March 2013

Oncology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

www.OncPracticeManagement.com

MARCH 2013

VOLUME 3 • NUMBER 2

Understanding the Introducing the Third Annual National Practitioner Conference of the Association for Value-Based Cancer Care Data Bank and

By Burt Zweigenhaft, BS What a Report Chief Executive Officer and Chairman, OncoMed Onco360; Means to You and Co-chair of the AVBCC Conference s we know, the American health- cancer care stakeholders in one unified care system is going through exor- meeting to discuss the many issues facing Your License

By Jennifer Kirschenbaum, Esq, and Kate Maguire, Esq

A

lthough the National Practition­ ers Data Bank (NPDB) could have a potentially vast im­­pact on any health­care practiJennifer Kirschenbaum tioner’s career, few fully understand its setup, its implications, or what to do if they are reported to this electronic repository.

The NPDB was established by Congress as part of the Health Care Quality Improvement Act of 1986. The purpose of the NPDB is to allow increased access Continued on page 18

A

bitant changes, changes that will affect all providers and all stakeholders in the cancer care ecosystem. The goal of the Association for Value-Based Cancer Care (AVBCC) is to bring together all of the

us today. One of the main objectives of the AVBCC Annual Conference is to be able to map out and help guide our members and attendees through the various changes in the US healthcare system.

Continued on page 8

Payer Negotiations Regarding Specialty Pharmacy: Implications for Oncology Practices

By Dawn Holcombe

H

ealth plans and oncology practices alike are evaluating the use of specialty pharmacy as a resource for the delivery of cancer drugs. Specialty pharmacy organizations are creating large divisions to manage oncology spending

and to provide not only oral drugs but injectable and infused drugs as well.

Negotiations between oncology centers and health plans regarding the use of specialty pharmacy are not always easy.

A practice may choose to use a local speContinued on page 12

From the publishers of

S

of n it o s D ia ter VI ssocCen ys 4 O A r a ..2 PR y thenceit Okion.. a t D N ou bity C ircu mo A y T t to mun nd Cel Pro N h m o b TIE roug Co Secff-La A B

ER

INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM

©2013 Engage Healthcare Communications, LLC

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ES

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In the newly metastatic CRPC patient who is asymptomatic or minimally symptomatic

STARTS THE FIGHT

AND HELPS HIS IMMUNE SYSTEM SUSTAIN* IT 1

• Targets and attacks prostate cancer cells • Statistically significant overall survival advantage1,2 • Sustained* immune response *A sustained immune response was seen out to 26 weeks in the pivotal study (the last time point measured).1 INDICATION: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION: PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

The most common adverse events (incidence ≥15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

For more information on PROVENGE, please see Brief Summary of Prescribing Information on adjacent pages. www.PROVENGEHCP.com

PROVENGE® (sipuleucel-T) Suspension for Intravenous Infusion

Rx Only

BRIEF SUMMARY — See full Prescribing Information for complete product information

INDICATIONS AND USAGE: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

DOSAGE AND ADMINISTRATION • For Autologous Use Only.

• The recommended course of therapy for PROVENGE is 3 complete doses, given at approximately 2-week intervals.

• Premedicate patients with oral acetaminophen and an antihistamine such as diphenhydramine.

• Before infusion, confirm that the patient’s identity matches the patient identifiers on the infusion bag.

• Do Not Initiate Infusion of Expired Product.

• Infuse PROVENGE intravenously over a period of approximately 60 minutes.

Do Not Use a Cell Filter.

• Interrupt or slow infusion as necessary for acute infusion reactions, depending on the severity of the reaction.

(See Dosage and Administration [2] of full Prescribing Information.)

CONTRAINDICATIONS: None.

WARNINGS AND PRECAUTIONS • PROVENGE is intended solely for autologous use.

• Acute infusion reactions (reported within 1 day of infusion) included, but were not limited to, fever, chills, respiratory events (dyspnea, hypoxia, and bronchospasm), nausea, vomiting, fatigue, hypertension, and tachycardia. In controlled clinical trials, 71.2% of patients in the PROVENGE group developed an acute infusion reaction.

In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. The incidence of severe events was greater following the second infusion (2.1% vs 0.8% following the first infusion), and decreased to 1.3% following the third infusion. Some (1.2%) patients in the PROVENGE group were hospitalized within 1 day of infusion for management of acute infusion reactions.

No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

Closely monitor patients with cardiac or pulmonary conditions. In the event of an acute infusion reaction, the infusion rate may be decreased, or the infusion stopped, depending on the severity of the reaction. Appropriate medical therapy should be administered as needed.

• Handling Precautions for Control of Infectious Disease. PROVENGE is not routinely tested for transmissible infectious diseases. Therefore, patient leukapheresis material and PROVENGE may carry the risk of transmitting infectious diseases to health care professionals handling the product. Universal precautions should be followed.

• Concomitant Chemotherapy or Immunosuppressive Therapy. Use of either chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. PROVENGE is designed to stimulate the immune system, and concurrent use of immunosuppressive agents may alter the efficacy and/or safety of PROVENGE. Therefore, patients should be carefully evaluated to determine whether it is medically appropriate to reduce or discontinue immunosuppressive agents prior to treatment with PROVENGE. • Product Safety Testing. PROVENGE is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth. The final (7-day incubation) sterility test results are not available at the time of infusion. If the sterility results become positive for microbial contamination after PROVENGE has been approved for infusion, Dendreon will notify the treating physician. Dendreon will attempt to identify the microorganism, perform antibiotic sensitivity testing on recovered microorganisms, and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the source of contamination.

(See Warnings and Precautions [5] of full Prescribing Information.)

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

The safety evaluation of PROVENGE is based on 601 prostate cancer patients in the PROVENGE group who underwent at least 1 leukapheresis procedure in four randomized, controlled clinical trials. The control was non-activated autologous peripheral blood mononuclear cells.

The most common adverse events, reported in patients in the PROVENGE group at a rate ≥15%, were chills, fatigue, fever, back pain, nausea, joint ache, and headache. Severe (Grade 3) and life-threatening (Grade 4) adverse events were reported in 23.6% and 4.0% of patients in the PROVENGE group compared with 25.1% and 3.3% of patients in the control group. Fatal (Grade 5) adverse events were reported in 3.3% of patients in the PROVENGE group compared with 3.6% of patients in the control group.

