OPM November 2012 Vol2 No6

ONCOLOGY PRACTICE MANAGEMENT ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

www.OncPracticeManagement.com

NOVEMBER 2012

Implementing a Patient Portal in Your Oncology Practice to Provide PatientCentered Care

By Gena Cook Founder and Chief Executive, Navigating Cancer, provider of oncology-specific patient portals

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stablishing a patient-centered approach is rapidly becoming a core requirement in US medical practices. Whether medical home models, accountable care organization (ACO) models, Health Information Technology for Economic and Clinical Health (HITECH) requirements, or new Commission on Cancer standards, all have components of engagContinued on page 6

VOLUME 2 • NUMBER 6

Cancer Center Business Summit

Health Plans Address the Rising Costs of Cancer Care

By Dawn Holcombe, MBA, FACMPE, ACHE

Dallas, TX—We have to control oncology costs; we think it makes sense to work with physicians to do so, but we have a long way to go in a short time frame.

These were the general messages from 4 leading payers at the 2012 Cancer Center Business Summit.

The panel members expressed worries about oncology costs rising to the top concern for many payers, as well as an ongoing concern about widespread varia-

tion in costs and in treatmentchoices for patients with cancer.

WellPoint Oncology Jennifer Malin Medical Home Jennifer Malin, MD, PhD, Medical Director of Oncology, Care Management, WellPoint, Los Angeles, CA, notContinued on page 23

Preparing for the Office of the Inspector General’s 2013 Work Plan

By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

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ftentimes providers finding themselves under review comment that they wish they had known oversight was potentially heading in their direction, and that they wish they had

insight into areas of potential areas of exposure. Such lamenting is, of course, wasted energy, because potential exposure is potential exposure, and having “not known” of potential exposure is not a Continued on page 13

C ght N om t D o m yo P u Th nit u b RO e y y VI Ac Af Ca th M t W ford nc e A DE ed il a er sso R ic l C ble Ce ci ar ha C n at AC e. n a te ion ... ge re rs o C 46 ES f

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From the publishers of

©2012 Engage Healthcare Communications, LLC

PA TIE N Br ou T

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INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM

with dedicated Amgen Reimbursement Counselors There is A place you can go for user-friendly online tools and reimbursement forms… …where your coverage questions can be Answered …where online Access to forms is simple …where you can talk to A single Amgen Reimbursement Counselor for all your reimbursement activity

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Amgen Assist® and Amgen Inc. do not guarantee success in obtaining reimbursement. Third-party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or resolved by our Amgen Assist® staff. ©Amgen. All rights reserved. MC48319-A-3 08/11

Making Access easier.

From the Editor

Early Lessons from Hurricane Sandy

By Dawn Holcombe, MBA, FACMPE, ACHE

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s practice administrators, we try to prepare for emergencies, but the unexpected always happens. Hurricane Sandy blew onto the East Coast and hit hard with rain, wind, and blizzard conditions. Many are still digging out; some are still without power more than a week later. It is not too early to see what we can apply from this storm to other storms that can hit here or anywhere else in the country.

Water Many of the affected areas were in low-lying areas that were vulnerable to both storm surges and driving rain. Flooding into basements and lower floors was the culprit for many of the power failures, and even many generator failures, for major healthcare institutions. To the extent possible, putting vulnerable emergency

Continued on page 12

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

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

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

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

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

Risë Marie Cleland President Oplinc, Inc Lawton, OK

Communications We all have disaster plans for communications, but when the power is out and when cell towers are out, even cell phones will not work. In our area, we have had lengthy power outages 3 times in the past 2 years, even before Hurricane Sandy. A part of the routine preparations we now make are building lists

Power The question is not, “Where were you when the lights went out?” but rather, “How isolated are you when the lights go out?” Medical offices that rely on elevators for patient and

Editor-in-Chief

Peggy Barton, RN Practice Manager Toledo Clinic, OH

staff access are severely affected when the building elevators stop working. Some healthcare facilities keep their emergency generators on upper floors to avoid flooding, but then find significant challenges in lugging the fuel needed to power the generators up several flights of stairs.

equipment in higher elevations could provide protection.

The power outages in southern Connecticut would have been greater if one of the major electrical substations had been flooded. As it was, Connecticut Light & Power built the substation to be higher than the 100-year flood maximum plus 1 foot. Water rose to within inches of even that height. As we renovate offices, or build new buildings, many of us do not routinely check 100-year flood stages in our planning, but we have seen the relevance of that increasing in recent years.

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

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

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

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

November 2012

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In This Issue

PUBLISHING STAFF Publisher Nicholas Englezos nick@engagehc.com 732-992-1884 Editorial Director Dalia Buffery dalia@engagehc.com 732-992-1889 Associate Publisher American Health & Drug Benefits Maurice Nogueira maurice@engagehc.com 732-992-1895 Associate Publisher Cristopher Pires cris@engagehc.com 732-992-1896 Associate Publisher Joe Chanley joe@engagehc.com 732-992-1524 Associate Editor Lara J. Lorton lara@engagehc.com 732-992-1892 Editorial Assistant Jennifer Brandt jbrandt@the-lynx-group.com 732-992-1536

FROM THE EDITOR Early Lessons from Hurricane Sandy........................................3

By Dawn Holcombe, MBA, FACMPE, ACHE

FEATURES Implementing a Patient Portal in Your Oncology Practice to Provide Patient-Centered Care....................... 1

By Gena Cook

Oncology Practices Challenged to Move Forward..........22

By Dawn Holcombe, MBA, FACMPE, ACHE

The Oncology Medical Home.................................................26

By Gail Thompson

The Nuts and Bolts of Physician and Hospital Practice Arrangements from the Oncology Front Line.....................40

By Gail Thompson

DRUG CODING Medications Used for the Treatment of Multiple Myeloma .................... ......................................36 DEPARTMENTS MEDICAL LEGAL UPDATE

Production Manager Marie R. S. Borelli

Preparing for the Office of the Inspector General’s 2013 Work Plan ........................................................1

National Accounts Manager Zach Ceretelle

By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

Quality Control Director Barbara Marino

PATIENT AND PROVIDER ACCESS

Business Manager Blanche Marchitto MISSION STATEMENT Oncology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line.

To continue to provide the high-quality care cancer patients deserve, providers must master the ever-changing business of oncology.

Oncology Practice Management will offer process solutions for members of the cancer care team—medical, surgical, and radiation oncologists, as well as executives, administrators, and coders/billers—to assist them in reimbursement, staffing, electronic health records, REMS, and compliance with state and federal regulations.

Brought to you by the Association of Community Cancer Centers

The Affordable Care Act Will Change Medicare: The Independent Payment Advisory Board......................46

By Sydney Abbott, JD

PHYSICIAN WEALTH MANAGEMENT

Term Life Insurance: What You Need to Know Before You Buy ....................................................................................49

By Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF

Oncology Practice Management™, ISSN 2164-4403(print), is published 6 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2012 by Engage Healthcare Communications, LLC. All rights reserved. Oncology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

The ideas and opinions expressed in Oncology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher.

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

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

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ONCOLOGY PRACTICE MANAGEMENT

I November 2012

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Oncology Patient Portal

Implementing a Patient Portal…Continued from page 1 ing patients in their care. To do this effectively and to meet these requirements, you will be required to institute a patient portal in your practice. More important, you will need to not only implement but also institutionalize new processes and ways to care for your patients using this technology. If done well, it could provide a competitive advantage to your practice, ease some of the administrative burdens on you and your staff, and provide a huge improvement in patient satisfaction and well-being as patients take a more active role in their care.

New Requirements Mandate a New Approach to Patient-Centered Care The following summary discusses the new models and their requirements related to a patient-centered care approach.

HITECH The HITECH Act was signed into law in 2009 by President Obama to digitize medicine and to provide incentives to providers to adopt certified electronic health record (EHR) technology. The majority of oncology practices have started to digitize their practices and are attesting for the stimulus incentives, which peak in 2012.

To meet meaningful use criteria, practices must provide clinical visit summaries and electronic access to parts of their patient’s health information. It is easier for a practice to attest for Stage 1, with less administrative burden using a patient portal, but a portal will be required for Stage 2 in 2014. One of the primary goals of the HITECH Act is to “engage patients and their families to improve care coordination”; therefore, it is likely that greater patient engagement will be required in Stage 3, which has yet to be finalized.

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The patient engagement objectives of HITECH include: • Electronic access to health information • Patient-specific education, using certified EHR technology • Online secure messaging.

Additional objectives are to be determined in Stage 3.

Although medical home models are new in oncology, pilots are emerging around the country to better define the model, and payers have been clear that they will pay differentially for oncology practices that provide medical home services.

Medical Home The medical home model concept first evolved in primary care; however, for patients with cancer, the medical oncologist becomes their primary doctor. Although medical home models are new in oncology, pilots are emerging around the country to better define the model, and payers have been clear that they will pay differentially for oncology practices that provide medical home services. Some of the patient engagement requirements in the medical home model are similar to those of HITECH; however, the medical home model takes them even further. It is clear that a patient portal will be needed for most of these requirements.

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The patient engagement requirements of the patient-centered medical home from the National Committee for Quality Assurance include1: • Electronic access to health information • Providing continuity of medical record information for care and advice when the office is not open • Providing timely clinical advice using a secure, interactive electronic system when the office is not open • Two-way communication between patients (and their families) and the practice • Requests for appointments, prescription refills, referrals, or test results • Instructions on obtaining care and clinical advice during office hours and when the office is closed • The practice functions most effectively as a medical home if patients and their families provide a complete medical history and information about care obtained outside of the practice • The care team gives the patients and their families access to evidence-based care and self-management support • Uses an EHR to identify patientspecific education resources and provides educational resources or refers at least 50% of patients and their families to educational resources to assist in self-management • Develops and documents self-management plans and goals in collaboration with at least 50% of patients and their families • Provides self-management tools to record self-care results for at least 50% of patients and their families.

American College of Surgeons Commission on Cancer Standards In 2015, new Commission on Continued on page 8

ts and Providers with the Reimburse n e i t a P ment g Proc Helpin ess 1-888-587-3263 www.TevaCORE.com

Our C RE commitment CORE Hotline Offers Assistance Related to: Benefit verification and coverage determination Precertifications / prior authorization support Coverage guidelines and claim requirements of payers Personalized support through the claims and appeals process Templates for letters of medical necessity Cephalon Oncology Patient Assistance Program

To enroll in CORE Phone 1-888-587-3263 Monday through Friday, 9 AM to 8 PM (ET), fax 1-866-676-4073, or visit www.TevaCORE.com

Supporting Teva Oncology Products Reimbursement Assistance and Support through CORE - the Comprehensive Oncology Reimbursement Expertise Program

CephalonCares® Foundation offers a Patient Assistance Program to provide FDA-approved products free of charge for patients who qualify.

Teva Oncology also partners with patient advocacy organizations, such as the Leukemia & Lymphoma Society, and others that have programs designed to help patients access the treatment they need.

© Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved, ONC-2139, Printed in USA

Oncology Patient Portal

Implementing a Patient Portal…Continued from page 6 Cancer standards will require more services to support patients. To do this efficiently, and with the best experience for your practice, you will need a combination of people, processes, and technology. The new patient-centered care requirements are focused on providing patients access to their health information, as well as navigation services and survivorship services.

The patient engagement requirements of the Commission on Cancer include: • Patient access to health information • Navigation of services • Survivorship services, which include a complete treatment record summary at the completion of treatment.

Accountable Care Organizations ACOs are groups of healthcare providers who provide coordinated care and disease management to improve the quality of care that patients receive. The organization’s payment is tied to achieving healthcare quality goals and outcomes that will result in cost-savings. Although there are no direct patient objectives that must be met, it will be imperative to engage patients to participate in their healthcare to achieve the best outcomes and cost-savings.

For patients with cancer, poorly managed patients and uneducated patients could likely be hospitalized at rates higher than patients who are actively participating in their care, which could be detrimental to healthcare professionals in this new model. In fact, a recent study that focused on the 10 most common types of cancer for which chemotherapy is a key treatment modality revealed that 93% of patients had chemotherapy-related emergency department visits, at an average cost of $800 per event.2

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Patients Want Access to Their Health Information Many studies have shown that patients want easier access to their health information so they could be more engaged in their care. A 2012 study revealed that 90% of patients want to self-manage their healthcare online, with access to health information and education to help manage their conditions.3 Another 2012 study focusing on patients with cancer revealed that 74% of the patients were interested in having secure access to their medical records online.4

At Navigating Cancer, we are also starting to see increased patient engagement as a result of giving patients access to their laboratory results and clinic visit summaries.

What patients say they want, and what they actually do, can be 2 different realities; however, we are starting to see that patients are following through on their stated desires. The OpenNotes project was a year-long study that evaluated the effect on doctors and patients of facilitating patient access to visit notes over a patient portal.5 More than 100 doctors and more than 13,500 patients participated across 3 different hospital settings that served urban, rural, and poor communities. The results were overwhelmingly positive, with the majority of patients viewing at least 1 note. Of those, 77% to 87% of patients across the 3 geographical

ONCOLOGY PRACTICE MANAGEMENT

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settings reported that open notes helped them feel more in control of their care, and 60% to 78% of patients taking medications reported increased adherence. Most impressive, nearly 99% of patients wanted open notes to continue, and no doctor elected to stop.5 At Navigating Cancer, we are also starting to see increased patient engagement as a result of giving patients access to their laboratory results and clinic visit summaries. Of patients who received a notification about a new clinic summary or a health update, 63% have logged in to their clinic’s patient portal to access and view their update.6 We are at the very beginning of being able to track patient engagement as a result of giving patients electronic access to their health information, but the initial results are very encouraging. We expect that as the information shared with patients becomes more relevant and personalized, such as educational resources specific to their diagnosis and secure messaging, patient engagement will continue to increase.

Practical Tips to Implementing a Patient Portal Do Your Research Implementing a new technology in your practice is a big decision. You have likely been through this process previously as you chose your EHR vendor, and you can draw on your experiences through that process.

What did you do well in selecting your vendor? What pitfalls did you discover through that process that you would have done differently?

Patient portal vendors have been around for the past 10 years, so you will have many options to choose from. You will need to decide if you want a general portal application Continued on page 10

VELCADE and Millennium are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners. *The VELCADE Reimbursement Assistance Program does not file claims or appeal claims for callers, nor can it guarantee that you will be successful in obtaining reimbursement

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

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Oncology Patient Portal

Implementing a Patient Portal…Continued from page 8 that is transaction-based or something that is specific to oncology.

Your EHR vendor will likely have a solution to consider. Some EHR vendors have built a modular patient portal into their application that can be used for your practice, and others have partnered with patient portal companies to provide an independent solution.

The features and functions of patient portals vary widely, so make sure that you examine several portals before making a decision. Some portals are very robust, and others are basic. Because patient portals are a new requirement, try to understand the vendor’s motivation for providing this service. Is it committed to the patient experience, or did it just create the basic features and functions for HITECH certification? Is the vendor actively continuing to develop the product?

Requirements are constantly changing, and many are not yet finalized, so you need to understand if your vendor will be up to the challenge of meeting all of these new requirements. How quickly does the vendor implement new features? What kind of customer service does it provide to the staff and to your patients? If possible, talk to the vendor’s current customers as well.

Think About the Patient Experience This is not just another technology for your practice to use; it is also an application that your patients will use and access on a consistent basis.

You need to view the products with that in mind. Choosing a vendor with the best patient experience is crucial. If you do not, you could not only provide a suboptimal experience for your patients, but you could also cause a significant administrative burden for your staff. Your portal technology should improve your

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practice and support your patients, not the opposite.

Patient portals will be offered by your competitors, and referring physicians and patients will quickly start to see the differences in products. Patients with cancer see many doctors, and your choices could either reflect positively or negatively, depending on if you choose a suboptimal product from the patient’s experience.

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What data do you have that demonstrate this will save your practice time?

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Do you have patient satisfaction survey information on your product? How about staff satisfaction information?

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How much does the application cost? Do you need additional software or hardware?

8 The features and functions of patient portals vary widely, so make sure that you examine several portals before making a decision. Some portals are very robust, and others are basic.

Besides Pricing, Features, and Functions, Ask Your Vendor Other Questions How do data flow from my EHR to the patient portal? How is information released to the patient?

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How are patients notified that they have new health information?

What features and functions do you provide for patients? What features and functions are available for staff? What is your product road map for new features?

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How do I handle a password reset for patients? Who do patients call if they have technical problems?

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What browsers do you support?

Consumers use a variety of browsers, so a portal supporting Microsoft IE 7 is not good enough.

This will cause significant problems for your patients and headaches for you if you are fielding the phone calls.

A Well-Implemented Portal Can Improve Your Practice It is clear that web-based patient portals are already, and will continue to be, a required tool to enable oncology practices to communicate with patients and engage them in their care. Most practices have been focused on selecting and implementing an EHR vendor to qualify for the Stage 1 meaningful use incentives, which peaked this year.

Savvy administrators should now be looking beyond meaningful use criteria to consider patient portal technology that will be required for Stages 2 and 3, but will also be necessary to qualify for emerging payer programs (eg, medical homes and ACOs) and new professional standards (eg, the Commission on Cancer guidelines). All of the options require patient access to their personal health information to enable more patient engagement, which is at the core of a patientcentered approach to care.

