise noted): urticaria (2%), large intestinal ulcer, esophagitis, acute respiratory distress syndrome, renal failure, and infusion reaction.

Based on the experience in the entire clinical program for melanoma, the incidence and severity of enterocolitis and hepatitis appear to be dose dependent.

1281558A2

IP-B0001A-03-11

Issued: March 2011

Drug Coding Supplied by RJ Health Systems

Medications Used for the Treatment of Breast Cancer The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with the management of breast cancer.

The following sections include: • Associated ICD-9-CM codes used for the classification of breast cancer • Drugs that have been FDA-approved in the treatment of breast cancer • Drugs that are Compendia listed for off-label use for breast 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

Associated ICD-9-CM codes for breast cancer: 174 Malignant neoplasm of female breast Includes: breast (female) connective tissue soft parts Paget’s disease of: breast nipple Use additional code to identify estrogen receptor status (V86.0, V86.1) Excludes: skin of breast (172.5, 173.5) 174.0 174.1 174.2 174.3 174.4 174.5 174.6 174.8

Nipple and areola Central portion Upper-inner quadrant Lower-inner quadrant Upper-outer quadrant Lower-outer quadrant Axillary tail Other specified sites of female breast Ectopic sites Inner breast Lower breast Malignant neoplasm of contiguous or overlapping sites of breast whose point of origin cannot be determined Midline of breast Outer breast Upper breast 174.9 Breast (female), unspecified

175 Malignant neoplasm of male breast Use additional code to identify estrogen receptor status (V86.0, V86.1) Excludes: skin of breast (172.5, 173.5) 175.0 Nipple and areola 175.9 Other and unspecified sites of male breast Ectopic breast tissue, male

34

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ONCOLOGY PRACTICE MANAGEMENT

I September 2012

Drug Coding Supplied by RJ Health Systems

FDA-approved for breast cancer

Compendia listed off-label use for breast cancer

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

anastrozole (Arimidex)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

anastrozole (Arimidex)

S0170: Anastrozole, oral, 1 mg

✓

N/A

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

✓

90471

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

✓

51720

Bacillus Calmette-Guerin J9031: BCG (intravesical), per installation (Tice BCG, TheraCys)

✓

51720

bevacizumab (Avastin)

C9257: Injection, bevacizumab, 0.25 mg

✓

67028

bevacizumab (Avastin)

J9035: Injection, bevacizumab, 10 mg

✓

96413, 96415

capecitabine (Xeloda)

J8520: Capecitabine, oral, 150 mg

✓

N/A

capecitabine (Xeloda)

J8521: Capecitabine, oral, 500 mg

✓

N/A

carboplatin (Paraplatin)

J9045: Injection, carboplatin, 50 mg

✓

96409, 96413, 96415

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

dexamethasone (Decadron)

J1100: Injection, dexamethasone sodium phosphate, 1 mg

✓

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

dexamethasone (Decadron)

J8540: Dexamethasone, oral, 0.25 mg

✓

N/A

docetaxel (Taxotere)

J9171: Injection, docetaxel, 1 mg

✓

96413

doxorubicin HCl (Adriamycin)

J9000: Injection, doxorubicin hydrochloride, 10 mg

✓

96409

doxorubicin HCl liposome (Doxil)

J9001: Injection, doxorubicin hydrochloride, all lipid formulations, 10 mg (Not payable by Medicare effective 7/1/12)

✓

96413

doxorubicin HCl liposome (Doxil)

Q2048: Injection, doxorubicin hydrochloride, liposomal, Doxil, 10 mg

✓

96413

epirubicin (Ellence)

J9178: Injection, epirubicin HCl, 2 mg

96409, 96413

✓

September 2012

I

www.OncPracticeManagement.com

I

35

Drug Coding Supplied by RJ Health Systems

FDA-approved for breast cancer

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

eribulin (Halaven)

J9179: Injection, eribulin mesylate, 0.1 mg

✓

96409

estradiol (Estrace)

J8499a: Prescription drug, oral, nonchemotherapeutic Not otherwise specified

✓

N/A

etoposide (Vepesid)