Serious adverse events were reported in 24.0% of patients in the PROVENGE group and 25.1% of patients in the control group. Serious adverse events in the PROVENGE group included acute infusion reactions (see Warnings and Precautions), cerebrovascular events, and single case reports of eosinophilia, rhabdomyolysis, myasthenia gravis, myositis, and tumor flare.

PROVENGE was discontinued in 1.5% of patients in Study 1 (PROVENGE group n=341; Control group n=171) due to adverse events. Some patients who required central venous catheters for treatment with PROVENGE developed infections, including sepsis. A small number of these patients discontinued treatment as a result. Monitoring for infectious sequelae in patients with central venous catheters is recommended.

Each dose of PROVENGE requires a standard leukapheresis procedure approximately 3 days prior to the infusion. Adverse events that were reported ≤1 day following a leukapheresis procedure in ≥5% of patients in controlled clinical trials included citrate toxicity (14.2%), oral paresthesia (12.6%), paresthesia (11.4%), and fatigue (8.3%).

Table 1 provides the frequency and severity of adverse events reported in ≥5% of patients in the PROVENGE group of randomized, controlled trials of men with prostate cancer.

The population included 485 patients with metastatic castrate resistant prostate cancer and 116 patients with non-metastatic androgen dependent prostate cancer who were scheduled to receive 3 infusions of PROVENGE at approximately 2-week intervals. The population was age 40 to 91 years (median 70 years), and 90.6% of patients were Caucasian.

Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients Randomized to PROVENGE PROVENGE (N = 601)

Any Adverse Event Chills Fatigue Fever Back pain Nausea Joint ache Headache Citrate toxicity Paresthesia Vomiting Anemia Constipation Pain Paresthesia oral Pain in extremity Dizziness Muscle ache Asthenia Diarrhea Influenza-like illness Musculoskeletal pain Dyspnea Edema peripheral Hot flush Hematuria Muscle spasms

Control* (N = 303)

All Grades n (%)

Grade 3-5 n (%)

All Grades n (%)

591 (98.3) 319 (53.1) 247 (41.1) 188 (31.3) 178 (29.6) 129 (21.5) 118 (19.6) 109 (18.1) 89 (14.8) 85 (14.1) 80 (13.3) 75 (12.5) 74 (12.3) 74 (12.3) 74 (12.3) 73 (12.1) 71 (11.8) 71 (11.8) 65 (10.8) 60 (10.0) 58 (9.7) 54 (9.0) 52 (8.7) 50 (8.3) 49 (8.2) 46 (7.7) 46 (7.7)

186 (30.9) 13 (2.2) 6 (1.0) 6 (1.0) 18 (3.0) 3 (0.5) 11 (1.8) 4 (0.7) 0 (0.0) 1 (0.2) 2 (0.3) 11 (1.8) 1 (0.2) 7 (1.2) 0 (0.0) 5 (0.8) 2 (0.3) 3 (0.5) 6 (1.0) 1 (0.2) 0 (0.0) 3 (0.5) 11 (1.8) 1 (0.2) 2 (0.3) 6 (1.0) 2 (0.3)

291 (96.0) 33 (10.9) 105 (34.7) 29 (9.6) 87 (28.7) 45 (14.9) 62 (20.5) 20 (6.6) 43 (14.2) 43 (14.2) 23 (7.6) 34 (11.2) 40 (13.2) 20 (6.6) 43 (14.2) 40 (13.2) 34 (11.2) 17 (5.6) 20 (6.6) 34 (11.2) 11 (3.6) 31 (10.2) 14 (4.6) 31 (10.2) 29 (9.6) 18 (5.9) 17 (5.6)

Grade 3-5 n (%) 97 (32.0) 0 (0.0) 4 (1.3) 3 (1.0) 9 (3.0) 0 (0.0) 5 (1.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 7 (2.3) 3 (1.0) 3 (1.0) 0 (0.0) 1 (0.3) 0 (0.0) 0 (0.0) 2 (0.7) 3 (1.0) 0 (0.0) 3 (1.0) 3 (1.0) 1 (0.3) 1 (0.3) 3 (1.0) 0 (0.0)

(Table 1 continued on next page.)

GBC_2013Conf_vertical_62512_Layout 1 7/11/12 11:38

Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients Randomized to PROVENGE PROVENGE (N = 601)

Hypertension Anorexia Bone pain Upper respiratory tract infection Insomnia Musculoskeletal chest pain Cough Neck pain Weight decreased Urinary tract infection Rash Sweating Tremor

Control* (N = 303)

All Grades n (%)

Grade 3-5 n (%)

All Grades n (%)

Grade 3-5 n (%)

45 (7.5) 39 (6.5) 38 (6.3) 38 (6.3)

3 (0.5) 1 (0.2) 4 (0.7) 0 (0.0)

14 (4.6) 33 (10.9) 22 (7.3) 18 (5.9)

0 (0.0) 3 (1.0) 3 (1.0) 0 (0.0)

37 (6.2) 36 (6.0)

0 (0.0) 2 (0.3)

22 (7.3) 23 (7.6)

1 (0.3) 2 (0.7)

35 (5.8) 34 (5.7) 34 (5.7) 33 (5.5) 31 (5.2) 30 (5.0) 30 (5.0)

0 (0.0) 3 (0.5) 2 (0.3) 1 (0.2) 0 (0.0) 1 (0.2) 0 (0.0)

17 (5.6) 14 (4.6) 24 (7.9) 18 (5.9) 10 (3.3) 3 (1.0) 9 (3.0)

0 (0.0) 2 (0.7) 1 (0.3) 2 (0.7) 0 (0.0) 0 (0.0) 0 (0.0)

*Control was non-activated autologous peripheral blood mononuclear cells.

Cerebrovascular Events. In controlled clinical trials, cerebrovascular events, including hemorrhagic and ischemic strokes, were reported in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

(See Adverse Reactions [6] of full Prescribing Information.)