Although many practice administrators are concerned that giving

Oncology Patient Portal

Important Meaningful Use Dates to Remember 2014: Last year to initiate participation in the Medicare Electronic Health Record (EHR) Incentive Program 2015: Medicare payment adjustments begin for eligible providers and eligible hospitals that are not meaningful users of EHR technology 2016: Last year to receive a Medicare EHR incentive payment and last year to participate in the Medicaid EHR Incentive Program 2021: Last year to receive a Medicaid EHR incentive payment Source: www.cdc.gov/EHRmeaningfuluse/ timeline.html.

American College of Oncology Administrators

patients more information will result in additional work, a well-implemented portal can increase efficiency by reducing data entry and will not add to staff workload as new processes become automated. When evaluating portal options, it is important to keep the big picture in mind—it should address multiple needs, make your practice more efficient, and increase patient satisfaction so you are better able to provide patientcentered care. l

Ms Cook can be reached at gena@ navigatingcancer.com.

References 1. National Committee for Quality Assurance.

Patient-Centered Medical Home 2011 Standards, Elements and Factors. June 5, 2012. www.ncqa.org/ Portals/0/Programs/Recognition/PCMH_2011_Data_ Sources_6.6.12.pdf. Accessed October 23, 2012.

2. Milliman, Inc. Cancer patients receiving chemotherapy: opportunities for better management.

March 30, 2010. http://publications.milliman.com/ research/health-rr/pdfs/cancer-patients-receivingchemothera py.pdf. Accessed October 23, 2012.

3. Accenture. Most patients want to self-manage healthcare online, Accenture survey finds. June 20, 2012. http://newsroom.accenture.com/article_display. cfm?article_id=5474. Accessed October 23, 2012.

4. Smyth B. Patient engagement survey results. February 27, 2012. www.navigatingcancer.com/blog/patient-en gagement-survey-results/. Accessed October 23, 2012.

5. Delbanco T, Walker J, Bell SK, et al. Inviting patients to read their doctors’ notes: a quasi-experimental study and a look ahead. Ann Intern Med. 2012;157:461-470.

6. Cook G. Giving patients access to their health record: does it help patient engagement? October 5, 2012. www.navigatingcancer.com/blog/health-record-accesspatient-engagement/. Accessed October 23, 2012.

Professionals dedicated to providing the best care to oncology patients. Here’s where you belong. ✓ Transform Your Leadership ✓ Work Smarter ✓ Access Solutions ✓ Make Key Contacts ✓ Strengthen Your Skills

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From the Editor

Early Lessons from Hurricane…Continued from page 3 of “landlines.” Every home and office should have old-school phones that do not rely on electricity and that simply connect directly to the phone line, which can be done easily with a split adapter at the wall sending 1 wire to the nonelectric phone and 1 wire to the electrified base for the remote/answering machine.

I keep 2 landline phones permanently attached to the phone lines in my own office and in my house (in addition to the numerous remote phones), and before storms, I remind key contacts of that number as opposed to my cell number. Key personnel in medical offices would do well to have such landline connections set up in advance of disasters so communications can still occur. Do you ask your patients for their emergency numbers, and remind them of how useful landline phones can be?

Fuel When the power is down, fuel often becomes in short supply, because it needs electricity to be pumped. If you have backup power planned, have you also made plans for sufficient fuel availability to keep that backup power working?

Do you know where your remote

backup servers are? At least 1 remote backup service was badly affected by the power outages in New York, as were all of its clients. Even if you have not been affected by a storm, identifying the risk of your own backups and servers based on their locations can be useful.

Hospitals prepare for natural disasters all of the time, and yet even major hospitals in New York had to punt when their safety net plans failed.

Backing Up Your Backups You may have a backup plan in your disaster preparedness, but have you gone 1 step further to identify what the backup may be to your backup plan failing? Hospitals prepare for natural disasters all of the

SECOND ANNUAL CONFERENCE

time, and yet even major hospitals in New York had to punt when their safety net plans failed. Perhaps even with generators, oncology practices might find it useful to invest in simple large coolers and fill them with ice before an emergency. I myself (having lost 3 freezers full of food over the past 2 years) bought an oversized cooler for $50 and stuffed it with 7 large bags of ice (approximately 5 lbs each). It was warranted to keep ice frozen for at least 5 days.

I did not lose power, but 8 days later, more than half of the ice in that cooler was still intact and frozen.

Our hearts go out to all of those who are still recovering and are facing not just getting power back but also the rebuilding process.

We are a close-knit community in oncology, and even if we were not directly affected, we are all touched by these events. It is interesting to note that even as we struggle for greater efficiency through the wonders of technology, there are simple, old-school solutions that we still need. Good luck to everyone touched by Hurricane Sandy. As you emerge from this, we look forward to hearing from you and learning from all that you have learned. l

• Melanoma • Basal Cell Carcinoma • Cutaneous T-Cell Lymphoma • Squamous Cell Carcinoma • Merkel Cell Carcinoma

July 26-28, 2013 Hyatt Regency La Jolla • at Aventine 3777 La Jolla Village Drive • San Diego, California 12

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Medical Legal Update

Preparing for the Office of the Inspector General’s 2013…Continued from page 1 defense to that exposure. In an effort to encourage provider compliance, and in its efforts to combat healthcare fraud, the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) is attempting to offer total transparency by telling all providers what main areas it will be reviewing in the coming year.

It is recommended that providers pay attention, because the OIG has the ability to cripple a provider in its review or with penalties and sanctions. For those who are unfamiliar, the OIG is tasked with protecting the integrity of the HHS programs and operations and the well being of beneficiaries by “detecting and preventing fraud, waste, and abuse; identifying opportunities to improve program economy, efficiency, and effectiveness; and holding accountable those who do not meet program requirements or who violate federal laws,” and it has taken a leading role in such investigations and audits (https://oig.hhs.gov/reports-and-pub lications/archives/workplan/2013/ WP00-Intro+Contents.pdf).

The OIG maintains a staff of more than 1700 individuals throughout the country to “conduct audits, evaluations, and investigations; provide guidance to industry; and, when appropriate, impose civil monetary penalties, assessments, and administrative sanctions” (https://oig.hhs.gov/ reports-and-publications/archives/ workplan/2013/WP00-Intro+Con tents.pdf). The OIG investigates a wide variety of conduct (42 CFR § 1003.102), and may seek civil monetary penalties against any person who, for example, (1) presents or causes to be presented claims to a federal health program that the person knows or should have known is for an item or service that was not

provided as claimed or is false or fraudulent (42 USC § 1320a7a[a][1][A] and [B]); (2) violates the antikickback statute by knowingly or willfully paying or receiving remuneration for referrals of federal healthcare program beneficiaries (42 USC § 1320a-7b[b]); 42 USC § 1320a-7a[a][7]); or (3) presents or causes to be presented a claim that a person knows or should know is for a service that may not be made under the physician self-referral or the Stark law (42 USC § 1395nn[g][3]).

ed recoveries of approximately $5.2 billion, consisting of $627.8 million in audit receivables and $4.6 billion in investigative receivables (which includes $952 million in non-HHS investigative receivables resulting from our work in areas such as the states’ share of Medicaid restitution).

In addition to projected recoveries, the OIG reported exclusions of 2662 individuals and entities from participation in federal healthcare programs; 723 criminal actions against individuals or entities that engaged in crimes against HHS programs; and 382 civil actions, which included false claims and unjust enrichment lawsuits that were filed in federal district court, civil monetary penalty settlements, and administrative recoveries related to provider self-disclosure matters (http://oig. hhs.gov/reports-and-publications/ archives/workplan/2012/WP00Intro.pdf).

In its FY 2013 work plan, the OIG sets forth with specificity areas of review, allowing practitioners the opportunity to address those areas and to take corrective action now, as opposed to during or after a review process (https://oig.hhs.gov/reportsand-publications/workplan/index. asp). Examples of a few identified areas of potential review include: • Payments for multiuse vials of trastuzumab (Herceptin): the OIG states it will review claims to Medicare for trastuzumab, which is used to treat breast cancer, to determine whether claims were billed and paid properly.

Trastuzumab is a multiuse-vial drug, and providers are required to bill the complete services provided with specificity (ie, the amounts expended; Centers for Medicare & Medicaid Services

The OIG has seen incredible success targeting healthcare providers.

One need only glance at the OIG’s website to glean that enforcement actions are merely ramping up.

The OIG has seen incredible success targeting healthcare providers; available statistics evidence that, as a result of the OIG’s efforts during fiscal year (FY) 2010, $3.8 billion in investigation receivables that were court ordered or agreed to be paid through civil settlements had been recovered, and $1.1 billion in audit receivables are to be pursued as a result of OIG audit disallowance recommendations (http://oig.hhs.gov/ reports-and-publications/archives/ workplan/2012/WP00-Intro.pdf).

The numbers available for 2011 show significant increases as the OIG continues to incorporate more sophisticated reviews and to expand the scope of its investigations. The available statistics for FY 2011 evidence that the OIG reported expect-

November 2012

Continued on page 14

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Medical Legal Update

Preparing for the Office of the Inspector General’s 2013…Continued from page 14 [CMS]. Medicare Claims Processing Manual. Pub 100-04, ch 1, §§ 70.2.3.1 and 80.3.2.2).

Medicare’s single-use vial rule does not apply for trastuzumab (CMS. Medicare Claims Processing Manual. Pub 100-04, ch 17, § 40). For certain drug claims, those involving a single-use vial or a package where a provider must discard the remainder of a single-use vial or package after administering a dose or quantity of the drug or biologic, Medicare provides payment for the amount discarded along with the amount administered, up to the amount of the drug or biologic as indicated on the vial or package label (https://oig.hhs.gov/reports-andpublications/archives/work plan/2013/Work-Plan-2013.pdf) •Payments for outpatient drugs and for the administration of the drugs: the OIG states that it will review Medicare outpatient payments to providers for certain drugs and for the administration of the drugs (ie, chemotherapy drugs) to determine whether Medicare overpaid providers because of incorrect coding or overbilling of units. The OIG has previously identified chemotherapy drugs as particularly vulnerable to incorrect coding. The OIG will review whether providers are billing accurately and completely for the services that were provided (CMS. Medicare Claims Processing Manual. Pub 100-04, ch 1, §§ 70.2.3.1 and 80.3.2.2), as well as whether providers are reporting units of service as the number of times that a service or procedure was performed (CMS. Medicare Claims Processing Manual. Pub 100-04, ch 5, § 20.2 and ch 26, § 10.4; https://oig.hhs.gov/reports-

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and-publications/archives/work plan/2013/WorkPlan-2013.pdf) • Payments for prostate cancer drugs under the current policy: the OIG states that this year it will begin to scrutinize the financial impact of rescinding the least costly alternative (LCA) policies,

The severity of a review by the OIG cannot be overstated, which is why it is imperative for all healthcare providers who are rendering services to federal healthcare programs to understand areas of potential exposure.

which were in effect from 1995 through 2010 and provided a Medicare reimbursement amount for a group of clinically comparable products that was based on that of the least costly product. In April 2010, LCA policies for Medicare Part B drugs were discontinued in response to a court ruling that found that the use of an LCA policy for certain prescription drugs was not authorized under Medicare (https://oig. hhs.gov/reports-and-publications/archives/workplan/2013/ Work-Plan-2013.pdf).

The severity of a review by the OIG cannot be overstated, which is why it is imperative for all health-

ONCOLOGY PRACTICE MANAGEMENT

I November 2012

care providers who are rendering services to federal healthcare programs to understand areas of potential exposure and to take proactive measures to ensure compliance.

Before discussing identified areas of focus for the OIG during FY 2013, it is important to note that the first step to maintaining compliance is to have a policy governing your practice’s compliance (ie, a compliance plan).

The OIG has specified—although it is not mandatory—that it recommends each and every practitioner implement a specific compliance plan that includes certain areas of compliance to protect a practice (www.kirsc henbaumesq.com/article/developingthe-right-compliance-plan-for-yourpractice). In fact, on review, the OIG will inquire initially whether the target of any such review has implemented a compliance program. We recommend each and every provider work with his or her healthcare counsel to implement the same and to operate according to its standards. l This article is for education and discussion purposes only and does not constitute legal advice.

Jennifer Kirschenbaum, Esq, manages Kirschenbaum & Kirschenbaum, PC’s healthcare department, which specializes in healthcare practitioner compliance, audit defense, licensure and transactional matters. Erica Youngerman, Esq, is an associate of the firm. For additional information regarding this topic and for assistance with compliance program creation and implementation, contact Jennifer at Jennifer@Kirschenbaum esq.com, or at (516) 747-6700 ext 302. To learn more about compliance options, visit www.kirschenbaumesq. com/page/practice-compliance.baum esq.com.

ADVANCING SCIENCE I N M E TA S TAT I C M E L A N O M A

The science of immunotherapy The significance of

long-term

survival

Median overall survival: YERVOY + gp100 arm: 10 months (95% CI: 8.5, 11.5); gp100: 6 months (95% CI: 5.5, 8.7); YERVOY alone: 10 months (95% CI: 8.0, 13.8). YERVOY + gp100: hazard ratio (HR) vs YERVOY=1.04 (95% CI: 0.83, 1.30), P=0.76; HR vs gp100: HR=0.68 (95% CI: 0.55, 0.85), P=0.0004; YERVOY vs gp100: HR=0.66 (95% CI: 0.51, 0.87), P=0.0026 (not adjusted for multiple comparisons).1,2

Indication YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.

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

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

Please see detailed Important Safety Information continued on following pages.

Please see brief summary of Full Prescribing Information on adjacent pages, including Boxed WARNING regarding immune-mediated side effects. Š2012 Bristol-Myers Squibb Company. All rights reserved. 731US12AB04903 10/12

The significance of a long-term survival benefit YERVOY (ipilimumab): The first and only immunotherapy to deliver a significant long-term survival benefit in metastatic melanoma in a phase 3 study3

0

1

2

A phase 3, double-blind, double-dummy study that randomized 676 patients with unresectable or metastatic melanoma previously treated with one or more of the following: aldesleukin (IL-2), dacarbazine, temozolomide, fotemustine, or carboplatin.

Patients were randomized in a 3:1:1 ratio to receive YERVOY 3 mg/kg in combination with an investigational gp100 peptide vaccine (gp100) (n=403), YERVOY 3 mg/kg (n=137), or gp100 (n=136). The primary endpoint was overall survival in the YERVOY + gp100 arm vs the gp100 arm.3

Estimated overall survival in the YERVOY pivotal phase 3 study publication s The YERVOY overall survival curve separated at approximately 16 weeks and remained separated throughout the study period2 s Overall survival rate at 1 year was 46% (95% CI: 37.0, 54.1) in the YERVOY arm vs 25% (95% CI: 18.1, 32.9) in the gp100 arm2,4 s Overall survival rate at 2 years was 24% (95% CI: 16.0, 31.5) in the YERVOY arm vs 14% (95% CI: 8.0, 20.0) in the gp100 arm2,4 s Median overall survival in the YERVOY + gp100 arm was 10 months (95% CI: 8.5, 11.5), 6 months (95% CI: 5.5, 8.7) in the gp100 arm, and 10 months (95% CI: 8.0, 13.8) in the YERVOY arm

Please see Important Safety Information, including Boxed WARNING regarding immune-mediated side effects, and brief summary of Full Prescribing Information on adjacent pages.

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

Permanently discontinue YERVOY (ipilimumab) for any of the following: s Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day s Failure to complete full treatment course within 16 weeks from administration of first dose s Severe or life-threatening adverse reactions, including any of the following – Colitis with abdominal pain, fever, ileus, or peritoneal signs; increase in stool frequency ( 7 over baseline), stool incontinence, need for intravenous hydration for >24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation – AST or ALT >5× the upper limit of normal (ULN) or total bilirubin >3× the ULN – Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by fullthickness dermal ulceration or necrotic, bullous, or hemorrhagic manifestations – Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis – Severe immune-mediated reactions involving any organ system – Immune-mediated ocular disease which is unresponsive to topical immunosuppressive therapy

Immune-mediated Enterocolitis:

s In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening or fatal (diarrhea of 7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immunemediated enterocolitis occurred in 34 (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) patients s Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis s Infliximab was administered to 5 of 62 (8%) patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids s Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms s Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients s Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent)

Immune-mediated Hepatitis: s In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5× the ULN or total bilirubin elevations >3× the ULN; Grade 3–5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%

Important Safety Information continued on following page.

To learn more, visit www.YERVOYinformation.com or call Medical Information at 1-855-YERVOY1(1-855-937-8691).

Important Safety Information (cont’d) Immune-mediated Hepatitis (cont’d): s 13 (2.5%) additional YERVOY (ipilimumab)-treated patients experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5× but 5× the ULN or total bilirubin elevation >1.5× but 3× the ULN; Grade 2) s Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution s Permanently discontinue YERVOY in patients with Grade 3-5 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids s Withhold YERVOY in patients with Grade 2 hepatotoxicity

Immune-mediated Dermatitis: s In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening or fatal immunemediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3–5) occurred in 13 (2.5%) patients – 1 (0.2%) patient died as a result of toxic epidermal necrolysis – 1 additional patient required hospitalization for severe dermatitis s There were 63 (12%) YERVOY-treated patients with moderate (Grade 2) dermatitis s Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated s Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent).

When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month.

