OPM July 2012, Vol 2, No 4

ONCOLOGY PRACTICE MANAGEMENT ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™ JULY 2012

www.OncPracticeManagement.com

VOLUME 2 • NUMBER 4

Practice Management Seeing Cancer Strategies for a New Age: Care Through the Oncology Resource Networks

2012 ACOA Conference

By Dawn Holcombe, MBA, FACMPE, ACHE President, DGH Consulting, and Executive Director, Connecticut Oncology Association, South Windsor, CT

Chicago, IL—Lou Levine, a cancer survivor from Chicago, IL, reminded a room full of cancer program executives at the American College of Oncology Administrators (ACOA) 2012 annual conference of the unique perspective that patients with cancer have on their treatment and care.

Ms Levine is a 10-year survivor who was treated at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago. She spoke simply and eloquently about the little things that are easy to forget when treating patients, but that can have a significant impact on the patient and his/her journey with cancer.

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Patient perspective. Ms Levine asked us to remember that patients with cancer may appreciate help in shaping their

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ecent estimates have put the cost of cancer care at an excess of $100 billion annually, much of which is borne by government payers, including Medicare, Medicaid, and TRICARE for outpatient treatments, including chemotherapy, its administration, and radiation therapy.

The Affordable Care Act (ACA) provided in part for the creation of account-

able care organizations (ACOs) and has encouraged the concept of medical homes. Throughout the United States, payers and physicians have been working on developing creative payment strategies that recognize quality care and value, while reducing cost.

One particular organization—Oncology Resource Networks—has worked diligently to build clinically integrated oncolContinued on page 18

Quality Standards 2.0

Rex Cancer Center: Integrating Quality Improvement Standards

By Neil Canavan

Baltimore, MD—Quality reporting is one of the cornerstones of the healthcare reform. Now is the time to integrate quality improvement mechanisms at your cancer center, suggested Cynthia Jones, BSHA, CPHQ, Quality Program Coordinator at Rex Cancer Center, NC, at the 2012 Association of Community Cancer Centers meeting.

Rex Cancer Center—with practices in Wakefield and in Raleigh, NC—consists of 2 hematology/oncology sites with infu-

sion suites, and 4 radiation oncology sites. The center employs more than 1100 medical personnel and treats an average of 150 new patients monthly.

In 2008, 2009, and Continued on page 6

g

PA TIE N Br T ou

A

Continued on page 9

By Craig Deligdish, MD Oncology Resource Networks, Orlando, FL

Ho Co ht t ND t T mm o y PR o u o O C pic nit u b en s y y VI C i t n te C a he DE r n C s: o c A R ar Th m er ss e e m C oc A Ac A un e ia C n f t f t . or ity te ion C ... d C rs o ES 22 ab a f S n le c er

Eyes of a Patient

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From the Editor

Supreme Court Wait Is Over, but Was It Worth It? Dawn Holcombe, MBA, FACMPE, ACHE

T

he media and political pundits were having a field day with predictions and countdowns. No matter what your politics were, opinions resonated all around you: What would the Supreme Court do? What would it mean?

Then the decision came down.

With a 5 to 4 vote, the Affordable Care Act (ACA) was largely upheld and justified as a “tax.” States would retain the right to decide whether to participate in the Medicaid expansion portion of the bill and not risk federal expulsion from Medicaid if they refuse to enact the portion of the ACA related to Medicaid eligibility expansion.

Immediately after, Republicans and Democrats found ways to present the ruling as a victory. People who have not read much, if any, of this controversial healthcare reform bill in its entirety voiced strong opinions about the findings of the Supreme Court.

Yes, there are aspects of the ACA bill that provide for deeper coverage for many people, including those with cancer, buried in the ACA law.

These include coverage of preventive screenings for cancer and for other diseases, without copayments or coinsurance charges to individuals; continued coverage of young people through age 26 under their parents’ insurance plan; elimination of lifetime caps on insurance coverage; coverage protections on the basis of preexisting conditions; and patient access to clinical trials expanded to private insurance. Like motherhood and apple pie, it is difficult to argue against most of those provisions, and, indeed, some major private insurers had already announced that they intended to continue many of those provisions even if the Supreme Court ruled against the ACA law.

The issue that we are having diffi-

Continued on page 8

Editorial Advisory Board

Editor-in-Chief 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 Deligdish, MD Chief Medical Officer Oncology Medical Officer Oncology Resource Networks Orlando, FL

Peggy Barton, RN Practice Manager Toledo Clinic, OH

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

Risë Marie Cleland President Oplinc, Inc Lawton, OK

culty facing is that we are still left with a lengthy bill that few people have fully read, let alone understood, and a virtual battle of the politicos looming to play tug of war over the specifics of the ACA provisions.

We are left with even more questions unanswered, such as: • Who will be insured under the health insurance exchanges once they are implemented?

• Will health insurance exchanges be implemented as set forth under the law? Several states are still not yet engaged in development efforts, and there will come a time when it is just too late to get started to meet the 2014 deadline—what happens then?

• Will commercial insurance be turned off by employers in

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

July 2012

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In This Issue

PUBLISHING STAFF Publisher Nicholas Englezos nick@engagehc.com 732-992-1884

FROM THE EDITOR Supreme Court Wait Is Over, but Was It Worth It?........ . . . . . 3

Editorial Director Dalia Buffery dalia@engagehc.com 732-992-1889

FEATURES Practice Management Strategies for a New Age: Oncology Resource Newtworks ..........................................1

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 jennifer@generaladminllc.com 732-992-1536

By Dawn Holcombe, MBA, FACMPE, ACHE

By Craig Deligdish, MD

ACOA Addresses Quality and Accreditation in Oncology ..........................................................................9

By Dawn Holcombe, MBA, FACMPE, ACHE

Measuring Oncology Quality through QOPI: A Growing Industry Standard ...............................................................11

By Dawn Holcombe, MBA, FACMPE, ACHE

DRUG CODING Medications Used for the Treatment of Lung Cancer .................. ............................................28 DEPARTMENTS

Production Manager Marie R. S. Borelli

PATIENT AND PROVIDER ACCESS

Sales Assistant Zach Ceretelle

Hot Topics in Community Cancer Centers: The Affordable Care Act ..................................................................................22

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.

Brought to you by the Association of Community Cancer Centers

By Sydney Abbott, JD

MEDICAL LEGAL UPDATE

Protecting Against Disallowance through Practice Structure ....................................................................32

By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

PHYSICIAN WEALTH MANAGEMENT

Retirement Plans and Your Medical Practice.......................34

By Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF, and Peter M. Coleman, ASA, EA, FCA, MAAA. MBA

Oncology Practice Management™, ISSN 2164-4403(print), is published 6 times a year by Engage Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. 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™, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

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ONCOLOGY PRACTICE MANAGEMENT

I July 2012

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Quality Standards 2.0

Rex Cancer Center: Integrating…Continued from page 1 2011, Rex Cancer Center’s Hematology/Oncology Associates received national recognition as one of the best national outpatient cancer programs for patient satisfaction by Professional Research Consultants, as well as the highest score in the national Outpatient Oncology Service Line database.

“So, given these accolades,” said Ms Jones, “why would Rex hire someone to do quality assessments?”

The center is growing, treating more patients, becoming organizationally more complex, and facing increasing competition.

Getting Started: Assessing the Problem Ms Jones’ first day at Rex Cancer Center was in February 2011. “The staff was somewhat frightened about having someone there who works for the director and is coming out to be her eyes and ears,” she recalled. “It was unsettling for them. So, my first task was to engage them and to make it clear that I was there for the greater good,” not only for the patient, but also to find ways to protect and maintain the staff that had already earned such high recognition.

Ms Jones set out to communicate to the directors that she was not interested in “mission values that hang on the wall,” as much as in discovering what was going on in the treatment areas.

“I first needed to know what we do really well,” which would (1) clarify how the awards for excellence were earned, and (2) show the staff an appreciation of skills and talents that were already contributing to the center’s success, to foster cooperation rather than blame.

Ms Jones started with an assessment of high-risk activities, including chemotherapy administration (740 bags mixed monthly) and blood products (150 blood/blood

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products transfused monthly).

“There was already a variance reporting system at Rex—most acute care centers have a risk management reporting system,” said Ms Jones.

They had quantitative data, but they were missing any qualitative component. “The problem was that the reporting was not detailed enough to explain why anything happened.”

“The problem was that the reporting was not detailed enough to explain why anything happened.”

— Cynthia Jones, BSHA, CPHQ

She started to spend time in the wards. “My goal was not to put Band-Aids on what goes wrong, but to identify the problem as it occurs, and as it will likely occur again.” She wanted to fix the workflow, which required more information.

Improving the Communication Procedures “Initially, nurses said, ‘I don’t have time for detailed reports.’ They just jot a brief note. But when you’re reporting events, you want to know the key facts that led to the event.

You should be able to do that in 3 lines or less,” Ms Jones said. The new process seemed like a huge culture change initially, but within weeks it began to bear fruit. “We have a robust reporting system now that includes the details I need to identify how a process is not working.”

For example, “We were seeing medical events that were tied to ordering,” she said. By going to the wards and talking to all the play-

ONCOLOGY PRACTICE MANAGEMENT

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ers—the nurses, the pharmacists, and the physicians—she established that there were basic miscommunications that were directly related to the order form.

Yet, everyone was wedded to that form, because they were used to it. “I had to convince them to revise it, because it did not communicate well with anyone.”A simple revision to the document’s formatting, to how it looked and read, improved its performance. “It became a much improved communication tool,” Ms Jones said. Errors and events were reduced.

Gaining the qualitative information was key to addressing treatment variance, which involved the right attitude to ensure the staff that the goal was not punitive, as well as patience, because, Ms Jones said, “at first you hear complaints. You need to deescalate the complaint, and then try to get at the facts.”

These facts were entered into an Excel spreadsheet, with the events down the x-axis and the reasons for the events across the y-axis.

Identifying Breakdowns in the Process: Improving Care Quality Ms Jones then addressed the problem of chemotherapy waste. “Again, the reporting was there, but there was no detail about the waste,” she said. She asked the pharmacists how they get through their busy day, to get a clearer picture of what was going on. Once the information was collected, trends emerged.