To report SUSPECTED ADVERSE REACTIONS, contact Dendreon Corporation at 1-877-336-3736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dendreon Corporation Seattle, Washington 98101

SECOND ANNUAL CONFERENCE

GLOBAL BIOMARKERS CONSORTIUM

™

Clinical Approaches to Targeted Technologies ™

October 4-6, 2013 The Seaport Boston Hotel 1 Seaport Lane Boston, MA 02210 REGISTER TODAY AT

GlobalBiomarkersConsortium.com WCMC_2013Conf_vertical_80612_Layout 1 11/13/12 2:4

SECOND ANNUAL CONFERENCE

2013 WORLD CUTANEOUS MALIGNANCIES CONGRESS TM

REFERENCES: 1. PROVENGE [package insert]. Dendreon Corporation; June 2011.

2. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.

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

July 26-28, 2013 ©2013 Dendreon Corporation.

All rights reserved. January 2013.

Printed in the U.S.A. Dendreon, the Dendreon logo, and PROVENGE are registered trademarks of Dendreon Corporation.

P-A-01.13-002.00

Hyatt Regency La Jolla at Aventine 3777 La Jolla Village Drive San Diego, California

To register, please visit www.CutaneousMalignancies.com

From the Editor

Seeking Fine Surgical Cuts Under Sequestration, Not Blunt Hacking

By Dawn Holcombe, MBA, FACMPE, ACHE

P

olitics makes extreme messes.

While Congress and the ad­­ ministration continue their political lunging and feinting (not to mention grandstanding), cancer care providers are hunkering down, buying drugs, and caring for patients with cancer.

Here is our biggest challenge: the looming “sequester” cuts for Medicare may—or may not—be applied to drugs. If the 2% cuts are applied to services, that is one thing. We, like every other service that will be affected by the cuts, can move staff, hours, and resources around to adjust to the cuts. The fact of the matter is, we will not have a choice.

However, if the 2% cuts are applied to drugs—which we buy to stock our inventory, and therefore need to recoup at least the costs of the drugs that we use for Medicare patients—

those of us who care for patients with cancer will not have the flexibility to adjust. Drug costs are direct out-ofpocket losses that no cancer program, whether hospital-based or private practice–based, can absorb.

As always, the devil is in the details.

The Health Resources and Services Administration has the ability to announce how the final total sequester cuts are applied, and to which line items those cuts will apply. We have a very short window in which to illuminate the differences between cuts to services and cuts to purchased product reimbursements that do not change the prices we pay for the product.

Every cancer program in the country that accepts Medicare reimbursement under the Part B program now has this critical chance to shine the spotlight on the difference between the services provided to Medicare

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

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

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

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

Risë Marie Cleland President Oplinc, Inc Lawton, OK

Continued on page 11

Editorial Advisory Board

Editor-in-Chief

Peggy Barton, RN Practice Manager Toledo Clinic, OH

patients and the drugs that need to be purchased and provided to those patients.

We need to let our congressional representatives —both senators and representatives alike—know that drug reimbursement prices are set based upon a legislated schedule, and that the sequester cuts should not be lumped together with services.

We all need to be aware that, right now, every program and service— including programs in education and defense—across the nation is actively lobbying Congress and Medicare to avoid cuts in their respective areas, with everyone at risk citing dire consequences if their programs and services are among those that will take a hit. Because of the magnitude that

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

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

March 2013

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www.OncPracticeManagement.com

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In This Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nick@engagehc.com 732-992-1884 Editorial Director Dalia Buffery dalia@engagehc.com 732-992-1889 Publisher Cristopher Pires cris@engagehc.com 732-992-1896 Vice President/ Director of Sales and Marketing Joe Chanley joe@engagehc.com 732-992-1524 Director, Client Services Lou Lesperance lou@greenhillhc.com 732-992-1890 Managing Editor Lisa Neuman lneuman@the-lynx-group.com 732-992-1885 Associate Editor Lara J. Lorton lara@engagehc.com 732-992-1892 Editorial Assistant Jennifer Brandt jbrandt@the-lynx-group.com 732-992-1536 Production Manager Marie R. S. Borelli National Accounts Manager Zach Ceretelle Quality Control Director Barbara Marino Business Manager Blanche Marchitto MISSION STATEMENT Oncology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the high-quality care cancer patients deserve, providers must master the ever-changing business of oncology. Oncology Practice Management will offer process solutions for members of the cancer care team— medical, surgical, and radiation oncologists, as well as executives, administrators, and coders/ billers—to assist them in reimbursement, staffing, electronic health records, REMS, and compliance with state and federal regulations.

From the Editor Seeking Fine Surgical Cuts Under Sequestration, Not Blunt Hacking..................................................................... 5

By Dawn Holcombe, MBA, FACMPE, ACHE

Features Introducing the Third Annual Conference of the Association for Value-Based Cancer Care.........................1

By Burt Zweigenhaft, BS

Payer Negotiations Regarding Specialty Pharmacy: Implications for Oncology Practices.......................................1

By Gail Thompson

Time to Review Practice Policies: HIPAA Privacy and Security Regulations Released..............................................22

By Ross D. Margulies, JD, MPH, and Jayson Slotnik, JD, MPH

Drug Coding FDA-Approved Medications Used for the Treatment of Multiple Myeloma...................................28 Departments MEDICAL LEGAL UPDATE

Understanding the National Practitioner Data Bank and What a Report Means to You and Your License......................................................................................1

By Jennifer Kirschenbaum, Esq, and Kate Maguire, Esq

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

Second Circuit Okays Off-Label Promotion: What Will Be the Impact on Provider/Rep Interaction?……............. 24

By Sydney Abbott, JD

PHYSICIAN WEALTH MANAGEMENT

Think You Earn Too Much Money to Contribute to a Roth IRA? Guess Again...................................................................34

By Lawrence B. Keller, CFP®

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 © 2013 by Engage Healthcare Communications, LLC. All rights reserved. Oncology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

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

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

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

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ONCOLOGY PRACTICE MANAGEMENT

I March 2013

This is the biologic medicine That the patient counts on That the nurse trusts That the pharmacist has confidence in That the doctor relies on Because it was manufactured knowing the patient’s treatment depends on it.