Withhold YERVOY in patients with moderate to severe signs and symptoms s Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically. Administer topical or systemic corticosteroids if there is no improvement within 1 week

Immune-mediated Neuropathies: s In the pivotal Phase 3 study in YERVOY-treated patients, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported s Across the clinical development program of YERVOY, myasthenia gravis and additional cases of GuillainBarré syndrome have been reported s Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-Barré–like syndromes s Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies.

Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities)

Immune-mediated Endocrinopathies: s In the pivotal Phase 3 study in YERVOY-treated patients, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients – All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism – 6 of the 9 patients were hospitalized for severe endocrinopathies s Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) YERVOY-treated patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing’s syndrome

Important Safety Information continued on following page.

Important Safety Information (cont’d) Immune-mediated Endocrinopathies (cont’d): s Median time to onset of moderate to severe immune-mediated endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the initiation of YERVOY (ipilimumab) s Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism – Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated – Monitor thyroid function tests and clinical chemistries at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland s Withhold YERVOY in symptomatic patients. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. Long-term hormone replacement therapy may be necessary

Other Immune-mediated Adverse Reactions, Including Ocular Manifestations: s In the pivotal Phase 3 study in YERVOY-treated patients, clinically significant immune-mediated adverse reactions seen in <1% were: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia s Across the clinical development program for YERVOY, immune-mediated adverse reactions also reported with <1% incidence were: myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, and autoimmune thyroiditis s Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions s Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy

Pregnancy & Nursing: s YERVOY is classified as pregnancy category C. There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus s Human IgG1 is known to cross the placental barrier and YERVOY is an IgG1; therefore, YERVOY has the potential to be transmitted from the mother to the developing fetus s It is not known whether YERVOY is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from YERVOY, a decision should be made whether to discontinue nursing or to discontinue YERVOY

Common Adverse Reactions: s The most common adverse reactions ( 5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%)

Please see brief summary of Full Prescribing Information on adjacent pages, including Boxed WARNING regarding immune-mediated side effects.

References: 1. YERVOY package insert. Princeton, NJ: Bristol-Myers Squibb Company. 2. Data on file.

YERV 008. Bristol-Myers Squibb Company. Princeton, NJ. April 2011. 3. Hodi FS, O’Day SJ, McDermott DF, et al.

Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711-723.

4. Wolchok JD, Weber JS, Hamid O, et al. Ipilimumab efficacy and safety in patients with advanced melanoma: a retrospective analysis of HLA subtype from four trials. Cancer Immun. 2010;10:9-14.

To learn more, visit www.YERVOYinformation.com or call Medical Information at 1-855-YERVOY1(1-855-937-8691).

YERVOY™ (ipilimumab) Injection, for intravenous infusion

Immune-mediated Dermatitis

Brief Summary of Prescribing Information. For complete prescribing information consult official package insert.

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

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

CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS YERVOY can result in severe and fatal immune-mediated reactions due to T-cell activation and proliferation. [See Boxed Warning] Immune-mediated Enterocolitis In Study 1, severe, life-threatening, or fatal (diarrhea of 7 or more stools above baseline, fever, ileus, peritoneal signs; Grade 3–5) immune-mediated enterocolitis occurred in 34 (7%) YERVOYtreated patients, and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) YERVOY-treated patients.

Across all YERVOY-treated patients (n=511), 5 (1%) patients developed intestinal perforation, 4 (0.8%) patients died as a result of complications, and 26 (5%) patients were hospitalized for severe enterocolitis.

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

Twenty-nine patients (85%) with Grade 3–5 enterocolitis were treated with high-dose (≥40 mg prednisone equivalent per day) corticosteroids, with a median dose of 80 mg/day of prednisone or equivalent; the median duration of treatment was 2.3 weeks (ranging up to 13.9 weeks) followed by corticosteroid taper. Of the 28 patients with moderate enterocolitis, 46% were not treated with systemic corticosteroids, 29% were treated with <40 mg prednisone or equivalent per day for a median duration of 5.1 weeks, and 25% were treated with high-dose corticosteroids for a median duration of 10 days prior to corticosteroid taper. Infliximab was administered to 5 of the 62 patients (8%) with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids.

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

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

Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least one month.

In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients.

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

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

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

The median time to onset of moderate, severe, or life-threatening immune-mediated dermatitis was 3.1 weeks and ranged up to 17.3 weeks from the initiation of YERVOY. Seven (54%) YERVOY-treated patients with severe dermatitis received high-dose corticosteroids (median dose 60 mg prednisone/day or equivalent) for up to 14.9 weeks followed by corticosteroid taper. Of these 7 patients, 6 had complete resolution; time to resolution ranged up to 15.6 weeks.

Of the 63 patients with moderate dermatitis, 25 (40%) were treated with systemic corticosteroids (median of 60 mg/day of prednisone or equivalent) for a median of 2.1 weeks, 7 (11%) were treated with only topical corticosteroids, and 31 (49%) did not receive systemic or topical corticosteroids.

Forty-four (70%) patients with moderate dermatitis were reported to have complete resolution, 7 (11%) improved to mild (Grade 1) severity, and 12 (19%) had no reported improvement.

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

Permanently discontinue YERVOY in patients with Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations. Administer systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent. When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. Withhold YERVOY dosing in patients with moderate to severe signs and symptoms. [See Dosage and Administration (2.2) in Full Prescribing Information] For mild to moderate dermatitis, such as localized rash and pruritus, treat symptomatically.

Administer topical or systemic corticosteroids if there is no improvement of symptoms within 1 week.

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

Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-Barré-like syndromes. Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids at a dose of 1 to 2 mg/kg/day prednisone or equivalent for severe neuropathies. Withhold YERVOY dosing in patients with moderate neuropathy (not interfering with daily activities). [See Dosage and Administration (2.2) in Full Prescribing Information] Immune-mediated Endocrinopathies In Study 1, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3–4) occurred in 9 (1.8%) YERVOY-treated patients. All 9 patients had hypopituitarism and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism.

Six of the 9 patients were hospitalized for severe endocrinopathies. Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and one case each of hyperthyroidism and Cushing’s syndrome. The median time to onset of moderate to severe immune-mediated endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the initiation of YERVOY. Of the 21 patients with moderate to life-threatening endocrinopathy, 17 patients required long-term hormone replacement therapy including, most commonly, adrenal hormones (n=10) and thyroid hormones (n=13).

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

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

Withhold YERVOY dosing in symptomatic patients. Initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent, and initiate appropriate hormone replacement therapy.

[See Dosage and Administration (2.2) in Full Prescribing Information] Other Immune-mediated Adverse Reactions, Including Ocular Manifestations The following clinically significant immune-mediated adverse reactions were seen in less than 1% of YERVOY-treated patients in Study 1: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia.

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

Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day prednisone or equivalent for severe immune-mediated adverse reactions.

Administer corticosteroid eye drops to patients who develop uveitis, iritis, or episcleritis.

Permanently discontinue YERVOY for immune-mediated ocular disease that is unresponsive to local immunosuppressive therapy. [See Dosage and Administration (2.2) in Full Prescribing Information]

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

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

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

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

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

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

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

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

Immunogenicity

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

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

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

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

Table 1:

Selected Adverse Reactions in Study 1 Percentage (%) of Patientsa YERVOY 3 mg/kg n=131

System Organ Class/ Preferred Term Gastrointestinal Disorders Diarrhea Colitis Skin and Subcutaneous Tissue Disorders Pruritus Rash General Disorders and Administration Site Conditions Fatigue a

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

YERVOY 3 mg/kg+gp100 n=380

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

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

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

DRUG INTERACTIONS No formal drug-drug interaction studies have been conducted with YERVOY. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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

gp100 n=132

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

Any Grade

Grade 3â&#x20AC;&#x201C;5

Any Grade

Grade 3â&#x20AC;&#x201C;5

Any Grade

Grade 3â&#x20AC;&#x201C;5

32 8

5 5

37 5

4 3

20 2

1 0

31 29

0 2

21 25

<1 2

11 8

0 0

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

41

7

34

5

31

3

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

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

Pediatric Use

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

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

Geriatric Use

Renal Impairment No formal studies of YERVOY in patients with renal impairment have been conducted. [See Clinical Pharmacology (12.3) in Full Prescribing Information] Hepatic Impairment

Table 2:

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

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

Including fatal outcome.

Including intestinal perforation.

Underlying etiology not established.

YERVOY 3 mg/kg n=131

YERVOY 3 mg/kg+gp100 n=380

15 7 1 2 1 4 4 0

12 7 2 3 <1 1 1 1

0 0 1 1 0

<1 <1 0 0 <1

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

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

1281558A2

IP-B0001A-03-11

Issued: March 2011

Cancer Center Business Summit

Oncology Practices Challenged to Move Forward

By Dawn Holcombe, MBA, FACMPE, ACHE

Dallas, TXâ&#x20AC;&#x201D;The Cancer Center Business Summit grew out of interest in innovative business models for the delivery of cancer care in community oncology. The 2012 Summit focused on oncologistâ&#x20AC;&#x201C;hospital relationships, changing payer and provider models, and developing market strategies for success in the rapidly changing face of cancer care and rising costs.

Appropriately, the theme of the Summit this year was Transitioning to Value-Based Oncology: Strategies to Survive and Thrive. With growing business and federal attention on rising healthcare costs, the costs of cancer care are often in the spotlight. Public and private payers are experimenting with new payment methodologies and programs to transition from the current volumebased, fee-for-service standard for payment to a value-based model that will increasingly shift risk for some portion of the cost and the quality of health services to the hospitals and physicians who provide those services.

Ronald Barkley, MS, JD, President of the Cancer Center Business Development Group, Bedford, NH, presented the Summitâ&#x20AC;&#x2122;s annual industry research survey, which focused on the rapidly growing accountable care organizations (ACOs), and how oncology was being addressed in those new models. In addition, research by The Advisory Board Company, the American Society for Radiation Oncology, and Oncology Metrics showed a world of oncology that is struggling to understand its own metrics and comparative benchmarks, but that is taking charge and, in key areas, is trying innovative

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solutions that may lead to universal approaches.

Several panel discussions addressed topics directly relevant to practice administrators and providers, focusing on current initiatives in the delivery of cancer care, especially the recent experiments in oncology medical homes and ACOs on the West Coast and on the East Coast. The participants of the first panel discussed what other practices

Community oncology will need to learn how to manage care and costs, to use data and analytics to monitor quality improvements and cost-savings opportunities.

can learn from their experience with these innovations in oncology, sharing the challenges they have faced, even as they have pioneered some of the most visible and innovative pilot programs with oncologists in the country. Several articles provide specific details in this issue.

The second panel included physician and executive leaders from community oncology who spoke frankly about provider initiatives they were developing, with and without specific payers, at The West Clinic in Tennessee, New Mexico Oncology Hematology Consultants,

ONCOLOGY PRACTICE MANAGEMENT

I November 2012

Regional Cancer Care Associates in New Jersey, and at Cancer Treatment Centers of America.

Thomas J. Smith, MD, FACP, FASCO, Director of Palliative Medicine at Johns Hopkins Medical Institutions, Professor of Oncology at Sidney Kimmel Comprehensive Cancer Center, and Harry J. Duffey Family Professor of Palliative Medicine, Baltimore, MD, addresses the opportunities and the challenges of integrating a palliative care focus early into the treatment process, providing tools that he uses in practice.

Ezekiel J. Emanuel, MD, PhD, former Special Advisor on Healthcare Policy, Office of Management and Budget, Executive Office of the President, and Chair of the Department of Bioethics at the National Institutes of Health, delivered the Keynote Address at the Summit, highlighting the journey and future of the Accountable Care Act and of healthcare delivery system reform.

The oncology community faces a very real challenge, for which there is no easy answer: how will physicians continue to fight cancer with and for their patients when the world is swirling in constant chaos around them?

Community oncology will need to learn how to manage care and costs, to use data and analytics to monitor quality improvements and cost-savings opportunities, to develop or use cost-effective care protocols that also meet their clinical expectations for appropriateness and evidence, to reengineer the way they deliver their care, and to utilize the broad range of treatment resources that are now available to us. This is not a small challenge. l

Community Cancer Business Center

Health Plans Address the Rising Costs of…Continued from page 1 ed that the WellPoint data for the use of colony-stimulating factors for breast cancer, show a variation in treatment and in cost of 10% to 80%.

As in other health plans, Dr Malin is seeing increasing charges for patients and for the health plan for care delivered in the hospital outpatient setting versus care delivered in the community practice setting.

Furthermore, some of the oncology cost-management strategies that have been implemented by WellPoint include fee schedule changes to support community oncology, adjustments to drug payment rates that are higher than the average sales price plus 6%, and raising individual rates for generic drugs.

WellPoint has implemented one of the few oncology medical home pilots in the country, with the Wilshire Oncology Medical Group serving as a test of the medical home concept in oncology. Dr Malin said that the overriding concern for a health plan that is undertaking such a pilot is the need to consider how to scale a successful pilot to the rest of the market. It will soon not be enough to have just a few good projects for a plan; a health plan will need workable tools to scale such projects to practices of every size across the region or across the country.

and lines of therapy for patients with similar disease.

Based on US Oncology published data on how its pathways program demonstrated reduction in costs and variability, Aetna decided to support clinical decision-making programs for oncologists, working with a num-

Aetna Addresses Variation in Cancer Care Variation in care was also a concern of Aetna, said Ira M. Klein, MD, MBA, FACP, Chief of Staff, Office of the Medical Officer, Aetna Oncology Strategy, Hartford, CT. Aetna’s internal data review revealed variation of costs and of treatments not just across the country in states and cities, but also within specific zip codes. The variations appear in factors such as rates of hospitalization, hospital costs, choices of drugs,

ber of different pathways programs and individual pilots with community practices across the country. So far, Aetna is surprised to see less of an impact on drug spending than it had anticipated, but it has seen solid savings on the downstream and the total cancer spending, including hospitalizations and emergency department costs.

Those findings make sense, because oncology drug costs constitute a relatively small part of the total cancer spending, so supporting con-

sistent medical decision-making in the oncology practice would affect the more costly aspects of a health plan’s total cancer spending.

Aetna learned that it was most effective to work closely with the practicing oncologists, supporting tools and protocols that physicians need to reduce the financial burden of managing cancer as well as to help build care process mechanisms that can help health plans and physicians reduce the current burdens of precertification and authorization processes. Aetna is now investing in technology solutions that practices could use to develop multipayer, scalable operations, according to Dr Klein.

BlueCross BlueShield of Florida Cancer-related costs in Florida became the major cost driver for all payers in the state years ago, reported Jonathan Gavras, MD, FCCP, Senior Vice President of Delivery System and Chief Medical Officer, BlueCross BlueShield of Florida (Florida Blue), Jacksonville.

Initially, the health plan focused on draconian drug reimbursement controls and saw small practices merge into larger practices, partly in reaction to the financial pressures those reimbursement changes caused. More recently, in response to several meetings with these larger physician groups, Florida Blue committed to collaborative programs with the oncologists.

Now Florida Blue has developed the country’s first oncology accountable care organization (ACO) in concert with Advanced Medical Specialties, a 47-physician oncology group, and Baptist Health, a leading hospital system in the area. This ACO-based program utilizes the pathways that the physician group had in place and is focused on the

Ira M. Klein

Aetna is now investing in technology solutions that practices could use to develop multipayer, scalable operations.

November 2012

Continued on page 24

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Community Cancer Business Center

Health Plans Address the Rising Costs of…Continued from page 23 total cost of patient care not just oncology-specific care for each patient. Early results from the first quarter of the program are showing positive impact. In developing this program, the participants have learned that building trust and fully engaging leadership in the care process are essential.

Priority Health Oncology Programs Leadership and trust were also themes of the oncology medical home programs that John L. Fox, MD, MHA, Senior Medical Director, Priority Health, Grand Rapids, MI., developed with Cancer & Hematology Centers of Western Michigan and several other leading oncology practices. Although they do not have all the answers yet, according to Dr Fox, they do have trust, commonality of purpose, and a shared vision that has let them move forward, even in the absence of solid numbers.

The Priority Health programs pay physicians for their professional services, plus a monthly case-management fee for every patient in active treatment. At the end of the year, the practices that have reduced Priority Health’s hospital and emergency department costs will receive shared savings from the health plan.

The expectation is that the real savings will come from aspects of the medical decision-making that physicians do for these patients, not from reduced drug costs.

Common Goals, Shared Challenges Aetna tends to outsource some of the technical solutions, whereas other plans tend to work more closely in house with their own and their physicians’ solutions. All payers agreed that close collaboration with the physicians rather than relying on external middlemen to intervene

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with physicians was their preference for achieving best results.

John L. Fox

The Priority Health programs pay physicians for their professional services, plus a monthly casemanagement fee for every patient in active treatment.

Common key elements of the diverse programs include: • Pathways • Triage of patient events • Care management • Advanced care planning.

Management of adverse events and hospitalizations tend to yield the most savings. Dr Malin noted that approximately 33% of patients receiving chemotherapy have at least 1 hospital admission, and more than 50% of those are admissions for the management of symptoms and toxicities. Supporting community physicians in better ways to manage symptoms lowers admissions and

ONCOLOGY PRACTICE MANAGEMENT

I November 2012

total costs of care. Those are the goals, but the challenge for a health plan becomes how to do that on a network level rather than on an individual practice-by-practice approach. Pathways are a common tool but they do not always affect costs as much as they lead to predictability of costs.

