OPM May 2014

MAY 2014

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VOLUME 4 • NUMBER 3

Oncology Practice Management ™

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

Cancer Care and Facing New Vulnerabilities

By Dawn Holcombe, MBA, FACMPE, ACHE Reimbursement President, DGH Consulting, South Windsor, CT Models: Changes Editor-in-Chief, Oncology Practice Management hallenges come from all direc- port for one of its still Continue tions, and good oncology man- most popular computer operating sysBy Anne M. Cooper, MA

Arlington, VA— Cancer care and reimbursement are changing, according to the keynote address, “Ensuring Quality Care for Each Patient: How Legislative and Re­g­ Kavita K. Patel, MD, ulatory Changes May MS Impact Commu­ ­nity Oncology,” at the 2014 Association of Community Cancer Centers’ 40th annual meeting.

Highlighting issues pertinent to oncology care, the presentation focused on the Patient Protection and Affordable Care Act (ACA), sustainable growth rate (SGR), congressional stalemates, costs and quality of cancer care, as well as alternative payment

C

agers have eyes in the backs of their heads. Two significant challenges arose recently, stemming from a common computer operating system platform as well as from the US government.

In April 2014, Microsoft ended sup-

tem platforms, Windows XP. Considered by many to be a reliable workhorse that has weathered the debacle of Windows Vista and the recent unveiling of the less popular Microsoft 8, several small business industries have hung onto Continued on page 6

Value, Quality of Care, and Technology Changes Spur Oncology Innovation

By Kurt Ullman, RN, MHA, BSPA

A

s physicians, nurses, and practice managers continue to adapt to an ever-changing landscape, healthcare disruptions affecting providers, payers, and patients have become the status quo. During a recent oncology conference, thought-leader panelists advised participants to expect the unex-

pected, not just in oncology, but in the medical system as a whole.

Oncologists and Primary Care The relationship between primary care and specialists is emerging as a key point of interest, as well as that between Continued on page 10

Continued on page 8 From the publishers of

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INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM

of n it o s D ia er VI ssoc ent O A rC l 4 PR y the nce nua …2 a n g D N ou bity C ’s Aeetin A y T t to mun CCal M N C n h m TIE roug Co Aatio A B

ER

©2014 Engage Healthcare Communications, LLC

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We Will

exhaust all possibilities.

We will…because patients are our priority.

Celgene Patient Support ® provides free and personalized assistance with patients’ access and reimbursement needs.

With continual communication and consistent follow-through, your dedicated Celgene Patient Support ® Specialist will streamline access to Celgene products by helping you and your patients with: • Benefits investigation

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• Prescription status • Celgene free medication program • Celgene products and restricted distribution programs 4 out of 5 patients who requested assistance from Celgene Patient Support ® received their medication.

Celgene Patient Support® is a registered trademark of Celgene Corporation. © 2013 Celgene Corporation 09/13 US-CELG110059(1)

Head May 2014 • Volume 4 • Number 3

Table of Contents PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Vice President/Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Publisher Cristopher Pires cpires@the-lynx-group.com Director, Client Services Lou Lesperance llesperance@the-lynx-group.com Editorial Directors Dalia Buffery dbuffery@the-lynx-group.com Anne Cooper acooper@the-lynx-group.com Associate Editor Lara J. Lorton Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Marie RS Borrelli The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Managers Andrea Boylston Jini Gopalaswamy Project Coordinators Jackie Luma Deanna Martinez IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

Oncology Practice Management ™

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

FROM THE EDITOR Facing New Vulnerabilities..................................................................................1

By Dawn Holcombe, MBA, FACMPE, ACHE

FEATURES ACCC Annual Meeting Cancer Care and Reimbursement Models: Changes Continue.................................................................................................1

By Anne M. Cooper, MA

Innovation in Oncology Value, Quality of Care, and Technology Changes Spur Oncology Innovations….....................................................................................1

By Kurt Ullman, RN, MHA, BSPA

Quality Care What Constitutes Good Oncology Care?....…..............................................12

By Sheryl Riley, RN, OCN, CMCN

Processing and Compliance Compliance: Cost or Investment.....................................................................22

By Kelli Weiss, RT (R)(T)

DEPARTMENTS FDA Update Zykadia Approved for Metastatic, ALK-Positive Lung Cancer........................7 Continued on page 4

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 that patients with cancer deserve, providers must master the ever-changing business of oncology. Oncology Practice Management offers process solutions for members of the cancer care team—medical, surgical, and radiation oncologists, as well as executives, administrators, and coders/billers—to assist them in reimbursment, staffing, electronic health records, REMS, and compliance with state and federal regulations.

POSTMASTER: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Oncology Practice Management™, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD. BPA Worldwide membership applied for September 2013.

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Table of Contents

May 2014 • Volume 4 • Number 3

Oncology Practice Management™, ISSN 2164-4403 (print), is published 8 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2014 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.

Oncology Practice Management ™

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

Continued from page 3

DEPARTMENTS Wealth Management Your 401(k) Plan Stinks: 3 Ways to Make the Best of a Bad Situation.....................................................................................................16

By W. Ben Utley, CFP®, and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

Patient and Provider Access ACCC’s Annual National Meeting: Keeping the Oncology Team on the Front Lines of Changing Policy............................................................24

By Sydney Abbott, JD

Clinical Trial Tracker New Clinical Trials Under Way…......................................................................29 Drug Coding FDA-Approved Medications for the Treatment of Colorectal Cancer...........................................................................................32

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

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

Peggy Barton, RN Practice Manager Toledo, OH

Mariana Lamb, MS Executive Director Medical Oncology Association of Southern California Upland, CA

Risë Marie Cleland President Oplinc, Inc Portland, OR Patrick A. Grusenmeyer, ScD, FACHE President Christiana Care Health Initiatives Newark, DE

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Bonnie J. Miller, RN, BSN, OCN, FAAMA Administrative Director Women’s Cancer Center Fox Chase Cancer Center Philadelphia, PA Karna W. Morrow, CPC, RCC, CCS-P, PCS Senior Consultant CSI Coding Strategies, Inc Powder Springs, GA

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

ONCOLOGY PRACTICE MANAGEMENT

I May 2014

Robert D. Orzechowski, MBA, SPHR Chief Operating Officer Lancaster Cancer Center Lancaster, PA

Sheryl A. Riley, RN, OCN, CMCN Director of Clinical Services SAI Systems Shelton, CT Mary Pat Whaley, FACMPE, CPC Physician Advocate and Consultant www.managemypractice.com Durham, NC Carla C. Wood Balch, CPC, MS President Altos Solutions, Inc Los Altos, CA

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

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

Primary Endpoint

Secondary Endpoints

• Overall response rate

• • • • • • • •

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

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

NCT#01889186 Reference: ClinicalTrials.gov.

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

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

From the Editor

Facing New Vulnerabilities Continued from the cover Windows XP, including medical practices. Windows XP can still run on computers; however, by withdrawing this support, Microsoft will no longer issue fixes to nonsecurity-related problems, provide new security updates, or offer online technical content updates. There will be some antimalware-related updates through July 2015, but not enough to protect an outdated operating system.

Medical practices make significant investments in technology, not the least of which are the computers, laptops, and operating systems on which to run that technology. Every time an operating system changes, the entire practice’s operational flow is put at risk. Even if the practice’s billing system or electronic medical record (EMR) system claims to be compatible with a newer operating system other than Windows XP, there is a time lag to purchase, install, and reload all software, and then train staff on the machines with the new operating software. What if supporting accessories, such as printers, applications, and medical equipment, are not readily upgradable to the new system? Each new operating system has a different style and approach, and busy staff members or physicians may become frustrated over the course of their learning curve.

However, the downside of not replacing Microsoft Windows XP can be significant. Without regular patches to repair bugs, any operating system will likely freeze up and crash.

A lack of security updates means that hackers will be actively looking to explore vulnerabilities in the old system, without protection from Microsoft and developers. In an article by Bree Fowler for the Associated Press, Sam Glines, chief executive officer of a threat-detection firm, noted that healthcare-related infor-

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mation is 10 to 20 times more valuable on the black market than financial information, because it can be used to create fraudulent medical claims and illegally obtain prescription drugs; therefore, doctors’ offices become likely targets of hackers.1 Medical offices are well aware of the front-end threats to private health information, and take significant precautions to protect patients and their personal information in the office, but the increased potential for hackers coming through unprotected back doors in a now unprotected practice computer system may not yet have hit offices’ radar. What is a practice to do to address this new vulnerability?

• Seek appropriate technical support to assist with the transfer to a new system, possibly through your billing or EMR providers • Identify any hardware currently in your office or at the homes of your physicians or staff who access patient information (do not forget laptops or tablets) • Process any current malware updates on a regular basis • Research upgrade options or whether new hardware is needed • Assess the impact on your operating system or medical records system, connections with any external software (eg, laboratories, imaging, or hospitals), and identify the best new operating system • Develop a plan for transfer, with substantial backups and concurrent operations until the new system is fully functional.

The other new vulnerability to hit practices in April 2014 came from the US government. As part of its increasing intent to bring transparency to healthcare, the Centers for Medicare & Medicaid Services (CMS) released data on physician payments to the press and

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general public for the first time in 35 years. The released data include physician names, addresses, specialties, bill rates per service, Medicare’s actual pay rate for that service, the number of Medicare beneficiaries for whom the physician billed, and the number of services provided for every Medicare provider.2,3 Instantly, the national and local news media wrote headlines and lead stories about individual physicians and specialties.4 Patients, staff, and physicians have been exploring the data and looking for answers and responses from practice administrators since the first news story hit. Medicare was to have provided physicians an opportunity to review and vet the data collected on them, but that never happened.

The biggest problem with this data (among many) is that it is being presented and used out of context.

Many of the analyses show average payments per physician but do not explain what services were attributed to that physician or whether that physician had extenders who also billed under their number. Most important for oncology as a specialty, there is no obvious explanation that doctors pay for their offices and staff from these Medicare payments, and also purchase drugs (at costs numbering in the millions of dollars for a group or physician) and then bill for treatments used. These Medicare data only show the payments, with an inference that these payments represent net income made by the physician from the Medicare program.

What steps can a practice administrator take to address these public perceptions (and, in some cases, misperceptions) and support their physicians who are profiled by local and national media?

• Route all questions about the data through 1 voice in your

From the Editor

group, preferably the practice administrator, so physicians are not put on the defensive discussing financial matters when they are trying to care for patients • Develop a short, concise statement that is made available to staff, patients, or anyone interested. This statement should include support for transparency, but also note the flaws and challenges with the data as it is presented • Look to resources for more detailed statements related to the data release that support your own position. These re­ sources may also offer help in crafting an opinion piece or letter to the editor for your local market (Table).

Both of the vulnerabilities noted here come from the outside, all while your group tries to continue serving its patients in their fight against cancer. Most of the burden of coordinating and addressing these vulnerabilities falls on the practice management team at a time when clinical and administrative staff members are already overstretched dealing with operational and fiscal issues. That is what makes the practice manager position so

Table

Resources for Support in Crafting a Public Statement Regarding the Medicare Data Release.

Name Community Oncology Alliance Website www.communityoncology.org/site/blog/detail/2014/04/10/coa-issues-statementon-release-of-medicare-data.html Resource(s) Position statement on the data release; other articles that may assist you in developing your own responses Name American Society of Clinical Oncology Website www.asco.org/asco-alarmed-about-medicare-payment-data-release Resource(s) Sample of a press release regarding the release of Medicare data

critical in 2014, and illustrates the depth of knowledge and skills needed to navigate running a practice today. We will get past these challenges, as we do all the others, and working together will help to ease the burden. l 1. Fowler B. End of Microsoft Windows XP support means trouble for some. Long Beach Press Telegram.

April 7, 2014. www.presstelegram.com/technolo gy/20140407/end-of-microsoft-windows-xp-supportmeans-trouble-for-some. Accessed April 25, 2014.

2. Centers for Medicare & Medicaid Services. Press

release. Historic release of data gives consumers unprecedented transparency on the medical services physicians provide and how much they are paid. http:// www.cms.gov/Newsroom/MediaReleaseDatabase/Pressreleases/2014-Press-releases-items/2014-04-09.html.

Published April 9, 2014. Accessed April 25, 2014.