Building confidence in the quality and supply of biologic medicines starts with a deeper understanding of how these medicines are made.

After all, there’s so much at stake.

That’s why manufacturing matters.

Learn more at buildingbiologics.com

An educational initiative from ©2012 Amgen Inc. All rights reserved. 71325-R1-V1

AVBCC Third Annual Conference

Introducing the Third Annual Conference…Continued from page 1 Changes in Reimbursement and Purchasing We are at an inflection point in cancer drug distribution and management. We are seeing the typical wholesaler-to-physician channel control change rapidly. Managed market payers are stepping up and exerting more control over what happens in oncologist offices. The landscape is changing in terms of reimbursement and their contracting capabilities as managed market payers are responding as we experiment and move into an accountable care organization (ACO) world.

It is very important that the AVBCC Annual Conference convenes an agenda and forum to guide and mentor people through the changes, and to be able to inflect strong opinions and to encourage people to participate in helping flush out important changes in the chain to ensure that we can impact change in a very positive way.

It is no longer the traditional wholesaler-to-physician group purchasing organization (GPO) model in this business today. This is rapidly changing as managed market payers, control and oversight of cancer care are taking hold and are influencing the outcomes of decisions, pathways, formulas, reimbursement, and prior authorization.

It is very important that your staff gets to meet and see all of the stakeholders and decision makers in this chain of rapidly changing events that impact cancer care today. Without that, you and your organization are not going to be prepared for the market changes, and the impact on your brand could be tremendous.

Then again, if you attend the meeting and you observe and understand the changes, enter into the discussion and debate, and lastly, you have the foresight to plan for the

8

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changes, you will be more successful in the long-run.

An All-Inclusive Agenda We have an all-inclusive agenda.

It allows us in the mornings, over the couple of days that we meet, to have all the “big-ticket” topics discussed by some of the greatest thought leaders—the people who are driving change in the oncology space today—whether it is regulatory, reimbursement, coverage, policy, benefits, healthcare systems, hospital systems, or the large community practices that are changing the way we operate in cancer care.

that we have available to enjoy and learn from.

We all know how important networking is. I know that we are in an e-mail and health information exchange market. But meeting key opinion leaders and exchanging in open dialogue, and being able to sit with them at lunch, at breakfast, or in between sessions and hear what their thoughts are, is very important.

This is the only conference where the key people in the channel are at the meeting, and are available for you to meet and to have personal time with them. There is no better way to get ahead and to stay ahead

There is no better way to get ahead and to stay ahead in cancer care than to be at the AVBCC conference in its third year. This is your chance to see some of the greatest key opinion leaders, the people who are truly driving change in cancer care today.

This allows all of the stakeholders, main issues, and agendas to be discussed in an open forum. We have panels, channel experts, and key opinion leaders. This is important; you never see such a mix in this business. Our afternoon tracks allow you to have breakouts, depending on whether it is reimbursement, genetics, product launch, pathways, or care management that is important to you. These are all separate tracks that allow you and your staff to move around with flexibility in the afternoon, and to make sure that everyone covers the wide array of topics

ONCOLOGY PRACTICE MANAGEMENT

I March 2013

in cancer care than to be at the AVBCC Annual Conference in its third year, in Hollywood, FL. This is your chance to see some of the greatest key opinion leaders, the people who are truly driving change in cancer care today.

Meeting Key Opinion Leaders Who are these key opinion leaders specifically? For the most part, they are the medical directors of the big insurance plans, the ones who are leading the change in cancer care, Continued on page 10

THIRD ANNUAL

Association for Value-Based Cancer Care Conference Influencing the Patient-Impact Factor

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

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 Hematologist/Oncologist Oncology Resource Networks

Gary M. Owens, MD President Gary Owens Associates

Burt Zweigenhaft, BS President and CEO OncoMed

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 Marcus Neubauer, 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

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.

2:45 pm - 3:30 pm

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

Ted Okon; John D. Sprandio, MD

TARGET AUDIENCE

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.

LEARNING OBJECTIVES

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.

DESIGNATION OF CREDIT STATEMENTS SPONSORS

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

COMMERCIAL SUPPORT ACKNOWLEDGMENT

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

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

5:15 pm - 5:45 pm

Summary/Wrap-Up of Day 1

6:00 pm - 8:00 pm

Cocktail Reception in the Exhibit Hall

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

Opening Remarks

8:30 am - 9:15 am

Session 8: The Role of Government in the Future of Oncology Care Jayson Slotnick, JD, MPH

9:15 am - 10:00 am

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

10:00 am - 10:15 am

Break

10:15 am - 11:00 am

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

11:00 am - 11:45 am

Session 11: National Coalition for Cancer Survivorship: Medication Nonadherence Issues Pat McKercher; Lillie Shockney, RN, BS, MAS

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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.

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

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Summary/Wrap-Up of Day 2

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

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

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

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).

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7:00 am - 8:00 am

Simultaneous Symposia/Product Theaters

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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 Oncology Group Practices—Successes, Issues, and Challenges Thomas Marsland, MD; David Eagle, MD

11:45 am - 12:00 pm

Summary and Conclusion of Conference

*Agenda is subject to change.

AVBCCAsize20413

AVBCC Third Annual Conference

Introducing the Third Annual Conference…Continued from page 8 whether in Medicare, Medicaid, or in commercial plans. We have certain leaders that you may recognize, because you have read about them frequently in many publications, including the association’s publication—Value-Based Cancer Care.

We have coding experts. We have advocacy experts. We have policy experts. This is why the AVBCC Annual Conference is a very inclusive meeting, because we bring all the stakeholders together.

When we put together the agenda, our goal was to make sure that we had the right people, the right health plans, the right health systems, and the right leaders. We did not want to see ourselves with another small, myopic view of this industry. We knew that the only way to effect change in a positive way was to get everyone and every voice in the room together to share information. That is the overall goal of the AVBCC Annual Conference— inclusiveness.

I have always believed that it is very important to meet face to face with the key people who are driving change in the business. One of the goals of our association is to make sure that we have a cast that includes everyone who is leading that change. We have people from Aetna, and people from the University of Pittsburgh Medical Center. We have people from hospital systems, such as the “Roswells” and the “Dana-Farbers” of the world.