When asked about the rapid siteof-care shifts being seen in the market as hospitals acquire private practices, the panelists noted that care delivered in the community setting is less expensive than care delivered in a hospital setting. They also recognized that earlier, traditional approaches to controlling oncology costs probably achieve the opposite effect and contribute to driving the migration of private practices into the hospital settings. Developing innovative programs for oncology is more difficult for health plans to accomplish with hospitals, because oncology is merely one of many specialties at a hospital.

The panelists noted that bundling payments will be a huge challenge, given the complexity of oncology care––even their actuaries are daunted at the thought of the resources involved; however, bundled payments may be more possible in the radiation oncology environment.

One of the biggest challenges that health plans and the oncology community face relates to data collection. As we move into considering the total cost of care rather than the limited focus on drug costs, the information needed to accurately evaluate those costs is spread in different data silos, so coordination and aggregation of data become a top priority.

There are still hurdles to cross in data coordination and aggregation, which is why trust is such a key element of innovative programs. Sometimes, the innovation needs to begin with trust, and the data will follow. l

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Oncology Medical Home

The Oncology Medical Home: Embodiment of the American Pioneering Spirit

By Gail Thompson

Dallas, TX—The American Pioneer Spirit is still alive today. At the 2012 Cancer Center Business Summit, attendees enjoyed the chance to walk through the challenges and possibilities of an emerging model in cancer care that is quickly becoming a buzzword for change—the oncology medical home.

Among the leading pioneers in the world of the oncology medical home are Linda D. Bosserman, MD, President of Wilshire Oncology Medical Group, La Verne, CA, and John D. Sprandio, MD, President of Consultants in Medical Oncology & Hematology and Chairman of Oncology Management Services, Drexel Hill, PA. Susan Tofani, MS, Director of Network and Payer Relations, Oncology Management Services, joined Dr Sprandio and Dr Bosserman in discussing their experiences involved in establishing the first oncology medical homes in the country. They offered updates for those involved in oncology on their efforts and on the progress of their initiatives.

Wilshire Oncology Medical Home Dr Bosserman said that her and her oncology team’s exploring the oncology medical home was driven by the need to look, in collaboration with payers, at how oncology could be paid differently for various outcomes. An oncology medical home absolutely requires a partnership between the payers, providers, and patients, she said.

The concept of the oncology medical home can be defined as patient care that delivers “cost-effective care on evidence-based guidelines, with

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The oncology medical home can be defined as patient care that delivers “cost-effective care on evidencebased guidelines, with warranted variations for fully engaged patients, given whenever patients need it, by experienced clinician teams led by doctors coordinating care with others.”

—Linda D. Bosserman, MD

warranted variations for fully engaged patients, given whenever patients need it, by experienced clinician teams led by doctors coordinating care with others, inside and outside of the clinic, that can lower

ONCOLOGY PRACTICE MANAGEMENT

I November 2012

costs and improve health outcomes for cancer care from prevention to end of life.”

One key difference for providers transitioning from a more traditional oncology practice setting to the world of an oncology medical home is that their practice and their focus is now patient-centric rather than physician- or clinic-centric. To accomplish this takes a fully engaged and reengineered oncology practice that involves the entire team.

Dr Bosserman’s group reengineered their practice to build a team of caregivers that is focused on patients’ needs and preferences in a cost-effective manner. The elements of that reengineering focus on a patient-centric oncology practice include: • The patient’s disease, health, and preferences • Engaged practice coordination of all care • Active partnership between providers and payers • Outcome validation and outcome reporting • Value-based quality and cost • Comprehensive care management and coordination • Comprehensive care plan and coordination.

The Wilshire oncology medical home was the culmination of approximately 4 years of development with Anthem BlueCross BlueShield of California. After much discussion regarding practice and plan capabilities, data collection, comparators, and potential models, an initial pilot was launched in mid-2011. The first year was focused on identifying trackable data elements and aligning payment modeling.

Oncology Medical Home

Anthem and Dr Bosserman’s group learned that their organizations could focus on the following trackable elements and components of patient care: • Therapies: cost-effectiveness by stage, tumor features, evidencebased guidelines, generics, consistency with age, comorbidities, and warranted variations, including clinical trials • Supportive care that is cost-effective for nausea and vomiting, white and red blood cell growth factors, and bone metastasis • Initial and interval symptom management to relieve suffering, lower complication costs, tackle the common toxicities of therapy (ie, pain, nausea and vomiting, diarrhea, constipation, dehydration, infections, and blood clots), and to encourage therapy compliance and adherence • Optimize the site of care: office, extended office, urgent care versus emergency department, hospital, and tertiary care • End-of-life care.

The Wilshire oncology medical home partnership is now able to track care progress through the following sets of data-based validated reports that form the basis for the payments: 1. Patients under care: achievable benchmarks of care (ABC) preferred provider organization population 2. Patients receiving therapy – Therapy and supportive care: choice, goal, line, and warranted variations – Guideline compliance and warranted variations 3. Interval care tracking with therapy – Extended office, urgent care versus emergency department, and hospital – Cancer therapy and cancer symptoms versus others 4. End-of-life care

– Advanced-care directives – Palliative care only and hospice care tracking – Site of care tracking 5. Quality measures: American Society of Clinical Oncology, meaningful use, ABC 6. Benchmarking.

One key element to executing the program was the issuance of an urgent care card to patients that contained explicit information

Some of the information learned at the end of the first year of the oncology medical home initiative with Anthem BlueCross BlueShield, said Dr Bosserman, included the key steps for the group and the payer that reflect the ongoing commitment, related to care and reporting, data exchange and analytics, and data export and accountability. They have identified opportunities for continued optimization of care— related to transfusions, generic drugs, and after-hours care—as well as plans to enhance the program in years 2 and 3 through benchmarking, cost reviews, and expanded patient care opportunities.

Dr Bosserman noted that her group and Anthem have learned that a patient-centered, value-based cancer program can benefit an accountable care organization and can provide value and positive care enhancement by leveraging delivery systems, costs, quality, and a strong payer partnership.

Oncology Patient-Centered Medical Home Dr Sprandio provided an update on the initiatives of his Consultants in Medical Oncology Group related to oncology medical homes on the East Coast. He noted that “every physician who treats a patient is a patient-centered medical home,” and that these programs provide a way to formalize the process and hopefully get paid for the care that is being provided.

Dr Sprandio added that “only those giving the care can improve it.”

And a part of that care improvement process will, of necessity, include: • Reengineering the processes of care, including information technology and support • Developing a patient-centric approach • Fixing accountability at the patient-physician locus

“Every physician who treats a patient is a patient-centered medical home. Only those giving the care can improve it.”

—John D. Sprandio, MD

about who and when to call with questions during their care. Prominently displayed on the card is, “First call your oncology care physician,” along with the appropriate contact information, which sums up the focus on the oncology medical home concept: the physician is the primary point of contact and serves as the hub through which all care is delivered.

November 2012

Continued on page 30

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www.OncPracticeManagement.com

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27

REGISTER online or Call (888) 4ASSIST Register for FREE to fill out, submit, and track requests such as insurance verifications online. You can also manage your facility profile and view current and historical account activity

Learn about our service offerings and how Amgen Assist® Online can help your practice • Insurance Verification • Prior Authorization • Billing and Claims Support

Learn about the various financial assistance programs that may be available to your patients to manage out-of-pocket expenses

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Oncology Medical Home

The Oncology Medical Home: Embodiment of the American Pioneering Spirit…Continued from page 27 • Minimizing clinically irrelevant physician activity • Communication, coordination, access, and engagement between patients and payers • Demonstration of value through measured outcomes and costs • Improving quality of care and reducing utilization (ie, costs).

In addition, Dr Sprandio has developed a branded oncology medical home model called the Oncology Patient Centered Medical Home (OPCMH) and has founded Oncology Management Services, Inc, to help practices that are interested in using his OPCMH model develop oncology medical homes in their markets.

Oncology Management Services has partnered with International Oncology Solutions to bring the OPCMH concept to medical oncology practices in southeastern Pennsylvania. The OPCMH model incorporates: • Clinical and business methodologies for practice and patient efficiencies in the community oncology practice • The organizational construct and use of the oncology medical home as a neighbor to the primary care patient-centered medical home • Establishment of the model as a bridge for oncologists to use for other care initiatives, including accountable care organizations, clinically integrated models, etc • Establishment of a platform for

pricing oncology in a bundled or episode-of-care payment.

Dr Sprandio provided the updated results and outcomes from the contract his group holds with Keystone Mercy Health Plan, noting that they have ongoing conversations with other key payers in the area to support his medical home model.

Further expansions of the model and concept are being explored with state oncology societies and practices across southeastern Penn-

The OPCMH model incorporates Clinical and business methodologies for practice and patient efficiencies in the community oncology practice.

sylvania. Dr Sprandio is also engaged in discussions with the National Committee for Quality Assurance and the American College of Physicians regarding inclusion of the OPCMH model in their specialty practice recognition programs.

Working in association with Dr Sprandio, Ms Tofani discussed the basic elements relevant to building

an oncology medical home. According to Ms Tofani, implementing an oncology medical home requires: • Fully implement an oncologyspecific electronic medical record system • Define clinical and financial goals • Secure buy-in from physicians via efficiencies • Engage payers and commit to new value proposition • Standardize processes of care • Overlay a clinical decision support system • Improve clinical communication and coordination • Integrate horizontally and vertically • Commit to continuous process improvement.

Accountable Care Organizations All 3 panelists agreed with the core value proposition that oncology patient-centered medical homes are in fact accountable care organizations. Dr Bosserman noted that sometimes it is a challenge to discuss these concepts with payers early in certain markets, but such discussions are crucial to establishing a medical home in oncology.

With a nod to the financial challenges that are facing community oncology practices of all sizes across the country, Dr Bosserman said, “If we can’t get payers to talk to us and look at these innovative systems in the next year, we may not be here to negotiate with them in 12 months.” l

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ONCOLOGY PRACTICE MANAGEMENT

I November 2012

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For appropriate patients receiving highly emetogenic chemotherapy who are at risk of chemotherapy-induced nausea and vomiting (CINV)

PREVENTION BEGINS WHERE TRIPLE THERAPY STARTS

On Cycle 1, Day 1, start with Triple Therapy—EMEND® (fosaprepitant dimeglumine) for Injection, a 5-HT3 antagonist, and a corticosteroid—for first-line prevention of CINV. EMEND for Injection, in combination with other antiemetic agents, is indicated in adults for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin.

EMEND for Injection has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of EMEND for Injection is not recommended.

Selected Important Safety Information t EMEND for Injection is contraindicated in patients who are hypersensitive to EMEND for Injection, aprepitant, polysorbate 80, or any other components of the product. Known hypersensitivity reactions include flushing, erythema, dyspnea, and anaphylactic reactions. t Aprepitant, when administered orally, is a moderate cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitor. Because fosaprepitant is rapidly converted to aprepitant, neither drug should be used concurrently with pimozide or cisapride. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions. t EMEND for Injection should be used with caution in patients receiving concomitant medications, including chemotherapy agents, that are primarily metabolized through CYP3A4. Inhibition of CYP3A4 by EMEND for Injection could result in elevated plasma concentrations of these concomitant medications. Conversely, when EMEND for Injection is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated. When EMEND for Injection is used concomitantly with medications that induce CYP3A4 activity, aprepitant plasma concentrations could be reduced, and this may result in decreased efficacy of aprepitant. t Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine.

In clinical studies, EMEND® (aprepitant) was administered commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents were not adjusted to account for potential drug interactions. In separate pharmacokinetic studies, EMEND did not influence the pharmacokinetics of docetaxel or vinorelbine. t Because a small number of patients in clinical studies received the CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular caution and careful monitoring are advised in patients receiving these agents or other chemotherapy agents metabolized primarily

by CYP3A4 that were not studied.

Selected Important Safety Information (continued) t There have been isolated reports of immediate hypersensitivity reactions including flushing, erythema, dyspnea, and anaphylaxis during infusion of fosaprepitant. These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy. It is not recommended to reinitiate the infusion in patients who have experienced these symptoms during first-time use. t Coadministration of EMEND for Injection with warfarin (a CYP2C9 substrate) may result in a clinically significant decrease in international normalized ratio (INR) of prothrombin time.

In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of EMEND for Injection with each chemotherapy cycle. t The efficacy of hormonal contraceptives may be reduced during coadministration with and for 28 days after the last dose of EMEND for Injection. Alternative or backup methods of contraception should be used during treatment with and for 1 month after the last dose of EMEND for Injection. t Chronic continuous use of EMEND for Injection for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profile may change during chronic continuous use. t In clinical trials of EMEND® (aprepitant) in patients receiving highly emetogenic chemotherapy, the most common adverse events reported at a frequency greater than with standard therapy, and at an incidence of 1% or greater were hiccups (4.6% EMEND vs 2.9% standard therapy), asthenia/fatigue (2.9% vs 1.6%), increased ALT (2.8% vs 1.5%), increased AST (1.1% vs 0.9%), constipation (2.2% vs 2.0%), dyspepsia (1.5% vs 0.7%), diarrhea (1.1% vs 0.9%), headache (2.2% vs 1.8%), and anorexia (2.0% vs 0.5%). t In a clinical trial evaluating safety of the 1-day regimen of EMEND for Injection 150 mg compared with the 3-day regimen of EMEND, the safety profile was generally similar to that seen in prior highly emetogenic chemotherapy studies with aprepitant.

However, infusion-site reactions occurred at a higher incidence in patients who received fosaprepitant (3.0%) than in those who received aprepitant (0.5%). Those infusion-site reactions included infusion-site erythema, infusion-site pruritus, infusion-site pain, infusion-site induration, and infusion-site thrombophlebitis.

Please see the adjacent Brief Summary of the Prescribing Information.

An antiemetic regimen including

Merck Oncology Copyright © 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. ONCO-1029338-0019 10/12 emendforinjection.com

Brief Summary of the Prescribing Information for

INDICATIONS AND USAGE EMEND for Injection is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in adults for use in combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.

Limitations of Use: EMEND for Injection has not been studied for the treatment of established nausea and vomiting.

Chronic continuous administration is not recommended [see Warnings and Precautions].

CONTRAINDICATIONS Hypersensitivity: EMEND for Injection is contraindicated in patients who are hypersensitive to EMEND for Injection, aprepitant, polysorbate 80, or any other components of the product. Known hypersensitivity reactions include flushing, erythema, dyspnea, and anaphylactic reactions [see Adverse Reactions].

Concomitant Use With Pimozide or Cisapride: Aprepitant, when administered orally, is a moderate cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitor following the 3-day antiemetic dosing regimen for CINV. Since fosaprepitant is rapidly converted to aprepitant, do not use fosaprepitant concurrently with pimozide or cisapride. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions [see Drug Interactions].

WARNINGS AND PRECAUTIONS CYP3A4 Interactions: Fosaprepitant is rapidly converted to aprepitant, which is a moderate inhibitor of CYP3A4 when administered as a 3-day antiemetic dosing regimen for CINV. Fosaprepitant should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4. Inhibition of CYP3A4 by aprepitant or fosaprepitant could result in elevated plasma concentrations of these concomitant medications.

When fosaprepitant is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated. When aprepitant is used concomitantly with medications that induce CYP3A4 activity, aprepitant plasma concentrations could be reduced, and this may result in decreased efficacy of aprepitant [see Drug Interactions].

Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine. In clinical studies, the oral aprepitant regimen was administered commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents were not adjusted to account for potential drug interactions.

In separate pharmacokinetic studies, no clinically significant change in docetaxel or vinorelbine pharmacokinetics was observed when the oral aprepitant regimen was coadministered. Due to the small number of patients in clinical studies who received the CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular caution and careful monitoring are advised in patients receiving these agents or other chemotherapy agents metabolized primarily by CYP3A4 that were not studied [see Drug Interactions].

Hypersensitivity Reactions: Isolated reports of immediate hypersensitivity reactions including flushing, erythema, dyspnea, and anaphylaxis have occurred during infusion of fosaprepitant. These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy.

Reinitiation of the infusion is not recommended in patients who experience these symptoms during first-time use.

Coadministration With Warfarin (a CYP2C9 substrate): Coadministration of fosaprepitant or aprepitant with warfarin may result in a clinically significant decrease in international normalized ratio (INR) of prothrombin time.

In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of fosaprepitant with each chemotherapy cycle [see Drug Interactions].

Coadministration With Hormonal Contraceptives: Upon coadministration with fosaprepitant or aprepitant, the efficacy of hormonal contraceptives may be reduced during and for 28 days following the last dose of either fosaprepitant or aprepitant. Alternative or backup methods of contraception should be used during treatment with and for 1 month following the last dose of fosaprepitant or aprepitant [see Drug Interactions].

Chronic Continuous Use: Chronic continuous use of EMEND for Injection for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profile may change during chronic continuous use.

ADVERSE REACTIONS Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adversereaction 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.

Since EMEND for Injection is converted to aprepitant, those adverse reactions associated with aprepitant might also be expected to occur with EMEND for Injection.

The overall safety of fosaprepitant was evaluated in approximately 1,100 individuals and the overall safety of aprepitant was evaluated in approximately 6,500 individuals.