3. Centers for Medicare & Medicaid Services.

Medicare Provider Utilization and Payment Data: Physician and Other Supplier. http://www.cms.gov/ Research-Statistics-Data-and-Systems/StatisticsTrends-and-Reports/Medicare-Provider-ChargeData/Physician-and-Other-Supplier.html. Updated April 23, 2014. Accessed April 25, 2014.

4. Hoyer M, Kennedy K; for USATODAY. First look at Medicare data in 35 years. USATODAY. April 10, 2014. www.usatoday.com/story/news/nation/2014/04/09/ government-releases-medicare-physician-pay ment/7462923/. Accessed April 25, 2014.

the treatment of patients with latestage NSCLC who were previously treated with crizotinib, the first and only other ALK tyrosine kinase inhibitor ap­­proved by the FDA. The FDA approved ceritinib under the FDA’s accelerated approval process, 4 months ahead of its scheduled final review date, to expedite access to this drug for a patient population with a life-threatening condition and very few treatment options available.

The safety and efficacy of ceritinib was established in a clinical

trial with 163 patients with metastatic, ALK-positive NSCLC. All patients received ceritinib: approximately 50% of the patients had their tumor shrink with this therapy, and this result lasted an average of approximately 7 months.

Reported side effects were mainly gastrointestinal, such as diarrhea, nausea, vomiting, and abdominal pain. Laboratory abnormalities included increased liver enzymes and pancreatic enzymes, as well as in­­ creased glucose levels. l

References

FDA Update Zykadia Approved for Metastatic, ALK-Positive Lung Cancer On April 29, 2014, the US Food and Drug Administration (FDA) approved ceritinib (Zykadia; Novartis) for the treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer (NSCLC). Ceritinib is an ALK tyrosine kinase inhibitor that blocks proteins that promote cancer cell growth. The drug is approved for

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ACCC Annual Meeting

Cancer Care and Reimbursement…Continued from the cover models and value-based care.

“I did not know what shared savings was, I would never have been able to tell you what a risk adjustment case management fee was,” said Kavita K. Patel, MD, MS, Primary Care Physician, Fellow and Managing Director in the Engelberg Center for Health Care Reform of the Brookings Institution, and former advisor to President Barack Obama and the late Senator Edward Kennedy. “These are terms when I went to medical school I never learned. You should take it as a signal that cancer care and reimbursement are 100% changing. You’ve already seen it with the sequester and with references in legislation to alternative payment models and value-based purchasing.”

Trends in Healthcare Dr Patel shared a graph demonstrating Democratic and Republican ideologies, evidencing a lessening overlap in common goals that has evolved in the last 30 years; this was the backdrop against which the ACA was passed and another SGR patch enacted. She addressed the importance of the ACA as well as Medicaid expansion in relation to cancer care; at the time of her presentation, open enrollment into exchanges offered through the healthcare marketplace had just come to a close.

“It’s worth pointing out that we have had a number of milestones that happened this year,” she said.

“It’s also important to look at how much of the Medicaid expansion combined with the enrollment in the exchanges is already helping those of us on the clinical side to not be in an uncomfortable position when we meet people who can’t afford their care because they didn’t have access to care.”

Quality, costs, and access to care

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were also addressed. Dr Patel cited a 1999 report from the Institute of Medicine that details a fragmented, uncoordinated cancer care system that impacted patients’ ability to access care. Fifteen years later similar concerns remain, Dr Patel stated.

Patients and caregivers still face poor access to information, and the gap that existed in the 1990s still exists today for those seeking information about their cancer and related issues.

“If I could have taken away that date and put in 2014 I don’t think any of you would be that shocked,” Dr Patel stated. “So it begs the question, ‘How much progress have we made in the last 15 years?’ I do believe that we’ve made progress.

However, we’re still coming up against more gaps in care, variations in care, even at our best.”

Costs are on the rise, Dr Patel added, citing information from the Chronic Conditions Data Warehouse.

Fifteen percent of Medicare beneficiaries who file a cancer claim represent 23% of all spending, according to their data. Furthermore, Dr Patel emphasized not just the need for chemotherapy, but also supportive services and testing that contribute to the increased cost of care.

Exploring Clinical Pathways Turning to solutions for issues related to quality and value of cancer care, Dr Patel discussed the use of pathways and their role in improving patient outcomes. She recalled coming together with community health plan managers, large payer organizations, and the Centers for Medicare & Medicaid Services as they worked toward changing reimbursement concepts from volume to value.

Many believed that pathways are necessary, but not sufficient.

“Put yourself in the seat of a policymaker, and if you’re thinking of an alternative payment model,

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something you would want to propose in the medical oncology setting, would you pick pathways?” Dr Patel asked. “Everybody unanimously said, ‘You start with pathways, and you need to build to something more.’”

In addition, she also addressed the move toward oncology patient–centered medical homes. The goals for this care model are straightforward: improving quality, care, and coordination, and reducing costs. Elements of the medical home in a clinical practice include adherence to clinical pathways, enhanced hours, and augmented access to clinicians/telephone triage, patient engagement and empowerment, the use of patient navigators/care coordinators, and the assumption of primary responsibility for coordination of a patient’s cancer care services.

Dr Patel discussed the advantages of the medical home, including patient-centered care, use of pathways, care-based payments, and payment tied to quality and performance. The disadvantages, she noted, include higher implementation costs, potential administrative burden, and moderate structural changes needed.

Whether the discussion or questions are related to payment models, care models, or methods of reimbursement, Dr Patel notes that the solutions often rest within the provider community. She urged participants to develop tangible solutions to help transform their practices.

“When we look for Congress or policymakers to have answers, oftentimes they turn that mirror back around and they say ‘you tell me what the solutions are,’” Dr Patel said. “They want you to show them viable solutions…they are going to say, ‘Tell us….what you want to do and propose how you will change your practice.’” l

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Innovation in Oncology

Value, Quality of Care, and Technology…Continued from the cover hospitals and payers, notes Roy A. Beveridge, MD, senior vice president and chief medical officer, Humana.

Dr Beveridge estimates that the payer world and the provider world are getting closer. Risk sharing will fundamentally change how all physicians do things over the next 5 years.

Fragmentation of care is another area in which changes are being made that oncologists will have to deal with, he notes. As the move continues toward accountable care organizations (ACOs) or paying for quality, the fact that no one individual is really responsible for the entire patient is going to cause problems. Norma J. Ferdinand, MSN, RN, senior vice president for quality and performance improvement, and chief quality officer, Lancaster General Health, agrees.

“We are now in a position where our primary health physicians are becoming eligible for the total cost of care, which is something that they haven’t had access to information [about] in the past,” Ms Ferdinand said. “It is changing the whole model of how they provide care and their accountabilities for managing a panel of patients, [which] include managing the cost of care. The current system is extremely fragmented, with no one provider ruling over access and cost of care. So, making a system that is more integrated will be needed.”

Integrating all of the stakeholders in patient care may be difficult or disruptive, notes Kim Woofter, RN, OCN, chief operating officer, at Michiana Hematology Oncology, PC, in South Bend, IN. While quality is understood to be the ultimate goal, it is unclear who is ultimately responsible for care of the oncology patient, and, importantly, who will own the quality process for optimal care. Resolving this uncertainty will drive oncology care going forward.

Even though a lot of time has been

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devoted to the changes, there is still much that is not well-understood.

“The current system is extremely fragmented, with no one provider ruling over access and cost of care. So, making a system that is more integrated will be needed.”

—Norma J. Ferdinand, MSN, RN

Practice and Patient Disruptions As with quality, healthcare exchanges may also change the nature of the purchase of oncology services, notes John E. Hennessy, MBA, vice president of operations, Midwest division oncology, Sarah Cannon Cancer Center. At the time people purchase insurance, they either have cancer and know they need good providers or do not and likely think they never will.

Because of this, cheap insurance often beats quality of the network.

This creates an imperfect buying environment, where people are making purchasing decisions that are separated from the time of actu-

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al medical need. Thus, different priorities will be at work.

“The concept that we can come out and produce the best cancer program in town may not translate to the purchaser recognizing it or wanting to buy it,” Mr Hennessy said.

Disruptions will also occur for the patient. Nancy DavenportEnnis, founder and chairman of the board, Patient Advocate Foundation, Hampton, VA, noted the accelerated growth of the completely uninsured patient. In 2012, 38% of those her foundation worked with had no insurance at all—the highest level in the 17 years they have been compiling that statistic.

“What is disruptive for patients is the complete lack of stability in the oncology community today,” Ms Davenport-Ennis said. “We may want to enroll a person in a clinical trial, only to be told that provider is out of network. The reimbursement structure for the physicians trying to take care of our patients, and the fact we have lost 217 practices over the last 2 years, is disruptive for our patients depending on those practices for treatment.”

The changes upcoming in Medicare are another disrupter in the payment system and the delivery system. Within 8 years, 60% of the patient population will be on Medicare or Medicaid. Both are heading away from a pay-for-service to a pay-for-value model.

“The remaining folks are going to be in a disproportionally large number of exchange programs, all of which are going to be managed,” said Dr Beveridge. “What we as specialists have not understood is this giant revolution that has [already] gone on in the family practice and primary care world. Right now, these doctors are paid on their quality scores by every insurer.”

Innovation in Oncology

Technology Disruptive Technology will be more and more disruptive to the oncology practice going forward.

“On the technology side, this is really going to be overwhelming,” said Al B. Benson III, MD, professor of medicine, Northwestern University Feinberg School of Medicine, Chicago, IL. “I wonder how a general medical oncologist is going to be able to adjust to the massive changes in technology. We are now able to subset our patients based on molecular biology and other areas, which will vastly increase the knowledge base that an oncologist will need to provide care across many different cancers and subsets of patients within each disease category.”

There will be a need to tailor entire systems and hierarchies of care based on the molecular profile of the patient in front of them.

“At the [American] Society of Clinical Oncology meeting in 2013, researchers from Sarah Cannon presented on results of anti–PD-L1 treatments for patients who had failed numerous regimens,” noted Mr Hennessy. “Now, we’re having extended disease-free survival curves of multiple years, which weren’t part of the picture when we developed early versions of clinical pathways. This has

turned the logic of what we thought was the last innovation on its ear.”

converted into behavior change.

“Transparency is also very impor­ tant to us,” noted Mr Hennessy. “If you’ve got information about what is working or isn’t, you have to share it. That may not sound terribly innovative, but actually making this information readily available to the community executing on it, is.”

Payers as Partners Another disruptive force may be the need for oncologists to put aside previous experience and look at payers as partners in the care of their patients—especially when looking at possible innovations in care.

With the rise of bundled payment systems, ACOs, and other similar modalities, establishing partnerships with payers to gain access to their information and knowledge becomes important.

“The payers have data systems that can help providers in terms of how we rank order risks in our patients,” noted Dr Beveridge. “They have data that allow rapid understanding of where your patient is within the system. This is a fundamental shift we’ve got to work through in terms of management.”

The existence of a data-rich environment is not the end of the series. The key is converting data to information that can be acted on, to highlight good ideas for general rollout, and to spotlight bad ones that need to be eliminated. It is not just collecting it, but also measuring.

What are we seeing and what are we learning? Learning has to then be

Efficiencies Pay for Things Insurance Will Not? Getting more efficient care may also help with some of the other issues, such as how to pay for services that are not reimbursed. Times are changing and the practice of oncology will too; these constraints have led to innovations at many levels. Michiana, for instance, has developed a triage system that takes responsibility for patients in their first 48 hours after discharge. They follow up with patients to make sure they have medications and other necessary resources.

“When discharged, my office calls the patient at 24 and 48 hours to go over their medication list, competency persistence, follow-up visits, and we also have day and night nursing availability,” said Ms Woofter.

“We can affect return admissions significantly by interacting with the patients. This reduces costs.” l

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ONCOLOGY PRACTICE MANAGEMENT ™

INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM

VBCC_ASCO51314

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

FOR PAYERS, PURCHASERS, POLICYMAKERS, AND OTHER HEALTHCARE STAKEHOLDERS

www.ValueBasedCancer.com

May 2014

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TOPICS INCLUDE Immuno-Oncology Lung Cancer Colorectal Cancer Head & Neck Cancer

www.OncPracticeManagement.com

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Quality Care

What Constitutes Good Oncology Care?