“Again, I could see communication breakdowns,” Ms Jones said, outlining the following problems: • Laboratory results were not assessed before the mixing of chemotherapies • Orders were mixed before the time the drugs were needed Continued on page 8

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From the Editor

Supreme Court Wait Is Over…Continued from page 3 droves, sending formerly commercially insured patients into the streets, seeking health insurance exchange coverage that is not yet defined, priced, or known if it will be available?

• Even if the health insurance exchanges materialize as planned under the ACA law, what rates of reimbursement will they offer to physicians and hospitals, and which physicians and hospitals will agree to participate?

• What will the evolving answers to these questions do to access to healthcare in the United States,

and at what levels of quality?

• What will happen to the existing delivery models of healthcare if suddenly the majority of insured patients in the United States become insured as Medicaid or Medicare populations?

Currently, Medicare represents approximately 50% of patients with cancer, with Medicaid running close to 5%, and commercial and other insurance picking up roughly the other 45%. If suddenly the percentage mix of Medicaid and commercial were to come close to reversing over the next 5 years, there would be a sig-

nificant impact (as yet undetermined, but probably very painful) on the current healthcare delivery system.

Practices and hospital centers already are embroiled in a variety of proactive and reactive discussions about new relationships. Strategic planning in these organizations will now need to consider these potential ramifications of the ACA law, in addition to the myriad other challenges facing cancer programs today. We may have received a ruling, but we have not yet received the answers we need to face the future of oncology. l

Quality Standards 2.0

Rex Cancer Center: Integrating…Continued from page 6 • There were port/intravenous problems that the pharmacists did not know about.

“This information helped my group go from complaining to seeing how waste could be prevented. This

we can prevent 75% of these events by changing just a few things about how we do what we do,” Ms Jones suggested.

She then assessed the radiation oncology services, using the same

“This information helped my group go from complaining to seeing how waste could be prevented. This new insight was not just on the part of the pharmacists, but the nurses and the doctors as well. I would estimate that we can prevent 75% of these events by changing just a few things.”

— Cynthia Jones, BSHA, CPHQ

new insight was not just on the part of the pharmacists, but the nurses and the doctors as well,” she said.

The proposed changes were not monumental. “I would estimate that

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process in gathering data. The main complaint from radiology was about treatment delays. The assessment revealed the main culprits: • The treatment plan was not ap-

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proved in either of the oncology management systems software programs (ie, Impac and ADAC) • Additional information was required by the treating physician • Miscommunications were common.

“I mapped it all out, and then even broke it down by diagnosis,” Ms Jones explained. She determined that patients with head and neck cancers were experiencing the most delays at the center. “We needed to recognize that treating these patients took more time, involved more variables, and therefore had more delaycausing complexities.”

This approach was focused on understanding the breakdowns in the process rather than on finger pointing.

This is just one example, and the story at your institution may be different, Ms Jones said, but to tell the story, and to change how the story ends, you need the qualitative data. l

ACOA 2012 Conference

ACOA Addresses Quality and Accreditation in Oncology

By Dawn Holcombe, MBA, FACMPE, ACHE

Chicago, IL—Oncology program administrators from across the country gathered in Chicago on June 21 and 22 at the American College of Oncology Administrators (ACOA) 2012 annual conference. The attendees of this meeting, held in the conference center of the American College of Surgeons, braved summer temperatures to focus on quality and accreditation issues in cancer care.

The conference was co-hosted by the American College of Surgeons’ Commission on Cancer (COC) and celebrated the 20th anniversary of ACOA, a specialty group of the American Academy of Medical Administrators (www.aameda.org).

The keynote and concurrent session speakers focused on how cancer programs can quantify, track, and prove quality in a value-based purchasing world. An afternoon preconference session with Virtua Fox Chase Cancer Center leaders tackled the thorny issue of demystifying quality metrics, illustrating mul-

tiple current measures in place at the center, as well as in other market sources.

A moving session from a cancer care survivor (see article in this issue) reminded attendees of why they were there, and how the patient perspective can influence quality program choices in treatment and care delivery.

One of the most prevalent oncology quality measurement programs in America today is the Quality Oncology Practice Initiative (QOPI) program (see page 11), developed by the American Society of Clinical Oncology (ASCO). The QOPI program and its new initiatives were presented by an ASCO leader, and detailed descriptions by 2 active QOPI participants brought the program and its contributions to the quality of cancer care to conference attendees on a very personal basis.

Other keynote programs concentrated on recent changes in the COC accreditation process, how to effec-

tively utilize consultants in times of rising demands and shrinking resources, and preparing for a shift from volume to value in cancer services.

Some of the concurrent conference sessions addressed current updates regarding drug shortages, growth of patient satisfaction, integrated palliative care, healthcare reform, institutional partnerships and affiliations, and the journey of the cancer patient.

Networking among the cancer program leaders and the thought leaders throughout the program led to speculation about the pending decision by the US Supreme Court on healthcare reform, but more frequently to speculation about the challenges that individual programs were having in satisfying their own needs for defining quality and developing appropriate metrics for discussions of quality.

The conference closed with invitations to participate in next year’s program—to be held April 10-12, 2013, in Las Vegas, NV. l

Seeing Cancer Care Through…Continued from page 1 perspective on the role they fill in their cancer treatment. Many patients may see themselves as victims, buffeted by their circumstances. If you can help these patients to see themselves as potential survivors even more than as patients, that can turn the treatment process into a more positive force.

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Listen and watch. We all know that hearing the diagnosis of cancer for the first time can be a “deer in the headlights” type of moment. The reality is that most people know very

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Keep the information simple. As many complicated specialties do, we have many terms that are unique to our oncology world and become so much a part of our way of speaking that we often use them with each other without explanation. However, most, if not all, of our patients have not been part of our world for long. Ms Levine urged the audience members to remind their colleagues to be careful about words and phrases they use, even terms that they think everyone knows.

little about cancer and treatment options until that one moment when it becomes a personal diagnosis. It is human nature to want to not appear stupid and to simply nod and respond that there are no questions, when inside there may be “a million” questions. Many patients are nervous or frightened, and they may not be hearing or registering what is being said. Even if you see the patient in front of you nodding his/her head in full agreement, please keep asking if they understand and wait for an answer.

July 2012

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ACOA 2012 Conference

Seeing Cancer Care Through…Continued from page 9

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“Read” the patients for their level of engagement. Ms Levine suggested that not all patients are willing to take on the burden of understanding their care and making decisions. Some may have consciously or unconsciously offloaded the responsibility of knowledge over to the physician or nurses as the experts—and this could affect how they hear instructions or information essential to their treatment.

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Be self-aware. This was a very important issue for Ms Levine.

She pointed out that she and other patients note many things going on around them, and they usually will try to interpret those (even little) things in terms of their own care.

Patients read signs—the little frown as the physician considers their chart, the serious conversation outside the waiting room, a sigh as the physician enters their examination room—and they may misinterpret them as bad signs about their care.

They do so even if that frown was remembering that you have to pick up milk on the way home, the serious conversation outside the room was about another person or situation, or perhaps that sigh was a deep breath to clear your mind and focus on this patient, and none of those little things were ever about the patient or his/her cancer.

Ms Levine observed that patients with cancer can turn into narcissists and interpret what goes on around them as being about them; therefore, physicians, nurses, and staff have a responsibility to recognize that every facial gesture, every tone of voice, and every sign can be interpreted as significant.

She remembered clearly how she would read the technicians’ faces as they looked at the mammograms— were they intense, or did they take extra time or repeated tests?—look-

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ing for signs of any hint about her condition.

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Lead with the good news. One key point she made was for oncology center staff to recognize how nervous patients are and to get to the bottom line quickly if it is good news. Ms Levine shared one example of how misleading poor communication can be: years after her cancer treatment, she had a mam-

Physicians, nurses, and staff have a responsibility to recognize that every facial gesture, every tone of voice, and every sign can be interpreted as significant. mogram that needed further explanation. She received a stereotactic breast biopsy (and noted that they really do hurt, no matter what anyone says) and then was told someone would call her on Friday. She explained that it was all right to leave a message on her answering machine, but she was told that that was against policy, especially because she did not identify her name on the answering machine message.

She also noted that setting expectations is important. (When a patient hears that the office will get back to her on Friday, she is waiting at 8:01 AM. Therefore, if you usually return calls at the end of the day, tell that to the patient up front to reduce anxiety.) Finally, in her case, her phone rang later in the afternoon.

The first thing she heard after

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answering was a somber voice asking, “Are you alone?” and “Is no one with you?” (2 immediate bad signs in her mind).

She was then told, “Because of your biopsy, we think we see calcification” (but she had no idea what that meant and it was not explained), and “We would like you to come back in 6 months, but there is no immediate concern.” The delay between the somber voice saying, “Are you alone?” and hearing, “There is no immediate concern” seemed like an eternity. It would have been better for the somber voice to have led with “This is Dr X. I have good news,” and then explain the details.

Another time Ms Levine’s physician left a message telling her that a test “looked funny,” but he did not call back in a timely fashion. She then got a recorded message on her cell phone from “Mike”, the physician assistant, saying that he could not leave a message on her home phone because she did not have her name on the home message machine, and he asked her to call back—the physician wants to discuss her biopsy. She called back and after some difficulty, she finally got Mike. He opened the conversation noting that the physician wants to talk with her about her biopsy, but then proceeded to say that all was fine. She went through needless hours of agony and worry, because of these communication insensitivities.

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Good communication is important at all times. Ms Levine had just had a biopsy, and although she still appeared unconscious, her physician came in to stand by her.

He noted repeatedly, “Can you hear me? The nodes were clean, you are fine. I will be back.” He then left to attend to another patient as he explained, but she, even semiconscious, had heard him and relaxed.

ACOA 2012 Conference

That was just what she needed to hear at that moment. To this day, years later, she still remembers floating in and out of consciousness but with the warmth and comfort of her physician’s words putting her mind at rest.

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Patients need reassurance. Patients want to know that they are doing the right things in their treatment and may try to exhibit good behavior during treatment based on the belief that if you “like” them, they will heal better and faster. This means that the physicians, staff, and social workers need to assure patients that there is no “right” way to go through this, and that all patients need to do what is right for them. The majority of patients are new at this “cancer thing” and do not know what to do.