Oral Aprepitant: Highly Emetogenic Chemotherapy (HEC): In 2 well-controlled clinical trials in patients receiving highly emetogenic cancer chemotherapy, 544 patients were treated with aprepitant during Cycle 1 of chemotherapy and 413 of these patients continued into the multiple-cycle extension for up to 6 cycles of chemotherapy. Oral aprepitant was given in combination with ondansetron and dexamethasone.

In Cycle 1, adverse reactions were reported in approximately 17% of patients treated with the aprepitant regimen compared with approximately 13% of patients treated with standard therapy. Treatment was discontinued due to adverse reactions in 0.6% of patients treated with the aprepitant regimen compared with 0.4% of patients treated with standard therapy.

The most common adverse reactions reported in patients treated with the aprepitant regimen (n=544) with an incidence of >1% and greater than with standard therapy (n=550), respectively, are listed below: Respiratory system: hiccups 4.6 vs 2.9 Body as a whole/Site unspecified: asthenia/fatigue 2.9 vs 1.6 Investigations: increased ALT 2.8 vs 1.5, increased AST 1.1 vs 0.9 Digestive system: constipation 2.2 vs 2.0, dyspepsia 1.5 vs 0.7, diarrhea 1.1 vs 0.9 Nervous system: headache 2.2 vs 1.8 Metabolism and nutrition: anorexia 2.0 vs 0.5 A listing of adverse reactions in the aprepitant regimen (incidence <1%) that occurred at a greater incidence than with standard therapy are presented in the Less Common Adverse Reactions subsection below.

In an additional active-controlled clinical study in 1,169 patients receiving aprepitant and HEC, the adverseexperience profile was generally similar to that seen in the other HEC studies with aprepitant.

Less Common Adverse Reactions: Adverse reactions reported in either HEC or moderately emetogenic chemotherapy (MEC) studies in patients treated with the aprepitant regimen with an incidence of <1% and greater than with standard therapy are listed below.

Infection and infestations: candidiasis, staphylococcal infection Blood and lymphatic system disorders: anemia, febrile neutropenia Metabolism and nutrition disorders: weight gain, polydipsia Psychiatric disorders: disorientation, euphoria, anxiety Nervous system disorders: dizziness, dream abnormality, cognitive disorder, lethargy, somnolence Eye disorders: conjunctivitis Ear and labyrinth disorders: tinnitus Cardiac disorders: bradycardia, cardiovascular disorder, palpitations

EMENDÂŽ (fosaprepitant dimeglumine) for Injection Vascular disorders: hot flush, flushing Respiratory, thoracic, and mediastinal disorders: pharyngitis, sneezing, cough, postnasal drip, throat irritation Gastrointestinal disorders: nausea, acid reflux, dysgeusia, epigastric discomfort, obstipation, gastroesophageal reflux disease, perforating duodenal ulcer, vomiting, abdominal pain, dry mouth, abdominal distension, hard feces, neutropenic colitis, flatulence, stomatitis Skin and subcutaneous tissue disorders: rash, acne, photosensitivity, hyperhidrosis, oily skin, pruritus, skin lesion Musculoskeletal and connective tissue disorders: muscle cramp, myalgia, muscular weakness Renal and urinary disorders: polyuria, dysuria, pollakiuria General disorders and administration site conditions: edema, chest discomfort, malaise, thirst, chills, gait disturbance Investigations: increased alkaline phosphatase, hyperglycemia, microscopic hematuria, hyponatremia, decreased weight, decreased neutrophil count In another chemotherapy-induced nausea and vomiting (CINV) study, Stevens-Johnson syndrome was reported as a serious adverse reaction in a patient receiving aprepitant with cancer chemotherapy.

The adverse-experience profiles in the multiple-cycle extensions of HEC studies for up to 6 cycles of chemotherapy were similar to that observed in Cycle 1.

Fosaprepitant: In an active-controlled clinical study in patients receiving HEC, safety was evaluated for 1,143 patients receiving the 1-day regimen of EMEND for Injection 150 mg compared with 1,169 patients receiving the 3-day regimen of EMEND. The safety profile was generally similar to that seen in prior HEC studies with aprepitant. However, infusion-site reactions occurred at a higher incidence in patients in the fosaprepitant group (3.0%) compared with those in the aprepitant group (0.5%). The reported infusion-site reactions included infusion-site erythema, infusion-site pruritus, infusion-site pain, infusion-site induration, and infusion-site thrombophlebitis.

The following additional adverse reactions occurred with fosaprepitant 150 mg and were not reported with the oral aprepitant regimen in the corresponding section above: General disorders and administration site conditions: infusion-site erythema, infusion-site pruritus, infusion-site induration, infusion-site pain Investigations: increased blood pressure Skin and subcutaneous tissue disorders: erythema Vascular disorders: thrombophlebitis (predominantly infusion-site thrombophlebitis) Other Studies: Angioedema and urticaria were reported as serious adverse reactions in a patient receiving aprepitant in a non-CINV/non-PONV study.

Postmarketing Experience: The following adverse reactions have been identified during postapproval use of fosaprepitant and aprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug.

Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, rarely Stevens-Johnson syndrome/toxic epidermal necrolysis Immune system disorders: hypersensitivity reactions including anaphylactic reactions DRUG INTERACTIONS Drug interactions following administration of fosaprepitant are likely to occur with drugs that interact with oral aprepitant.

Aprepitant is a substrate, a moderate inhibitor, and an inducer of CYP3A4 when administered as a 3-day antiemetic dosing regimen for CINV. Aprepitant is also an inducer of CYP2C9.

Fosaprepitant 150 mg, given as a single dose, is a weak inhibitor of CYP3A4 and does not induce CYP3A4. Fosaprepitant and aprepitant are unlikely to interact with drugs that are substrates for the P-glycoprotein transporter.

The following information was derived from data with oral aprepitant, 2 studies conducted with fosaprepitant and oral midazolam, and 1 study conducted with fosaprepitant and dexamethasone.

Effect of Fosaprepitant/Aprepitant on the Pharmacokinetics of Other Agents: CYP3A4 Substrates: Aprepitant, as a moderate inhibitor of CYP3A4, and fosaprepitant 150 mg, as a weak inhibitor of CYP3A4, can increase plasma concentrations of concomitantly coadministered oral medications that are metabolized through CYP3A4 [see Contraindications].

5-HT3 antagonists: In clinical drug interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).

Corticosteroids: Dexamethasone: Fosaprepitant 150 mg administered as a single intravenous dose on Day 1 increased the AUC0â&#x20AC;&#x201C;24hr of dexamethasone, administered as a single 8-mg oral dose on Days 1, 2, and 3, by approximately 2-fold on Days 1 and 2. The oral dexamethasone dose on Days 1 and 2 should be reduced by approximately 50% when coadministered with fosaprepitant 150 mg I.V. on Day 1.

An oral aprepitant regimen of 125 mg on Day 1 and 80 mg/day on Days 2 through 5, coadministered with 20-mg oral dexamethasone on Day 1 and 8-mg oral dexamethasone on Days 2 through 5, increased the AUC of dexamethasone by 2.2-fold on Days 1 and 5. The oral dexamethasone doses should be reduced by approximately 50% when coadministered with a regimen of fosaprepitant 115 mg followed by aprepitant.

Methylprednisolone: An oral aprepitant regimen of 125 mg on Day 1 and 80 mg/day on Days 2 and 3 increased the AUC of methylprednisolone by 1.34-fold on Day 1 and by 2.5-fold on Day 3, when methylprednisolone was coadministered intravenously as 125 mg on Day 1 and orally as 40 mg on Days 2 and 3. The intravenous methylprednisolone dose should be reduced by approximately 25% and the oral methylprednisolone dose should be reduced by approximately 50% when coadministered with a regimen of fosaprepitant 115 mg followed by aprepitant.

Chemotherapeutic agents: Docetaxel: In a pharmacokinetic study, oral aprepitant (CINV regimen) did not influence the pharmacokinetics of docetaxel [see Warnings and Precautions].

Vinorelbine: In a pharmacokinetic study, oral aprepitant (CINV regimen) did not influence the pharmacokinetics of vinorelbine to a clinically significant degree [see Warnings and Precautions].

Oral contraceptives: When oral aprepitant, ondansetron, and dexamethasone were coadministered with an oral contraceptive containing ethinyl estradiol and norethindrone, the trough concentrations of both ethinyl estradiol and norethindrone were reduced by as much as 64% for 3 weeks posttreatment.

The coadministration of fosaprepitant or aprepitant may reduce the efficacy of hormonal contraceptives (these can include birth control pills, skin patches, implants, and certain IUDs) during and for 28 days after administration of the last dose of fosaprepitant or aprepitant. Alternative or backup methods of contraception should be used during treatment with and for 1 month following the last dose of fosaprepitant or aprepitant.

Midazolam: Interactions between aprepitant or fosaprepitant and coadministered midazolam are listed below (increase is indicated as K, decrease as L, no change as ): Fosaprepitant 150 mg on Day 1, oral midazolam 2 mg on Days 1 and 4: AUC K 1.8-fold on Day 1 and AUC on Day 4 Fosaprepitant 100 mg on Day 1, oral midazolam 2 mg: oral midazolam AUC K 1.6-fold Oral aprepitant 125 mg on Day 1 and 80 mg on Days 2 to 5, oral midazolam 2 mg SD on Days 1 and 5: oral midazolam AUC K 2.3-fold on Day 1 and K 3.3-fold on Day 5 Oral aprepitant 125 mg on Day 1 and 80 mg on Days 2 and 3, intravenous midazolam 2 mg prior to 3-day

EMEND® (fosaprepitant dimeglumine) for Injection regimen of aprepitant and on Days 4, 8, and 15: intravenous midazolam AUC K 25% on Day 4, AUC L 19% on Day 8, and AUC L 4% on Day 15 Oral aprepitant 125 mg, intravenous midazolam 2 mg given 1 hour after aprepitant: intravenous midazolam AUC K 1.5-fold A difference of less than 2-fold increase of midazolam AUC was not considered clinically important.

The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) should be considered when coadministering these agents with fosaprepitant or aprepitant.

CYP2C9 Substrates (Warfarin, Tolbutamide): Warfarin: A single 125-mg dose of oral aprepitant was administered on Day 1 and 80 mg/day on Days 2 and 3 to healthy subjects who were stabilized on chronic warfarin therapy.

Although there was no effect of oral aprepitant on the plasma AUC of R(+) or S(–) warfarin determined on Day 3, there was a 34% decrease in S(–) warfarin trough concentration accompanied by a 14% decrease in the prothrombin time (reported as INR) 5 days after completion of dosing with oral aprepitant. In patients on chronic warfarin therapy, the prothrombin time (INR) should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of fosaprepitant with each chemotherapy cycle.

Tolbutamide: Oral aprepitant, when given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, decreased the AUC of tolbutamide by 23% on Day 4, 28% on Day 8, and 15% on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of the 3-day regimen of oral aprepitant and on Days 4, 8, and 15.

Effect of Other Agents on the Pharmacokinetics of Aprepitant: Aprepitant is a substrate for CYP3A4; therefore, coadministration of fosaprepitant or aprepitant with drugs that inhibit CYP3A4 activity may result in increased plasma concentrations of aprepitant. Consequently, concomitant administration of fosaprepitant or aprepitant with strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir) should be approached with caution. Because moderate CYP3A4 inhibitors (eg, diltiazem) result in a 2-fold increase in plasma concentrations of aprepitant, concomitant administration should also be approached with caution.

Aprepitant is a substrate for CYP3A4; therefore, coadministration of fosaprepitant or aprepitant with drugs that strongly induce CYP3A4 activity (eg, rifampin, carbamazepine, phenytoin) may result in reduced plasma concentrations and decreased efficacy.

Ketoconazole: When a single 125-mg dose of oral aprepitant was administered on Day 5 of a 10-day regimen of 400 mg/day of ketoconazole, a strong CYP3A4 inhibitor, the AUC of aprepitant increased approximately 5-fold and the mean terminal half-life of aprepitant increased approximately 3-fold. Concomitant administration of fosaprepitant or aprepitant with strong CYP3A4 inhibitors should be approached cautiously.

Rifampin: When a single 375-mg dose of oral aprepitant was administered on Day 9 of a 14-day regimen of 600 mg/day of rifampin, a strong CYP3A4 inducer, the AUC of aprepitant decreased approximately 11-fold and the mean terminal half-life decreased approximately 3-fold.

were treated with oral doses ranging from 2.5 to 2000 mg/kg/day. The highest dose produced a systemic exposure of about 2.8 to 3.6 times the human exposure at the recommended dose. Treatment with aprepitant produced skin fibrosarcomas at 125 and 500 mg/kg/day doses in male mice. Carcinogenicity studies were not conducted with fosaprepitant.

Aprepitant and fosaprepitant were not genotoxic in the Ames test, the human lymphoblastoid cell (TK6) mutagenesis test, the rat hepatocyte DNA strand break test, the Chinese hamster ovary (CHO) cell chromosome aberration test and the mouse micronucleus test.

Fosaprepitant, when administered intravenously, is rapidly converted to aprepitant. In the fertility studies conducted with fosaprepitant and aprepitant, the highest systemic exposures to aprepitant were obtained following oral administration of aprepitant. Oral aprepitant did not affect the fertility or general reproductive performance of male or female rats at doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended human dose and exposure in female rats at about 1.6 times the human exposure).

PATIENT COUNSELING INFORMATION [See FDA-Approved Patient Labeling]: Physicians should instruct their patients to read the patient package insert before starting therapy with EMEND for Injection and to reread it each time the prescription is renewed.

Patients should follow the physician’s instructions for the regimen of EMEND for Injection.

Allergic reactions, which may be sudden and/or serious, and may include hives, rash, itching, redness of the face/skin, and may cause difficulty in breathing or swallowing, have been reported. Physicians should instruct their patients to stop using EMEND and call their doctor right away if they experience an allergic reaction. In addition, severe skin reactions may occur rarely.

Patients who develop an infusion-site reaction such as erythema, edema, pain, or thrombophlebitis should be instructed on how to care for the local reaction and when to seek further evaluation.

EMEND for Injection may interact with some drugs, including chemotherapy; therefore, patients should be advised to report to their doctor the use of any other prescription or nonprescription medication or herbal products.

Patients on chronic warfarin therapy should be instructed to have their clotting status closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of fosaprepitant with each chemotherapy cycle.

Administration of EMEND for Injection may reduce the efficacy of hormonal contraceptives. Patients should be advised to use alternative or backup methods of contraception during treatment with and for 1 month following the last dose of fosaprepitant or aprepitant.

For detailed information, please read the Prescribing Information.

Rx only

Coadministration of fosaprepitant or aprepitant with drugs that induce CYP3A4 activity may result in reduced plasma concentrations and decreased efficacy.

Additional Interactions: Diltiazem: In a study in 10 patients with mild to moderate hypertension, intravenous infusion of 100 mg of fosaprepitant with diltiazem 120 mg 3 times daily resulted in a 1.5-fold increase of aprepitant AUC and a 1.4-fold increase in diltiazem AUC. It also resulted in a small but clinically meaningful further maximum decrease in diastolic blood pressure (mean [SD] of 24.3 [±10.2] mmHg with fosaprepitant vs 15.6 [±4.1] mmHg without fosaprepitant) and resulted in a small further maximum decrease in systolic blood pressure (mean [SD] of 29.5 [±7.9] mmHg with fosaprepitant vs 23.8 [±4.8] mmHg without fosaprepitant), which may be clinically meaningful, but did not result in a clinically meaningful further change in heart rate or PR interval beyond those changes induced by diltiazem alone.

In the same study, administration of aprepitant once daily as a tablet formulation comparable to 230 mg of the capsule formulation, with diltiazem 120 mg 3 times daily for 5 days, resulted in a 2-fold increase of aprepitant AUC and a simultaneous 1.7-fold increase of diltiazem AUC. These pharmacokinetic effects did not result in clinically meaningful changes in ECG, heart rate, or blood pressure beyond those changes induced by diltiazem alone.

Paroxetine: Coadministration of once-daily doses of aprepitant as a tablet formulation comparable to 85 mg or 170 mg of the capsule formulation, with paroxetine 20 mg once daily, resulted in a decrease in AUC by approximately 25% and Cmax by approximately 20% of both aprepitant and paroxetine.

USE IN SPECIFIC POPULATIONS Pregnancy: Teratogenic effects: Pregnancy Category B: In the reproduction studies conducted with fosaprepitant and aprepitant, the highest systemic exposures to aprepitant were obtained following oral administration of aprepitant. Reproduction studies performed in rats at oral doses of aprepitant of up to 1000 mg/kg twice daily (plasma AUC0–24hr of 31.3 mcgshr/mL, about 1.6 times the human exposure at the recommended dose) and in rabbits at oral doses of up to 25 mg/kg/day (plasma AUC0–24hr of 26.9 mcgshr/mL, about 1.4 times the human exposure at the recommended dose) revealed no evidence of impaired fertility or harm to the fetus due to aprepitant. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: Aprepitant is excreted in the milk of rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for possible serious adverse reactions in nursing infants from aprepitant and because of the potential for tumorigenicity shown for aprepitant in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of EMEND for Injection in pediatric patients have not been established.