By Sheryl Riley, RN, OCN, CMCN, Director of Clinical Services, SAI Systems, Shelton, CT

Q

uite often I am asked what constitutes “good” oncology care. Many people have their opinions; patients, doctors, allied medical professionals, and even health plan administrators like to weigh in on this issue. Those in the industry often use buzzwords—eg, quality, outcomes, and cost—interchangeably, but are they really the same? Unfortunately, no one seems to be in agreement on the answer.

Most healthcare professionals know that good oncology care is essential, but without a set of unified standards or distinct definitions on how to measure good care, it is almost impossible for everyone to speak the same language.

We must then ask ourselves, “What is our benchmark?” Should we turn to medical terminology— overall survival, time to recurrence, and response—in order to standardize our language? Perhaps the cost of a drug versus total treatment should be considered, and, consequently, whether we can demonstrate any savings in this analysis? In this ever-changing world of healthcare, where so many of the services we provide are guided by a bottom line, would it be prudent to teach more self-management skills to patients and families, such as how to monitor tumor markers and laboratory results, so they can ascertain the effectiveness of their treatment?

A defining element of good care may also come in the form of a standardized care plan that allows patients to stay in their homes rather than in the hospital, or helps to maintain their health during and after treatment, maximizing patients’ time in normal pursuits, such as work and family experiences. Yet often we must also assist with end-of-life care (ie, helping patients and families

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determine whether a clinical trial, palliative care, or hospice care would provide the greatest quality of life).

After surveying available data on this subject of good, quality care, one of the key problems I have seen is that the medical profession has a set of criteria, payers may have

After surveying available data on this subject of good, quality care, one of the key problems I have seen is that the medical profession has a set of criteria, payers may have another, and, subsequently, patients and patient advocacy groups may have yet another set of criteria.

another, and, subsequently, patients and patient advocacy groups may have yet another set of criteria. This separation begs the question: If we are all attempting to provide what is best for the patient, how do we blend these criteria together so that they make sense, not just for us, but for our patients and their families?

A close review of the literature identifies organizations responsible for creating standards for oncology care, as well as those that monitor these standards to make certain they are given appropriate attention.

Speaking with colleagues, practicing oncologists, oncology care manage-

ONCOLOGY PRACTICE MANAGEMENT

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ment nurses, medical directors from health plans, and those working in cancer education and advocacy also provides insights into standards of care. Finally, in order to round out the analysis, one should speak with patients and families to see how they measure quality care. Recent literature and Internet research demonstrated some of the following findings.

On its website, the Susan G. Komen Foundation for Breast Cancer states, “Every person diagnosed with breast cancer deserves the best care possible. Quality of care is a measure of how well your breast cancer is treated [and] how well you are cared for during and after treatment.”1 The Institute of Medicine (IOM) defines quality healthcare as “The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”2 IOM advises that a quality hospital or medical center should have clean, up-to-date facilities; well-stocked examination and operating rooms; up-to-date diagnostic equipment; and healthcare providers with appropriate professional credentials.

In an April 1999 IOM report, “Ensuring Quality Cancer Care,” the National Cancer Policy Board suggested that many patients with cancer are not receiving the care known to be effective for their disease. The board believed the problem to be significant, but observed there was insufficient evidence to determine the true magnitude.3 Organizations such as the American Society of Clinical Oncology (ASCO) recognize the importance of integrating continuous quality improvement into patient-centered clinical practice; it Continued on page 15

Take a bite out of G-CSF acquisition costs* GRANIX is another option in short-acting G-CSF therapy TM

GRANIX™ is an option for hospitals and payers to consider when determining health system budgets » FDA approved through the rigorous BLA† process » Teva’s short-acting G-CSF was first introduced in Europe in 2008 and is available in 42 countries‡1 » GRANIX J Code: J 1446-Injection, tbo-filgrastim, 5 micrograms, effective January 1, 2014 †Biologics License Application. ‡As of February 2014. *Based on wholesale acquisition cost (WAC) of all short-acting G-CSF products as of November 11, 2013. WAC represents published catalogue or list prices and may not represent actual transactional prices. Please contact your supplier for actual prices.

Indication

» GRANIX is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Important Safety Information » Splenic rupture: Splenic rupture, including fatal cases, can occur following the administration of human granulocyte colonystimulating factors (hG-CSFs). Discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture in patients who report upper abdominal or shoulder pain after receiving GRANIX. » Acute respiratory distress syndrome (ARDS): ARDS can occur in patients receiving hG-CSFs. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS. » Allergic reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving hG-CSFs. Reactions can occur on initial exposure. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim. » Use in patients with sickle cell disease: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving hG-CSFs. Consider the potential risks and benefits prior to the administration of GRANIX in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis. » Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colony-stimulating factor (G-CSF) receptor, through which GRANIX acts, has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded. » Most common treatment-emergent adverse reaction: The most common treatment-emergent adverse reaction that occurred in patients treated with GRANIX at the recommended dose with an incidence of at least 1% or greater and two times more frequent than in the placebo group was bone pain.

Please see brief summary of Full Prescribing Information on adjacent page.

For more information, visit GRANIXhcp.com.

Reference: 1. Data on file. Teva Pharmaceuticals: Filgrastim MA Approvals Worldwide. February 2014.

©2014 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. All rights reserved. GRX-40134 February 2014.

BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR GRANIX™ (tbo-filgrastim) Injection, for subcutaneous use SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE GRANIX is indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

4 CONTRAINDICATIONS None.

5 WARNINGS AND PRECAUTIONS 5.1 Splenic Rupture Splenic rupture, including fatal cases, can occur following administration of human granulocyte colony-stimulating factors. In patients who report upper abdominal or shoulder pain after receiving GRANIX, discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture.

5.2 Acute Respiratory Distress Syndrome (ARDS) Acute respiratory distress syndrome (ARDS) can occur in patients receiving human granulocyte colony-stimulating factors. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS. 5.3 Allergic Reactions Serious allergic reactions including anaphylaxis can occur in patients receiving human granulocyte colony-stimulating factors. Reactions can occur on initial exposure. The administration of antihistamines‚ steroids‚ bronchodilators‚ and/or epinephrine may reduce the severity of the reactions. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim.

5.4 Use in Patients with Sickle Cell Disease Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving human granulocyte colony-stimulating factors. Consider the potential risks and benefits prior to the administration of human granulocyte colony-stimulating factors in patients with sickle cell disease.

Discontinue GRANIX in patients undergoing a sickle cell crisis.

5.5 Potential for Tumor Growth Stimulatory Effects on Malignant Cells The granulocyte colony-stimulating factor (G-CSF) receptor through which GRANIX acts has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded.

6 ADVERSE REACTIONS The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling: • Splenic Rupture [see Warnings and Precautions (5.1)] • Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2)] • Serious Allergic Reactions [see Warnings and Precautions (5.3)] • Use in Patients with Sickle Cell Disease [see Warnings and Precautions (5.4)] • Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.5)] The most common treatment-emergent adverse reaction that occurred at an incidence of at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group was bone pain.

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

GRANIX clinical trials safety data are based upon the results of three randomized clinical trials in patients receiving myeloablative chemotherapy for breast cancer (N=348), lung cancer (N=240) and non-Hodgkin’s lymphoma (N=92). In the breast cancer study, 99% of patients were female, the median age was 50 years, and 86% of patients were Caucasian. In the lung cancer study, 80% of patients were male, the median age was 58 years, and 95% of patients were Caucasian. In the non-Hodgkin’s lymphoma study, 52% of patients were male, the median age was 55 years, and 88% of patients were Caucasian. In all three studies a placebo (Cycle 1 of the breast cancer study only) or a non-US-approved filgrastim product were used as controls. Both GRANIX and the non-US-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of ≥10,000 x 106/L after nadir was reached.

Bone pain was the most frequent treatment-emergent adverse reaction that occurred in at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group. The overall incidence of bone pain in Cycle 1 of treatment was 3.4% (3.4% GRANIX, 1.4% placebo, 7.5% non-US-approved filgrastim product).

Leukocytosis In clinical studies, leukocytosis (WBC counts > 100,000 x 106/L) was observed in less than 1% patients with non-myeloid malignancies receiving GRANIX. No complications attributable to leukocytosis were reported in clinical studies.

6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The incidence of antibody development in patients receiving GRANIX has not been adequately determined.

7 DRUG INTERACTIONS No formal drug interaction studies between GRANIX and other drugs have been performed.

Drugs which may potentiate the release of neutrophils‚ such as lithium‚ should be used with caution.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone-imaging results.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of GRANIX in pregnant women. In an embryofetal developmental study, treatment of pregnant rabbits with tbo-filgrastim resulted in adverse embryofetal findings, including increased spontaneous abortion and fetal malformations at a maternally toxic dose. GRANIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In the embryofetal developmental study, pregnant rabbits were administered subcutaneous doses of tbo-filgrastim during the period of organogenesis at 1, 10 and 100 mcg/kg/day. Increased abortions were evident in rabbits treated with tbo-filgrastim at 100 mcg/kg/day. This dose was maternally toxic as demonstrated by reduced body weight. Other embryofetal findings at this dose level consisted of post-implantation loss‚ decrease in mean live litter size and fetal weight, and fetal malformations such as malformed hindlimbs and cleft palate. The dose of 100 mcg/kg/day corresponds to a systemic exposure (AUC0-24) of approximately 50-90 times the exposures observed in patients treated with the clinical tbo-filgrastim dose of 5 mcg/kg/day.

8.3 Nursing Mothers It is not known whether tbo-filgrastim is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GRANIX is administered to a nursing woman. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates.

8.4 Pediatric Use The safety and effectiveness of GRANIX in pediatric patients have not been established.

8.5 Geriatric Use Among 677 cancer patients enrolled in clinical trials of GRANIX, a total of 111 patients were 65 years of age and older. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.

8.6 Renal Impairment The safety and efficacy of GRANIX have not been studied in patients with moderate or severe renal impairment. No dose adjustment is recommended for patients with mild renal impairment.

8.7 Hepatic Impairment The safety and efficacy of GRANIX have not been studied in patients with hepatic impairment.

10 OVERDOSAGE No case of overdose has been reported. ©2013 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved.

GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. Manufactured by: Distributed by: Sicor Biotech UAB Teva Pharmaceuticals USA, Inc. Vilnius, Lithuania North Wales, PA 19454 U.S. License No. 1803 Product of Israel GRX-40189 January 2014 This brief summary is based on TBO-003 GRANIX full Prescribing Information.

Quality Care

What Constitutes Good Oncology…Continued from page 12 has collaborated with the world’s leading cancer care experts to develop 2 key quality programs: the Quality Oncology Practice Initiative (QOPI) and the QOPI Certification Program.4 These tools assist oncologists and their practice in creating programs that effectively measure and compare their care with other practices in a continuous and meaningful way.

The Association of Community Cancer Centers (ACCC) is working with advocacy organizations, such as the Oncology Nursing Society (ONS), the American Cancer Society Cancer Action Network, and others, to increase support for ensuring good, quality oncology care. These actions are evident by the introduction of 2 bills in 2013.

The first, H.R. 1661, Improving Cancer Treatment Education Act of 2013, would provide reimbursement for a 1-hour chemotherapy nurse-led teaching session in the physician office setting.5 This legislation has been introduced in previous Congresses, with support from ONS and ACCC. The second bill is the Patient Centered Quality Care for Life Act (H.R. 1666).6 This bill would support the growing demand for palliative care, which is specialized medical care that focuses on care coordination and relief from pain, stress, and other symptoms of treatment for a life-threatening disease, such as cancer. This bipartisan bill would facilitate and expand federal research into palliative care, and support training for nurses, nurse practitioners, and other allied health professionals to effectively practice palliative care.

Oncology nurses, care managers, and alike believe that good oncology care is related to early detection, early and accurate diagnosis, and timely implementation of accurate first-line treatment, followed by

proper monitoring of tumor markers for treatment adjustments and proactive control of side effects, as well as strong patient advocacy for palliative and end-of-life care when appropriate. Subsequently, they focus on the patient’s physical, emotional, and social needs being met early on in the process and throughout.

Oncology professionals who manage, treat, and educate patients and families measure good care based on the patient’s ability to continue to function in daily routines, including work and family life.

sometimes they may be influenced by the wrong incentives.

In my conversations with health plan medical directors in the same forums as stated above, it appears they are looking for ways to cut costs and be effective, but also to partner with community oncologists and their practices. We have discussed their ideas and thoughts around the oncology patient-centered medical home and how that may work to improve care as well as cost. The ideas include giving more control of patient care and management back to the oncologist, but also requesting assurances based on the use of treatment guidelines, clinical trials, and strong oncology care management that patients and their needs remain at the center of care and treatment plans.