We have employer groups and coalitions, such as Caterpillar, Delta, the National Business Group on Health, UnitedHealthcare, and many others.

The goal of the AVBCC Annual Conference is to bring them all together to make sure that we all have access to each other and that we could share ideas in an open forum and help chart the future of cancer care in America. This is why

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you want to be with us at this meeting, and this is why you need to have your staff attend the conference.

This is the only meeting I am aware of that affords this type of inclusive venue, where everyone in the space can get to meet those important leaders who are driving change in cancer care.

We have people from Aetna, and people from the University of Pittsburgh Medical Center. We have people from hospital systems, such as the “Roswells” and the “Dana-Farbers” of the world. We have employer groups and coalitions, such as Caterpillar, Delta, the National Business Group on Health, UnitedHealthcare, and many others.

One of the most important things that we know is changing is the distribution model, as we are moving from the typical manufacturer to the wholesaler through GPO to community-based or system-based oncologists. As the system is changing, manufacturers are now finding that they are no longer totally dependent on the wholesale channel or on GPOs to make and control the influential buying decisions to drive their products to market. Today it is being

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heavily influenced by the managed care channels and by payers, coverage and reimbursement decisions.

In this meeting, in addition to having all of the managed market payers represented, we also have the new stakeholders in the distribution channel. We have specialty pharmacies, we have oncology pharmacies, and we have hospital systems and others that are now taking hold of a new distribution model in cancer care.

As this business is changing, what we have done at the AVBCC is to make sure that we have at this Third Annual Conference all of the people who are effecting change, so that they can discuss that change and what it means to the healthcare markets. One of the major challenges that most manufacturers have to address today in the cancer marketplace is now dealing in a comparative world of clinicaland cost-effectiveness, where evidence is increasingly being weighed to come up with the value-based purchasing proposition.

The “New World” of Healthcare Part of the mission of the AVBCC is to come up with a formula for value-based purchasing that will include not only clinical elements but economic elements of overall cost as well. Part of our agenda is to make sure that the association can put forth a framework for “value-based purchasing” and the corresponding proper process and formula for evaluating effectiveness so appropriate contracting for cancer drug therapies is in the marketplace.

The timing of the Third AVBCC Annual Conference could not be better. We are coming right off of a national election. We did not know whether ObamaCare was going to last. Now we know that health information exchanges, state exchanges, and the novel products of the “new

AVBCC Third Annual Conference

world” of healthcare are going to take effect and are here to stay, and change is permanent.

Obviously, we are moving from a utilization-focused model to a quality model of healthcare. These changes are going to be dramatic.

These issues are part of the agenda of change that we are going to be discussing this year at the AVBCC Annual Conference in the various segments and forums.

Community- versus Hospital-Based Care Also at this year’s AVBCC Annual Conference, we are going to explore one of the biggest changes in cancer care—the move from community oncology to hospital-based cancer care. We have representatives from the Community Oncology Alliance, the Association of Community Cancer Centers, the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and others, who are going to be discussing these changes.

We have seen a tremendous consolidation in the purchase of hematology and oncology practices by

hospital systems as they are getting ready for ACO opportunities. This is going to have a dramatic impact on our marketplace. We are going to

must know what is going on, and must be able to predict the new models of distribution and service, given the consolidation and the changes in cancer care as we go forward.

Personalized medicine is probably going to be launched through cancer care. Why? Because cancer is so expensive, and all of the molecular tests that can really make a difference in clinical utility and driving change are going to be the companion diagnostics to cancer care.

Personalized Medicine Personalized medicine is probably going to be launched through cancer care. Why? Because cancer is so expensive, and all of the molecular tests that can really make a difference in clinical utility and driving change are going to be the companion diagnostics to cancer care. Thus, given the effect on comparative, effectiveness research and the value-based approach of cancer care purchasing, the economics around personalized medicine makes economic sense to embrace beyond the quality drivers.

This is a hugely important topic, and it is part of our agenda at the Third Annual Conference of AVBCC, where we have experts who will be speaking on the impact of personalized medicine, companion diagnostics, and molecular pathways as we move forward in improving patient care in America. l

explore this critical change in depth in some of the sessions. Anyone who is involved in this oncology space

From the Editor

Seeking Fine Surgical Cuts…Continued from page 5 the sequestration cuts possibly hold for every program and service that may be affected, those of us who care for patients with cancer need to be incredibly focused in our own messages, and we need to present a rational argument that objectively distinguishes between the hardships that will be created with cuts to cancer drugs as opposed to the hardships created with cuts to cancer services.

Several national groups have joined forces to present a common

message to our federal decision makers. Whether you are a hospital-based or private practice–based group, please take a look at the requests that national groups such as the American Society of Clinical Oncology and the Community Oncology Alliance are making. Place the phone calls and write the e-mails to your district’s congressional representatives—and engage your patients as well. This is not about saying “do not cut”—that boat sailed when the sequestration

March 2013

went into effect. It is about saying “apply the cuts discriminately and intelligently.”

So call your legislators today, and set up phone systems in your offices so that your patients can call their legislators, too. Remember that we are fighting a massive tidal wave of pleas from many groups and interests to not make cuts in other areas of the budget. Our voice must be clear, loud, and constant—and it must be immediate. l

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Specialty Pharmacy

Payer Negotiations Regarding Specialty…Continued from page 1 cialty pharmacy company for select situations, but a health plan or a major employer may wish to use a different, perhaps national, company for other reasons. Both groups have been limited in the negotiation process by missing information about the complexity of the treatment of patients with cancer, and the impact that knowledge may have on the costs of cancer treatment.

One main negotiation issue for oncology practices and for health plans is whether the drugs used in the treatment of patients with cancer in the practice will be purchased by the practice (ie, stored internally and used at the time of treatment), which is often referred to as “buy and bill” or “direct acquisition,” or whether an external entity, such as a specialty pharmacy, will be used to supply the drugs to the practice before the patient arrives for treatment, which is referred to as “scrip for ship” or “external delivered” drug. Both models result in the drug designated in the original treatment plan supposedly sitting in the practice ready for the patient on the day of treatment, but these models are billed and paid through different mechanisms and entities.