One other memorable moment

for Ms Levine was when, after her diagnosis, she met with the physician to discuss her treatment. She was trying to be a “perfect patient” and not cry, which of course did not

your family.” This made her feel like an individual who was part of the care team, and that they would support her and do whatever was necessary to get her through to the other side of this, and that it was all right to trust her own feelings and her care team.

Physicians, staff, and social workers need to assure patients that there is no “right” way to go through this, that all patients need to do what is right for them.

Quality Measures Ms Levine’s comments were particularly illuminating at the ACOA conference that was focused on quality and measurement of quality in cancer care. Some of the most valued moments that can have a significant impact on the ability and confidence of the patient to battle cancer are not easily measurable but come from the heart and the daily interactions, gestures, and smiles that the cancer support team shares with each patient every day. l

work. The physician then called in the nurse and social worker, and they said simply to her, “Today and for however long you need us, we are

Measuring Oncology Quality through QOPI: A Growing Industry Standard

By Dawn Holcombe, MBA, FACMPE, ACHE

Chicago, IL—The question of how to define and measure quality in oncology is one of the hottest topics in oncology care today. At the 2012 annual conference of the American College of Oncology Administrators in Chicago this past June, a keynote panel discussed how they are meeting that challenge. Robert Hauser, PharmD, PhD, the new Senior Director of Quality and Guidelines at the American Society of Clinical Oncology (ASCO), joined Beth Hayden, RN, BSN, MBA, OCN, Director of Oncology Services at the OSF Saint Anthony Medical Center, Rockford, IL, and Jenna VanGilder, RN, BSN, OCN, Director of Cancer Services at

lives—at the OSF Saint Anthony Medical Center and the Edward Hospital Cancer Services.

ASCO launched the QOPI pilot program in 2002, and expanded the program to all members in 2006.

After a period of measure and content expansion, the QOPI certification program was launched in 2010.

Practices have the option to participate in 2 chart review programs each year, and by spring 2012, more than 6700 individual charts have now been reviewed in almost 300 participating practices. More than one third of participating QOPI practices (approximately 130) have now also achieved QOPI certification. More

Edward Hospital, Naperville, IL, in describing the national ASCO Quality Oncology Practice Initiative (QOPI), and how it is being adapted across the country and in their own centers.

The QOPI Program Practices not only have the ability to voluntarily participate in the QOPI program but also to obtain certification under the QOPI certification program. Conference attendees very much appreciated the chance to better understand the program itself and also to listen to 2 real-world examples of colleague institutions adapting the program and its processes to their daily

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ACOA 2012 Conference

Measuring Oncology Quality…Continued from page 11 QOPI Quality Measures The QOPI measures cover 3 significant areas of care: Core measures • Care documentation • Chemotherapy administration • Pain management • Smoking cessation • Psychological support Disease-specific modules • Breast cancer • Colorectal cancer • Non-Hodgkin lymphoma • Non–small-cell lung cancer Additional domain-specific modules • End-of-life care • Symptom/toxicity management than 100 measures are now actively being tracked, and expansion is planned for measures such as pediatric oncology, gynecologic cancer, urology/prostate cancer, cost of care, and efficiency.

Quality Measures In 2012, oncology practices and payers are struggling to find universally acceptable measures that reflect quality in cancer care. In the absence of universal measures, it could be too easy to focus solely on the cost of treatment, without enough attention paid to how that treatment is being delivered. The QOPI program offers not only universal measures but also a way to track and benchmark success against those measures in practices and cancer centers of all sizes and types, even though much of the needed information is still buried in the patient’s medical chart.

This helps payers and practices to change their negotiations from a claims-based discussion to more of a quality initiative–based discussion.

ASCO does not release individual practice information or scores, but it does encourage practices and payers

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to recognize the value of QOPI participation and certification.

Program Participation Participation in the QOPI program itself is fairly straightforward. If a cancer center desires physicianlevel reporting, it will be necessary to review and submit findings for a minimum of 24 charts for each of 2 or more modules. ASCO offers significant support through a help desk, training videos, and teleconferences as practices prepare for the chart review process. As increasing numbers of practices implement electronic medical records (EMRs), many are finding it easier to extract QOPI-related data this way rather than by manual review.

ASCO suggests the following 4step process for practices planning to participate in the QOPI program:

1

Gaining access to the system and setting up the needed accounts and any restrictions on access for staff at different locations, depending on patient and program privacy expectations

2

Getting familiar with the tools and methods of the program, including the forms and the questions

3

Getting prepared, that is, defining passwords, training staff, getting ready for the 5-week period of participation and submission

4

Participating (which entails identifying eligible charts no more than 1 week before the actual data collection) and completing submissions within the 5-week allotted time frame for each data collection session.

OSF Saint Anthony Medical Center Two participating cancer centers offered great insight into what par-

ONCOLOGY PRACTICE MANAGEMENT

I July 2012

ticipation actually entailed for their programs.

Ms Hayden, from OSF Saint Anthony Medical Center, reported that the key to successful participation and eventual certification under the QOPI program was to create a solid base of support and visibility for the program. She and her colleagues made participation in QOPI a 20112012 oncology service line goal, as well as a cancer committee programmatic goal. They solicited a physician champion to shepherd the program through internal discussions, as well as the support of the oncology medical director. They also assigned resources to the program in the form of a QOPI resource/audit team.

The first time Ms Hayden and her colleagues tried to participate, they started late and were unable to finish within the designated 5-week period, but once they became active in later sessions, they found that they loved the participation. Ms Hayden noted that the data collection covers a 2year window—if the data are related to initial visits and you were not following those measures at the time, the previous lack of measures will still be reflected in lower measure scores.

Because active participation in the program, with attention to individual measures, evolves, the scores will improve as the data time frame catches up with more diligent following of measured data elements over time.

Ms Hayden shared the following strategies that her cancer center implemented to improve outcomes, as a result of participating in the QOPI program: • Creating and implementing a standardized physician progress note • Incorporating specific questions into dictation templates that address the areas that need improvement Continued on page 14

“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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Measuring Oncology Quality…Continued from page 12 • Discussing indicators at weekly physician meetings • Incorporating specific QOPI indicators into the oncology service line scorecard.

For illustrative purposes, Ms Hayden also shared the following measures, for which she and her colleagues at the center extracted data and participated: Core measures module. Under this module, the cancer center staff extracted data and received benchmarking for several measures, including: 1. Pain addressed appropriately 2. Documented plan for chemotherapy, including doses, route, and time intervals 3. Chemotherapy intent (curative vs palliative) documented 4. Cigarette-smoking status documented by the second office visit 5. Patient emotional well-being assessed by the second office visit.

Breast cancer measures module.

Under this module, some of the data extractions covered the following: 1. Combination chemotherapy received within 4 months of diagnosis by women aged <70 years with American Joint Committee on Cancer (AJCC) stage I (T1c) to stage III estrogen receptor (ER)-negative/progesterone receptor (PR)-negative breast cancer 2. Test for HER2/neu gene over expression 3. Trastuzumab not received when HER2/neu status is negative or undocumented 4.Trastuzumab received by patients with AJCC stage I (T1c) to stage III HER2/neu-positive breast cancer 5. Tamoxifen or aromatase inhibitor received within 1 year of diagnosis of patients with AJCC stage I (T1c) to stage III ER-positive or PR-positive breast cancer.

Colon/rectal cancer measures

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module. Under this module, the data collection included the following: 1. Carcinoembryonic antigen test within 4 months of curative resection for colorectal cancer 2. Adjuvant chemotherapy received within 4 months of diagnosis by patients with AJCC stage III colon cancer 3. Adjuvant chemotherapy received within 9 months of diagnosis by patients with AJCC stage II or stage III rectal cancer 4. Colonoscopy before or within 6 months of curative colorectal resection or completion of primary adjuvant chemotherapy.

Ms Hayden expressed extreme satisfaction with the process and the potential value of their center’s QOPI certification. She noted that the ability to benchmark and focus on quality initiatives that were more clinically driven and cancer specific helped with the standardization of the process and even with some other certification and accreditation processes they needed to follow.

Edward Hospital Cancer Center Ms VanGilder from Edward Hospital stated that the center was already accredited by the Commission on Cancer, and the center’s leadership decided to seek QOPI certification as well, after their first very successful QOPI participation session.

Ms VanGilder shared much of the preparation and the process they instituted for the certification-related QOPI site visit. She noted that much of the program seems to reside in the responsibilities of the nurses, and that she found it was appropriate to spend much upfront time preparing internally for the certification process and the site visit.

The QOPI program has very specific expectations for a certification

ONCOLOGY PRACTICE MANAGEMENT

I July 2012

site visit, including: • Introduction/tour of the facility • Observation of 2 to 3 patients scheduled for chemotherapy (QOPI randomly selected) • Observation of the preparation, delivery, and administration of chemotherapy • Observation of how ASCO/ Oncology Nursing Society safety standards are implemented • Review of chart documentation of patients who are observed • Policy and procedure review • Review of policies related to QOPI selected standards • Interview of 2 to 3 nurses, 1 pharmacist, 1 administrator, and 1 educator • Exit interview.

Ms VanGilder shared the process that her cancer center created internally to prepare for the site visit.

Some of the materials were available through the ASCO resources and help desk, and others were created internally by Ms VanGilder and her staff.

All of the cancer center staff were required to attend a QOPI certification update and a presentation to introduce them to the QOPI and give them an overview of the program. The presentation reviewed what the staff could expect during the certification visit. All policies and procedures related to the 17 QOPI standards specific to the preparation and administration of chemotherapy were organized in a binder, which was made readily available for the nurses to review.

The staff was educated on the QOPI standards, and the evidence to meet different criteria was reviewed and shown to them in the EMRs. Demonstrations were also made on how they would talk about the evidence, with the surveyor utilizing the EMRs. Most important, Continued on page 16

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ACOA 2012 Conference

Measuring Oncology Quality…Continued from page 14 practice interviews were done with staff members when they were preparing to give chemotherapy and during its administration to make them more comfortable with the questions that would most likely be asked by the surveyor.

Ms VanGilder noted that no matter how experienced or skilled the staff was in delivering cancer care, not everyone was prepared at first to clearly describe what they were doing and how those actions were consistent with the QOPI care standards; therefore, a good deal of time was spent in adding those skills to the skill sets of all their staff, in preparation for the site review.