Geriatric Use: In 2 well-controlled CINV clinical studies, of the total number of patients (N=544) treated with oral aprepitant, 31% were 65 and over, while 5% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment in the elderly is not necessary.

Patients With Severe Hepatic Impairment: There are no clinical or pharmacokinetic data in patients with severe hepatic impairment (Child-Pugh score >9). Therefore, caution should be exercised when fosaprepitant or aprepitant is administered in these patients.

OVERDOSAGE There is no specific information on the treatment of overdosage with fosaprepitant or aprepitant.

In the event of overdose, fosaprepitant and/or oral aprepitant should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of aprepitant, drug-induced emesis may not be effective. Aprepitant cannot be removed by hemodialysis.

Thirteen patients in the randomized controlled trial of EMEND for Injection received both fosaprepitant 150 mg and at least one dose of oral aprepitant, 125 mg or 80 mg. Three patients reported adverse reactions that were similar to those experienced by the total study population.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies were conducted in Sprague-Dawley rats and in CD-1 mice for 2 years. In the rat carcinogenicity studies, animals were treated with oral doses ranging from 0.05 to 1000 mg/kg twice daily. The highest dose produced a systemic exposure to aprepitant (plasma AUC0–24hr) of 0.7 to 1.6 times the human exposure (AUC0–24hr=19.6 mcgshr/mL) at the recommended dose of 125 mg/day. Treatment with aprepitant at doses of 5 to 1000 mg/kg twice daily caused an increase in the incidences of thyroid follicular cell adenomas and carcinomas in male rats. In female rats, it produced hepatocellular adenomas at 5 to 1000 mg/kg twice daily and hepatocellular carcinomas and thyroid follicular cell adenomas at 125 to 1000 mg/kg twice daily. In the mouse carcinogenicity studies, the animals

Copyright © 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. ONCO-1029338-0019

Oncology Practice Innovation

Cost-Effective Cancer Care: Thoughts from Leading Physicians

By Gail Thompson

Dallas, TX—Can we create a system of care that will demonstrate costeffectiveness and change the way oncology is being practiced? This was the focus of several providerdriven innovative solutions discussed at the 2012 Cancer Center Business Summit.

We have learned that we must collect and share information, develop benchmarks, and make them actionable. The panelists described 4 distinct oncology models that are being developed toward effective cancer management.

Innovative Oncology Business Solutions: Oncology Medical Homes Barbara L. McAneny, MD, Chief Executive Officer, New Mexico Oncology Hematology Consultants, Albuquerque, described a 3-year, $19.7-million grant that was recently awarded by the Centers for Medicare & Medicaid Services (CMS) to a new company that she created named Innovative Oncology Business Solutions. This grant will support the infrastructure and software to develop community oncology medical homes in New Mexico, Florida, Georgia, Maine, Ohio, Pennsylvania, and Tennessee.

“We seem to have learned in oncology that good practices have to be designed around patient flow and building processes that manage patients and their care. Programs that focus solely on drugs and cutting costs become self-limiting,” Dr McAneny stated.

A bundled payment model will be established to pay the physicians a set amount to manage their patients.

In addition, the program will develop a personalized medicine program

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for Medicare patients with cancer that will include genetic testing.

Another key feature of the program is the use of triage processes that integrate nurse care managers with the practice.

The results from these practices will be compared with data from CMS

“We seem to have learned in oncology that good practices have to be designed around patient flow and building processes that manage patients and their care. Programs that focus solely on drugs and cutting costs become self-limiting.”

—Barbara L. McAneny, MD

on how patients are being treated at major cancer hospitals across the country, with the expectation that the community practices would show the same quality of care as CMS, or better, but at a lower cost.

Dr McAneny observed that “part of this transitional process is going to be engaging and teaching patients how and when to contact their physician to better manage clinical outcomes.” In addition, she noted that the oncology community will “also have to come up with specific mea-

ONCOLOGY PRACTICE MANAGEMENT

I November 2012

sures of the patient experience—the whole experience, not just the clinical outcomes and experience. The top 2 complaints we hear from patients are ‘we have been waiting too long for care,’ and ‘no one listened to me, and what I was trying to say.’”

Engaging the Patient: Cancer Treatment Centers of America Cancer care at the Cancer Treatment Centers of America (CTCA) in Schaumburg, IL, is focused on engaging the oncology consumer, according to Stephen B. Bonner, President and Chief Executive Officer of CTCA. Patients self-refer to CTCA for treatment, and Mr Bonner described the manner in which CTCA engages the oncology consumer in making informed choices about their care.

He believes that oncology patients are hungry for information about their choices, their treatments, and about side effects and how to manage them. CTCA has a widespread direct-to-consumer focus, and it publishes self-reported quality results on its website, by cancer type and site.

Another CTCA initiative is transparent pricing. Many of their patients travel up to 300 miles one way for care, and they appreciate the work that CTCA has done to build a bundled pricing for the evaluation services, including guarantees for the timing of the evaluation and provision of a written care plan.

Bundled pricing for treatment is also in development. CTCA is underwriting research to allow consumers to define quality in oncology, and it is identifying meaningful future metrics for quality measurement in oncology. Mr Bonner

Oncology Practice Innovation

expects that “Real-world care models and outcomes and payment models will eventually be more powerful in determining effective and appropriate care than clinical trials.”

Value-Based Cancer Network: John Theurer Cancer Center Andrew L. Pecora, MD, FACP, CPE, Chief Innovations Officer and Professor and Vice President of Cancer Services, John Theurer Cancer Center at Hackensack University Medical Center, NJ, described an oncology model for clinical integration by the establishment of Value-Based Cancer Network.

In New Jersey, 80 like-minded oncologists (with dozens more soon to join) have designed Regional Cancer Care Associates, with the goal of oncologists taking action to coordinate efforts with health plans and drug companies to provide quality cancer care to patients, while reducing the cost of care. Each practice will retain autonomy (the physicians will be able to make specific medical decisions for their individual patients), but a doctor-dominated board of trustees will standardize the care and will identify the relative effectiveness of chemotherapies or the number of diagnostic tests that will be appropriate.

In the face of escalating costs of cancer care as a result of the growing population and because people are living longer and are getting cancer, models such as the Value-Based Cancer Network are focused on rational care by providing the treatments that offer best survival rates, at a reasonable cost.

Hospital–Physician Partnership Model: The West Clinic Erich A. Mounce, MHA, Chief Executive Officer, The West Clinic, Memphis, TN, and Lee Schwartzberg, MD, FACP, Medical Director,

The West Clinic, and Chief, Division of Hematology/Oncology, University of Tennessee Health Science Center, Memphis, described how The West Clinic has continued to evolve from a 1-stop, quick, efficient, and economical community oncology practice.

through improved drug pricing programs. (The hospital partner participates as a designated-services hospital and receives access to drug pricing programs that allow the practice and the hospital partner to serve the uninsured members of the community.)

These programs are being used for unfunded services that did not previously exist—patient navigation, physical therapy, and building a multidisciplinary approach to cancer care. The partnership includes integration of research.

Part of the reason The West Clinic decided to expand its services and to include a partner was that its referral base was being captured by a competing hospital in the marketplace.

A key element of the partnership is a management agreement: The West Clinic’s physicians manage the entire service line now.

Mr Mounce said that “engaging senior leadership is imperative. The Chief Executive of Operations and the Chief Financial Officer of this 7hospital system sit with us monthly as we develop programs.”

Out of concern for the challenges that the patients and the payers may face that arise when private practices shift to hospital-based programs, the hospital and The West Clinic approached all payers collaboratively to figure out how they could bill as a hospital provider, but under the physician setting contracts.

This innovation allowed the patients’ copays and the patient and health plan billings to remain the same and to not rise as a result of the partnership. The hospital partner walked away from millions of dollars in potential higher billings by agreeing to this component of the partnership, and this then allowed deeper engagement of patients and patient management.

The next steps will include moving toward development of quality outcomes and patient outcomes that will further drive quality discussions. l

“Engaging senior leadership is imperative. The Chief Executive of Operations and the Chief Financial Officer of this 7-hospital system sit with us monthly as we develop programs.”

—Erich A. Mounce, MHA

The West Clinic has always been at the center of cancer care innovation and quality, including being a founder of the Cancer Clinics of Excellence and now participating in an episode-of-care payment model with UnitedHealthcare.

Recognizing that there are limitations to the cost-savings that a single practice can achieve without touching on huge cost drivers embedded elsewhere along the entire spectrum of care delivered outside of its offices, The West Clinic developed a request for proposal for possible partners among the hospitals that were in its local market. One partner was selected because of the presence of a shared vision and willingness to move forward with initiatives and a desire to take better care of the community.

This partnership is becoming the vehicle to get better access to data covering the full continuum of care.

Dollars are now being saved

November 2012

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Drug Coding Supplied by RJ Health Systems

Medications Used for the Treatment of Multiple Myeloma The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with the management of multiple myeloma.

The following sections include: • Associated ICD-9-CM codes used for the classification of multiple myelomar • Drugs that have been FDA-approved in the treatment of multiple myeloma • Drugs that are Compendia listed for offlabel use for multiple myeloma based on clinical studies that suggest beneficial use in some cases.

Please note: If a check mark appears in the FDA column it will NOT appear in the Compendia off-label use column • Corresponding HCPCS/CPT® codes and code descriptions

Associated ICD-9-CM codes for multiple myeloma: 203 Multiple myeloma and immunoproliferative neoplasms The following fifth-digit subclassification is for use with category 203: 0 Without mention of having achieved remission >Failed remission< 1 In remission 2 In relapse 203.0 Multiple myeloma Kahler’s disease Myelomatosis Excludes: solitary myeloma (238.6)

Compendia listed FDA-approved off-label use for for multiple myeloma multiple myeloma

Generic (brand) name

HCPCS code: code description

arsenic trioxide (Trisenox)

J9017: Injection, arsenic trioxide, 1 mg

betamethasone acetate J0702: Injection, betamethasone acetate and sodium phosphate 3 mg and betamethasone sodium (Celestone Soluspan) phosphate 3 mg

36

CPT ® administration codes

✓

96413, 96415

✓

11900, 11901, 20600, 20605, 20610, 96372

bortezomib (Velcade)

J9041: Injection, bortezomib, 0.1 mg

✓

96409

carfilzomib (Kyprolis)

C9399a: Unclassified drugs or biological (Hospital outpatient use ONLY)

✓

96409

carfilzomib (Kyprolis)

J9999a: Not otherwise classified, antineoplastic drugs

✓

96409

carmustine (BiCNU)

J9050: Injection, carmustine, 100 mg

✓

96413, 96415

cisplatin (Platinol AQ)

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

cyclophosphamide (Cytoxan)

J8530: Cyclophosphamide, oral, 25 mg

✓

N/A

cyclophosphamide (Cytoxan)

J9070: Cyclophosphamide, 100 mg

✓

96409, 96413, 96415

dexamethasone (Decadron)

J8540: Dexamethasone, oral, 0.25 mg

✓

N/A

dexamethasone (Decadron)

J1100: Injection, dexamethasone sodium phosphate, 1 mg

✓

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

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ONCOLOGY PRACTICE MANAGEMENT

I November 2012

✓

96409, 96413, 96415

Drug Coding Supplied by RJ Health Systems

Compendia listed FDA-approved off-label use for for multiple myeloma multiple myeloma

Generic (brand) name

HCPCS code: code description

doxorubicin HCl (Adriamycin) doxorubicin HCl liposomal (Doxil)

J9000: Injection, doxorubicin hydrochloride, 10 mg J9001: Injection, doxorubicin hydrochloride, all lipid formulations, 10 mg (Not payable

by Medicare, effective 7/1/12)—see Q2048 Q2048: Injection, doxorubicin hydrochloride, liposomal, Doxil, 10 mg J9178: Injection, epirubicin HCl, 2 mg

doxorubicin HCl liposomal (Doxil) epirubicin (Ellence) etoposide (Vepesid) etoposide (Etopophos, Toposar) hydrocortisone (Solu-Cortef) hydrocortisone (Cortef) ifosfamide (Ifex) interferon alfa-2b (Intron-A) interferon alfa-n3 (Alferon-N) lenalidomide (Revlimid) lomustine (CeeNu) lomustine (CeeNu) melphalan (Alkeran) melphalan (Alkeran) methylprednisolone (Medrol) methylprednisolone (Depo-Medrol)

✓

CPT ® administration codes 96409 96413

✓

96413

✓

✓

96409, 96413

J8560: Etoposide, oral, 50 mg

✓

N/A

J9181: Injection, etoposide, 10 mg

✓

96413, 96415

J1720: Injection, hydrocortisone sodium succinate, up to 100 mg J8499a: Prescription drug, oral, nonchemotherapeutic Not otherwise specified J9208: Injection, ifosfamide, 1 g

✓

✓

96365, 96366, 96372, 96374 N/A

✓

96413, 96415

✓

J9214: Injection, interferon, alfa-2b, recombinant, 1 million units J9215: Injection, interferon, alfa-n3 (human leukocyte derived), 250,000 IU J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified S0178: Lomustine, oral, 10 mg

✓

96372, 96401

✓

11900, 11901 N/A

✓

✓

N/A

✓

N/A

J8600: Melphalan, oral, 2 mg

✓

N/A

J9245: Injection, melphalan hydrochloride, 50 mg J7509: Methylprednisolone, oral, per 4 mg

✓

96409, 96413 ✓

N/A

J1020: Injection, methylprednisolone acetate, 20 mg

✓

methylprednisolone (Depo-Medrol)

J1030: Injection, methylprednisolone acetate, 40 mg

✓

methylprednisolone (Depo-Medrol)

J1040: Injection, methylprednisolone acetate, 80 mg

✓

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

November 2012

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37

Drug Coding Supplied by RJ Health Systems

Compendia listed FDA-approved off-label use for for multiple myeloma multiple myeloma

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

methylprednisolone (Solu-Medrol)

J2930: Injection, methylprednisolone sodium succinate, up to 125 mg

✓

96365, 96366, 96372, 96374

paclitaxel (Taxol)

J9265: Injection, paclitaxel, 30 mg

✓

96413, 96415

peginterferon alfa-2b (Peg-Intron)

J3590a: Unclassified biologics

✓

96372

peginterferon alfa-2b (Peg-Intron)

S0148: Injection, pegylated interferon alfa-2b, 10 mcg

✓

96372

prednisolone (eg, Millipred, Prelone)

J7510: Prednisolone, oral, per 5 mg

✓

N/A

prednisone J7506: Prednisone, oral, per 5 mg (eg, Deltasone, Orasone)

✓

N/A

procarbazine (Matulane)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

procarbazine (Matulane)

S0182: Procarbazine HCl, oral, 50 mg

✓

N/A

teniposide (Vumon)

Q2017: Injection, teniposide, 50 mg

✓

96413, 96415

thalidomide (Thalomid)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

✓

96413

vinCRIStine (Vincasar PFS)

J9370: Vincristine sulfate, 1 mg

✓

96409

N/A

✓

a

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

References HCPCS Level II Expert 2012 • Current Procedural Terminology (CPT ®), 2012 (CPT® copyright 2012 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Vol 1, 2, 2012 • FDA-approved indication (from product prescribing information) • Compendia references available upon request • www.ReimbursementCodes.com powered

by RJ Health Systems International, LLC, Rocky Hill, Connecticut • CMS (Centers for Medicare & Medicaid Services).

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

This information was supplied by:

30 Cold Spring Road, Rocky Hill, CT 06067 T: (860) 563-1223 • F: (860) 563-1650 • www.RJHealthSystems.com 38

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ONCOLOGY PRACTICE MANAGEMENT

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RJ Health Systems The Creators of ReimbursementCodes.com

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

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

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

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

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

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

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

rjhealthsystems.com

Hospital–Physician Contracting

The Nuts and Bolts of Physician and Hospital Practice Arrangements from the Oncology Front Line

By Gail Thompson

Dallas, TX—Many hospitals and physician groups are courting now, exploring the possible option of physicians going hospital-based.

There are many drivers leading to the dance: financial pressures, an excess of administrative burden on doctors who just want to practice medicine, an aging physician population, an aging patient population that will need more care, and changing policy and reimbursement models that appear daunting to the community oncologist.

At the 2012 Cancer Center Business Summit, 3 oncology practice executives presented some of the daily details that can be forgotten during the hospital–physician integration.

Issues to Consider Before the Contract Is Signed Teri U. Guidi, MBA, FAAMA, President and Chief Executive Officer of the Oncology Management Consulting Group, Pipersville, PA, opened with a discussion of the dayto-day issues listed below that may not be considered in the heat of contract negotiations with a hospital that may become unwelcome surprises once the deal is done.

Control. The shift in control is often a surprise, both to the physicians and to the staff. Who is making the daily operations decisions now, and how much input do the physicians have compared with what they were used to having in private practice? Who will be making the hiring and the firing decisions? Other pressure points to watch include labora-

40

I

tory and pharmacy turnaround times, check-in and registration processes and timing, scheduling of visit lengths, and distribution of new and established visits.

“Payer contracts [for the practice and the hospital] are not likely to be parallel…it may be a challenge to get clean claims out the door and to collect on them.”

—Teri U. Guidi, MBA, FAAMA

Performance and compensation.

There may be unmatched expectations between the hospital and the physicians that come to light after the deal is done, or that may even surface 2 to 3 years later when the

ONCOLOGY PRACTICE MANAGEMENT

I November 2012

original contract comes up for renewal. Is there agreement on productivity targets, management duties, expectations for corporate citizenship duties, and other expectations?