Changes in Treatment Plans and Drug Costs A recent national study shed light on these treatment complexity issues, and provided oncology practices and health plans better information for use in the negotiation process.1 The National Association of Managed Care Physicians (NAMCP) developed this study after facing questions from their membership (which is composed of medical directors of health plans, employers, and larger provider groups) about the costs and implications of different delivery models for oncology drugs.

The purpose of the study was

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to analyze the rate and volume of drug changes for patients with cancer during treatment.1 Despite some variations in payment structure and other drug delivery models in use across the country, the direct acquisition model and the external delivered model are, by far, the most common currently in use.

When cancer drugs are acquired only by the provider, under buy and bill, any specific drug changes are accommodated from within the practice inventory, and the drugs actually used are billed to the health plan after treatment.

Although an oncologist determines a treatment regimen for a particular patient in advance, every patient is evaluated on the day of treatment to determine the health status and whether that planned treatment remains appropriate. If changes are indicated, the physician will approve them, and the treatment can continue.

When cancer drugs are acquired only by the provider, under buy and bill, any specific drug changes are accommodated from within the practice inventory, and the drugs actually used are billed to the health plan after treatment. Historically, these changes were noted in the patient’s paper chart, but the health plan was unaware of the changes,

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because the plan was billed only for the drugs actually used on the day of treatment.

With the rise in health plan and specialty pharmacy interest in cancer management, oncology practices began to realize that there may be an added cost to the health system if drugs were delivered before the day of treatment based on the original treatment plan. It was difficult to quantify the impact of the treatment changes that happened on the actual day of treatment when the only tracking of those changes was in the paper chart. One early ad hoc review did quantify that changes were happening, and that the possible costs to health plans would be significant if a mandate to shift all oncology drugs to the external delivered model occurred,2 but further documentation was needed on a national scale.

The national study commissioned by the NAMCP examined the incidence of changes in the original treatment plan versus the actual treatment regimen, as well as the potential cost of such changes to health plans under the direct acquisition model and the external delivered model, through access to deidentified data from national oncology electronic medical records.1 The modification in the actual treatment delivered and the associated cost implications were found to be significant.1 The cost implications were determined by comparing any changes from the original treatment plan to the regimen delivered to the patient on the day of the treatment. Most cancer drugs continue to be acquired by oncology practices and not delivered from external entities.

However, the purpose of this study was to evaluate the cost implications from existing clinical situations if the drugs were provided to the pracContinued on page 14

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Specialty Pharmacy

Payer Negotiations Regarding Specialty…Continued from page 12 tice before the day of treatment by the direct acquisition or the external delivered model.1 The NAMCP study quantified the amount of drug doses that differed from the original treatment plan and the actual treatment, and then applied a market value generally equivalent to the amount that health plans may conceivably pay for a cancer drug when paying a specialty pharmacy to deliver that drug to the oncology practice—average wholesale price minus 17%.

The findings of the study showed what a health plan could be paying to an external entity that would ship the drug upon receiving a physician order, and then bill the health plan for drugs that were shipped but not used for treatment as planned.

When prescribed cancer drugs are shipped for a patient but are not used, this creates a costly situation for the patient, the practice, and the health plan. The cost for the drug is incurred at the point of shipment, not at the point of use (as it is under the direct acquisition model).

Most state pharmacy regulations prohibit the reuse or return of complex drugs, such as oncology drugs, which have tight handling parameters. Therefore, if a drug is issued under a prescription but is not actually used, it must be discarded appropriately according to biohazardous waste regulations; it cannot be returned or used for another patient. Consequently, the costs for an unused drug could include the patient’s copay, the specialty pharmacy claim paid by the health plan, and the staff and physical resource costs of the practice for ordering, receiving, storing, and disposing of any drugs not used for treatment.

The Cost of Cancer Drug Waste The data set used in this study

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represents one of the most complete sources available to track the differences between planned and actual treatment. The study tracked differences for the eligible (deidentified) database, and the analysis—based on actual data for a specific 12-month period between April 1, 2011, and March 31, 2012—was noted to be conservative.1 About 1 in 10 cancer treatments were found to have variations be­­ tween the originally planned regimen and the actual treatment used for breast, lung, colon, and prostate can-

When cancer drugs are shipped for a patient but not used, this creates a costly situation for the patient, the practice, and the health plan.

The cost for the drug is incurred at the point of shipment, not at the point of use. cer. More than 90% of the variations involved the planned dose not being given. The remaining variations in treatment regimens involved increases or decreases in the dose.

The impact of this “waste” in drug variation amounted to an average of $5000 per treating physician, a total of $1,154,304 for the patients in the database, and an average of $62.14 of “waste” per patient per month for the 12 months tracked in the study.1 Potential high-impact “waste” dollars in drug use also resulted from low (<10%) variations in same-day treatment changes for chemotherapy

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drugs and for ancillary drugs that are delivered to the provider or practice.

The NAMCP study looked at costs that would be incurred solely for a drug that was ordered but not ultimately used for treating a patient, assigning a traditional rate found for specialty pharmacies to this “waste,” because the waste would only occur for the drugs ordered through, shipped by, and billed from a specialty pharmacy.

The drugs acquired and used by physician groups for treatment are billed only for the exact amount of the drug used for the treatment, regardless of the original prescription; therefore, there is no waste generated. The net amount paid for the drugs actually administered in the treatment regimen, whether through the direct acquisition model or external delivered model, would still be incurred by the health plan outside of any potential waste for drugs shipped but not administered.

Oncology Practices–Health Plan Negotiations Much can happen between the original treatment plan and the day of treatment for a patient with cancer. Once a prescription is written, whether for cancer drugs or for supportive care drugs to be used during treatment, the drug must be used within its limited shelf life for the prescribed patient, or it must be discarded. It usually may not be returned to the distributor, and it definitely may not be used for another patient according to safe-handling pharmacy regulations. Even a small percentage of variation from planned treatment can lead to high costs for a cancer drug.