Part of the constant preparation process for the site visit included using a clinical educator to observe clinical practice in action and conduct mock interviews of staff; safety standards were also reviewed on a one-on-one basis with the key individuals who would be present in the infusion clinic during the site visit.

By creating an internal binder with all the policies and procedures, Ms VanGilder and her staff also found that there was a need for, and a value in, a standardized orientation process for the staff in general. The center has also added a quality coordinator to follow through with consistency in the process and training at the center, a direct benefit and result of preparing for the QOPI certification.

Ms VanGilder also shared some of the recommendations she and her staff received as a result of their participation in the QOPI program.

One recommendation was to have all the physicians become certified in CPR (cardiopulmonary resuscitation). Another was that depression

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(ie, the psychosocial effects of treatment) was a huge issue that they were addressing inconsistently. A third recommendation involved the clarification of cancelled appointments versus “no shows” in their records.

The time required to participate in the data extraction has shrunk measurably with ongoing program participation, according to Ms VanGilder. When she first started,

Increasingly, payers will be asking for evidence of such certification participation as a mark of quality, making participation almost a necessity for providing cancer services. the process took a while, even when she used her EMRs as much as possible; it now takes approximately 15 to 20 minutes per patient. There is a learning curve involved with knowing what the questions are—the more you do it, the easier it becomes.

What Does a QOPI Certification Entail?

Practices or cancer centers have to participate in the QOPI program to become certified, but certification is a full program on its own.

The QOPI certification process entails abstracting and scoring cer-

ONCOLOGY PRACTICE MANAGEMENT

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tain levels for all modules of QOPI participation, as well as attestation to meeting all 17 chemotherapy preparation and administration safety standards, submitting policies and documentation for safety standards, and random (personal health information de-identified) medical records for validation. A majority of practices seeking certification will also participate in an onsite review by advanced-degree oncology nurses.

Findings and results for the measures and standards scoring and the onsite visit are evaluated for qualification for a QOPI certification.

The certification standards center on staffing, treatment planning and chart documentation, informed consent, chemotherapy orders, drug preparation, chemotherapy administration, patient monitoring and assessment, and preparedness for emergency situations. Once certification is awarded, the certification is valid for a period of 3 years, after which recertification is expected.

QOPI certification is one of the few certification programs available to private cancer practices, and it fully complements cancer center certifications by the Commission on Cancer and other hospital-based accreditation programs.

Increasingly, payers will be asking for evidence of such certification participation as a mark of quality, making participation almost a necessity for providing cancer services.

Another value to such certification programs is that they set the bar for care delivery very high clinically and may reduce the risk of nonphysicianor hospital-based programs seeking to deliver cancer care services in alternative treatment models. l

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Practice Management

Practice Management Strategies…Continued from page 1 ogy networks for the purpose of implementing a comprehensive oncology practice management strategy. This strategy has been designed to address the cost of cancer care, while improving treatment quality and health Craig Deligdish, MD outcomes. Equipping physicians with the electronic infrastructure and up-to-date evidencebased pathways needed to deliver cost-effective, evidence-based care is one of the aims of this organization.

In addition, programs are made available to practices that enable physicians to deliver state-of-the-art care, while also assisting patients and their families at the end of life.

Practice Tools Moving beyond data and infrastructure, Oncology Resource Networks has worked with providers to implement financial incentives that put these tools into practice in an expeditious manner. These tools include assisting practices to network in a procompetitive manner with other physicians for the purpose of implementing pay-for-performance programs, shared-savings models, quality initiatives, rational fee schedules, and bundled payment models.

These approaches enhance practice value from the perspective of health plans and payers and have helped practices that have an interest in differentiating themselves in this increasingly challenging marketplace. The goals of such an approach include sustaining community oncology practices, as well as assisting hospital-based and academic practices that are facing many of the same challenges as community practices.

Clinical Integration Oncology Resource Networks’

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core benefit for community practices is its representation with employers and health plans. The hallmark of clinical integration, which is the basis for the concept of ACOs, allows practices to invest both financial and human capital to improve patient care. Oncology Resource Networks has created a patient-centric approach by embracing a model that addresses patient care in a prospective manner. This was done through the adoption of a web-based decision support tool that ensures evidencebased care at the point of care. This decision support tool helps physicians to take advantage of new diagnostic tools to include molecular and companion diagnostics and, in the near future, next-generation sequencing. This approach allows physicians to deliver targeted, personalized care and provides costeffective benefits to patients.

Pathways The development of pathways that are based on nationally accepted treatment guidelines has been designed by oncologists to improve practice profitability and yet reduce the cost of cancer treatment. The development of pathways that incentivize cost-effective approaches to care and the creation of pay-forperformance programs with payers have been designed to reduce the inefficiencies associated with the reimbursement process. The webbased decision support tool made available to Oncology Resource Networks’ member practices obviates the need for the more inefficient and time-consuming paper-driven prior approval and preauthorization programs, while avoiding practices that increase payment delays and bad debt.

Oncology Resource Networks’ evidence-based practice pathways are designed to incentivize physi-

ONCOLOGY PRACTICE MANAGEMENT

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cians to utilize protocols and pathways that provide cost-effective treatment options. The program is designed to foster interdependence among physician participants through the use of incentives that reward physicians and practices that adhere to evidence-based practice guidelines that reduce cost. Physicians are rewarded for the financial investments of “human capital” that are necessary to build this approach to care coordination in an oncology medical home. The physician’s office staff is an integral component of the care coordination team, utilizing the technology tools that are provided

by Oncology Resource Networks.

The uniqueness of this program in the treatment of patients with cancer—the implementation of advanced illness programs and palliative care programs—and the incentives that have been created to utilize these programs, as well as the evidence-based guidelines, contribute to the network’s representation of practices with payers and health plans.

Collaboration Oncology Resource Networks’ programs facilitate and ensure collaboration among physician members, thereby improving patients’ health and potentially reducing the cost of cancer treatment by creating a comprehensive care management approach that also increases the quality of care rendered to patients.

The benefits to payers and patients include an integrated set of services that include a web-based technology system that monitors adherence to evidence-based practice guidelines and implements policies and procedures related to the program’s utilization management, case management, and disease management activities.

This program is designed to create

Practice Management

substantial integration among its participants and is expected to create significant efficiencies, including improved quality of care and more cost-effective care. The network’s representation of its membership with payers results in greater coordination of care through the use of advanced illness programs that have been previously demonstrated to reduce hospital length of stay, emergency department visits, and hospital admissions, while also improving the quality of care that patients and their family members receive.

Innovation One of the hallmarks of Oncology Resource Networks’ commitment to patient care is testing these innovative approaches.

Physicians who participate in the network agree to use a web-based decision support tool, receive enhanced reimbursement for participation, have the opportunity to receive bonuses that result from the network’s shared-savings model, and participate in an oncology ACO. The reduction in costs related to hospitalization, radiation therapy, and other cancer-related treatment expenditures will be distributed between participating physicians and the health plan, employer, or the Centers for Medicare & Medicaid Services (CMS). This model of accountable care and clinical integration created by Oncology Resource Networks also encourages patients to participate in the treatment decision-making process. As part of the ACA, CMS has permitted Oncology Resource Networks to operate as an ACO and share with its practices the savings that are generated through programs that reduce the cost of cancer treatment in the Medicare population.

Recently, Oncology Resource Networks collaborated with a number of

discussed the potential for a bundled payment approach as an alternative strategy for reimbursement. This approach, which has been tested by UnitedHealthcare in a number of large practices, is clearly attractive to payers and to providers, who see it as a potential opportunity to reduce costs and improve margins.

However, many practices would be challenged by assessing the risks associated with providing patients with chemotherapy drugs, given the ever-changing treatments and the novel treatments that are constantly being made available to patients with cancer. Such an approach, which removes the drug cost from the treatment paradigm, potentially results in administrative and patient care challenges that can prevent it from becoming a scalable approach in today’s complex care system. In addition, applying this approach to a Medicare population is potentially problematic. The complexities of variable patient care settings, including academic medical centers, hospital-based practices, community oncology practices, and practices providing access to 340B drug pricing, can potentially further complicate this as a scalable approach to reimbursement.

Along with traditional forms of reimbursement and bundled payment approaches, there are a variety of methods that include rational reimbursement. In this scenario, physicians are incentivized to receive higher reimbursements for generic alternatives, where costeffective options are available, suggesting those as reasonable choices.

Oncology Resource Networks has pioneered this approach, as well as pay-for-performance strategies, in markets where a rational reimbursement strategy is a not an option for physicians or for health plans. l

organizations, including the RAND Corporation, led by Mireille Jacobson, PhD, Deputy Director of Health Economics, Finance and Organization, for the purpose of funding opportunities. Jalpa Doshi, PhD, Director of Value-Based Insurance Design Initiatives at the Leonard Davis Institute’s Center for Health Incentives and Director of the Economic Evaluations Unit of the Center for Evidence-Based Practice at the University of Pennsylvania Health System, and Henry Glick, PhD, at the University of Pennsylvania also collaborated with the networks to provide ongoing outcomes analysis. Other collaborations include the Florida Agency for Health Care Administration on behalf of Florida Medicaid, Blue Cross Blue Shield of Florida, the Florida Health Care Coalition, CIGNA, EQ Health, Vital Decisions, and eviti.