Has physician compensation been clearly defined with regard to the base and basis, the timing of revisions, the amounts for ceilings and floors, and any additional incentives?

Compensation issues may arise for staff as well, regarding pay scales, bonus policies, and seniority status for transferred staff. Will there be additional nononcology duties expected of staff and physicians, and what impact will these have on the process and flow of normal patient care in the acquired practice?

Billing and collecting. Practices are often much more efficient at billing oncology claims than hospital staff, but the transition may not be easy.

The oncology practice staff understands physician practice claim forms and rules, but hospital billing forms and billing constructs are different.

Ms Guidi warns that “payer contracts [for the practice and the hospital] are not likely to be parallel…it may be a challenge to get clean claims out the door and to collect on them.” That can affect the cash flow for the new entity.

Technology. There may be challenges related to a different type of technology used by either institution, such as when a practice bills electronically and the hospital is still paper-based. Or the hospital may have a completely new billing sysContinued on page 43

Connecting to Access, Reimbursement, Education, and Support for Jakafi®.

IncyteCARES about you.

Helping patients with intermediate or high-risk myelofibrosis (MF) stay connected to care Patients living with MF face many challenges. IncyteCARES is a program created by Incyte to connect patients with MF, who qualify for the program, to continuing support and resources during their treatment with Jakafi®.

Treatment with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache

IncyteCARES helps care for patients with MF Access and reimbursement services Benefit verification Prior authorization Appeal support Jakafi delivery coordination Co-pay assistance Free medication program

Patient education and support Educational information to help teach patients about MF and Jakafi Patient Starter Packet IncyteCares Welcome Packet Access to trained nurse professionals

Visit www.IncyteCARES.com or call 1-855-4-Jakafi (855-452-5234), Monday−Friday, 8 AM – 8 PM ET, to learn more about Incyte’s patient support program.

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 Gradesb Grade 3 Parameter BRIEF SUMMARY: For Full Prescribing Information, see package insert. (%) (%) (%) (%) (%) (%) INDICATIONS AND USAGE Jakafi is indicated for treatment of patients with intermediate or high-risk 69.7 9.0 3.9 30.5 1.3 0 Thrombocytopenia 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 hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia.

A complete blood count must be performed before initiating therapy with Jakafi [see Dosage and Additional Data from the Placebo-controlled Study 25.2% of patients treated with Jakafi and 7.3% of Administration (2.1) in Full Prescribing Information]. Patients with platelet counts of less than 200 X 109/L patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transat the start of therapy are more likely to develop thrombocytopenia during treatment. Thrombocytopenia was aminase (ALT). The incidence of greater than or equal to Grade 2 elevations was 1.9% for Jakafi with 1.3% Grade 3 and no Grade 4 ALT elevations. 17.4% of patients treated with Jakafi and 6.0% of patients treated generally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase clinically indicated, platelet transfusions may be administered [see Dosage and Administration (2.2) in Full (AST). The incidence of Grade 2 AST elevations was 0.6% for Jakafi with no Grade 3 or 4 AST elevations.

Prescribing Information, and Adverse Reactions]. Patients developing anemia may require blood trans16.8% of patients treated with Jakafi and 0.7% of patients treated with placebo developed newly occurring or fusions. Dose modifications of Jakafi for patients developing anemia may also be considered. Neutropenia worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was 0.6% for (ANC less than 0.5 X 109/L) was generally reversible and was managed by temporarily withholding Jakafi Jakafi with no Grade 3 or 4 cholesterol elevations. [see Adverse Reactions]. Complete blood counts should be monitored as clinically indicated and dosing DRUG INTERACTIONS Drugs That Inhibit or Induce Cytochrome P450 Enzymes Ruxolitinib adjusted as required [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse is predominantly metabolized by CYP3A4. Strong CYP3A4 inhibitors: The C max and AUC of ruxolitinib Reactions]. Infections Patients should be assessed for the risk of developing serious bacterial, mycobac- increased 33% and 91%, respectively, with Jakafi administration (10 mg single dose) following ketoconazole terial, fungal and viral infections. Active serious infections should have resolved before starting therapy with 200 mg twice daily for four days, compared to receiving Jakafi alone in healthy subjects. The half-life was also Jakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection and prolonged from 3.7 to 6.0 hours with concurrent use of ketoconazole. The change in the pharmacodynamic initiate appropriate treatment promptly. Herpes Zoster Physicians should inform patients about early signs marker, pSTAT3 inhibition, was consistent with the corresponding ruxolitinib AUC following concurrent adminand symptoms of herpes zoster and advise patients to seek treatment as early as possible [see Adverse istration with ketoconazole. When administering Jakafi with strong CYP3A4 inhibitors a dose reduction is Reactions]. recommended [see Dosage and Administration (2.4) in Full Prescribing Information]. Patients should be ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under closely monitored and the dose titrated based on safety and efficacy. Mild or moderate CYP3A4 inhibitors: widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly There was an 8% and 27% increase in the Cmax and AUC of ruxolitinib, respectively, with Jakafi administration compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The (10 mg single dose) following erythromycin, a moderate CYP3A4 inhibitor, at 500 mg twice daily for 4 days, safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 compared to receiving Jakafi alone in healthy subjects. The change in the pharmacodynamic marker, pSTAT3 months, including 301 patients with myelofibrosis in two Phase 3 studies. In these two Phase 3 studies, inhibition was consistent with the corresponding exposure information. No dose adjustment is recommended patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 88.7% of when Jakafi is coadministered with mild or moderate CYP3A4 inhibitors (eg, erythromycin). CYP3A4 patients treated for more than 6 months and 24.6% treated for more than 12 months. One hundred and inducers: The Cmax and AUC of ruxolitinib decreased 32% and 61%, respectively, with Jakafi administration eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In (50 mg single dose) following rifampin 600 mg once daily for 10 days, compared to receiving Jakafi alone in a double-blind, randomized, placebo-controlled study of Jakafi, 155 patients were treated with Jakafi. The healthy subjects. In addition, the relative exposure to ruxolitinib’s active metabolites increased approximately most frequent adverse drug reactions were thrombocytopenia and anemia [see Table 2]. Thrombocytopenia, 100%. This increase may partially explain the reported disproportionate 10% reduction in the pharmacoanemia and neutropenia are dose related effects. The three most frequent non-hematologic adverse reactions dynamic marker pSTAT3 inhibition. No dose adjustment is recommended when Jakafi is coadministered with were bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless of a CYP3A4 inducer. Patients should be closely monitored and the dose titrated based on safety and efficacy. causality, was observed in 11.0% of patients treated with Jakafi and 10.6% of patients treated with placebo. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: There are no adequate Following interruption or discontinuation of Jakafi, symptoms of myelofibrosis generally return to and well-controlled studies of Jakafi in pregnant women. In embryofetal toxicity studies, treatment with pretreatment levels over a period of approximately 1 week. There have been isolated cases of patients discon- ruxolitinib resulted in an increase in late resorptions and reduced fetal weights at maternally toxic doses. tinuing Jakafi during acute intercurrent illnesses after which the patient’s clinical course continued to worsen; Jakafi should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. however, it has not been established whether discontinuation of therapy contributed to the clinical course in Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses these patients. When discontinuing therapy for reasons other than thrombocytopenia, gradual tapering of the 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 teratodose of Jakafi may be considered [see Dosage and Administration (2.6) in Full Prescribing Information]. genicity. However, decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times Table 1 presents the most common adverse reactions occurring in patients who received Jakafi in the doublethe clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights blind, placebo-controlled study during randomized treatment. of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of Table 1: Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlled 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In Study During Randomized Treatment a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implanJakafi Placebo tation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for (N=155) (N=151) fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest Adverse All All dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily).

Reactions Gradesa Grade 3 Grade 4 Grades Grade 3 Grade 4 Nursing Mothers It is not known whether ruxolitinib is excreted in human milk. Ruxolitinib and/or its metabolites were excreted in the milk of lactating rats with a concentration that was 13-fold the maternal (%) (%) (%) (%) (%) (%) plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse 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 Urinary Tract Infectionsd 9.0 0 0 5.3 0.7 0.7 myelofibrosis patients in clinical studies with Jakafi, 51.9% were 65 years of age and older. No overall differWeight Gaine 7.1 0.6 0 1.3 0.7 0 ences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in 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 c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis normal renal function. However, plasma AUC values of ruxolitinib metabolites increased with increasing 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 urine, bacteria urine identified, nitrite urine present hemodialysis. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the 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 (2.5) 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 (2.5) in cytopenia occurred in 0.7% of patients receiving Jakafi and 0.9% of patients receiving control regimens. Full 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 © 2011-2012 Incyte Corporation. All rights reserved. reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study.

Issued: June 2012 RUX-1040a

Hospital–Physician Contracting

The Nuts and Bolts of Physician and Hospital…Continued from page 40 tem that will present a learning curve for the practice staff members.

Is it possible for the billing systems to be integrated or merged? Have plans been made for the “transitional eon,” as Ms Guidi calls it?

Outsourcing to Specialty Pharmacies Burt Zweigenhaft, BS, Chief Executive Officer of OncoMed Onco360 in Great Neck, NY, spoke about some of the considerations that a hospital may encounter when deciding whether to outsource to an oncology pharmacy. With continuing Medicare and commercial payer drug reimbursement reductions, some hospitals are evaluating the option of outsourcing the acquisition and the mixing of oncology drugs to specialty pharmacies.

Access to oncology drugs is no longer as simple as using a sole drug distributor. Many pharmaceutical manufacturers now choose to name specific channels for new drug distribution, and drugs may have to be acquired from multiple sources, thereby requiring dedicated resources for inventory acquisition and for management.

The population of patients with cancer is growing exponentially as America ages, and it is likely to run right up against a concurrent reduction in the number of treating oncologists. Oncology pharmacists can be a valued asset to the oncology care team in providing drug management support to oncologists in the coming years, Mr Zweigenhaft suggests.

Mr Zweigenhaft anticipates an increase in payer imposition of prior authorization processes, formularies, and selected pathways. Part of that increased payer oversight is also very likely to include payer network contracting with pharmacy benefits managers and with specialty pharmacies. He suggests that hospitals

that outsource the management of cancer drugs to specialty pharmacies would benefit from: • Medication treatment management interventions

oral formulations of cancer therapies • Inclusion of advanced care directives • Stronger reporting and measurement of data.

Pharmacy regulations in the hospital setting are different from those in the physician office setting, but they may also differ from those in the commercial pharmacy setting.

Mr Zweigenhaft suggests that recent state Board of Pharmacy changes, such as in Georgia, may set forth dispensing expectations that hospital pharmacies will find difficult to meet. He also noted that some facility accreditation expectations may be a challenge for physician-based or hospital-based pharmacies and for the new models in which hospitals now manage physician practice–based pharmacy needs.

Mr Zweigenhaft suggests that recent state Board of Pharmacy changes, such as in Georgia, may set forth dispensing expectations that hospital pharmacies will find difficult to meet.

Recommendations for Integrating Hospitals and Physician Practices Martin Shenk, CMPE, Chief Operating Officer, The Medical Oncology Group, PA, Gulfport, MS, discussed the process of integrating his practice physicians with the local hospital. His practice began the negotiations with the hospital in January 2009 and completed the deal by December 2009 that was based on a provider services arrangement.

Mr Shenk outlined the following 7 tips for practice managers, based on his experience with this hospital–practice integration process.

• Support of a board-certified oncology pharmacist • Increased focus on pathways and concordance with evidence in treatment decisions • Increased focus on care and minimizing side effect management • Pharmacists who would follow the physician care plan and manage to quality end points • Increased focus on the management of patient adherence for

1

Beware of promises made in the courtship phase. The longest part of the process was determining the valuation of the practice. The hospital had initially offered substantial salaries, with fine print noting that the offer was subject to fair market value. One of the most difficult chalContinued on page 44

November 2012

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Hospital–Physician Contracting

The Nuts and Bolts of Physician and Hospital…Continued from page 43 lenges for the practice and the physicians was coming to grips with how valuations are developed.

The strategic value of the practice as an acquired asset for a hospital is not quantifiable; in fact, it does not enter into the valuation process at all. The postvaluation compensation was considerably lower than the original offer.

Mr Shenk also commented that the current compensation was based on Current Procedural Terminology® code volumes, and that, so far, there is no provision for what would happen should care payment move to a bundled rate, which could happen in oncology—specifically with certain payers or on a national scale with accountable care organizations— and in payment reform.

2

Understand where the power really lies in the hospital organization. During the negotiation process, Mr Shenk’s practice learned quickly how to distinguish between those who said they had the power to make decisions and those who actually did have the power. If someone in the room says he or she needs to check with someone else, perhaps that person is not the right person to be in the room for this negotiation.

The Medical Oncology Group was glad that it maintained employment of its own staff as opposed to leasing the staff members back to the hospital, so that the hiring and firing process was not as difficult as it could have been had they had to work within the hospital infrastructure.

Mr Shenk also noted a concern that current strong relationships are grounded with existing hospital leadership, and he wondered what might happen should those leaders move away from the hospital.

3

Watch the clinic’s design and layout. Hospitals often have severe

44

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space limitations and many fragmented services (eg, registration in one area, laboratories and imaging in centralized locations) that create very different patient and staff workflow situations from those seen in private practice. Mr Shenk warned about the unanticipated impact on the historical practice workflow and on staff and patient expectations.

“340B prices are not a floor—they are a ceiling—which makes a difference when the hospital integrates inpatient and outpatient volume.”

—Martin Shenk, CMPE

4

Understand EMR complications.

Many hospitals have multispecialty EMRs electronic medical records that may not have a strong oncology module and that may not integrate well with the systems you already use.

Understand the challenges, and negotiate for an arrangement that works best for you, your physicians, and your staff. An oncology-specific EMR is absolutely essential.

5

Understand the challenges of 340B pricing. Make sure you understand what 340B pricing means to hospitals. Mr Shenk warned that “340B prices are not a floor—they are a ceiling—which makes a difference when the hospital integrates inpatient and outpatient volume.” He also warned that practices need to be aware that 340B pricing may not be applied to a component of an eligible hospital until

ONCOLOGY PRACTICE MANAGEMENT

I November 2012

that component (ie, division) of the hospital has appeared on the hospital cost report. This can take as long as 16 months, which can be an unpleasant surprise for hospitals and practices who entered negotiations and new arrangements without fully understanding that timing delay.

6

Understand the impact of your own referrals. Before the negotiations go too far, measure your practice’s volume of referrals to the radiation oncology, radiology, and surgical specialties that are affiliated with the hospital. In many cases, your clinic may refer more than 50% of the hospital’s positron emission tomography and computed tomography scans. It will be important for both parties to understand that in the negotiation processes.

7

Keep your physicians focused on patient care. Both during and after the negotiations, it will be easy for physicians to get drawn into hospital and administration issues. If you work with them and support them to stay focused on patient care, it will help keep the practice on an even keel. After the negotiations are done, this will protect the physicians from being burdened down with hospital administration tasks.

Conclusion Then Ms Guidi, Mr Zweigenhaft, and Mr Shenk reminded the attendees that there is much more involved in hospital–physician negotiations than often meets the eye.

They shared these process details with the hope that these points would make it easier for oncology practices to come out on the other side of the negotiation process better equipped to handle the new reality of hospital–physician relationships in cancer care, no matter how the negotiations end. l

“Quality care is everyone’s business.”

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

6

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

The Affordable Care Act Will Change Medicare: The Independent Payment Advisory Board

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

T

he Patient Protection and Affordable Care Act (ACA) of 2010 created many important reforms in healthcare. Many of the ACA’s provisions are very popular, such as the ability of parents to keep children on their health insurance plans until age 26 years and the elimination of insurance denials for preexisting conditions. Other provisions are not as popular.

The Independent Payment Advisory Board (IPAB), slated to begin in 2013, is one of the more controversial provisions. Created by sections 3403 and 10320 of the ACA, the IPAB has the explicit task of achieving specified savings in Medicare without affecting coverage or quality. Under current law, the Medicare Payment Advisory Council (MedPAC) reviews payment policies and makes recommendations to Congress about ways to reduce spending.

Congress must then debate and vote on these recommendations for them to become law.

What Is IPAB? The IPAB is a 15-member panel appointed by the president and confirmed by the Senate, similar to the US Supreme Court appointment process. Unlike Supreme Court Justices, however, IPAB members will serve in 6-year staggered terms.

The panel will replace the decisionmaking power of MedPAC, but MedPAC will remain an advisory

46

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body for Congress. Beginning next year, if the chief Medicare actuary determines that the projected 5-year average growth rate spending per Medicare beneficiary is projected to outpace the target growth rate, the IPAB must submit a proposal to Congress to reduce spending on Medicare by a specified amount.

The IPAB significantly changes the current Medicare policy development structure.

Once appointed, the Board will be essentially “unchecked.”

Through 2017, the target growth rate is the 5-year projected average of the Consumer Price Index (CPI) for all consumers and the CPI for medical care. For 2018 and beyond, the target growth rate is the 5-year projected average percentage increase in the per-capita gross domestic product plus 1%. If spending exceeds these targets, the IPAB must submit a proposal to Congress that reduces spending on Medicare down to the target spending rate per beneficiary. Congress must then accept the proposal without amendments or come up with its own plan that achieves at least the same amount of savings.