J8560: Etoposide, oral, 50 mg

✓

N/A

etoposide (Etopophus, Toposar)

J9181: Injection, etoposide, 10 mg

✓

96413, 96415

everolimus (Afinitor)

C9399a: Unclassified drugs or biological (Hospital Outpatient Use ONLY)

✓

N/A

everolimus (Afinitor)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

exemestane (Aromasin)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

exemestane (Aromasin)

S0156: Exemestane, 25 mg

✓

N/A

fluorouracil (Adrucil)

J9190: Injection, fluorouracil, 500 mg

✓

96409

fluoxymesterone (Androxy)

J8499a: Prescription drug, oral, nonchemotherapeutic Not otherwise specified

✓

N/A

fulvestrant (Faslodex)

J9395: Injection, fulvestrant, 25 mg

✓

96402

gemcitabine (Gemzar)

J9201: Injection, gemcitabine hydrochloride, 200 mg

✓

96413

✓

96372, 96402

goserelin acetate J9202: Goserelin acetate implant, (Zoladex 3.6 mg ONLY) per 3.6 mg

36

Compendia listed off-label use for breast cancer

hydrocortisone sodium J1720: Injection, hydrocortisone sodium (Solu-Cortef) succinate, up to 100 mg

✓

96365, 96366, 96372, 96374

hydroxyurea (Hydrea)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

hydroxyurea (Hydrea)

S0176: Hydroxyurea, oral, 500 mg

✓

N/A

ifosfamide (Ifex)

J9208: Injection, ifosfamide, 1 gram

✓

96413, 96415

irinotecan (Camptosar)

J9206: Injection, irinotecan, 20 mg

✓

96413, 96415

ixabepilone (Ixempra)

J9207: Injection, ixabepilone, 1 mg

✓

96413, 96415

lapatinib (Tykerb)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

I

ONCOLOGY PRACTICE MANAGEMENT

I September 2012

Drug Coding Supplied by RJ Health Systems

Generic (brand) name

Compendia listed off-label use for breast cancer

HCPCS code: code description

FDA-approved for breast cancer

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified leucovorin calcium J0640: Injection, leucovorin calcium, (Wellcovorin) per 50 mg leuprolide J9217: Leuprolide acetate (for depot (Eligard, Lupron Depot) suspension), 7.5 mg leuprolide J9218: Leuprolide acetate, per 1 mg (Lupron) lomustine J8999a: Prescription drug, oral, (CeeNu) chemotherapeutic Not otherwise specified lomustine S0178: Lomustine, oral, 10 mg (CeeNu) medroxyprogesterone J1051: Injection, medroxyprogesterone (Depo-Provera) acetate, 50 mg megestrol J8999a: Prescription drug, oral, (Megace) chemotherapeutic Not otherwise specified megestrol S0179: Megestrol acetate, oral, 20 mg (Megace) melphalan J8600: Melphalan, oral, 2 mg (Alkeran) melphalan J9245: Injection, melphalan hydrochloride, (Alkeran) 50 mg methotrexate J8610: Methotrexate, oral, 2.5 mg methotrexate sodium J9250: Methotrexate sodium, 5 mg

✓

methotrexate sodium

J9260: Methotrexate sodium, 50 mg

✓

methylprednisolone (Depo-Medrol)

J1020: Injection, methylprednisolone acetate, 20 mg

✓

methylprednisolone (Depo-Medrol)

J1030: Injection, methylprednisolone acetate, 40 mg

✓

methylprednisolone (Depo-Medrol)

J1040: Injection, methylprednisolone acetate, 80 mg

✓

methylprednisolone (Solu-Medrol)

J2920: Injection, methylprednisolone sodium succinate, up to 40 mg

✓

letrozole (Femara)

CPT ® administration codes N/A

✓

96372, 96374, 96409 96402

✓

96402

✓

N/A

✓

N/A

✓

96402

✓

✓

N/A

✓

N/A ✓

N/A

✓

96409, 96413

✓ ✓

September 2012

I

N/A 96372, 96374, 96401, 96409, 96450 96372, 96374, 96401, 96409, 96450 11900, 11901, 20600, 20605, 20610, 96372, 96374 11900, 11901, 20600, 20605, 20610, 96372, 96374 11900, 11901, 20600, 20605, 20610, 96372, 96374 11900, 11901, 20600, 20605, 20610, 96372, 96374

www.OncPracticeManagement.com

I

37

Drug Coding Supplied by RJ Health Systems

FDA-approved for breast cancer

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

methylprednisolone (Medrol)