Finally, I have spoken extensively with patients, their families, and other caregivers, and their focus is much different from that of the oncology patient-centered medical home. They view good cancer care as whether the patient or family member was diagnosed correctly and given the right treatment the first time, how rapidly their social and emotional needs were met, and the type of experience they had moving a family member to palliative care or hospice.

Most national organizations do their best to manage the process, place tools in the hands of practicing oncologists and their teams, and promote the best care possible for patients and their families. However, I am still concerned that they have lost sight of what the patient’s care expectations are, and how the patient gauges good care. Quite often, the focus is on the diagnosis, which is important, but in doing so we forget to ask patients what their goals and expectations are in the process of treating their cancer. For us to truly measure good care, we need to make

For us to truly measure good care, we need to make certain that we address our patients’ needs in the beginning, and continue to reassess and reevaluate their needs throughout the process.

As I have spoken with physician colleagues throughout the United States, in my daily work as an oncology care manager, as a moderator at regional and national meetings, and as an educator and presenter, the feedback I have received from physicians indicates that their focus has been on cost and efficiency. That focus seems to be driven by the necessity of serving dual roles as physicians and business owners. Another key factor in this conundrum is the healthcare reimbursement system. While physicians want to do what is best for their patients and patients’ families,

May 2014

Continued on page 17

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Wealth Management

Your 401(k) Plan Stinks: 3 Ways to Make the Best of a Bad Situation

By W. Ben Utley, CFP®; and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

in retirement, and that’s after-tax. It would take a miraculously high rate of return to turn $1400 per month pre-tax into $10,000 per month after-tax, so many physicians are well on their way to a retirement disaster.

W. Ben Utley

Lawrence B. Keller

W

e see a number of changes phy­sicians might make to improve their financial security, but 1 item is usually beyond their control: the 401(k) plan. Un­less you are self-employed, there is practically nothing you can do about your 401(k)’s underwhelming investment options, ridiculously low con­­tri­­­bution limits, or perverse tax consequences.

If your 401(k) is your main (or maybe your only) investment vehicle for retirement, we have good news for you: It is possible to work around your 401(k) plan’s limitations so you can get back on track toward retirement.

Low Limits Many physicians operate under the mistaken belief that, if they max out their 401(k) plan contributions, they will be all set for retirement. But did you know that the maximum amount of money you can elect to defer into your 401(k) this year is only $17,500 ($23,000 if you will be aged 50 years or older

by December 31)? That’s roughly $1400 deducted from your paycheck each month ($1900 per month if you are aged 50 years or older).

Have you ever met a physician who could live well on $1400 a month? We haven’t. In fact, the physicians we serve are planning to spend more like $10,000 per month

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Unless you are selfemployed, there is practically nothing you can do about your 401(k)’s underwhelming investment options, ridiculously low contribution limits, or perverse tax consequences.

To improve your odds of reaching your retirement goal, you can save outside your 401(k) plan. Even if you cannot deduct the contributions you make to a traditional IRA, you can still contribute $5500 this year ($6500 if you will be aged 50 years or older by December 31), and if you max out your own IRA, your spouse can also contribute up to $5500 to his or her IRA ($6500 if he or she will be aged 50 years or older by December 31) even if he or she is not earning an income. Depending upon your tax situation, it might also make sense to convert these contributions to a Roth IRA, doing what is known as a “backdoor” Roth IRA contribution. Once the money is in a Roth IRA, it can grow tax-free for

ONCOLOGY PRACTICE MANAGEMENT

I May 2014

the rest of your life. Of course, this still might not be enough to allow you to retire comfortably, so you should consider investments outside of your 401(k) plan and IRAs.

Underwhelming Options You probably haven’t read the fine print behind your 401(k) plan, but you are betting that your practice manager has carefully vetted both your 401(k) plan provider and the investments offered inside your plan. Don’t believe it! We have found that busy managers may lack the time or expertise to make well-informed decisions regarding investment-related fees or available investment options. If your plan charges more than 50 basis points (0.50%) on top of mutual fund operating expenses, your plan’s costs are draining an unfair share of your retirement savings. To get this under control, you need to raise your voice, but be careful. We regularly see very expensive plans that persist simply because of office politics.

It’s more common to see an investment lineup consisting mostly, if not entirely, of actively managed mutual funds. This is a sign of ignorance on the part of your plan fiduciaries. At a time when most prudent investors recognize that passively managed index funds have been shown to have delivered better results at a lower cost than the average actively managed fund, there’s no good reason that your plan should continue to limit you to subpar investment options.

To work around these issues, look at your retirement investments holistically. Think about your 401(k) plan, your traditional IRAs, and your after-tax accounts (mutual funds and brokerage accounts) as if they were

Wealth Management

all 1 “retirement portfolio.” Then use the least-bad investment options from your 401(k) and pair them with the best options available within other accounts that make up the balance of your portfolio.

Tax Time Bomb You already know that physicians pay more than their fair share of taxes. But did you know that you are probably setting yourself up to pay more taxes on your 401(k) than you really should? That’s right. There’s a perverse little wrinkle in the tax code that can turn your 401(k) plan into a tax time bomb.

To understand this trap, you need to know a little bit about how investments are taxed. Withdrawals from your 401(k) plan will be taxed at your marginal income tax rate, which may be as high as 39.6% for federal income tax. At the same time, capital gains and qualified dividends from mutual funds held in taxable accounts outside your 401(k) plan are taxed at a maximum federal rate of 23.8% (which is 20% plus the new 3.8% Medicare surtax).

This means that your 401(k) nearly doubles the tax rate you pay on capital gains and qualified income by effectively converting these tax-fa-

vored returns into tax-trapped ordinary income. Consider holding equity mutual funds in a taxable account, or better yet, own them in your Roth IRA or the Roth subaccount of your 401(k), if you have one.

If your 401(k) is a lousy place to stash your stock funds, what should you hold there instead? Consider lowgrowth, income-producing in­ vest­ ments, including bond funds and stable value funds. If you have an appetite

your 401(k) plan, your IRAs, and your other accounts that are earmarked for retirement—as 1 portfolio. Choose to own the best investments in the accounts that make the most sense from the standpoint of expense, risk, return, and taxation.

Summary Even if you are stuck with a stinky 401(k) plan, you can still make the best of a bad situation. All you have to do is take a look at the big picture, think outside the box, and make smart moves to put yourself on track for a solid retirement. l

Even if you are stuck with a stinky 401(k) plan, you can still make the best of a bad situation.

W. Ben Utley, CFP®, is the lead advisor with Physician Family Financial Advisors, a fee-only financial planning firm helping doctors throughout the United States to save for college and invest for retirement. Contact him at 541-463-0899 or visit www.physician family.com.

Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF, is the founder of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 800-481-6447 or by e-mail to Lkeller@physicianfinancialservices. com with comments or questions.

for more aggressive fare, consider high-yield (“junk”) bond funds or emerging market bond funds. Outside your 401(k) plan, these investments may be taxed at your highest marginal rate, so it’s a good idea to protect their income by keeping it inside the tax shelter of your 401(k) plan.

Again, the best workaround for this tax trap is to view your entire retirement portfolio—including

What Constitutes Good Oncology…Continued from page 15 certain that we address our patients’ needs in the beginning, and continue to reassess and reevaluate their needs throughout the process.

The collective oncology community must work together more closely and begin to gather and assess patients’ expectations of care; this information has been lacking in our quality metrics. Just as we set goals for our patients, we should make our primary goal asking the patient, “What are your expectations through your treatment process?” In doing

so, we may be surprised at some of the answers, and, subsequently, how that may affect the treatment path followed. By making this step part of the workflow and operational process, we will have the missing information needed to measure good oncology care and treatment.

Without this information, we may never reach this goal in patients’ eyes, and they are the ones who matter the most. l

Care)? ww5.komen.org/BreastCancer/WhatisGoodCare. html. Updated March 24, 2014. Accessed April 20, 2014.

2. US Department of Health & Human Services, Health Resources and Services Administration. What is Quality? http://www.hrsa.gov/healthit/toolbox/ HealthITAdoptiontoolbox/QualityImprovement/whatisquality.html. Accessed April 30, 2014.

3. National Cancer Policy Board, Institute of Medicine and Commission on Life Sciences, National Research Council. Summary. In: Hewitt M, Simone JV, eds.

Ensuring Quality Cancer Care. Washington, DC: The National Academies Press, 1999:1-12. http://books.nap. edu/openbook.php?record_id=6467&page=1. Accessed April 30, 2014.

4. American Society of Clinical Oncology. Guidelines. http://www.asco.org/quality-guidelines/guidelines.

Accessed April 30, 2014.

5. Library of Congress. H.R.1661 - Improving Cancer Treat­ment Education Act of 2013. http://beta.congress.gov bill/113th-congress/house-bill/1661. Accessed April 30, 2014.

6. Library of Congress. H.R.1666 - Patient Centered Quality Care for Life Act. http://beta.congress.gov/bill/ 113th-congress/house-bill/1666. Accessed April 30, 2014.

References

1. Susan G. Komen. What is Quality of Care (Good

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Your Patients, Your Practice…

Helping Your Practice This comprehensive financial assistance program offers ongoing support across the reimbursement spectrum to help you help your patients.

Complete Provider Assistance Benefit verification Prior authorization tracking Regionally dedicated case managers Local access and reimbursement specialists Denied claims assistance

INDICATION XTANDI (enzalutamide) capsules is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel.

IMPORTANT SAFETY INFORMATION Contraindications – XTANDI (enzalutamide) capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant.

Warnings and Precautions – In the randomized clinical trial, seizure occurred in 0.9% of patients on XTANDI. No patients on the placebo arm experienced seizure.

Patients experiencing a seizure were permanently discontinued from therapy. All seizures resolved. Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizure were excluded from the clinical

    

trial. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others.

Adverse Reactions – The most common adverse drug reactions (≥ 5%) reported in patients receiving XTANDI in the randomized clinical trial were asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% grade 3-4) and in 6% of patients on placebo (no grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients and 2% of patients on placebo. One percent of XTANDI patients compared to 0.3% of patients on placebo died from

We’ve Got You Covered Helping Your Patients Financial assistance is available for patients.* Private Insurance $5,000/month copay assistance, up to $12,000/year

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New Patients Awaiting Coverage Decision Free XTANDI through XTANDI QuickStart+™ Program

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infections or sepsis. Falls or injuries related to falls occurred in 4.6% of XTANDI patients vs 1.3% of patients on placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients and included non-pathologic fractures, joint injuries, and hematomas.

Grade 1 or 2 hallucinations occurred in 1.6% of XTANDI patients and 0.3% of patients on placebo, with the majority on opioid-containing medications at the time of the event.

Drug Interactions: Effect of Other Drugs on XTANDI – Administration of strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI. Coadministration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If coadministration of XTANDI cannot be avoided, reduce the dose of XTANDI. Coadministration of XTANDI with strong or moderate CYP3A4 and CYP2C8 inducers can alter the plasma exposure of XTANDI and should be avoided if possible.

XtandiAccess.com

Effect of XTANDI on Other Drugs – XTANDI is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is coadministered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

PLEASE SEE BRIEF SUMMARY OF COMPLETE PRESCRIBING INFORMATION ON FOLLOWING PAGES.

XTANDI Access ServicesSM, a component of Astellas Access ServicesSM 1-855-8XTANDI (1-855-898-2634); Fax 1-855-982-6341; XtandiAccess.com ©2014 Astellas Pharma US, Inc. All rights reserved. 076-0153-PM 4/14 Printed in USA XTANDI, Astellas, and the flying star logo are trademarks of Astellas Pharma, Inc.

(continued) Table 1. Adverse Reactions in the Randomized Trial XTANDI N = 800 Grade 1-4 Grade 3-4 (%) (%)

XTANDI® (enzalutamide) capsules for oral use Initial U.S. Approval: 2012 BRIEF SUMMARY OF PRESCRIBING INFORMATION The following is a brief summary: please see the package insert for full prescribing information.

------------------------------ INDICATIONS AND USAGE ----------------------------XTANDI is indicated for the treatment of patients with metastatic castrationresistant prostate cancer who have previously received docetaxel.