New Ways to Incentivize Oncologists to Provide Cost-Effective Care A number of pilot projects have been developed for the purpose of looking at innovative strategies to realign the financial incentives associated with treating patients with cancer. The concept of episodebased payments has been proposed intermittently over the past several decades and has received more prominence as a result of the ACA. In a 2011 article published in Health Affairs, Peter Bach, MD, and colleagues discussed the idea of episode-based payments for cancer care and proposed a pilot for Medicare. More recently, the April 2012 issue of Health Affairs was dedicated to “Cancer Care: Value, Costs, and Quality.” Lee Newcomer, MD, of UnitedHealthcare, reviewed the historical context of the “buyand-bill” reimbursement model and

July 2012

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www.OncPracticeManagement.com

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Third Annual Navigation and Survivorship Conference PRELIMINARY AGENDA* Friday, September 14 12:45 – 1:00pm

1:00 – 2:00pm & 2:15 – 3:15pm

3:15 – 3:30pm 3:30 – 5:00pm

5:00 – 6:00pm 6:00 – 8:00pm

Welcome Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS Pre-Conference Workshops Beginners Track • Core Principles of Navigation Nicole Messier, RN, BSN Pamela J. Vlahakis, RN, MSN, CBCN Members • Getting Excited about Research – Case Examples Linda Fleisher, PhD, MPH Elaine Sein, RN, BSN, OCN, CBCN • Panel Discussion: Building Optimal Community Outreach – Lay and Community Jean B. Sellers, RN, MSN (Moderator) Leah Leilani Beck, BS Jessica Denton, MSW • Implementing a Survivorship Program/Clinic Cynthia Waddington, RN, MSN, AOCN Break Administrators Track • Administering a Navigation Program Bonnie J. Miller, RN, BSN, OCN, FAAMA Elizabeth Whitley, PhD, RN Navigators Track • How Do Case Managers and Navigators Interface?

Nancy Skinner, RN-BC, CCM FREE TIME Welcome Reception/Posters in the Exhibit Hall

Saturday, September 15 7:30 – 8:30am

8:30 – 8:45am 8:45 – 9:45am

9:45 – 10:00am 10:00 – 11:30am

Breakfast/Product Theater: New Route of Administration for Velcade® supported by Millennium Pharmaceuticals, Inc. Welcome & Introductions Conference Co-Chairs General Session 1: Navigation Update: 2012 Current Regulations – Navigation & Survivorship Care Plan Linda Ferris, PhD Break Disease-Site–Specific Breakouts Stand-Alone Sessions • Breast Cancer Navigation Mary Rooney, RN, BSN, OCN • Thoracic Oncology Navigation Pamela Matten, RN, BSN, OCN • GI Cancer Navigation Coralyn Martinez, MSN, RN, OCN • Colorectal Cancer Navigation Maura Kadan, RN, MSN, OCN

11:45 – 1:00pm 1:15 – 2:15pm 2:15 – 3:15pm

3:15 – 4:15pm

4:15 – 5:00pm

5:00 – 7:00pm 7:00pm

• GYN Cancer Navigation Robin A. Atkinson, RN, BSN, OCN • Prostate Cancer Navigation Juli Aistars, RN, MS, APN, AOCN Rapid Fire Sessions with Panel • Head, Neck, & Neuro Navigation Heather Stern, RN, BSN, CNOR, OCN And • Hematology/Oncology Tina Scherer, RN, MSN, OCN Administrators Session • The Role of the Administrator Lisa Shalkowski, RN, BSN, MSM Lunch in the Exhibit Hall Advocacy Keynote TBD General Session 2: Best Practices in Survivorship Care Rehabilitation Julie Silver, MD General Session 3: Plenary Session Financial and Legal Issues for Our Cancer Patients David S. Landay, JD The Art of Exceptional Professional Performance – Making a Difference in Your Patients’ Lives Selinza Mitchell, RN Poster Award Reception in the Exhibit Hall Pamela Matten, RN, BSN, OCN Conclusion of Day – Networking FREE TIME

Sunday, September 16 7:30 – 8:30am 8:30 – 9:30am

9:30 – 10:30am

10:30 – 10:45am 10:45 – 12:15pm

12:15 – 1:15pm 1:30 – 2:30pm

2:30 – 2:45pm

Breakfast Symposium/Product Theater General Session 4: Navigation in the Age of Personalized Cancer Care Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS General Session 5: Best Practices in Addressing Health Inequities Lauren Kelley, MSW, MPA Adrienne Lofton, RN, MSN Break Practice Setting – Panel Discussion with Moderator • Office-Based Roxanne Parker, RN, MSN, CPN (Moderator) • Academic Bonnie J. Miller, RN, BSN, OCN, FAAMA • Community Hospital–Based Karyl Blaseg, RN, MSN, OCN Lunch in the Exhibit Hall Clinical Survivorship Guidance Mandi Pratt-Chapman, MA Katherine Sharpe, MTS Conclusion/Final Remarks Conference Co-Chairs

*Preliminary agenda, subject to change.

September 14-16, 2012 Phoenix, Arizona Arizona Grand

CONFERENCE REGISTRATION Register online: www.regonline.com/aonn2012 *Early Bird Rate: $295 Includes Membership through September 30, 2013.

Conference Registration: $345 Includes Membership through September 30, 2013. *Early bird expires August 1, 2012.

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

Lillie D. Shockney, RN, BS, MAS University Distinguished Associate Professor of Breast Cancer Adm Director, Johns Hopkins Clinical Breast Programs Adm Director, Johns Hopkins Cancer Survivorship Programs Depts of Surgery and Oncology Associate Professor, JHU School of Medicine, Depts of Surgery, Oncology and Gynecology Associate Professor, JHU School of Nursing Johns Hopkins Avon Foundation Breast Center Baltimore, MD

FACULTY* Juli Aistars, RN, MS, APN, AOCN Robin A. Atkinson, RN, BSN, OCN Leah Leilani Beck, BS Karyl Blaseg, RN, MSN, OCN Jessica Denton, MSW Linda Ferris, PhD Linda Fleisher, PhD, MPH Maura Kadan, RN, MSN, OCN Lauren Kelley, MSW, MPA David S. Landay, JD Adrienne Lofton, RN, MSN Coralyn Martinez, MSN, RN, OCN Pamela Matten, RN, BSN, OCN Nicole Messier, RN, BSN Bonnie J. Miller, RN, BSN, OCN, FAAMA

Roxanne Parker, RN, MSN, CPN Mandi Pratt-Chapman, MA Mary Rooney, RN, BSN, OCN Tina Scherer, RN, MSN, OCN Elaine Sein, RN, BSN, OCN, CBCN Jean B. Sellers, RN, MSN Lisa Shalkowski, RN, BSN, MSM Katherine Sharpe, MTS Julie Silver, MD Nancy Skinner, RN-BC, CCM Heather Stern, RN, BSN, CNOR, OCN Pamela J. Vlahakis, RN, MSN, CBCN Cynthia Waddington, RN, MSN, AOCN Elizabeth Whitley, PhD, RN *For full information visit www.aonnonline.org

TARGET AUDIENCE AONN’s Third Annual Conference is the only meeting that gives you access to decision-makers and key practitioners involved in oncology navigation and survivorship. If your company provides any of the following services/products for the oncology healthcare community, this is the meeting for you.

This educational initiative is directed toward oncology nurse navigators, patient navigators, and social workers.

• • • • •

Pharmaceutical/Biotech Genetic Laboratory Services Navigation Software Patient Advocacy Training

• • • • •

Patient Access Reimbursement Publishers Education Certification

CONTINUING EDUCATION INFORMATION Goal AONN’s Third Annual Navigation and Survivorship Conference will advance the role of navigation and survivorship in cancer care to ultimately improve the quality of patient care.

Objectives • Discuss the evolution of the role of navigation in healthcare • Assess strategies for navigating diverse patient populations by cancer type and environmental factors • Define methods for providing patient support and guidance in the age of personalized cancer care • Evaluate best practices regarding survivorship and psychosocial care

CALL FOR ABSTRACTS This is an opportunity to share research, programs, and results with your colleagues.

Submit your abstract via e-mail to conference@aonnonline.org.

Abstract Deadline: August 1, 2012

SPONSORS This activity is jointly sponsored by AONN Foundation for Learning, Inc., Center of Excellence Media, LLC, and Medical Learning Institute, Inc.

CONFERENCE OVERVIEW

REGISTERED NURSE DESIGNATION

AONN’s Third Annual Conference will continue to advance the navigation profession by expanding the scope of educational sessions, networking opportunities, and poster presentations. In addition, this year’s conference will address the evolving challenges of program improvement, the role of personalized medicine, and implementing best practices in navigation, survivorship, and psychosocial care.

Medical Learning Institute, Inc. Provider approved by the California Board of Registered Nursing, Provider Number 15106, for up to 12.25 contact hours.

SOCIAL WORK DESIGNATION This activity is pending approval from the National Association of Social Workers. Contact hours for this continuing social worker education activity have been submitted to the National Association of Social Workers.

www.regonline.com/aonn2012

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

Hot Topics in Community Cancer Centers: The Affordable Care Act

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

E

very summer and fall, the Association of Community Cancer Centers (ACCC) hosts a series of Regional Oncology Economic and Management Meetings.

These meetings are targeted for members who are in the business of delivering cancer care in the hospital or the office setting. The regional gatherings offer ACCC members the opportunity to get together with other providers in their region to receive up-to-date information on the latest trends and the economics of oncology care. The ACCC has just completed its third regional meeting in Berkeley, CA. The recent regional meetings have highlighted tips and trends on quality reporting and the transition to the International Classification of Diseases, Tenth Edition (ICD-10), updates from the new Commission on Cancer standards, financial counseling, payer negotiation in the age of accountable care organizations, patient navigation education, and a legislative update discussing the impact of policy measures on cancer care policy.

The hot topic at the most recent ACCC meetings has been the Patient Protection and Affordable Care Act (ACA) and how the US Supreme Court would rule on the constitutionality of the mandate within the ACA. After much anticipation, the Supreme Court recently upheld the law (with one exception

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regarding Medicaid expansion).

As expected, the decision on the constitutionality of the individual mandate in the ACA came down to a vote of 5 to 4, with Chief Justice John Roberts providing the swing vote for the majority. This is a bit surprising. Most people (including myself) believed that Justice Kennedy would be the swing vote.

The decision: The ACA, including the individual mandate that virtually all Americans buy health insurance, is constitutional (with the exception of one provision).

An Interesting Conundrum What is interesting in this decision is the grounds on which the justices determined the law to stand. As you may remember, the primary argument for the upholding of the individual mandate rested in Congress’s power to regulate commerce between the states to require everyone to buy health insurance (ie, the Commerce Clause). There were not 5 votes to uphold the mandate on this ground. However, 5 justices (Roberts, Breyer, Sotomayor, Ginsburg, and Kagan) did agree that the penalty a citizen must pay if he or she refuses to buy insurance is a kind of tax that Congress can impose using its taxing power.

What this means: Congress does not have the power to tell you to buy health insurance, but it does hold the power to tax you if you do not.