J7509: Methylprednisolone, oral, per 4 mg

✓

N/A

mifepristone (Mifeprex)

J8499a: Prescription drug, oral, nonchemotherapeutic Not otherwise specified

✓

N/A

mifepristone (Mifeprex)

S0190: Mifepristone, oral, 200 mg

✓

N/A

mitomycin (Mutamycin)

J9280: Mitomycin, 5 mg

✓

96409

mitoxantrone (Novantrone)

J9293: Injection, mitoxantrone hydrochloride, per 5 mg

✓

96409, 96413

oxaliplatin (Eloxatin)

J9263: Injection, oxaliplatin, 0.5 mg

✓

96413, 96415

paclitaxel protein-bound particles (Abraxane)

J9264: Injection, paclitaxel protein-bound particles, 1 mg

✓

96413

paclitaxel (Taxol)

J9265: Injection, paclitaxel, 30 mg

✓

96413, 96415

pemetrexed (Alimta)

J9305: Injection, pemetrexed, 10 mg

pertuzumab (Perjeta)

C9399a: Unclassified drugs or biological (Hospital Outpatient Use ONLY)

✓

96413

pertuzumab (Perjeta)

J9999a: Not otherwise classified, antineoplastic drugs

✓

96413

prednisone

J7506: Prednisone, oral, per 5 mg

✓

prednisolone J7510: Prednisolone, oral, per 5 mg (eg, Orapred, Millipred)

38

Compendia listed off-label use for breast cancer

96409

✓

N/A

✓

N/A

tamoxifen (Nolvadex)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

tamoxifen (Nolvadex)

S0187: Tamoxifen citrate, oral, 10 mg

✓

N/A

thiotepa (Thiotepa)

J9340: Injection, thiotepa, 15 mg

✓

51720, 96409

topotecan (Hycamtin)

J8705: Topotecan, oral, 0.25 mg

✓

N/A

topotecan (Hycamtin)

J9350: Injection, topotecan, 10 mg

✓

96413

toremifene (Fareston)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

trastuzumab (Herceptin)

J9355: Injection, trastuzumab, 10 mg

✓

96413, 96415

triptorelin (Trelstar)

J3315: Injection, triptorelin pamoate, 3.75 mg

I

ONCOLOGY PRACTICE MANAGEMENT

I September 2012

✓

96372, 96402

Drug Coding Supplied by RJ Health Systems

FDA-approved for breast cancer

Compendia listed off-label use for breast cancer

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

vinblastine (Velban)

J9360: Injection, vinblastine sulfate, 1 mg

vincristine (Vincasar PFS)

J9370: Vincristine sulfate, 1 mg

✓

96409

vinorelbine (Navelbine)

J9390: Injection, vinorelbine tartrate, per 10 mg

✓

96409

zoledronic acid (Zometa)

J3487: Injection, zoledronic acid (Zometa), 1 mg

✓

96365, 96413

zoledronic acid (Reclast)

J3488: Injection, zoledronic acid (Reclast), 1 mg

✓

96365, 96374

96409

✓

a

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 to ensure appropriate reimbursement.

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

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

This information was supplied by:

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

September 2012

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www.OncPracticeManagement.com

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RJ Health Systems The Creators of ReimbursementCodes.com

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Patient and Provider Access Br ought t o you by t he Associ at i on of Communi t y

Medicare Cuts: What’s Coming for Community Oncology

By Sydney Abbott, JD, Policy Coordinator, Association of Community Cancer Centers

M

any people talk about the ever-changing landscape of healthcare—and this is true now more than ever. In the months to come, the sustainable growth rate (SGR), several Centers for Medicare & Medicaid Services (CMS) rules, federal debt negotiations, and sequestration are likely to come together to have an impact on physicians’ ability to provide care for Medicare beneficiaries. But how, specifically, will these factors affect community oncology?