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

-------------------------- WARNINGS AND PRECAUTIONS ------------------------Seizure In the randomized clinical trial, 7 of 800 (0.9%) patients treated with XTANDI 160 mg once daily experienced a seizure. No seizures occurred in patients treated with placebo. Seizures occurred from 31 to 603 days after initiation of XTANDI. Patients experiencing seizure were permanently discontinued from therapy and all seizures resolved. There is no clinical trial experience re-administering XTANDI to patients who experienced seizures.

The safety of XTANDI in patients with predisposing factors for seizure is not known because these patients were excluded from the trial. These exclusion criteria included a history of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, brain arteriovenous malformation or the use of concomitant medications that may lower the seizure threshold.

Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others.

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

In the randomized clinical trial in patients with metastatic castration-resistant prostate cancer who had previously received docetaxel, patients received XTANDI 160 mg orally once daily (N = 800) or placebo (N = 399). The median duration of treatment was 8.3 months with XTANDI and 3.0 months with placebo.

All patients continued androgen deprivation therapy. Patients were allowed, but not required, to take glucocorticoids. During the trial, 48% of patients on the XTANDI arm and 46% of patients on the placebo arm received glucocorticoids.

All adverse events and laboratory abnormalities were graded using NCI CTCAE version 4.

The most common adverse drug reactions (≥ 5%) reported in patients receiving XTANDI in the randomized clinical trial were asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade 3 and higher adverse reactions were reported among 47% of XTANDI-treated patients and 53% of placebo-treated patients. Discontinuations due to adverse events were reported for 16% of XTANDI-treated patients and 18% of placebo-treated patients. The most common adverse reaction leading to treatment discontinuation was seizure, which occurred in 0.9% of the XTANDI-treated patients compared to none (0%) of the placebo-treated patients. Table 1 shows adverse reactions reported in the randomized clinical trial that occurred at a ≥ 2% absolute increase in frequency in the XTANDI arm compared to the placebo arm.

Table 1. Adverse Reactions in the Randomized Trial XTANDI Placebo N = 800 N = 399 Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 (%) (%) (%) (%) General Disorders 50.6 9.0 44.4 9.3 Asthenic Conditionsa Peripheral Edema 15.4 1.0 13.3 0.8 Musculoskeletal And Connective Tissue Disorders Back Pain 26.4 5.3 24.3 4.0 Arthralgia 20.5 2.5 17.3 1.8 Musculoskeletal Pain 15.0 1.3 11.5 0.3 Muscular Weakness 9.8 1.5 6.8 1.8 Musculoskeletal 2.6 0.3 0.3 0.0 Stiffness

Placebo N = 399 Grade 1-4 Grade 3-4 (%) (%)

Gastrointestinal Disorders Diarrhea 21.8 1.1 17.5 0.3 Vascular Disorders Hot Flush 20.3 0.0 10.3 0.0 Hypertension 6.4 2.1 2.8 1.3 Nervous System Disorders Headache 12.1 0.9 5.5 0.0 9.5 0.5 7.5 0.5 Dizzinessb Spinal Cord 7.4 6.6 4.5 3.8 Compression and Cauda Equina Syndrome Paresthesia 6.6 0.0 4.5 0.0 4.3 0.3 1.8 0.0 Mental Impairment Disordersc Hypoesthesia 4.0 0.3 1.8 0.0 Infections And Infestations 10.9 0.0 6.5 0.3 Upper Respiratory Tract Infectiond Lower Respiratory 8.5 2.4 4.8 1.3 Tract And Lung Infectione Psychiatric Disorders Insomnia 8.8 0.0 6.0 0.5 Anxiety 6.5 0.3 4.0 0.0 Renal And Urinary Disorders Hematuria 6.9 1.8 4.5 1.0 Pollakiuria 4.8 0.0 2.5 0.0 Injury, Poisoning And Procedural Complications Fall 4.6 0.3 1.3 0.0 Non-pathologic 4.0 1.4 0.8 0.3 Fractures Skin And Subcutaneous Tissue Disorders Pruritus 3.8 0.0 1.3 0.0 Dry Skin 3.5 0.0 1.3 0.0 Respiratory Disorders Epistaxis 3.3 0.1 1.3 0.3 a Includes asthenia and fatigue. b Includes dizziness and vertigo. c Includes amnesia, memory impairment, cognitive disorder, and disturbance in attention. d Includes nasopharyngitis, upper respiratory tract infection, sinusitis, rhinitis, pharyngitis, and laryngitis. e Includes pneumonia, lower respiratory tract infection, bronchitis, and lung infection.

Laboratory Abnormalities In the randomized clinical trial, Grade 1-4 neutropenia occurred in 15% of patients on XTANDI (1% Grade 3-4) and in 6% of patients on placebo (no Grade 3-4). The incidence of Grade 1-4 thrombocytopenia was similar in both arms; 0.5% of patients on XTANDI and 1% on placebo experienced Grade 3-4 thrombocytopenia. Grade 1-4 elevations in ALT occurred in 10% of patients on XTANDI (0.3% Grade 3-4) and 18% of patients on placebo (0.5% Grade 3-4).

Grade 1-4 elevations in bilirubin occurred in 3% of patients on XTANDI and 2% of patients on placebo.

Infections In the randomized clinical trial, 1.0% of patients treated with XTANDI compared to 0.3% of patients on placebo died from infections or sepsis. Infection-related serious adverse events were reported in approximately 6% of the patients on both treatment arms.

Falls and Fall-related Injuries In the randomized clinical trial, falls or injuries related to falls occurred in 4.6% of patients treated with XTANDI compared to 1.3% of patients on placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in patients treated with XTANDI and included non-pathologic fractures, joint injuries, and hematomas.

Hallucinations In the randomized clinical trial, 1.6% of patients treated with XTANDI were reported to have Grade 1 or 2 hallucinations compared to 0.3% of patients on placebo. Of the patients with hallucinations, the majority were on opioidcontaining medications at the time of the event. Hallucinations were visual, tactile, or undefined.

----------------------------------DRUG INTERACTIONS ------------------------------Drugs that Inhibit or Induce CYP2C8 Co-administration of a strong CYP2C8 inhibitor (gemfibrozil) increased the composite area under the plasma concentration-time curve (AUC) of enzalutamide plus N-desmethyl enzalutamide in healthy volunteers.

Co-administration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If co-administration of XTANDI with a strong CYP2C8 inhibitor cannot be avoided, reduce the dose of XTANDI [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].

The effects of CYP2C8 inducers on the pharmacokinetics of enzalutamide have not been evaluated in vivo. Co-administration of XTANDI with strong or moderate CYP2C8 inducers (e.g., rifampin) may alter the plasma exposure of XTANDI and should be avoided if possible. Selection of a concomitant medication with no or minimal CYP2C8 induction potential is recommended [see Clinical Pharmacology].

Drugs that Inhibit or Induce CYP3A4 Co-administration of a strong CYP3A4 inhibitor (itraconazole) increased the composite AUC of enzalutamide plus N-desmethyl enzalutamide by 1.3 fold in healthy volunteers [see Clinical Pharmacology (12.3)].

The effects of CYP3A4 inducers on the pharmacokinetics of enzalutamide have not been evaluated in vivo. Co-administration of XTANDI with strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine) may decrease the plasma exposure of XTANDI and should be avoided if possible. Selection of a concomitant medication with no or minimal CYP3A4 induction potential is recommended. Moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) and St. John’s Wort may also reduce the plasma exposure of XTANDI and should be avoided if possible [see Clinical Pharmacology ].

Effect of XTANDI on Drug Metabolizing Enzymes Enzalutamide is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. At steady state, XTANDI reduced the plasma exposure to midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate). Concomitant use of XTANDI with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin) should be avoided, as enzalutamide may decrease their exposure. If co-administration with warfarin cannot be avoided, conduct additional INR monitoring [see Clinical Pharmacology ].

-------------------------- USE IN SPECIFIC POPULATIONS -----------------------Pregnancy- Pregnancy Category X [see Contraindications].

XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action. While there are no human or animal data on the use of XTANDI in pregnancy and XTANDI is not indicated for use in women, it is important to know that maternal use of an androgen receptor inhibitor could affect development of the fetus. XTANDI is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with XTANDI. Nursing Mothers XTANDI is not indicated for use in women. It is not known if enzalutamide is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from XTANDI, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

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

Geriatric Use Of 800 patients who received XTANDI in the randomized clinical trial, 71 percent were 65 and over, while 25 percent were 75 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Patients with Renal Impairment A dedicated renal impairment trial for XTANDI has not been conducted. Based on the population pharmacokinetic analysis using data from clinical trials in patients with metastatic castration-resistant prostate cancer and healthy volunteers, no significant difference in enzalutamide clearance was observed in patients with pre-existing mild to moderate renal impairment (30 mL/min ≤ creatinine clearance [CrCL] ≤ 89 mL/min) compared to patients and volunteers with baseline normal renal function (CrCL ≥ 90 mL/min). No initial dosage adjustment is necessary for patients with mild to moderate renal impairment.

Severe renal impairment (CrCL < 30 mL/min) and end-stage renal disease have not been assessed [see Clinical Pharmacology].

Patients with Hepatic Impairment A dedicated hepatic impairment trial compared the composite systemic exposure of enzalutamide plus N-desmethyl enzalutamide in volunteers with baseline mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively) versus healthy controls with normal hepatic function. The composite AUC of enzalutamide plus N-desmethyl enzalutamide was similar in volunteers with mild or moderate baseline hepatic impairment compared to volunteers with normal hepatic function. No initial dosage adjustment is necessary for patients with baseline mild or moderate hepatic impairment. Baseline severe hepatic impairment (Child-Pugh Class C) has not been assessed [see Clinical Pharmacology].

-------------------------------------- OVERDOSAGE -------------------------------------In the event of an overdose, stop treatment with XTANDI and initiate general supportive measures taking into consideration the half-life of 5.8 days. In a dose escalation study, no seizures were reported at < 240 mg daily, whereas 3 seizures were reported, 1 each at 360 mg, 480 mg, and 600 mg daily. Patients may be at increased risk of seizures following an overdose.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of enzalutamide.

Enzalutamide did not induce mutations in the bacterial reverse mutation (Ames) assay and was not genotoxic in either the in vitro mouse lymphoma thymidine kinase (Tk) gene mutation assay or the in vivo mouse micronucleus assay.

Based on nonclinical findings in repeat-dose toxicology studies, which were consistent with the pharmacological activity of enzalutamide, male fertility may be impaired by treatment with XTANDI. In a 26-week study in rats, atrophy of the prostate and seminal vesicles was observed at ≥ 30 mg/kg/day (equal to the human exposure based on AUC). In 4- and 13-week studies in dogs, hypospermatogenesis and atrophy of the prostate and epididymides were observed at ≥ 4 mg/kg/day (0.3 times the human exposure based on AUC).

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (PATIENT INFORMATION).

• Instruct patients to take their dose at the same time each day (once daily).

XTANDI can be taken with or without food. Each capsule should be swallowed whole. Do not chew, dissolve, or open the capsules.

• Inform patients receiving a GnRH analog that they need to maintain this treatment during the course of treatment with XTANDI. • Inform patients that XTANDI has been associated with an increased risk of seizure. Discuss conditions that may predispose to seizures and medications that may lower the seizure threshold. Advise patients of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others.

• Inform patients that XTANDI may cause dizziness, mental impairment, paresthesia, hypoesthesia, and falls.

• Inform patients that they should not interrupt, modify the dose, or stop XTANDI without first consulting their physician. Inform patients that if they miss a dose, then they should take it as soon as they remember.

If they forget to take the dose for the whole day, then they should take their normal dose the next day. They should not take more than their prescribed dose per day.

• Apprise patients of the common side effects associated with XTANDI: asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. • Inform patients that XTANDI may be harmful to a developing fetus.

Patients should also be informed that they should use a condom if having sex with a pregnant woman. A condom and another effective method of birth control should be used if the patient is having sex with a woman of child-bearing potential. These measures are required during and for three months after treatment with XTANDI.

Manufactured by: Catalent Pharma Solutions, LLC, St. Petersburg, FL 33716 Manufactured for and Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Medivation, Inc., San Francisco, CA 94105 Issued: August 2012 12A005-ENZ-BRS Rx Only © 2012 Astellas Pharma US, Inc. XTANDI® is a registered trademark of Astellas Pharma Inc.