A recent report from the IMS Institute for Healthcare Informatics showed that the drug spending for oncology (both traditional and speContinued on page 16

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Specialty Pharmacy

Payer Negotiations Regarding Specialty…Continued from page 14 cialty drugs) was more than $23.2 billion in 2011.3 As noted before, the NAMCP study found that potentially 1 in 10 oncology drug doses changed between the original treatment plan and the actual treatment.1 If the impact of such changes led to potential waste of 10% of the 2011 oncology drug spending of $23.2 billion, that would amount to almost 50% of all the dollars spent in the United States on antiviral drugs (excluding anti-HIV), immunostimulating agents, erythropoietins, or hormonal agents.3 For the most part, the potential waste indicated in the NAMCP study does not yet exist, because the direct acquisition model is still the predominant model used across the country.1 There will likely always be a role for specialty pharmacy in oncology.

In some states, pharmacy regulations mandate that oral oncology drugs be provided through an entity such as a specialty pharmacy. Many oncology practices have recently developed close relationships with local specialty pharmacies for the delivery of oncology drugs.

The new reality is that a balance will be required between the appropriate use of external delivered drugs and direct acquisition drugs, so that unnecessary costs are not incurred for drugs that are shipped but are not used on the day of treatment.

That may mean the development of a closer relationship between the treating practice and a local spe-

cialty pharmacy that can deliver on a just-in-time basis. It may mean health plan recognition of in-office or hospital-based pharmacies with closer physical proximity to the patient for just-in-time delivery for reimbursement policies.

It may also mean transformation of the specialty pharmacy model to accommodate the growing body

In 2013, the proactive oncology practice is reviewing all of the alternatives and options for costeffective care, and many are choosing to integrate specialty pharmacy drugs, but under carefully crafted situations and policies. of understanding of the complexity of the patient with cancer and the changes that can result in adjusted treatment regimens on the day of service.

Individual oncology practices can use this information, and can even conduct an internal review of the impact a change in drug delivery models may have for individual health plans, as a way of preparing for negotiations with health plans

on the role of specialty pharmacy for cancer drugs in their market.

Questions to consider include: What relationships and experience do we have with local and health plan–suggested specialty pharmacies to date?

1

2

Based on the volume of patients with cancer seen for this health plan, what cost implications are suggested by a potential change in policy from direct acquisition to external delivered drug models?

3

What model or solutions would you recommend to avoid incurring “waste” for unused external delivered drugs?

In 2013, the proactive oncology practice is reviewing all of the alternatives and options for cost-effective care, and many are choosing to in­tegrate specialty pharmacy drugs, but under carefully crafted situations and policies. Additional information, such as the NAMCP study, can provide useful, tangible data that can be used by health plans and by oncology practices in choosing effective solutions and avoiding unintended additional costs and consequences. l

References

1. Holcombe D, Force W, Bradley K, et al. Impact on health plan cancer drug costs in different delivery models. J Manag Care Med. 2012;15:69-80.

2. Holcombe D. Is oncology compatible with specialty pharmacy? Community Oncol. 2005;2:173-181.

3. IMS Institute for Healthcare Informatics. The use of medicines in the United States: review of 2011. Revised May 30, 2012. www.imshealth.com/ims/Global/Content/ Insights/IMS%20Institute%20for%20Healthcare%20 Informatics/IHII_Medicines_in_U.S_Report_2011. pdf. Accessed January 10, 2013.

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Medical Legal Update

Understanding the National Practitioner…Continued from page 1 to reports of negative actions that have been taken against healthcare practitioners. Although the general public does not have access to the NPDB, licensing boards, professional societies, hospitals, and other healthcare entities do have access to these reports, and upon review, any one of these entities may decide not to work with a particular practitioner based on an NPDB report.

Because the NPDB is national in scale, a practitioner cannot escape the repercussions of a negative action by attempting to practice in another state.

Medical Malpractice and Adverse Actions There are 2 basic areas in which the NPDB keeps reports on practitioners: medical malpractice payments and adverse actions.

Whenever a medical malpractice payment is made on behalf of a practitioner, either in settlement or as the result of a judgment, the payment must be reported to the NPDB. This includes payments made by medical malpractice insurers on behalf of their insured. For an adverse action, certain actions must be reported to the NPDB, including but not limited to an action by a licensing board, by a hospital or other healthcare entity where a practitioner maintains privileges, by a professional society, or when Medicare or Medicaid excludes a practitioner from receiving benefits.

Such actions are reportable because an authorized body has determined that a practitioner has experienced an event or determination capable of affecting that practitioner’s ability to practice. When a formal determination is made to revoke a practitioner’s license, that determination is also reported to the NPDB. The following example illustrates the effect of an NPDB report. Dr Z,

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an oncologist, maintains privileges at Hospital A. The head of oncology at Hospital A receives complaints from multiple patients that Dr Z was rude to the patients and their family members during their hospital stay.

The head of oncology brings these complaints to Hospital A’s board.

The board makes a determination

Practitioners often underestimate the impact or fail to educate themselves of the ramifications of National Practitioner Data Bank reporting.

Once made, an NPDB report is difficult to unmake, and its implications may have a lasting impact on the subject practitioner, which is why practitioners should be advised that the time to challenge an NPDB report is before it is made. that Dr Z’s manner of dealing with patients directly interferes with his ability to properly care for and treat them, and suspends Dr Z’s privileges for 60 days. Hospital A now must report the suspension to the NPDB because the board determined that Dr Z’s behavior interfered with his ability to properly care for and treat his patients.

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It is important to note here that the NPDB allows reporting entities to create the reports themselves, and although the NPDB reviews reports, it will not investigate them for accuracy or make any changes to them.

It is also important to note that NPDB reports do not expire; they are permanently maintained for the entirety of a practitioner’s lifetime.

As a result of what he believes is unfair treatment from Hospital A, 2 years later Dr Z begins to seek employment elsewhere. He believes that his 60-day suspension was not related to his care and treatment of his patients at all, but instead resulted from a personal grudge that the chief of oncology held against him.

Unfortunately, when Dr Z applies to Hospital B, Hospital B does a search of Dr Z’s records in the NPDB. There, Hospital B finds the record of Hospital A’s 60-day suspension of Dr Z 2 years ago. Based on this report alone, Hospital B elects to forego hiring Dr Z or to provide him with clinical privileges at its facility.