Because the mandate survives, the Supreme Court did not need to decide what other parts of the statute were constitutional, except for a provision in the ACA requiring states to

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I July 2012

comply with new eligibility requirements for Medicaid or risk losing all of their Medicaid funding. On that question, the Court held that the provision is not constitutional. States will have a choice whether to expand their Medicaid programs; those that do not comply with this new requirement will lose additional expanding Medicaid funding moving forward, but they will retain the federal funding they currently receive for their Medicaid program.

Assessing the Full Impact of the Decision ACCC members can look forward to hearing a full breakdown of the Supreme Court’s decision on the ACA and the impact of the decision on community cancer care, as well as how Congress will address unresolved issues from the 2012 session—including next steps on a permanent solution for the sustainable growth rate—at the ACCC 29th Annual National Oncology Conference on October 3-6, 2012, in San Antonio, TX. In addition, to help members better manage services, maximize resources, engage staff, and promote transformational change, they will learn pioneering strategies and practical tools from some of the top achievers in community cancer care—the winners of the 2012 Innovator Award.

More information about this meeting and others is available at www.accc-cancer.org/meetings/. As always, the ACCC will keep members up to date on the most current topics in cancer care. l

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Replaces J9999, J3490, J3590, and C9284.

Product Description

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

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

10-digit

0003-2327-11

0003-2328-22

11-digit

00003-2327-11

00003-2328-22

NDC Number

The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. This coding guidance is not intended to provide specific directions on requesting prior authorization or submitting claims for YERVOY and does not provide a guarantee of receiving prior authorization or reimbursement. Oncology practices need to make coding decisions based on the diagnosis and treatment of each patient and the specific insurer requirements. www.destinationaccess.com 1-800-861-0048 (phone) Monday through Friday, 8:00 1-888-776-2370 (fax)

AM

to 8:00

PM

ET

Important Safety Information WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs) and thyroid function tests at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Please see Important Safety Information, including Boxed WARNING regarding immune-mediated adverse reactions, continued on the following pages.

REFERENCES 1. YERVOY (ipilimumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb; March 2011.

2. Alpha-numeric HCPCS. Centers for Medicare & Medicaid Services Web site. http://www.cms.gov/ HCPCSReleaseCodeSets/Downloads/12anweb.zip. Accessed November 1, 2011.

Important Safety Information (cont) Recommended Dose Modifications Withhold dose for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5 mg prednisone or equivalent per day.

Permanently discontinue YERVOY for any of the following: t Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day t Failure to complete full treatment course within 16 weeks from administration of first dose t Severe or life-threatening adverse reactions, including any of the following – Colitis with abdominal pain, fever, ileus, or peritoneal signs; increase in stool frequency (≥7 over baseline), stool incontinence, need for intravenous hydration for >24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation – AST or ALT >5 × the upper limit of normal (ULN) or total bilirubin >3 × the ULN – Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full-thickness dermal ulceration or necrotic, bullous, or hemorrhagic manifestations – Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis – Severe immune-mediated reactions involving any organ system – Immune-mediated ocular disease which is unresponsive to topical immunosuppressive therapy Immune-mediated Enterocolitis: t In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) patients t Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis t Infliximab was administered to 5 of 62 (8%) patients with moderate, severe, or life-threatening immunemediated enterocolitis following inadequate response to corticosteroids t 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 t Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/ kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid

tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients t Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent) Immune-mediated Hepatitis: t In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3–5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4% t 13 (2.5%) additional YERVOY-treated patients experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5x but ≤5x the ULN or total bilirubin elevation >1.5x but ≤3x the ULN; Grade 2) t Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution t Permanently discontinue YERVOY in patients with Grade 3-5 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month.

Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids t Withhold YERVOY in patients with Grade 2 hepatotoxicity Immune-mediated Dermatitis: t In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3–5) occurred in 13 (2.5%) patients – 1 (0.2%) patient died as a result of toxic epidermal necrolysis – 1 additional patient required hospitalization for severe dermatitis t There were 63 (12%) YERVOY-treated patients with moderate (Grade 2) dermatitis t 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 t Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/ kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. Withhold YERVOY in patients with moderate to severe signs and symptoms

Please see brief summary of Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions, on the following spread.

Important Safety Information (cont) t Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically. Administer topical or systemic corticosteroids if there is no improvement within 1 week Immune-mediated Neuropathies: t In the pivotal Phase 3 study in YERVOY-treated patients, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported t Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported t Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-Barré–like syndromes t Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities) Immune-mediated Endocrinopathies: t In the pivotal Phase 3 study in YERVOY-treated patients, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients – All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism – 6 of the 9 patients were hospitalized for severe endocrinopathies t Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) YERVOY-treated patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing’s syndrome t Median time to onset of moderate to severe immunemediated endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the initiation of YERVOY t 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 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 t Withhold YERVOY in symptomatic patients. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. Long-term hormone replacement therapy may be necessary Other Immune-mediated Adverse Reactions, Including Ocular Manifestations: t In the pivotal Phase 3 study in YERVOY-treated patients, clinically significant immune-mediated adverse reactions seen in <1% were: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia t Across the clinical development program for YERVOY, immune-mediated adverse reactions also reported with <1% incidence were: myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, and autoimmune thyroiditis t Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions t Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy Pregnancy & Nursing: t YERVOY is classified as pregnancy category C. There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus t Human IgG1 is known to cross the placental barrier and YERVOY is an IgG1; therefore, YERVOY has the potential to be transmitted from the mother to the developing fetus t It is not known whether YERVOY is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from YERVOY, a decision should be made whether to discontinue nursing or to discontinue YERVOY Common Adverse Reactions: t The most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%)

Please see brief summary of Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions, on the following spread.

© 2012 Bristol-Myers Squibb 731US11AB18316 YERVOY is a trademark of Bristol-Myers Squibb.

01/12

Printed in USA

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 YERVOY 3 mg/kg n=131

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

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

USE IN SPECIFIC POPULATIONS Pregnancy

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

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

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:

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 Lung Cancer The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with the management of lung cancer.

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

28

Associated ICD-9-CM codes for lung cancer: 162 Malignant neoplasm of trachea, bronchus, and lung 162.0 Trachea Cartilage of trachea Mucosa of trachea 162.2 Main bronchus Carina Hilus of lung 162.3 Upper lobe, bronchus or lung 162.4 Middle lobe, bronchus or lung 162.5 Lower lobe, bronchus or lung 162.8 Other parts of bronchus or lung Malignant neoplasm of contiguous or overlapping sites of bronchus or lung whose point of origin cannot be determined 162.9 Bronchus and lung, unspecified CPT ® administration codes

Generic (brand) name

HCPCS code: code description

amifostine (Ethyol)

J0207: Injection, amifostine, 500 mg

bevacizumab (Avastin)

J9035: Injection, bevacizumab, 10 mg

bexarotene (Targretin)

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

✓

N/A

bleomycin (Blenoxane)

J9040: Injection, bleomycin sulfate, 15 units

✓

96401, 96409

carboplatin (Paraplatin)

J9045: Injection, carboplatin, 50 mg

✓

96409, 96413, 96415

cetuximab (Erbitux)

J9055: Injection, cetuximab, 10 mg

✓

96413, 96415

cisplatin (Platinol AQ)

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

✓

96409, 96413, 96415

crizotinib (Xalkori)

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

✓

N/A

crizotinib (Xalkori)

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

✓

N/A

cyclophosphamide (Cytoxan)

J8530: Cyclophosphamide, oral, 25 mg

✓

N/A

cyclophosphamide (Cytoxan)

J9070: Cyclophosphamide, 100 mg

✓

96409, 96413, 96415

I

ONCOLOGY PRACTICE MANAGEMENT

FDA-approved for lung cancer

Compendia listed off-label use for lung cancer

I July 2012

✓

96374 96413, 96415

✓

Drug Coding Supplied by RJ Health Systems

FDA-approved for lung cancer

Compendia listed off-label use for lung cancer

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

docetaxel (Taxotere)

J9171: Injection, docetaxel, 1 mg

✓

96413

doxorubicin HCl (Adriamycin)

J9000: Injection, doxorubicin hydrochloride, 10 mg

✓

96409

doxorubicin (Doxil)

J9001: Injection, doxorubicin hydrochloride, all lipid formulations, 10 mg

✓

96413

doxorbicin (Doxil)

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

✓

96413

epirubicin (Ellence)

J9178: Injection, epirubicin HCl, 2 mg

✓

96409, 96413

erlotinib (Tarceva)

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

✓

N/A

erlotinib (Tarceva)

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

✓

N/A

etoposide (Vepesid)

J8560: Etoposide, oral, 50 mg

✓

N/A

etoposide (Etopophus, Toposar)

J9181: Injection, etoposide, 10 mg

✓

96413, 96415

fluorouracil (Adrucil)

J9190: Injection, fluorouracil, 500 mg

gefitinib (Iressa)

J8565: Gefitinib, oral, 250 mg

✓

N/A

gemcitabine (Gemzar)

J9201: Injection, gemcitabine hydrochloride, 200 mg

✓

96413

ifosfamide (Ifex)

J9208: Injection, ifosfamide, 1 g

✓

96413, 96415

irinotecan (Camptosar)

J9206: Injection, irinotecan, 20 mg

✓

96413, 96415

lomustine (CeeNu)

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

✓

N/A

lomustine (CeeNu)

S0178: Lomustine, oral, 10 mg

✓

N/A

mechlorethamine HCl (Mustargen)

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

✓

96409

methotrexate

J8610: Methotrexate, oral, 2.5 mg

✓

N/A

methotrexate

J9250: Methotrexate sodium, 5 mg

✓

96372, 96374, 96401, 96409, 96450

methotrexate

J9260: Methotrexate sodium, 50 mg

✓

96372, 96374, 96401, 96409, 96450

mitomycin (Mutamycin)

J9280: Mitomycin, 5 mg

✓

✓

July 2012

I

96409

96409

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Drug Coding Supplied by RJ Health Systems

Generic (brand) name

HCPCS code: code description

FDA-approved for lung cancer

oxaliplatin (Eloxatin)

J9263: Injection, oxaliplatin, 0.5 mg

paclitaxel protein-bound J9264: Injection, paclitaxel protein-bound particles particles, 1 mg (Abraxane)