The Sustainable Growth Rate The SGR is a method used by CMS to control Medicare spending that is designed to ensure that the annual increase in spending per Medicare beneficiary does not exceed growth in gross domestic product. Each year in its physician fee schedule (PFS) rule, CMS includes a conversion factor that will change the payments for physician services for the next year to match the target SGR. The conversion factor for 2013 is proposed to reduce physician reimbursement by more than 27%. In past years, to avoid such enormous cuts, Congress had stepped in with a temporary suspension, or “doc fix.”

Most members of Congress today agree that the SGR formula is fundamentally flawed. However, given the current Congress’s hyperpartisan environment and no-spending mentality, a long-term solution to fix the SGR formula is not expected; the cost to repeal the SGR is estimated at more than $300 billion. So, although repeal is probably out of the question in the short-term, once again the

As mentioned earlier, in the 2013 PFS, CMS is proposing to reduce the conversion factor to $24.7124, thereby reducing physician payment rates in 2013 by 27.4%.

Assuming that Congress once again enacts a “doc fix,” proposals under the 2013 PFS would reduce reimbursement to hematology/ oncology providers by 1%, although the bulk of the cuts affect radiation oncology and stem from the reduction in reimbursement for intensitymodulated radiation therapy and stereotactic body radiation therapy, as well as the expansion of the multiple procedure payment rate.

In the proposed OPPS rule, CMS suggests abandoning its policy of setting reimbursement on the basis of claims data for separately paid drugs and biologics without pass-through status. Instead, CMS is proposing to reimburse these drugs at the average sales price (ASP) + 6% for 2013, which is the rate required by the Social Security Act when data on drug acquisition costs are not available. (In 2012, these drugs are reimbursed at ASP + 4%.)

expectation this year is that Congress will step in with another short-term “doc fix” to prevent the 27% cut to Medicare reimbursement. Does this mean that oncology is safe from cuts in 2013? Not exactly.

CMS Rules CMS recently released the 2013 proposed PFS and the hospital outpatient prospective payment system

Most members of Congress today agree that the SGR formula is fundamentally flawed. However, given the current Congress’s hyperpartisan environment and no-spending mentality, a long-term solution to fix the SGR formula is not expected.

(OPPS) rules. Procedures require CMS to issue these proposed rules, followed by a 60-day public comment period, before the agency releases the final Medicare reimbursement rules for the upcoming calendar year. Each year, groups such as the Association of Community Cancer Centers (ACCC) submit comments to CMS on the proposed Medicare rules.

September 2012

Debt Negotiations and Sequestration You probably remember the congressional bickering related to the national debt that took place last year. A debt Super Committee was formed to find a solution to our country’s debt crisis, but not many people were surprised when the comContinued on page 44

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www.OncPracticeManagement.com

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41

HalavenReimbursem Your source for reimbursement information related to Halaven

速

CODING & BILLING Coding & Pricing

Billing Forms

HCPCS Level II Codes CPT Drug Administration Code ICD-9-CM Diagnosis Codes National Drug Codes Revenue Codes Billing for Wastage Medicare Reimbursement Rate

Annotated CMS 1500 (08/05) Form Annotated UB-04 Form Checklist for Claims Submission CMS 1500 (08/05) Form UB-04 Form

COVERAGE POLICY Physician Office

Hospital Outpatient

Medicare Medicaid Commercial Payors

Medicare Medicaid Commercial Payors

RESOURCES Patient Assistance Program Coverage Scenarios FAQ FDA Approval Letter

Prescribing Information Eisai Assistance Program Enrollment Form Insurance Verification Form

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Patient and Provider Access

Medicare Cuts: What’s Coming…Continued from page 41 mittee could not agree on a solution.

Because no resolution was reached, an automatic sequestration, or reduction, of domestic spending was set into action. Cuts to defense spending and healthcare will start in January 2013.

This means that unless Congress acts before the end of December 2012, Medicare reimbursement will be cut by 2% across the board.

Unlike the SGR cut, Congress is not expected to immediately reverse this. This cut has the potential to dramatically impact community oncology, particularly in cancer centers with a high proportion of Medicare beneficiaries.