ONCOLOGY

Processing and Compliance

Compliance: Cost or Investment?

By Kelli Weiss, RT(R)(T), Revenue Cycle, Austin, TX

A

s they navigate payer re­­ quirements, practices and care facilities find that they are able to reach their highest standard of documentation and billing compliance only by applying fo­ cused effort and dedicated resources. Although the importance of efficient, accurate processes seems obvious, it is often overlooked or minimized in light of the resources it takes to implement them (money, staff, and the ability to manage often unpopular policies) and achieve what should be the highest standard of care in today’s healthcare environment.

Over the past decade or so, quality and efficiency have been well-publicized goals of our healthcare system.

This is evidenced by the numerous programs developed and put forth to providers, including but not limited to the Physician Quality Reporting System as well as incentives for implementing electronic medical records and attesting to the meaningful use of these systems.

To further examine these goals, the Centers for Medicare & Medicaid Services (CMS) released a paper in November 2013 titled “CMS Quality Strategy 2013– Beyond.”1 Developed in accordance with legislation in the Patient Protection and Affordable Care Act of 2010, the paper outlines clearly defined goals as well as strategies to attain them.

“CMS, is working to support the delivery of consistent high-quality care, promote efficient outcomes in our healthcare system, and ensure that health insurance remains affordable for the millions of Americans who seek coverage,” the report states.

Along with CMS goals and initiatives for quality, numerous pro-

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grams, task forces, and agencies have been developed to ensure that payments received are warranted and supported within a patient’s medical record. In February 2014, Attorney General Eric Holder and US Department of Health & Human Services Secretary Kathleen Sebelius released the annual Health Care Fraud and Abuse Control (HCFAC) Program report.2 It showed that for every dollar spent on healthcare-related fraud and abuse investigations through this and other programs in the past 3 years, the government has recovered $8.10.

What is the cost of compliance for your facility or practice?

How is your return on investment quantified for implementing a strong compliance program?

This represented the highest return on investment in the 17-year history of the HCFAC Program.

With these results, it is safe to assume that these programs will continue to seek and recoup inappropriately paid monies by conducting extensive medical record reviews and close oversight of healthcare providers.

“The Program’s continued success confirms the soundness of a collaborative approach to identify and prosecute the most egregious instances of health care fraud, to

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prevent future fraud and abuse, and to protect program beneficiaries,” the report states.

So, what is the cost of compliance for your facility or practice?

How is your return on investment quantified for implementing a strong compliance program? Ac­ cording to the Patient Protection and Affordable Care Act, providers who treat Medicare and Medicaid beneficiaries are required to establish a compliance program. On its website, the Office of the Inspector General (OIG) provides a blueprint for the requirements of a successful compliance plan. These include medical record reviews and a well-publicized action plan on ways deficiencies will be addressed.

Program guidance documents for various segments of the healthcare industry can be located on the OIG website.3 To focus on one component of the overall goal of compliance, facilities and providers can implement a streamlined process of thoroughly reviewing all medical record documentation and accurate charge capture before submitting claims to payers. By implementing a comprehensive review in which every service captured for billing is assessed to compare documentation to the charge capture, a provider may alleviate inappropriate billing practices. This process will not only identify inappropriate billing for undocumented services, but may also reveal procedures billed at incorrect levels, items or procedures that were performed and not billed, and, finally, provide a means for continuous education of physicians and staff regarding compliant documentation and billing habits.

As a provider, you have options when considering the cost of this

Processing and Compliance

vital review process. Perhaps a current staff member can be designated to manage it. You may hire a person dedicated to performing these duties, or the review may be outsourced to a qualified entity. Be sure to avoid a cavalier attitude that discounts the potential issues your facility or practice may have. At the very least, an in-depth evaluation will help assess your level of current documentation and billing compliance, and identify what you need.

While focusing on the incentives put forth by payers, getting the basics right can ensure that the monies you receive are justified and are not at risk for recoupment.

Beyond documentation and billing compliance, it is essential to

focus on your entire revenue cycle to ensure financial health. Making sure each phase of the entire revenue cycle is conducted properly will pay off in terms of revenue and compliance. Too many facilities concentrate solely on one component of the revenue cycle, such as the documentation and coding aspect. You must go beyond and investigate the effectiveness of the interfaces that move charges from one software system to another. In addition, the coding scrubber systems being utilized, whether they are software driven or manual, should be tested.

Lastly, the information that is going to the payer must be scoured for correctness. Compliance doesn’t

end in the clinical department, but should be verified throughout the revenue cycle process. While implementation and review of so many processes and systems may sound daunting and costly, you will find that investments to ensure compliance are worth making. l

References

1. Centers for Medicare & Medicaid Services. CMS Quality Strategy 2013 – Beyond. www.cms.gov/ Medicare/Quality-Initiatives-Patient-AssessmentInstruments/QualityInitiativesGenInfo/Downloads/ CMS-Quality-Strategy.pdf. Published November 18, 2013. Accessed April 30, 2014.

2. US Department of Health & Human Services, US Department of Justice. Health Care Fraud and Abuse Control Program: Annual Report for Fiscal Year 2013. https://oig.hhs.gov/publications/docs/hcfac/ FY2013-hcfac.pdf. Published February 2014. Accessed April 30, 2014.

3. US Department of Health & Human Services, Office of the Inspector General. Compliance Guidance. http:// oig.hhs.gov/compliance/compliance-guidance/index. asp. Accessed May 1, 2014.

Your Expert Oncology Resource

Revenue Cycle Inc. delivers customized, leading-edge strategies and services.

Regardless of your practice setting, our team is able to offer an array of services customized to meet your needs.

Medical & Radiation Oncology Services • Billing, Coding & Compliance • Training & Education • Electronic Medical Record Implementation • Process Review & Development • Client Resource Center

• Remote Solutions • Front Office & Back Office Process Review • Revenue Enhancement • Regulatory Summation Updates • Proforma Creation

To speak to one of our experts, call 512.583.2000 or visit our website at www.revenuecycleinc.com.

May 2014

I

www.OncPracticeManagement.com

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Patient and Provider Access

ACCC’s Annual National Meeting: Keeping the Oncology Team on the Front Lines of Changing Policy

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

T

he 2014 As­ sociation of Co­m­­munity Cancer Centers (ACCC) Annual National Meeting brought together oncology care providers from across the country to network and learn about the legislative and regulatory policies impacting cancer care—and the timing could not have been better. Members in attendance at the meeting, held March 31 to April 2, were present for an important congressional vote on the sustainable growth rate (SGR) formula, and even celebrated a victory with the passage of oral parity legislation in Wisconsin.

The meeting started off on a high note, with more than 50 members participating in more than 100 meetings on Capitol Hill in Washington, DC. Some of the hot topics focused on SGR reform, sequestration, oral parity, and the prompt payment discount. Congressional representatives and staff members heard firsthand accounts of how sequestration, particularly when consid-

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ered in addition to the prompt payment discount, reduces Medicare reimbursement to the point where providers are actually losing money by caring for some of their patients.

Other advocates discussed the need for a permanent solution to the flawed SGR formula. Congress seemed to agree, and even worked out reasonable reform legislation, which ACCC members supported until the end of the day when the Senate voted on the issue. In some cases, ACCC members were the last voices heard by the Senate offices before votes were cast. In the end, it was not the policy of SGR reform that proved problematic—it was how to pay for the permanent fix. Democratic and Republican congressmen and congresswomen could not agree on how to pay for the $140-billion reform over the next 10 years, and ultimately another 12-month patch was passed. ACCC advocates vowed to continue the conversation with Congress to reach a long-term, sustainable solution before the next patch.

Following the trend of Capitol Hill Day, the rest of the national meeting looked at other relevant policy topics, including alternative payment reforms, patient access issues, and implementation of the Affordable Care Act. In particular, with the close of the first health insurance marketplace open enrollment period, there was a robust discussion of the exchanges’ successes, failures, and issues to watch moving forward.

Of note, members learned that although the state and federal insur-

ONCOLOGY PRACTICE MANAGEMENT

I May 2014

ance marketplaces did help bring coverage to more Americans than private insurance had previously, many of the newly covered— especially on lower-tiered plans— may not be able to afford the high deductibles (more than $6000 for an individual) and other cost-sharing mechanisms that are standard among all exchange plans. Concern was expressed for patients’ ability to access the most appropriate provider inside some of the limited networks that have proven to be a core component of bronze level plans, in particular. Meeting attendees talked about individuals moving from uninsured to underinsured, and not necessarily knowing it.

The meeting ended on a high note as 4 cancer care providers were recognized for their grassroots advocacy efforts to pass oral parity legislation at the state level. To make the recognition even sweeter, 2 of the advocates from the Medical College of Wisconsin celebrated the passage of the Wisconsin law just 1 day prior. The grassroots champions also talked about their experiences with the legislative process, encouraged other members to get involved.

If you missed the ACCC Annual National Meeting, please join us October 9-11, 2014, in San Diego, CA, for the ACCC National Oncology Conference, where we will highlight innovators and leaders in cancer care, and discuss the trends and changes facing the oncology team today and in the future. For more information, please visit www.accc-cancer.org/ meetings. l

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

•REIMBURSEMENT SERVICES

•EDUCATION AND SUPPORT SERVICES

•BENEFIT VERIFICATIONS

•PATIENT ASSISTANCE

•DELIVERY COORDINATION

•CO-PAY ASSISTANCE

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

Important Safety Information • Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated • Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary • Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi • Severe neutropenia (ANC <0.5 × 109/L) was generally reversible. Withhold Jakafi until recovery Please see additional Important Safety Information and the Brief Summary of Full Prescribing Information within this ad.

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

Patients living with intermediate or high-risk MF face many challenges.

IncyteCARES is a program created by Incyte to connect patients who qualify for the program to ongoing support and resources during their treatment with Jakafi.

Enrollment sent to

93% of patients had insurance coverage for

95% of patients referred to the IncyteCARES patient assistance program were eligible for assistance

97% of patients have opted in to the nurse educator program

Patients without insurance coverage were screened for patient assistance eligibility

96% of prior authorizations were approved for

72% of commercially insured patients had co-pays of less than $100/month

94% of patients referred to the IncyteCARES commercial co-pay assistance program were eligible for assistance

Information is based upon patients enrolled in IncyteCARES from launch through December 31, 2013.

IncyteCARES: ASSISTING PROVIDERS AND PATIENTS IN OBTAINING ACCESS TO JAKAFI

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

Indications and Usage Jakafi is indicated for treatment of patients with intermediate or high-risk MF, including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF. Important Safety Information for Jakafi (ruxolitinib), continued • Serious bacterial, mycobacterial, fungal and viral infections may occur. Active serious infections should have resolved before starting Jakafi. Tuberculosis (TB) has been reported; attention should be given to the possibility of latent or active TB. Observe patients receiving Jakafi for signs and symptoms of infection and initiate appropriate treatment promptly • Progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate • Advise patients about early signs and symptoms of herpes zoster and to seek early treatment • The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache • A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or in patients with renal or hepatic impairment. Patients should be closely monitored and the dose titrated based on safety and efficacy • Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus. Women taking Jakafi should not breast-feed Please see additional Important Safety Information and the Brief Summary of Full Prescribing Information within this ad.

Jakafi is a registered trademark of Incyte Corporation. © 2014, Incyte Corporation. All rights reserved. RUX-1227p

05/14

Table 2: Worst Hematology Laboratory Abnormalities in the Placebo-controlled Studya Jakafi Placebo (N=155) (N=151) Laboratory All All Grade 4 Grades Grade 3 Grade 4 Parameter Gradesb Grade 3 BRIEF SUMMARY: For Full Prescribing Information, see package insert. (%) (%) (%) (%) (%) (%) INDICATIONS AND USAGE Jakafi is indicated for treatment of patients with intermediate or high-risk Thrombocytopenia 69.7 9.0 3.9 30.5 1.3 0 myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential Anemia 96.1 34.2 11.0 86.8 15.9 3.3 thrombocythemia myelofibrosis.