Compendia listed off-label use for lung cancer

CPT ® administration codes

✓

96413, 96415

✓

96413

paclitaxel (Taxol)

J9265: Injection, paclitaxel, 30 mg

panitumumab (Vectibix)

J9303: Injection, panitumumab, 10 mg

pemetrexed (Alimta)

J9305: Injection, pemetrexed, 10 mg

✓

96409

porfimer sodium (Photofrin)

J9600: Injection, porfimer sodium, 75 mg

✓

96409

tamoxifen (Nolvadex)

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

✓

N/A

tamoxifen (Nolvadex)

S0187: Tamoxifen citrate, oral, 10 mg

✓

N/A

temozolomide (Temodar)

J8700: Temozolomide, oral, 5 mg

✓

N/A

teniposide (Vumon)

Q2017: Injection, teniposide, 50 mg

✓

96413, 96415

topotecan (Hycamtin)

J8705: Topotecan, oral, 0.25 mg

✓

N/A

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

✓

96413

trastuzumab (Herceptin)

J9355: Injection, trastuzumab, 10 mg

✓

96413, 96415

vinblastine (Velban)

J9360: Injection, vinblastine sulfate, 1 mg

✓

96409

vincristine (Vincasar PFS)

J9370: Vincristine sulfate, 1 mg

✓

96409

vinorelbine (Navelbine)

J9390: Injection, vinorelbine tartrate, per 10 mg

96413, 96415

✓

✓

✓

96413, 96415

96409

*When billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code (eg, J8999 for Xalkori) in Column 24D and the drug name, strength, and NDC (National Drug Code) in Box 19 or 24A to ensure appropriate reimbursement. Please note: check with payer regarding correct placement of medication information in Box 19 or 24A. 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.

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ONCOLOGY PRACTICE MANAGEMENT

I July 2012

RJ Health Systems The Creators of ReimbursementCodes.com

RJ Health Systems — the pharmaceutical specialists that healthcare professionals have turned to since 1983 for their drug information.

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

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

ReimbursementCodes.com incorporates the CMS HCPCS and AMA CPT Drug codes into a system that crosswalks each drug code with the drug’s NDC and brand/generic name.

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

>> ReimbursementCodes.com >> Drug Diagnosis Coding >> CMAC >> PartBorPartD.com This information was supplied by: >> NDC Conversion Database >> Min/Max Dosing >> Advisories >> Notations 30 Cold Spring Road, Rocky Hill, CT 06067 T: (860) 563-1223 • F: (860) 563-1650 • www.RJHealthSystems.com Consulting >> Clinical rjhealthsystems.com

Legal Update

Protecting Against Disallowance through Practice Structure

By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

M

ore so than ever, regulators are using a provider’s practice structure as the tool to investigate or deny reimbursement, and convict providers of improper conduct. Doing so has proved fairly simple from the regulator’s standpoint, mainly because many physicians enter and exit medical school, residency, and fellowship programs without having been subjected to education regarding the laws, and regulations that govern appropriate practice structure. As such, many practices are structured and operate in violation of the many healthcare laws.

Although our current educational system is arguably the best for the patient, a gaping hole is left in many physicians’ knowledge base about the requirements of operating their own medical practices. The lack of know-how or understanding of allowable practice structures or constraints is by no means the physician’s fault; in fact, physicians likely did not come across many opportunities to expose themselves to “business of medicine” topics, and when they were exposed, likely such exposure was not more than a glazing of preliminary topics. For instance, a physician may have attended an hour seminar on HIPAA or heard mention of times when a physician is not authorized to make a referral to oneself. Some physicians opt to go it alone, “open up shop,” and see what happens, whereas others elect to work with a knowledgeable attorney to assist in practice structure or potentially with a practice consultant, of whom there are many.

In fact, an entire industry of consultants has arisen to fill the physician “business of medicine” knowledge

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gap, about which we caution, caveat emptor (buyer beware): a consultant who is not a physician, not a lawyer, not an accountant, and not a financial planner has no formal specialty, so be sure to check credentials, including referrals by a healthcare attorney, before paying a retainer.

The purpose of this article is to highlight the need for each physician and practice manager to understand the importance of their practice structure to ensurereimbursement for services rendered, and to ensure compliance in operations to protect from potential exposure.

In addition to potential criminal exposure for improper structure, many practices are at risk of financial exposure.

In most cases, practices are not in compliance because the practice owners and managers are unaware of the compliance requirements; however, being unaware is not an excuse, should the practice come under scrutiny by a payer (ie, Medicare) or a government regulator (ie, the Office of Inspector General). Failure to comply with applicable structural requirements is a strict liability offense in some instances. If you are not in compliance, then you may not be entitled to payment for a particular claim for Designated Health Services (DHS) or any claim submitted while the practice was not in compliance; this is called “disallowance.” DHS includes most ancillary testing, imaging, durable medical equipment, and physical therapy, as well as other critical services needed by many patients.

Whether a service constitutes DHS is not subjective; Medicare has a list of DHS services, by CPT® (Current

ONCOLOGY PRACTICE MANAGEMENT

I July 2012

Procedural Terminology) code, on its website (www.cms.gov/Medicare/Fraudand-Abuse/PhysicianSelf Referral/ List_of_Codes.html).

The concept of disallowance is set forth in the Stark Law, as follows (42 CFR § 411.353): (1) Except as provided in paragraph (e) of this section, no Medicare payment may be made for a designated health service that is furnished pursuant to a prohibited referral. The period during which referrals are prohibited is the period of disallowance. For purposes of this section, with respect to the following types of noncompliance, the period of disallowance begins at the time the financial relationship fails to satisfy the requirements of an applicable exception and ends no later than— (i) Where the noncompliance is unrelated to compensation, the date that the financial relationship satisfies all of the requirements of an applicable exception; (ii) Where the noncompliance is due to the payment of excess compensation, the date on which all excess compensation is returned by the party that received it to the party that paid it and the financial relationship satisfies all of the requirements of an applicable exception; or (iii) Where the noncompliance is due to the payment of compensation that is of an amount insufficient to satisfy the requirements of an applicable exception, the date on which all additional required compensation is paid by the party that owes it to the party to which it is owed and the financial relationship satisfies all of the requirements of an appli-

Legal Update

cable exception [emphasis added].

Below are examples of hypothetical situations that may arise under the 3 subparts of the statute referenced above.

First, subpart (i) of 42 CFR § 411.353(c)(1) defines the period of disallowance from the date the financial relationship fails to meet the requirements of an exception until such time that the practice is no longer structured improperly. An example of how simple it is for a practice to be structured improperly may be evinced by a simple Stark Law hypothetical. The Stark Law (one of the main statutes applicable to medical practices when ensuring structural compliance) prohibits selfreferring for DHS unless the practice is structured in accordance with certain requirements and meets applicable exceptions (see 42 U.S.C.§ 1395nn). Under the Stark Law, a practice with more than 1 physician must meet the definition of a group practice to potentially qualify for a Stark Law exception, which is required to enable the practice to self-refer to DHS. One of the “group practice” requirements of the Stark Law is that the majority (75%) of all of the patient care services (75%) of the physicians who are members of the group must be furnished through the group (see 42 CFR § 411.351).

Smaller group practices with parttime physicians who are ordering and conducting their own imaging services may not be in compliance and, therefore, the analysis as to whether the practice is in compliance need not continue. That practice may be in a period of disallowance.

Second, subpart (ii) of 42 CFR § 411.353(c)(1) defines the period of disallowance from the date the financial relationship fails to meet the requirements of an exception until such time that the identified overpayment is returned to the payer and the financial relationship meets the requirements of an exception. This

definition is utilized when the noncompliance is a result of payment of excess compensation. An example of when a practice may be in a period of disallowance for excess compensation is during such period as a practice has received compensation in excess of what it has been entitled to for services rendered, which, for example, may be a result of intentional upcoding. This period of disallowance would continue until such time as the practice returns excess funds to Medicare and all practice structural requirements are met.

Third, subpart (iii) of 42 CFR § 411.353(c)(1) defines the period of disallowance from the date the financial relationship fails to meet the requirements of an exception until the date when additional required compensation is paid and the financial relationship meets the requirements of an exception. This definition may apply where a practice fails to meet an exception due to insufficient compensation. By way of example, where an oncology practice agrees to rent equipment from a vendor and for one reason or another the vendor agrees to offer the equipment at well below the fair market value, the fair market value is a requirement that must be met to qualify for an exception under rental of equipment, should such equipment be used for DHS. Under subpart (iii), until such time as the practice is paying fair market value for the equipment rental, and has paid back-owed rent for underpayments, the period of disallowance would continue and the practice would not be authorized to receive reimbursement for services rendered to Medicare beneficiaries, reimbursable by Medicare for that period of disallowance.

These examples are provided as an explanatory tool, so that practice owners and managers may better understand the definitions of disallowance and how the same may be applicable to a potential practice

July 2012

arrangement. This does not constitute a complete analysis, nor should it be utilized to evaluate an individual practice arrangement. To understand the nuances and intricacies of the applicable laws referenced herein would require a level of mastery above and beyond reviewing an individual article. Equally as important as understanding appropriate practice structure issues is to ensure that you are working with professionals best able to guide you and assist in appropriate practice structure matters.

The intricate laws governing structure and prohibiting certain financial relationships and referrals create strict liability offenses if certain structure parameters are not met. “I didn’t know” is not a tenable defense. The good news is that there is still time to ensure you are operating compliantly. Regulators are conducting more reviews of practice structures, but those reviews are just ramping up, and if you have not yet been targeted, there is still time to take preventive action. 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. She may be reached at 516747-6700 x302 or by e-mail at Jennifer@kirschenbaumesq.com. For updates on changes in documentation requirements and general healthcare updates, visit www.nyhealthcareattor neys.com.

Erica Youngerman, Esq, an associate in Kirschenbaum & Kirschenbaum’s healthcare department, assisted in the preparation of this article and may be reached at 516-747-6700 x308 or by e-mail at EYoungerman@kirschen baumesq.com.

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Physician Wealth Management With Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF

Retirement Plans and Your Medical Practice

By Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF, and Peter M. Coleman, ASA, EA, FCA, MAAA, MBA

tion, but, as a result, receive the most favorable tax treatment. Two of the biggest benefits are (1) immediate income tax deductions, and (2) creditor protection.