Tying It All Together So, what do all these figures and percentages mean for a community oncology practice or cancer center?

CMS proposes an ASP + 6% reimbursement rate for all drugs, but the SGR will reduce reimbursement by 27.4%, then sequestration will take 2% off of all Medicare reimbursement across the board. Help!

The good news is that we can

44

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expect Congress to step in with another short-term “doc fix” to avoid the 27.4% cuts to the SGR.

The good news is that we can expect Congress to step in with another short-term “doc fix” to avoid the 27.4% cuts to the SGR. The bad news is that sequestration means that Medicare reimbursement will be cut by 2% across the board.

The bad news is that sequestration means that Medicare reimbursement will be cut by 2% across the board.

Under the sequester, providers will

ONCOLOGY PRACTICE MANAGEMENT

I September 2012

bill everything—the cost of the drug, the drug overhead, evaluation and management codes, and all other services—to Medicare as they normally would; all reimbursement costs will be calculated, and CMS will then take the total reimbursement amount and reduce it by 2%. That will be the final reimbursement amount sent to providers.

The SGR, the rules, and sequestration may each have a negative impact on reimbursement. Taken together, these cuts will make it extraordinarily difficult for providers to continue to deliver the best care for the growing Medicare population. Today, it is more important than ever for the oncology community to work together to educate our elected officials and regulatory bodies on these issues.

The ACCC’s comments on the proposed PFS and OPPS rules, along with other information on these important issues, are available at www.accc-cancer.org/advocacy. As always, the ACCC will keep members up to date on the most current topics in cancer care. l

“Quality care is everyone’s business.”

Beth Faiman, RN, MSN, APRN, BC, AOCN Nurse Practitioner, Multiple Myeloma Program Cleveland Clinic Taussig Cancer Institute Cleveland, OH

6

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Physician Wealth Management Wi t h Lawr ence B. Kel l er , CFP®, CLU, ChFC, RHU,

Ten Rules for Asset Protection Planning

By Jay D. Adkisson, JD, and Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF

T

he question of whether a medical malpractice lawsuit will be commenced is not a matter within the discretion of the physician, but rather within the discretion of the patient and the patient’s lawyer.

Lawrence B. Keller Therefore, although making oneself “lawsuit proof ” is simply not possible, making oneself “judgment proof,” or nearly so, is often very possible, provided only that there has been sufficient advance planning.

There is a gambling saying that goes something like, “If you want to be a winner, you have to walk away from the table a winner.” One timehonored method of reaching this result is to systematically take your chips off the table as you win them, so that your potential for losses stays small.

Asset protection planning is all about taking chips off the table in good times, so that you still can walk away from the table a winner, no matter what happens in bad times.

Technically, asset protection planning is the debtor’s side of creditordebtor law. Whereas creditors are concerned about the strategies and techniques of collection, debtors are interested in the strategies and techniques for protecting their most valuable assets from potential creditors. However, in this calculation, it is not just about protecting assets but also about making sure that one does not end up in jail for contempt of court or bankruptcy fraud for engaging in the process.

Keeping in mind the law school adage that “general rules are generally inapplicable,” the following 10

46

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rules should always be considered when you try to take your chips off the table.

1. Start planning before a claim arises. Many things you can do will effectively provide asset protection before a claim or liability arises, but few things will provide this protection afterwards. That is because what you do after a claim arises could be undone by “fraudulent transfer” law.

Moreover, the point at which a claim arises is earlier than a layman might think—it is, for example, usually much earlier than when a demand letter or a process server shows up at the door.

2. Late planning usually backfires.

Asset protection planning after a claim arises is apt to make matters worse; think of it as getting a flu shot while you have the flu, and the shot itself is making you even more woozy. It is a common misconception that the only thing a judge can do is to unwind a fraudulent transfer, leaving a debtor who unsuccessfully tried late planning no worse off than if the debtor had done nothing. To the contrary, both the debtor and whoever assisted in the fraudulent transfer can become liable for the creditor’s attorney fees, and the debtor can lose the hope of getting a discharge in bankruptcy.