Neutropenia 18.7 5.2 1.9 4.0 0.7 1.3 CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia and Neutropenia Treatment a Presented values are worst Grade values regardless of baseline b National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 with Jakafi can cause thrombocytopenia, anemia and neutropenia. [see Dosage and Administration (2.1) in Full Prescribing Information]. Thrombocytopenia was generally reversible and was usually managed by Additional Data from the Placebo-controlled Study 25.2% of patients treated with Jakafi and 7.3% of reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary [see Dosage and patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transAdministration (2.2) in Full Prescribing Information, and Adverse Reactions]. Patients developing anemia aminase (ALT). The incidence of greater than or equal to Grade 2 elevations was 1.9% for Jakafi with 1.3% may require blood transfusions and/or dose modifications of Jakafi. Severe neutropenia (ANC less than Grade 3 and no Grade 4 ALT elevations. 17.4% of patients treated with Jakafi and 6.0% of patients treated 0.5 X 109/L) was generally reversible. Withhold Jakafi until recovery [see Adverse Reactions]. Perform a pre- with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and (AST). The incidence of Grade 2 AST elevations was 0.6% for Jakafi with no Grade 3 or 4 AST elevations. then as clinically indicated [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse 16.8% of patients treated with Jakafi and 0.7% of patients treated with placebo developed newly occurring or Reactions]. Risk of Infection Serious bacterial, mycobacterial, fungal and viral infections may occur. worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was 0.6% for Jakafi with no Grade 3 or 4 cholesterol elevations.

Active serious infections should have resolved before starting therapy with Jakafi. Tuberculosis has been reported in patients receiving Jakafi for myelofibrosis. Attention should be given to the possibility of latent or DRUG INTERACTIONS Drugs That Inhibit or Induce Cytochrome P450 Enzymes Ruxolitinib is predominantly metabolized by CYP3A4. Strong CYP3A4 inhibitors: The Cmax and AUC of ruxolitinib active tuberculosis. Observe patients receiving Jakafi for signs and symptoms of infection and initiate increased 33% and 91%, respectively, with Jakafi administration (10 mg single dose) following ketoconazole appropriate treatment promptly. PML Progressive multifocal leukoencephalopathy (PML) has been reported 200 mg twice daily for four days, compared to receiving Jakafi alone in healthy subjects. The half-life was also with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate. Herpes Zoster prolonged from 3.7 to 6.0 hours with concurrent use of ketoconazole. The change in the pharmacodynamic Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible marker, pSTAT3 inhibition, was consistent with the corresponding ruxolitinib AUC following concurrent adminif suspected [see Adverse Reactions]. istration with ketoconazole. When administering Jakafi with strong CYP3A4 inhibitors a dose reduction is ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other recommended [see Dosage and Administration (2.7) in Full Prescribing Information]. Patients should be sections of the labeling: • Myelosuppression [see Warnings and Precautions]; • Risk of Infection [see closely monitored and the dose titrated based on safety and efficacy. Mild or moderate CYP3A4 inhibitors: Warnings and Precautions] Clinical Trials Experience Because clinical trials are conducted under There was an 8% and 27% increase in the C and AUC of ruxolitinib, respectively, with Jakafi administration max widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly (10 mg single dose) following erythromycin, a moderate CYP3A4 inhibitor, at 500 mg twice daily for 4 days, compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The compared to receiving Jakafi alone in healthy subjects. The change in the pharmacodynamic marker, pSTAT3 safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 inhibition was consistent with the corresponding exposure information. No dose adjustment is recommended months, including 301 patients with myelofibrosis in two Phase 3 studies. In these two Phase 3 studies, when Jakafi is coadministered with mild or moderate CYP3A4 inhibitors (eg, erythromycin). CYP3A4 patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 88.7% of inducers: The Cmax and AUC of ruxolitinib decreased 32% and 61%, respectively, with Jakafi administration patients treated for more than 6 months and 24.6% treated for more than 12 months. One hundred and (50 mg single dose) following rifampin 600 mg once daily for 10 days, compared to receiving Jakafi alone in eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In healthy subjects. In addition, the relative exposure to ruxolitinib’s active metabolites increased approximately a double-blind, randomized, placebo-controlled study of Jakafi, 155 patients were treated with Jakafi. The 100%. This increase may partially explain the reported disproportionate 10% reduction in the pharmacomost frequent adverse drug reactions were thrombocytopenia and anemia [see Table 2]. Thrombocytopenia, dynamic marker pSTAT3 inhibition. No dose adjustment is recommended when Jakafi is coadministered with anemia and neutropenia are dose related effects. The three most frequent non-hematologic adverse reactions a CYP3A4 inducer. Patients should be closely monitored and the dose titrated based on safety and efficacy. were bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless of USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: There are no adequate causality, was observed in 11.0% of patients treated with Jakafi and 10.6% of patients treated with placebo. and well-controlled studies of Jakafi in pregnant women. In embryofetal toxicity studies, treatment with Following interruption or discontinuation of Jakafi, symptoms of myelofibrosis generally return to ruxolitinib resulted in an increase in late resorptions and reduced fetal weights at maternally toxic doses. pretreatment levels over a period of approximately 1 week. There have been isolated cases of patients discon- Jakafi should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. tinuing Jakafi during acute intercurrent illnesses after which the patient’s clinical course continued to worsen; Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses however, it has not been established whether discontinuation of therapy contributed to the clinical course in of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There was no evidence of teratothese patients. When discontinuing therapy for reasons other than thrombocytopenia, gradual tapering of the genicity. However, decreases of approximately 9% in fetal weights were noted in rats at the highest and dose of Jakafi may be considered [see Dosage and Administration (2.9) in Full Prescribing Information]. Table maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times 1 presents the most common adverse reactions occurring in patients who received Jakafi in the double-blind, the clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights placebo-controlled study during randomized treatment. of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In Table 1: Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlled a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implanStudy During Randomized Treatment tation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for Jakafi Placebo fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest (N=155) (N=151) dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily).

Adverse All All Nursing Mothers It is not known whether ruxolitinib is excreted in human milk. Ruxolitinib and/or its Reactions Gradesa Grade 3 Grade 4 Grades Grade 3 Grade 4 metabolites were excreted in the milk of lactating rats with a concentration that was 13-fold the maternal (%) (%) (%) (%) (%) (%) plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse Bruisingb 23.2 0.6 0 14.6 0 0 reactions in nursing infants from Jakafi, a decision should be made to discontinue nursing or to discontinue Dizzinessc 18.1 0.6 0 7.3 0 0 the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effecHeadache 14.8 0 0 5.3 0 0 tiveness of Jakafi in pediatric patients have not been established. Geriatric Use Of the total number of myelofibrosis patients in clinical studies with Jakafi, 51.9% were 65 years of age and older. No overall differUrinary Tract Infectionsd 9.0 0 0 5.3 0.7 0.7 ences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Weight Gaine 7.1 0.6 0 1.3 0.7 0 Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in Flatulence 5.2 0 0 0.7 0 0 healthy subjects [CrCl 72-164 mL/min (N=8)] and in subjects with mild [CrCl 53-83 mL/min (N=8)], Herpes Zosterf 1.9 0 0 0.7 0 0 moderate [CrCl 38-57 mL/min (N=8)], or severe renal impairment [CrCl 15-51 mL/min (N=8)]. Eight (8) a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 b includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site additional subjects with end stage renal disease requiring hemodialysis were also enrolled. The pharmacokinetics of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with hematoma, increased tendency to bruise, petechiae, purpura normal renal function. However, plasma AUC values of ruxolitinib metabolites increased with increasing c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis d includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria severity of renal impairment. This was most marked in the subjects with end stage renal disease requiring hemodialysis. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the urine, bacteria urine identified, nitrite urine present e includes weight increased, abnormal weight gain corresponding increase in metabolite exposure. Ruxolitinib is not removed by dialysis; however, the removal f includes herpes zoster and post-herpetic neuralgia of some active metabolites by dialysis cannot be ruled out. When administering Jakafi to patients with Description of Selected Adverse Drug Reactions Anemia In the two Phase 3 clinical studies, median moderate (CrCl 30-59 mL/min) or severe renal impairment (CrCl 15-29 mL/min) with a platelet count time to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks. One patient (0.3%) between 100 X 109/L and 150 X 109/L and patients with end stage renal disease on dialysis a dose reduction discontinued treatment because of anemia. In patients receiving Jakafi, mean decreases in hemoglobin is recommended [see Dosage and Administration (2.8) in Full Prescribing Information]. Hepatic reached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in gradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This pattern healthy subjects (N=8) and in subjects with mild [Child-Pugh A (N=8)], moderate [Child-Pugh B (N=8)], or was observed in patients regardless of whether they had received transfusions during therapy. In the severe hepatic impairment [Child-Pugh C (N=8)]. The mean AUC for ruxolitinib was increased by 87%, 28% randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving and 65%, respectively, in patients with mild, moderate and severe hepatic impairment compared to patients placebo received red blood cell transfusions during randomized treatment. Among transfused patients, the with normal hepatic function. The terminal elimination half-life was prolonged in patients with hepatic median number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebo impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours). The change in the pharmacotreated patients. Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3 dynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in ruxolitinib exposure or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was except in the severe (Child-Pugh C) hepatic impairment cohort where the pharmacodynamic activity was generally reversible with dose reduction or dose interruption. The median time to recovery of platelet counts more prolonged in some subjects than expected based on plasma concentrations of ruxolitinib. When above 50 X 109/L was 14 days. Platelet transfusions were administered to 4.7% of patients receiving Jakafi administering Jakafi to patients with any degree of hepatic impairment and with a platelet count between and to 4.0% of patients receiving control regimens. Discontinuation of treatment because of thrombo- 100 X 109/L and 150 X 109/L, a dose reduction is recommended [see Dosage and Administration (2.8) in Full cytopenia occurred in 0.7% of patients receiving Jakafi and 0.9% of patients receiving control regimens. Prescribing Information].

Patients with a platelet count of 100 X 109/L to 200 X 109/L before starting Jakafi had a higher frequency of Grade 3 or 4 thrombocytopenia compared to patients with a platelet count greater than 200 X 109/L (16.5% Jakafi is a registered trademark of Incyte Corporation. All rights reserved. versus 7.2%). Neutropenia In the two Phase 3 clinical studies, 1.0% of patients reduced or stopped Jakafi U.S. Patent No. 7,598,257 because of neutropenia. Table 2 provides the frequency and severity of clinical hematology abnormalities © 2011-2013 Incyte Corporation. All rights reserved.

Issued: November 2013 RUX-1326 reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study.

Clinical Trial Tracker

New Clinical Trials Under Way

T

he following clinical trials are currently recruiting patients with colorectal cancer for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with Clinical Trials.gov.

1

Adjuvant Aflibercept for Meta­ static Colorectal Cancer This phase 2, randomized, open-label efficacy study aims to evaluate whether aflibercept can reduce the chance that metastatic colorectal cancer can grow back after finishing standard treatment.

The study also examines the side effects of aflibercept and the effect on quality of life, and is expected to enroll 69 patients. Patients who are aged ≥18 years who have received first-line therapy for metastatic colo­ rectal cancer are eligible to participate if other criteria are met.

Those participating in the study will be randomized to receive aflibercept until progression for up to 2 years or observation with no intervention.

The primary outcome for this study is disease-free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites. Additional outcomes include adverse events for patients receiving adjuvant aflibercept up to 2 years’ duration, for patients who previously received systemic chemotherapy and surgical resection/ablation, as well as quality-of-life measurements and biomarkers in peripheral blood and fresh and archived tumor tissues. Study locations include California, Florida, New York, and Rhode Island. For more information, contact Kayla Rosati, EdM, Brown University, Providence, RI, at 401-863-3000 or Kayla_rosati@

3

brown.edu. The NLM Identifier is NCT01669720.

Genistein in the Treatment of Metastatic Colorectal Cancer The objective of this phase 1/2 interventional study is to assess whether combining genistein with the standard-of-care chemotherapeutic regimens reduces chemotherapy resistance and improves the response rate of patients with newly diagnosed metastatic (stage IV) colon or rectal neoplasm. It is estimated that 24 patients will be enrolled. The response rate will be measured using the radiologic Response Evaluation Criteria in Solid Tumors criteria; progression-free survival will also be assessed.

Patients who are aged ≥18 years with pathologically confirmed colon or rectal carcinomas, have a plan by their treating physician to receive FOLFOX or FOLFOX-Avastin, and have an Eastern Cooperative Oncology Group performance status ≤2 may be eligible to participate in the study if additional criteria are met. For more information, contact Randall F. Holcombe, MD, Icahn School of Medicine at Mount Sinai, New York, NY, at 212-659-5420 or randall.holcombe@mssm.edu. The NLM Identifier is NCT01985763.