Lawrence B. Keller

Peter M. Coleman

I

n today’s turbulent economic times, physicians are looking for solutions that provide tax deductions and the opportunity to save efficiently for their retirement.

No matter whether you are selfemployed, run a small medical practice, own shares in a large surgical center, or are directly involved in running a corporation/tax-exempt organization, you have the ability to establish a qualified retirement program for you and for your employees.

However, how do you create a retirement program to maximize your tax-deductible contributions without “breaking the bank” on employee costs? This article presents plan design concepts successfully used by others in the medical community, to help you better understand the elements that go into a well-designed and well-executed retirement program.

What Is a Qualified Retirement Plan?

The term “qualified” generally indicates that the plan must meet statutory requirements under the Employee Retirement Income Security Act of 1974 (ERISA), regarding issues such as participant eligibility, benefit coverage, vesting, funding requirements, and employee communication. Qualified plans are subject to the most stringent regula-

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Defined Contribution versus Defined Benefit Plans As with any project, there is usually more than one way to accomplish your objective. The same holds true for retirement plans. Most people have heard about 401(k) plans, where you can defer a portion of your salary and the employer makes a discretionary contribution as a match or as a percentage of your compensation. These plans are called Defined Contribution Plans and function as a savings account that is affected by investment gains and losses. The contribution going into such a plan is “defined,” but not the end benefit. The reverse of this is the Defined Benefit/Cash Balance Plan, in which an actuary determines the annual employer contribution that will provide a specific benefit payable at retirement.

Participants who begin saving later in life are at a distinct disadvantage in Defined Contribution Plans, because they have fewer years to accumulate funds for retirement.

Conversely, Defined Benefit/Cash Balance Plans, for these same employees, allow them to accumulate considerable retirement assets in a relatively short period, because the end benefit has been predetermined.

401(k)/Profit-Sharing Plans It is common for a medical practice to combine a 401(k) plan with a profit-sharing component. The 401(k) plans have become one of the most popular types of employersponsored retirement plans. The purpose is to permit you to defer a

ONCOLOGY PRACTICE MANAGEMENT

I July 2012

portion of your salary, up to $17,000 ($22,500 for those aged 50 years or older) annually, on a pretax or posttax (ie, Roth) basis. In addition, when there are ample funds, the employer can make a discretionary contribution that could increase the business owner up to $50,000 ($55,500 if aged 50 or older) in annual contributions. As your money grows in these plans, all income taxes are deferred until you take distributions at retirement.

This all sounds good, but is there a catch? The catch is that if you have employees, you must also provide them with a benefit and prove to the IRS that your plan encourages and benefits those rank-and-file employees. Although every organization’s demographics are different, some of the best design tools include the following features: • The Safe Harbor 401(k) plan is a 401(k) plan that eliminates all compliance testing. With this type of plan, employers with lowto-very-poor 401(k) participation by staff can safely defer their full $17,000 ($22,500 for those aged 50 or older) contribution, without fear that the plan will fail nondiscrimination testing and that part of their deferral will be refunded at the end of the year, creating a taxable event.

Based on the design chosen, the employer will provide either a matching benefit (ie, 100% on the first 3% deferred, plus 50% on the next 2% deferred) or a nonelective benefit (ie, 3% of salary) for all participants. The “cost” for using this plan design is that all employer contributions are immediately vested.

• When additional benefits are desired, many business owners augment their 401(k) plan with a

Age, yr

53

Physician 4

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Subtotal: Group 3

www.OncPracticeManagement.com

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7.5

7.5

7.5

7.5

Total

2.5

2.5

2.5

2.5

2.5

2.5

2.5

2.5

2.5

2.5

2.5

2.5

0.0

0.0

Max

Max

Max

Max

Estimated tax savings for partners/firm

47

21

Staff 11

Staff 12

7.5

28

35

Staff 9

Staff 10

7.5

35

42

Staff 7

Staff 8

7.5 7.5

27

25

Staff 5

7.5

7.5

7.5

7.5

3.0

3.0

13.2

13.2

13.2

13.2

Staff 6

28

35

Staff 3

Staff 4

33

32

Staff 1

Staff 2

Group 3: Staff

Subtotal: Group 2

40

52

RN 1

RN 2

Group 2: Registered nurses (RNs)

Subtotal: Group 1

58

55

Physician 2

Physician 3

60

Physician 1

Group 1: Owner physicians

Participants

ProfitCash sharing balance contribution, contribution, % %

1,871,000

629,000

32,000

55,000

60,000

50,000

37,000

40,000

35,000

35,000

65,000

65,000

75,000

80,000

242,000

130,000

112,000

1,000,000

250,000

250,000

250,000

250,000

Maximum salary for benefit purposes, $

36,000

124,840

25,160

1280

2200

2400

2000

1480

1600

1400

1400

2600

2600

3000

3200

9680

5200

4480

90,000

22,500

22,500

22,500

22,500

(A) Projected voluntary employee 401(k) deferral, $

74,600

186,435

47,175

2400

4125

4500

3750

2775

3000

2625

2625

4875

4875

5625

6000

7260

3900

3360

132,000

33,000

33,000

33,000

33,000

(B) Employer profitsharing contribution, $

329,500

823,844

11,024

470

1265

1068

808

726

712

543

558

1157

1051

1281

1385

0

0

0

812,820

169,231

187,179

217,949

238,462

(C) Employer defined benefit contribution, $

404,100

1,010,279

58,199

2870

5390

5568

4558

3501

3712

3168

3183

6032

5926

6906

7385

7260

3900

3360

944,820

202,231

220,179

250,949

271,462

440,100

1,034,820

224,731

242,679

273,449

293,962

100

5.1

0.2

0.5

0.5

0.4

0.3

0.3

0.3

0.3

0.4

0.5

0.6

0.7

0.8

0.4

0.4

94.1

20.4

22.1

24.9

26.7

(B) + (C) (A) + (B) + (C) Total Total Allocation employer partner of total contribution, benefits, benefits, $ $ %

Table. The Medical Practice Traditional 401(k) Plan with New Comparability Profit-Sharing and Cash Balance Components Objective: Provide Maximum Benefit for Partners/Minimize Overall Costs

Physician Wealth Management

Continued on page 36

35

Physician Wealth Management

Retirement Plans and Your…Continued from page 35 profit-sharing feature. Offering such a plan helps to attract quality employees and reduces employee turnover. The best part about the profit-sharing contribution is that it is discretionary in nature, and you are not required to make a set contribution (or any contribution) in any given year. This flexible standard allows medical practices considerable latitude in budgeting, especially for those with varying or uncertain profits.

And with a properly designed program, the majority of the contributions will be allocated to the key employees in your practice.

A Properly Designed Program What is a properly designed program? This is typically a plan in which the key staff members, inclusive of the owner(s), receive more than 60% of the total dollars going into the plan. One of the best ways we have accomplished this goal is by using a New Comparability ProfitSharing (NCPS) design. An NCPS plan will allow you to place all participants in the appropriate group and to provide them with different contribution percentages, as long as you pass discrimination tests. For example, a profit-sharing allocation for the following participants could include: • Senior physician (owner): 20% of compensation • Junior physician (owner): 10% • Office manager: 7% • Remaining staff: 5%.

The employer contributions are usually made after the end of the plan year (but before filing your taxes), and when you have determined your ability to make the contribution.

Each year, working with your retirement consultant, you determine the percentages to allocate to each group. If your demographics do not work well with this type of design, there are many other variations to

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choose from, including pro rata, age based, service based, and integration with Social Security wage base.

However, regardless of the design chosen, the maximum contribution any one person can receive, inclusive of the 401(k) component, is $50,000 ($55,500 for those aged 50 or older) per employee.

still maintaining a reasonable cost for the staff. As a result, the owners are able to collectively contribute more than $1 million for themselves and receive more than 93% of all dollars going into the plan. In addition, if any of the physicians did not want such a large benefit, this could easily be modified.

Combination Program For some business owners, the benefits provided through a 401(k)/profit-sharing plan are just not enough.

They are looking for programs that will provide tax-deductible contributions for themselves in excess of $100,000. In these cases, the solution is the combination of a 401(k)/ ProfitSharing and Defined Benefit/Cash Balance Program. Like an NCPS, the Defined Benefit Plan can be structured to provide greater benefits for the key employees and minimize overall costs for the staff. With a Defined Benefit Plan, after 10 years of participation and retirement at age 62, you could amass an account balance of approximately $2.5 million in addition to the account balance in your 401(k) profit-sharing plan. Please note that unlike the profit-sharing plan, the contribution to the Defined Benefit Plan is not discretionary and must be made for at least 3 to 5 years.

Conclusion When it comes to choosing an appropriate retirement program, there are many choices available, often too many. What we say to all our clients is, “Pretend there are no rules and regulations, and you can do whatever you would like. Now tell us how you would like to design your specific program.” You should never be presented a solution before you have been able to communicate exactly what you would like from your plan. More often than not, a customized retirement program can very closely mirror the objectives of your practice. Working with an experienced third-party administrator and financial advisor, you will be able to craft the right tax-efficient program for your practice. l

Multiple Plans: An Example In this hypothetical medical practice listed in the Table, there are 4 high wage earners looking for ways to defer additional sums of money in excess of the $50,000 permitted under a 401(k)/profit-sharing plan.

The solution was to use the Combination Program, including a 401(k)/profit-sharing plan and a Defined Benefit/Cash Balance component. By adding on the Cash Balance Plan, the physicians’ taxdeductible contributions increased by more than $150,000 each, while

ONCOLOGY PRACTICE MANAGEMENT

I July 2012

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

Peter M. Coleman, ASA, EA, FCA, MAAA, MBA, is the Managing Partner of The Benefit Practice, a firm specializing in pension consulting, administration, and related actuarial services to clients nationwide. He can be reached at (203) 517-3502 or Pcoleman@benefitpractice.com for comments or questions.

Quality Assessment 2.0

Quality Assessment 2.0

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:

Benefit Investigation

Care Coordination

• Rapid assessment of patient eligibility/coverage • Prior authorization support • Concise benefit summary • Identification of specialty pharmacy provider

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

Take advantage of ZytigaOne™ Support today.

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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