3. Asset protection planning is not a substitute for insurance.

Asset protection planning should not be a substitute for liability and professional insurance; rather, this should supplement insurance. It is a myth that asset protection plans invariably scare away plaintiffs, and an asset protection plan does not pay legal fees to defend against a lawsuit.

Insurance also supplements asset protection planning, because it can help a debtor survive a fraudulent transfer claim. If you get sued, let the

ONCOLOGY PRACTICE MANAGEMENT

I September 2012

insurance company pay to defend it and pay to settle it—that is what you are paying the premiums for.

4. Personal assets are for trusts; business assets are for business entities. Business entities, such as corporations, partnerships, and limited liability companies (LLCs), are meant to be vehicles for commercial operations, not to act as personal piggy banks. When personal assets are placed into a business entity, the potential for the entity to be pierced by a creditor, based on one theory or another, such as alter ego, increases dramatically. The place to put personal assets is in a trust. A long and solid body of law protects trust assets, when the trust is properly drafted and funded. And please do not name the entity the “Family” partnership or LLC, unless your family is famous for making sausage or some such other commodity.

5. Too much control is a bad thing. Asset protection planning attempts to reach a balance between giving the client sufficient control so that the assets do not disappear, but at the same time not so much control that a creditor can successfully argue that the debtor and the asset protection structure are effectively one-and-the-same and thus should be disregarded, based on alter ego or a similar theory.

6. Asset protection planning and tax and estate planning do not always jibe. Asset protection planning and estate planning often work together, but sometimes they are at odds, and what may be a good idea for tax and estate planning may not be such a great idea for asset protection. For example, the making of gifts (to children and other prospective heirs) is common in estate planning but anathema in asset protecContinued on page 48

MAY 2-5, 2013

THIRD ANNUAL CONFERENCE

Influencing the Patient-Impact Factor May 2-5, 2013 Westin Diplomat Hollywood, Florida

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Physician Wealth Management

Ten Rules for Asset…Continued from page 46 tion planning, because gifts are often easy to set aside as fraudulent transfers. Meanwhile, homestead exemptions are a very powerful asset protection planning tool, but their use usually traps the value of the home in the debtor’s estate.

7. Your money may be offshore, but you are here. Recent cases have recognized the power of courts to require debtors to bring their offshore money back to the United States through what are known as “repatriation orders.” If the debtor does not comply with a repatriation order, a court may issue a bench warrant for contempt of court and hold you in contempt (and in jail) until the money comes back, or for many years. The record? It is 14 years in jail served by former corporate lawyer H. Beatty Chadwick, who refused to repatriate money from overseas to pay alimony to his ex-wife.

8. Don’t count on bankruptcy as the last refuge of a desperate debtor.

Once upon a time, bankruptcy was akin to a warm shower that allowed a debtor to wash all debts away, while still retaining a goodly amount of assets. This is not true anymore. In 2005, the bankruptcy laws changed to become a cold acid bath that leaves debtors with bare bones and little flesh. State homestead exemptions have been substantially limited, and other new provisions in the bankruptcy code and new bankruptcy case law can make parts of asset protection plans very difficult to protect in bankruptcy. In addition, bankruptcy judges have some of the strongest powers to make debtors cough up assets.

9. If you can’t explain it, it will never work. Many asset protection plans become so complicated that even the client cannot explain how assets are held or how those assets were transferred. However, such questions can be expected in deposi-

48

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tions or a debtor’s examination, and a failure to fully and clearly explain what happened and why will make the court very suspicious and potentially give the court grounds to begin disregarding entities or setting aside transfers. Most judges start asking themselves, “What is really going on here?” If the structure and transfers are too complicated and not well explained, there is a much higher chance that the judge will find fraud on creditors. Indeed, the best asset protection plans are often simple plans, such as creating and funding an irrevocable trust for the benefit of your children.

10. Usually everything sees the light of day. Asset protection planning should be based on the presumption that the entirety of the planning and its purpose will eventually become known to creditors, because one way or another it usually does. Asset protection plans that require secrecy will face a plethora of problems, from how not to disclose the structure or activity of these plans on tax returns, to how to keep a mad ex-spouse or disgruntled employee from talking to creditors.