2

RAD001, FOLFOX, and Bevacizumab in Treatment of Colorectal Carcinoma The purpose of this phase 1/2 open-label, interventional study is to determine the safety and efficacy of using RAD001 (everolimus) in combination with FOLFOX (folinic acid, fluorouracil, oxaliplatin) and bevacizumab for the treatment of colorectal cancer. Everolimus has been in clinical development since 1996 as an immunosuppressant in solid organ transplantation; it has been in development for patients with certain malignancies since 2002.

Patients who are aged ≥18 years with advanced or metastatic colorectal cancers for whom chemotherapy is indicated are eligible to participate if other criteria are met. All patients enrolled in the study will receive a combination therapy of everolimus, FOLFOX, and bevacizumab.

The primary outcomes for this study are to evaluate progression-free survival in patients receiving this combination therapy for previously untreated metastatic or advanced colorectal cancers, as well as to determine the safety of the combination at specified doses. Other outcomes include a determination of the toxicity profile and response rates of the combination, as well as serum proteomic profiles of patients treated with this therapy. The study will be conducted at Huntsman Cancer Institute and Utah Cancer Specialists, both in Salt Lake City, UT. For more information, contact Marlene Mitchell, RN, at 801-5874779 or marlene.mitchell@hci.utah. edu, or Cindy Davidson, APRN, at 801-587-5581 or cynthia.davidson@ hci.utah.edu. The NLM Identifier is NCT01047293.

May 2014

4

Combination Therapy Assess­ ment in Patients with KRAS and NRAS Wild-Type Cancer The purpose of this phase 2 randomized trial is to assess combination therapy of PF-05212384 plus irinotecan compared with combination therapy of cetuximab plus irinotecan in patients with KRAS and NRAS wild-type metastatic colo­ rectal cancer. Progression-free survival at 36 weeks will be evaluated as the primary outcome measure.

Dose-limiting toxicities, objective response, and duration of response will also be evaluated.

Continued on page 30

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Clinical Trial Tracker

New Clinical Trials Under Way…Continued from page 29 Criteria for inclusion include progression following treatment for colorectal cancer with irinotecan, oxaliplatin, and fluoropyrimidine therapy in the metastatic setting; Eastern Cooperative Oncology Group performance status of 0, 1, or 2; and ≥1 measurable lesion by Response Evaluation Criteria in Solid Tumors. The trial is currently recruiting an estimated 159 patients in several states, including Alabama, California, Florida, and Missouri.

For additional information about the trial and eligibility, contact the Pfizer CT.gov call center at 800718-1021. The NLM Identifier is NCT01925274.

5

Colorectal Cancer Umbrella Protocol The Assessment of Targeted Therapy Against Colorectal Cancer screening protocol trial is testing for biomarkers in patients with metastatic or unresectable, locally advanced colorectal cancer. The primary end point of interest is the rate of successful biomarker determination.

Study participants who are eligible for inclusion will undergo a blood draw for biomarker test and will be asked whether they are able to perform normal daily activities (ie, performance status). In addition, a leftover sample of tumor tissue will be collected from a previous procedure, if available, and participants will be asked to fill out a questionnaire about their cancer symptoms. Researchers are attempting to determine whether certain biomarkers can be used to help predict which cancer drugs may work better than other drugs in different people with colorectal cancer.

This study is recruiting 660 patients and is taking place at the University of Texas MD Anderson Cancer Center in Houston. For more information about the trial and criteria for participation, contact the

30

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Principal Investigator, Scott Kopetz, MD, at 713-792-2828. The NLM Identifier is NCT01196130.

6

Chemokine-Modulatory Reg­ imen for Recurrent Resectable Colorectal Cancer The objective of this randomized phase 1/2 study is to evaluate the safety of combination therapy with interferon, celecoxib, and rintatolimod in patients with recurrent colorectal cancer. This will also test whether the above combination can help the immune system to fight the tumors.

The treatment group consists of a chemokine-modulating regimen plus surgery, and chemokine modulatory regimen before surgical resection; the control group comprises surgical resection only, performed as standard of care for the disease.

To be eligible for inclusion, patients should be aged ≥18 years, have isolated hepatic metastasis, complete resection based on preoperative imaging, and meet additional criteria. Fifty patients will be recruited for this trial. For more information, contact Principal Investigator Amer H. Zureikat, MD, at 412-6237931 or zureikatah@upmc.edu. The NLM Identifier is NCT01545141.

7

Surgery Plus Sulindac or Surgery Alone In this phase 2, prospective, randomized, double-blind trial, investigators are assessing whether sulindac improves treatment outcomes in patients undergoing surgery for advanced colorectal cancer.

Patients in the treatment group will get sulindac 1 tablet twice daily, and patients in the control group receive placebo 1 tablet twice daily.

Patients with histologically confirmed colorectal adenocarcinoma with metastatic disease confined to the liver, or limited extrahepatic intraabdominal disease, as well as

ONCOLOGY PRACTICE MANAGEMENT

I May 2014

patients with hepatic and intraabdominal metastases measurable with computed tomography, magnetic resonance imaging, and/or positron emission tomography scan are eligible for inclusion.

The study will be conducted at the National Institutes of (NIH) Health Clinical Center in Bethesda, MD, and 57 patients may be recruited.

For more details about the trial and inclusion/exclusion criteria, contact the NIH Clinical Center, National Cancer Institute/Surgery Branch Recruitment Center at 866-820-4505 or ncisbirc@mail.nih.gov. The NLM Identifier is NCT01856322.

8

Irinotecan and BKM120 in Patients with Previously Treated Advanced Disease The purpose of this phase 1 trial is to evaluate combination therapy of irinotecan and BKM120 in patients with advanced colorectal cancer who did not respond to or become intolerant of ≥1 line of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy. The primary outcome measure is maximum tolerated dose in 28 days; approximately 30 patients will be enrolled in this study.

Patients who are aged ≥18 years with histologically or cytologically confirmed metastatic or unresectable adenocarcinoma of the colon or rectum with measurable disease, Eastern Cooperative Oncology Group performance status ≤2 (Karnofsky >60%), and absolute neutrophil count ≥1.5 × 109/L, platelets ≥100 × 109/L, hemoglobin >9 g/dL may be eligible for participation. For more information on inclusion criteria and study details, contact Principal Investigator Joaquina Baranda, MD, at 913-588-6077 or jbaranda@kumc.edu, or Stacey Purinton, RN, at 913-588-2545 or spurinton@ kumc.edu. The NLM Identifier is NCT01304602. l

Dear Physician Colleague...

Your Support Is Critical

5

YE A R A N N I V E R S A RY

Lillie D. Shockney, RN, BS, MAS

5

Program Director, Academy of Oncology Nurse & Patient Navigators University Distinguished Service Assoc Professor of Breast Cancer, Depts of Surgery & Oncology; Admin Director, The Johns YE A R Hopkins Breast Center; ANNI VERSARY Admin Director, Johns Hopkins Cancer Survivorship Programs; Assoc Prof, JHU School of Medicine, Depts of Surgery, Oncology & Gynecology and Obstetrics; Assoc Prof, JHU School of Nursing

Show continued support for your oncology nurse and patient navigator colleagues by referring them to join forces with me and more than 4500 of their colleagues. Recommend they become a member of AONN+ today so they may take advantage of our exclusive benefits and educational opportunities.

Together we can increase our network and define the future of oncology navigation.

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RECEIVE A $100 DISCOUNT on registration to the Fifth Annual AONN+ Conference at the Walt Disney World Dolphin Hotel in Orlando, Florida!

Best regards, Lillie D. Shockney, RN, BS, MAS Program Director, Academy of Oncology Nurse & Patient Navigators

www.AONNonline.org

AONN2014 Lillie Support Asize_40714

AONN+ is the largest national specialty organization dedicated to improving patient care and quality of life by defining, enhancing, and promoting the role of oncology nurse and patient navigators.

Drug Coding Supplied by RJ Health Systems

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

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

Associated ICD-9-CM codes for the treatment of colorectal cancer: 153 Malignant neoplasm of colon Excludes: benign carcinoid tumor of colon (209.50-209.56)

malignant carcinoid tumor of colon (209.10-209.16)

153.0 Hepatic flexure

153.1 Transverse colon

153.2 Descending colon

Left colon

153.3 Sigmoid colon

Sigmoid (flexure) Excludes: rectosigmoid function (154.0) 153.4 Cecum

Ileocecal valve 153.5 Appendix

153.6 Ascending colon

Right colon

153.7 Splenic flexure

153.8 Other specified sites of large intestine

Malignant neoplasm of contiguous or overlapping

sites of colon whose point of origin cannot be determined Excludes: ileocecal valve (153.4)

rectosigmoid junction (154.0)

153.9 Colon, unspecified

Large intestine NOS 154 Malignant neoplasm of rectum, rectosigmoid junction, and anus Excludes: benign carcinoid tumor of rectum (209.57)

malignant carcinoid tumor of rectum (209.17)

154.0 Rectosigmoid junction

Colon with rectum

Rectosigmoid (colon) 154.1 Rectum

Rectal ampulla

32

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ONCOLOGY PRACTICE MANAGEMENT

I May 2014

Drug Coding

154.8 Other

Anorectum

Cloacogenic zone

Malignant neoplasm of contiguous or overlapping

sites of rectum, rectosigmoid junction, and anus

whose point of origin cannot be determined

FDA approved for colorectal cancer

Compendia listed off-label use for colorectal cancer

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: code description

bevacizumab (Avastin)

J9035: Injection, bevacizumab, 10 mg

√

96413, 96415

capecitabine (Xeloda)

J8520: Capecitabine, oral, 150 mg

√

N/A

capecitabine (Xeloda)

J8521: Capecitabine, oral, 500 mg

√

N/A

carmustine (BiCNU)

J9050: Injection, carmustine, 100 mg

cetuximab (Erbitux)

J9055: Injection, cetuximab, 10 mg

cisplatin (Platinol AQ)

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

√

96409, 96413, 96415

doxorubicin (Adriamycin)

J9000: Injection, doxorubicin hydrochloride, 10 mg

√

96409

floxuridine (FUDR)

J9200: Injection, floxuridine, 500 mg

√

96422, 96423, 96425

fluorouracil (Adrucil)

J9190: Injection, fluorouracil, 500 mg

√

96409

irinotecan (Camptosar)

J9206: Injection, irinotecan, 20 mg

√

96413, 96415

leucovorin calcium (Wellcovorin)

J0640: Injection, leucovorin calcium, per 50 mg

√

96372, 96374, 96409

levoleucovorin calcium (Fusilev)

J0641: Injection, levoleucovorin calcium, 0.5 mg

√

96365, 96366

lomustine (CeeNu)

J8999*: Prescription drug, oral, chemotherapeutic, NOS

√

N/A

lomustine (CeeNu)

S0178: Lomustine, oral, 10 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

√

96409

√

96413, 96415 96413, 96415

√

May 2014

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33

Drug Coding

FDA approved for colorectal cancer

Compendia-listed off-label use for colorectal cancer

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: code description

mitoxantrone (Novantrone)

J9293: Injection, mitoxantrone hydrochloride, per 5 mg

oxaliplatin (Eloxatin)

J9263: Injection, oxaliplatin, 0.5 mg

√

96413, 96415

panitumumab (Vectibix)

J9303: Injection, panitumumab, 10 mg

√

96413, 96415

pemetrexed (Alimta)

J9305: Injection, pemetrexed, 10 mg

regorafenib (Stivarga)

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

√

N/A

regorafenib (Stivarga)

J8999*: Prescription drug, oral, chemotherapeutic, NOS

√

N/A

topotecan (Hycamtin)

J8705: Topotecan, oral, 0.25 mg

√

N/A

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

√

96413

vinCRIStine (Vincasar PFS)

J9370: Vincristine sulfate, 1 mg

√

96409

ziv-aflibercept (Zaltrap)

J9400: Injection, ziv-aflibercept, 1 mg

√

√

√

96409, 96413

96409

96413

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

Please note: Payer NDC requirements and placement may vary; check with payer.

References: • HCPCS Level II Expert 2014 • Current Procedural Terminology (CPT ®) 2014 (copyright 2014 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Volumes 1 & 2, 2014 • 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; NOS, not otherwise specified.

This information was supplied by:

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