Congress has a poor track record of compromise and agreement, and it is likely that identification of more

ONCOLOGY PRACTICE MANAGEMENT

I November 2012

than $3 billion in savings (the expected savings necessary to achieve targets for Medicare in 2015) will be no different. If the IPAB does not submit a proposal, and if Congress is unable to develop a plan, the Secretary of the US Department of Health and Human Services (HHS) must act unilaterally to achieve the target spending rates in Medicare. Ultimately, it will be the job of the HHS Secretary to implement the final savings plan.

The IPAB significantly changes the current Medicare policy development structure. Once appointed, the Board will be essentially “unchecked,” because there is no oversight by Congress or voters. This means that an unpopular proposal by the IPAB will have no recourse at the polls. In addition, it is still unknown who will serve on the Board and how, and how well community oncology will be represented.

Authority of the IPAB Achieving $3 billion in savings starting in 2015 could mean significant changes for providers and for beneficiaries. The following 2 questions are just examples of the many questions about IPAB’s ability to change healthcare:

1

What exactly can the IPAB do?

The IPAB’s power is limited to Medicare. Medicaid and other programs are exempt.

2

What kind of changes can the IPAB make to Medicare? The IPAB’s authority is limited to Continued on page 48

THIRD ANNUAL

Association for Value-Based Cancer Care Conference Influencing the Patient-Impact Factor May 2-5, 2013 • Westin Diplomat • Hollywood, Florida CONFERENCE CO-CHAIRS

AGENDA* THURSDAY, MAY 2, 2013 8:00 am - 5:00 pm

Registration

FRIDAY, MAY 3, 2013

Craig K. Deligdish, MD Chief Medical Officer Oncology Resource Networks

Gary M. Owens, MD President Gary Owens Associates

Burt Zweigenhaft, BS President and CEO OncoMed

PROGRAM OVERVIEW Following on the success of our Second Annual Conference, AVBCC will be coming to Hollywood, Florida, on May 2-5, 2013. We continue to be guided by the expertise of leaders in these fields providing attendees with a thorough understanding of the evolution of the value equation as it relates to cancer therapies. Our goal is to be able to assist them in implementing, improving, and sustaining their organizations and institutions, while improving access for patients and ultimately quality patient care.

7:00 am - 8:00 am

Simultaneous Symposia/Product Theaters

8:15 am - 9:15 am

Session 1: Welcome, Introductions, and Opening Remarks Conference Co-Chairs - Craig K. Deligdish, MD; Gary M. Owens, MD; Burt Zweigenhaft, BS

9:15 am - 10:15 am

Keynote Address

10:15 am - 10:30 am

Break

10:30 am - 11:45 am

Session 2: Trends in Treatment Decision-Making: Pathways and Stakeholder Collaborations Roy A. Beveridge, MD; Michael Kolodziej, MD

12:00 pm - 1:00 pm

Exclusive Lunch Symposium/Product Theater

1:15 pm - 2:00 pm

Session 3: Cost of Cure: When, How, and How Much?

John Fox, MD; John Hennessy

2:00 pm - 2:45 pm

Session 4: Where Is Oncology Care Headed in the Future?

Jayson Slotnick, JD, MPH (Moderator); Barbara L. McAneny, MD

2:45 pm - 3:30 pm

Session 5: What Will the Cancer Delivery System Look Like in 2015?

Linda Bosserman, MD, FACP; John D. Sprandio, MD

3:30 pm - 3:45 pm

Break

3:45 pm - 4:30 pm

Session 6: Employers and Oncology Care F. Randy Vogenberg, PhD, RPh (Moderator); Bridget Eber, PharmD; Patricia Goldsmith; Darin Hinderman

4:30 pm - 5:15 pm

Session 7: The Role of Government in the Future of Oncology Care Jayson Slotnick, JD, MPH

TARGET AUDIENCE

5:15 pm - 5:45 pm

Summary/Wrap-Up of Day 1

This conference is intended for medical oncologists, practice managers/administrators, and managed care professionals. Stakeholders in a position to impact cancer patient care, such as advanced practice nurses, pharmacists, and medical directors, are also invited to join this exciting forum.

6:00 pm - 8:00 pm

Cocktail Reception in the Exhibit Hall

SATURDAY, MAY 4, 2013 7:00 am - 8:00 am

Simultaneous Symposia/Product Theaters

DESIGNATION OF CREDIT STATEMENTS

8:15 am - 8:30 am

Opening Remarks

8:30 am - 9:15 am

Session 8: Advanced Care Directives: Palliative Care, Hospice, Ethics J. Russell Hoverman, MD, PhD Thomas J. Smith, MD, FACP, FASCO

9:15 am - 10:00 am

Session 9: Medicaid: A Healthcare Delivery System Review Matthew Brow

LEARNING OBJECTIVES Upon completion of this activity, the participant will be able to: • Discuss the current trends and challenges facing all stakeholders in optimizing value in cancer care delivery.

• Define the barriers associated with cost, quality, and access as they relate to healthcare reform and what solutions are currently being considered.

• Compare and contrast the different approaches/tools providers and payers are utilizing to manage and deliver care collaboratively.

• Examine the current trends in personalized care and companion diagnostics.

• Analyze the patient issues around cost, quality, and access to care.

SPONSORS This activity is jointly sponsored by Medical Learning Institute Inc, the Association for Value-Based Cancer Care, Inc., Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

COMMERCIAL SUPPORT ACKNOWLEDGMENT

10:00 am - 10:15 am

Break

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

10:15 am - 11:00 am

Session 10: Payer, Government, and Industry Insights: Balancing Cost and Quality

11:00 am - 11:45 am

Session 11: National Coalition for Cancer Survivorship: Medication Nonadherence Issues Pat McKercher

12:00 pm - 1:00 pm

Exclusive Lunch Symposium/Product Theater

1:15 pm - 3:00 pm

Session 12: Meet the Experts Networking Roundtable Session

3:00 pm - 3:45 pm

Session 13: Personalized Medicine, Companion Diagnostics, Molecular Profiling, Genome Sequencing—The Impact on Cost, Treatment, and the Value Proposition Mark S. Boguski, MD, PhD

3:45 pm - 4:15 pm

Summary/Wrap-Up of Day 2

4:30 pm - 6:30 pm

Cocktail Reception in the Exhibit Hall

PHYSICIAN CREDIT DESIGNATION The Medical Learning Institute Inc designates this live activity for a maximum of 17.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Medical Learning Institute Inc and the Center of Excellence Media, LLC. The Medical Learning Institute Inc is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

REGISTERED NURSE DESIGNATION Medical Learning Institute Inc. Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 17.25 contact hours.

SUNDAY, MAY 5, 2013 7:00 am - 8:00 am

Simultaneous Symposia/Product Theaters

REGISTERED PHARMACY DESIGNATION

8:15 am - 8:30 am

Opening Remarks

The Medical Learning Institute Inc is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Completion of this knowledge-based activity provides for 17.25 contact hours (1.725 CEUs) of continuing pharmacy education credit. The Universal Activity Number for this activity is (To be determined).

8:30 am - 9:15 am

Session 14: Cancer Rehabilitation: The Next Frontier in Survivorship Care Julie Silver, MD

9:15 am - 10:00 am

Session 15: Current and Future Considerations for the Oncology Practice Manager Dawn Holcombe, MBA, FACMPE, ACHE; Leonard Natelson

10:00 am - 10:15 am

Break

10:15 am - 11:00 am

Session 16: Access to Drugs—Shortages, Biosimilars Douglas Burgoyne, PharmD; James T. Kenney, Jr., RPh, MBA

11:00 am - 11:45 am

Session 17: Perspectives from Large Oncology Group Practices—Successes, Issues, and Challenges

11:45 am - 12:00 pm

Summary and Conclusion of Conference

CONFERENCE REGISTRATION Discounted Pricing Available!

$375.00 until January 15, 2013 $475.00 until March 15, 2013 $675.00 after March 15, 2013

REGISTER TODAY AT

www.regonline.com/avbcc2013

*Agenda is subject to change.

Patient and Provider Access

The Affordable Care Act Will Change…Continued from page 46 changes in reimbursement only. It is the intent of the ACA that patients not be impacted by the Medicare savings that must be achieved.

Therefore, the IPAB may consider reimbursement rates, payment models, and other mechanisms for achieving these goals; however, patient benefits, such as Medicare rosters and beneficiary composition, cannot be altered. Although the aim of the ACA is to achieve savings without impacting access, those in the provider community understand that you cannot dramatically reduce reimbursement without impacting access to care on some level.

Continued squeezing of reimbursement rates—particularly in light of the broken sustainable growth rate formula and sequestration—will only make it increasingly difficult for providers to continue to give the most fitting care at the most appropriate time to all of their patients with Medicare.

The Future of the IPAB Because of the concern that the IPAB will not report directly to the voting public, many in Congress want to repeal the IPAB. In fact, a number

or in the Senate. It is increasingly important for the oncology community to work together to educate our elected officials and our regulatory bodies on the issues that impact

The IPAB could remove reimbursement policy decision-making from the legislature and place the power to make these important decisions with an independent body—a body without congressional oversight. of efforts have already been made. To date, however, there has not been sufficient agreement between both chambers to pass the measure; however, that does not mean legislation will not pass in the future.

As elements of the IPAB become more visible, we may see a resurgence of repeal efforts in the House

community cancer care. The Association of Community Cancer Centers (ACCC) continues to stay on the forefront of this issue and on other issues to educate members of Congress about community oncology. As always, the ACCC will keep its members up to date on the most current topics in cancer care. l

THIRD ANNUAL CONFERENCE

Influencing the Patient-Impact Factor

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May 2-5, 2013 Westin Diplomat • Hollywood, Florida

REGISTER TODAY AT www.AVBCConline.org 48

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ONCOLOGY PRACTICE MANAGEMENT

I November 2012

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

Term Life Insurance: What You Need to Know Before You Buy

By Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF

O

ver their careers, physicians generally purchase large amounts of term life insurance. Term life insurance, for the most part, is a commodity, so the pricing is very competitive and comparison shopping is easy.

So, why is it that so many physicians have the wrong type of term life insurance and/or are paying significantly higher premiums than they should be for their policies?

This article will serve as a guide to help you purchase the right type of term life insurance at the lowest cost to meet your individual needs and goals.

What Is Term Life Insurance?

Term life insurance provides pure insurance protection and does not build cash value. It allows you to purchase the largest death benefit while minimizing your (initial) premium outlay. When you purchase a term life insurance policy, you are buying coverage for a specified period of time. If you die within the term of the policy, the insurance company will pay the death benefit to your beneficiary or beneficiaries.

Annual Renewable Term Life Insurance Annual renewable term life insurance, also known as yearly renewable term life insurance, provides coverage for a period of 1 year and then automatically renews at an increased premium. This type of policy provides you with 2 sets of premium rates: a current or scheduled premium and a guaranteed maximum premium.

In general, after the first policy year, the annual premium payable may be equal to or higher than the scheduled renewal premium, but it

the premiums paid during the level premium period will be returned, on an income tax–free basis, if the insured does not surrender the policy and lives to the end of the guarantee period selected.

Although this may sound very appealing, few companies offer this type of policy, the premiums are much more expensive compared with a basic level premium term life insurance policy, and this type of policy does not provide the insured with the ability to “refinance” the policy should premium rates decrease.

For example, assuming a 35-yearold male physician in New York qualified for Prudential’s best underwriting classification, the annual premium for a 30-year level premium term life insurance policy would be $885.00.

The same policy, but including the return of premium feature, would cost $1747.90 annually (a difference of $862.90). If the doctor kept the policy for the full 30 years, then $52,437.00 would be returned, providing him with a return of 4.23% by electing the return of premium option—a return which, in my opinion, is less than adequate over that time horizon compared with other investments.

Because websites such as www.term 4sale.com compare the premium rates of several insurance companies, as well as the pricing for various types of term life insurance, death benefit amounts, and guarantee periods, it is easy to determine if the

will never be more than the guaranteed maximum renewal premium.

Because of its low initial cost, this type of term life insurance is really only ideal for those individuals looking for short-term life insurance protection, or for those who desire to convert their coverage to a permanent or “cash value” life insurance policy shortly after the initial purchase.

Level Premium Term Life Insurance In general, level premium term life insurance policies provide costeffective financial protection for periods of 5, 10, 15, 20, 25, or 30 years. This is the time in which premium rates are guaranteed to remain the same. However, after the level premium period expires, most policies become annually renewable.

Therefore, in the same way as described above, premium rates will ultimately become cost-prohibitive and will limit the options available in the future. Therefore, it makes more sense to purchase a policy with a longer guarantee period compared with one with a shorter guaranteed period to lower your overall costs.

That being said, if budget is an issue, you might want to opt for a policy with a larger death benefit and a shorter guarantee period (eg, 20 years) instead of one with a smaller death benefit and a longer guarantee period (eg, 30 years) if the premium amount is similar. After all, if things go well, you will most likely outlive both anyhow.

Return of Premium Term Life Insurance Return of premium is term life insurance that guarantees that all of

November 2012

Continued on page 52

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HalavenReimbursem Your source for reimbursement information related to Halaven

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CODING & BILLING Coding & Pricing

Billing Forms

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

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

COVERAGE POLICY Physician Office

Hospital Outpatient

Medicare Medicaid Commercial Payors

Medicare Medicaid Commercial Payors

RESOURCES Patient Assistance Program Coverage Scenarios FAQ FDA Approval Letter

Prescribing Information Eisai Assistance Program Enrollment Form Insurance Verification Form

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W E B S I T E N A V I G AT I O N M A D E E A S Y

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Physician Wealth Management

Term Life Insurance: What You Need…Continued from page 49 agent or financial planner that you are working with is providing you with the lowest cost options for the coverage that you want to purchase.

Term Life Insurance Underwriting It is important to note that various insurance companies may use a different set of guidelines to qualify for the best underwriting classification.

For example, if you are being treated for hypertension, certain companies will allow you to qualify for their best underwriting classification whereas others will not. The same may be true if you have an immediate family history of a cardiac disorder or cancer, even if you are currently healthy.

Finally, height and weight are also taken into consideration, and some carriers are more liberal than others.

For these reasons, you should employ the services of an experienced insurance agent who represents several companies to help you get the best rates, especially if your health is less than perfect. The agent will know which carriers are likely to provide you with a better underwriting classification, based on the specifics of your situation, to allow you to secure a lower premium rate.

After all, using an agent or applying for the product online will not cost you any additional money.

Conversion Option Most term life insurance policies contain a conversion option. This option allows you to convert your term insurance policy into a permanent or “cash value” policy, regardless of your future health. The major advantage of this feature is that you maintain the underwriting classification in which your policy was originally issued.

Therefore, assuming that you qualified for the best underwriting classification when your policy was pur-

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chased, but would not qualify for it today based on your health, the new policy would also be issued in the best underwriting classification.

Although most life insurance companies will allow you to convert for the entire guaranteed period in the policy, others may limit the conversion option to a specified period of time, such as the first 5 or 10 policy years.

Most term life insurance policies contain a conversion option. This option allows you to convert your term insurance policy into a permanent or “cash value” policy, regardless of your future health.

If your goal is to ultimately convert some or all of your term insurance to permanent insurance, you should only purchase your policy from a company that has a reputation for offering a broad array of those types of policies. Otherwise, you will most likely be better off with a company that specializes in lowcost term life insurance. Either way, it is important that you understand the conversion options available for the policies that you are considering before making your final decision.

Waiver of Premium Rider Another important aspect of a life insurance policy is the waiver of a premium rider. This rider enables

ONCOLOGY PRACTICE MANAGEMENT

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you to have the premiums of the policy paid for by the insurance company in the event of your disability. Again, if your goal is to ultimately convert some or all of your term life insurance to permanent life insurance, it is important that this rider be included in your term life insurance policy. This way, when you convert to a permanent insurance policy, it will allow the premiums—which are substantially higher compared with term life insurance—to be waived. Otherwise, if you plan on sticking with term insurance, you will want to forego this rider, because it is relatively expensive and will only waive the premiums associated with your (inexpensive) term life insurance policy.

Conclusion For the most part, term life insurance is a commodity, so the pricing is very competitive and comparison shopping is easy. The type of term life insurance that should be purchased depends on factors such as your age, health, budget, and your long-term financial plans. If you are considering the purchase of a new life insurance policy, or if you are replacing an existing policy, it is best to consult with a knowledgeable insurance agent who represents several companies. He or she can review your situation and can then help you make intelligent and informed choices regarding your life insurance protection. l Lawrence B. Keller, CFP®, CLU, ChFC, RHU, LUTCF, is the founder of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached for comments or questions at 516-677-6211, or by e-mail at Lkeller@ physicianfinancialservices.com.

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

IMPORTANT SAFETY INFORMATION

Please see brief summary of Prescribing Information on adjacent pages.

© Janssen Biotech, Inc. 2012

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

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

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

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

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

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

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

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

Drug Interactions ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. Additionally, abiraterone is a substrate of CYP3A4 in vitro. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution.

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

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

Support for you:

Support for your patients:

Benefit Investigation

Care Coordination

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

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

Take advantage of ZytigaOne™ Support today.

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

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

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

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

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

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