And do not even think about going into bankruptcy without making a full disclosure about assets and transfers. The failure to make a full disclosure will usually lead to a denial of discharge, and the failure to make a truthful disclosure can amount to charges of perjury and bankruptcy fraud.

A Final Caution for Physicians Asset protection protects assets but not necessarily income streams.

Physicians are often sued not based on what assets they have or do not have, but rather based on their future income potential. Despite the often Pollyannaish claims of some asset protection marketers, it is

ONCOLOGY PRACTICE MANAGEMENT

I September 2012

extremely difficult, if not impossible, to protect from creditors one’s future earnings derived from professional fees. Although federal law limits the amount of wages that a creditor can garnish to 25% of the net after taxes, this can still be a very substantial amount.

Often, the only effective way to protect those future earnings is through bankruptcy. If, however, the physician has engaged in asset protection that is defective, too aggressive, or—most frequently—started only after the claim has arisen, then the most likely result will be that the physician’s discharge will be denied, or the creditor’s claim excepted from discharge. If that happens, the result is that the claim will not go away until it is fully paid, and the creditor will have little incentive to settle by that point.

The lesson from this is, similar to so many medical treatment procedures, do not engage in asset protection planning unless you are prepared to do it in a timely fashion, and the right way. Or, to borrow a phrase, “First, do no harm.” l

Jay D. Adkisson, JD, is a partner in the law firm of Riser Adkisson LLP, with offices in Newport Beach, CA, and Athens, GA. Mr Adkisson is one of the authors of “Asset Protection: Concepts and Strategies” (McGraw-Hill, 2004).

He can be reached for questions or comments at (949) 200-7773 or by e-mail at jay@risad.com.

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

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

IMPORTANT SAFETY INFORMATION

Please see brief summary of Prescribing Information on adjacent pages.

© Janssen Biotech, Inc. 2012

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Contraindications ZYTIGA® (abiraterone acetate) may cause fetal harm (Pregnancy Category X) and is contraindicated in women who are or may become pregnant.

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

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

Adrenocortical Insufficiency (AI) AI has been reported in clinical trials in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress.

Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

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

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

Adverse Reactions The most common adverse reactions (≥5%) are joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection.

Drug 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. Additionally, abiraterone is a substrate of CYP3A4 in vitro. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution.

Use in Specific Populations The safety of ZYTIGA® in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA®.

Our goal is to make access to ZYTIGA®(abiraterone acetate) simple, convenient, and easy.

Support for you:

Support for your patients:

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• Access to the ZytigaOne™ Instant Savings Program • Referral to a patient assistance program • Coordination with SPP for processing/delivery of medication • Educational materials and prescription reminders

Take advantage of ZytigaOne™ Support today.

1-855-ZYTIGA-1 (998-4421) Monday–Friday, 8:00 AM–8:00 PM ET Single-Source Support for Access to ZYTIGA® Also available online at janssenaccessone.com

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

Patient insurance benefit investigation is provided as a service by TheraCom, LLC and The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, TheraCom, LLC, and The Lash Group, Inc., assist healthcare professionals in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer and patient information provided by the healthcare provider under appropriate authorization following the provider’s exclusive determination of medical necessity.

Importantly, insurance verification is the ultimate responsibility of the provider. Third-party reimbursement is affected by many factors. Therefore, TheraCom, LLC, The Lash Group, Inc., and Janssen Biotech make no representation or guarantee that full or partial insurance reimbursement or any other payment will be available. This information is provided as an information service only. While TheraCom, LLC, and The Lash Group, Inc., try to provide correct information, they and Janssen Biotech make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall TheraCom, LLC, The Lash Group, Inc., or Janssen Biotech or its employees or agents be liable for any damages resulting from or relating to the services. All providers and other users of this information agree that they accept responsibility for the use of this service.

Janssen Biotech assumes no responsibility for, and does not guarantee the quality, scope, or availability of the services including but not limited to reimbursement support services, patient education, and other support services. Each provider, not Janssen Biotech, is responsible for the services they provide. These support services have no independent value to providers apart from the product and are included within the cost of the product. © Janssen Biotech, Inc. 2012

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