In this example, there are steps that Dr Z could have—and should have—taken to soften the blow of the NPDB report. When Hospital A initially reported Dr Z’s suspension to the NPDB, the NPDB was required to send Dr Z a notice that it had received the report. Once he received the notice, Dr Z had the option of adding a statement to the report, which would have allowed him the opportunity to provide his point of view regarding his suspension. A practitioner posting an explanation of the circumstances cited in a report will often lend credibility and otherwise substantiate the action that was taken by that practitioner. Without such a response to a report, the practitioner is left without the benefit of the doubt, and action without explanation.

NPDB reports made regarding

Medical Legal Update

medical malpractice payments may similarly impact a professional’s career. Unfortunately, when deciding to file suit, plaintiff attorneys often bring actions against any and all of the practitioners listed as treating a patient. Thus if you are affiliated with a hospital and you saw a patient for an issue unrelated or ancillary to the central issue of a malpractice suit, you may still be named in the suit. Should your insurance carrier choose to settle during litigation, either you or your employer will be required to report the settlement to the NPDB. If you run your own practice, you will be afforded the opportunity to self-report, and may draft the report in the light most favorable to you.

However, if your employer drafts the report, you should be fully apprised of the information contained in the report, and ensure that your employer provides a proper account of the events that led to the malpractice action.

Disputing an NPDB Report When a report is made and the information contained in the report is inaccurate, the practitioner may request that the reporting entity file a correction. If the reporting entity declines to change the report, the practitioner may initiate a dispute of the report through the dispute process. However, the dispute process does not serve as a means to protest a payment or to appeal any underlying reason of an adverse action. Neither the merits of a medical malpractice claim nor the appropriateness of—or the basis for—an adverse action may be disputed. In the first step of the dispute process, the reporting entity is notified that the practitioner disputes the report.

If the reporting entity declines to change the report or takes no action, the practitioner may then request that the Secretary of the US Department of Health and Human

Services (HHS) review the disputed report for accuracy of the factual information and to ensure that the information was required to be provided. Any request made to the Secretary of HHS for review should state, in writing, all of the facts that are in dispute. It should include substantiation of the practitioner’s posi-

with the information relayed about the previous determination based on facts. Because of this, secretarial review is not the right path for practitioners looking to challenge the underlying determination.

Practitioners often imagine secretarial review as another bite into the apple of justice, another chance at vindication, or a challenge to the original underlying adverse action or malpractice matter. This is not the case at all, and practitioners should be advised that the time to challenge an NPDB report is before it is made.

The dispute process does not serve as a means to protest a payment or to appeal any underlying reason of an adverse action. Neither the merits of a medical malpractice claim nor the appropriateness of—or the basis for—an adverse action may be disputed.

Conclusion Although fighting to clear your name in a malpractice matter is often the road less traveled (because it is cheaper for the insurance company to settle in most instances), and fighting a hospital or administrative and/or government agency that renders an adverse decision may seem insurmountable, these processes do not just impact you and your career at the time. The determinations that are made and the records that are established as a result may follow you for the rest of your professional career, and even beyond. Take precautions, understand your risk, and protect yourself against an adverse report to the degree that you can. l

tion, and provide any proof to support the practitioner’s position. The request for review may not exceed 10 pages, and the review may result in one of the following determinations:

1 2 3

The issues in dispute are outside the scope of secretarial review.

Jennifer Kirschenbaum, Esq, manages Kirschenbaum & Kirschenbaum’s healthcare department, which specializes in representing healthcare practitioners in regulatory compliance, audit defense, licensure, and transactional matters. She may be reached at 516-747-6700 x302 or by e-mail at Jennifer@kirschenbaumesq.com.

The issues that are relevant to a secretarial review are not related to the fairness of the final determination that resulted in the report being generated at the NPDB level.

Secretarial review is concerned only

Kate Maguire, Esq, is an Associate in Kirschenbaum & Kirschenbaum’s healthcare litigation practice. For more information about Kirschenbaum & Kirschenbaum’s healthcare practice visit www.nyhealthcareattorneys.com

The NPDB report is accurate as submitted.

The NPDB report is inaccurate as submitted.

March 2013

I

www.OncPracticeManagement.com

I

19

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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

Navigator is a registered trademark of Engage Healthcare Communications, LLC, an affiliate of The Lynx Group. No part of these materials 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.

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Health Policy

Time to Review Practice Policies: HIPAA Privacy and Security Regulations Released

By Ross D. Margulies, JD, MPH, and Jayson Slotnik, JD, MPH

O

n January 18, 2013, nearly 3 years after its initial proposed rule, the US Department of Health and Human Services (HHS) issued the long-awaited and much-anticipated HIPAA “omnibus” rule, extending the Ross D. Margulies scope of the privacy law beyond providers to their business associates and subcontractors and adding increased penalties.

Regulated entities must be in compliance with the new rules by September 22, 2013, although covered entities and Jayson Slotnik business associates will have up to 1 year after the 180-day compliance date to modify existing contracts to comply with these revised rules. Oncology practices should begin examining their policies now to ensure a seamless transition to these new rules.

Among the most dramatic changes to existing law is that HIPAA’s privacy and security requirements will now directly apply to business

associates. Business associates will now include health information organizations, e-prescribing gateways, other entities that provide data transmission services for covered entities and that require access on a routine basis, entities that offer a personal health record to individ-

Among the most dramatic changes to existing law is that HIPAA’s privacy and security requirements will now directly apply to business associates. uals on behalf of a covered entity, and subcontractors. Penalties for noncompliance will range depending on the degree of culpability, including the number of individuals affected and whether there is a history of noncompliance.

Central to the new regulations (which total a whopping 563 pages) is the sharing of patient-protected health information (PHI). Patients are given new control over their

PHI, including allowing patients to request a copy of their electronic medical record in an electronic format and permitting patients to instruct their provider not to share information about treatment with their health plan when the individual pays for that care out of pocket.

In addition, the final rule expands the definition of a “breach” under HIPAA, thus eliminating the “harm” standard, which previously allowed entities to avoid breach notification if they could demonstrate that the breach posed no significant risk of harm to the individual. Under the new rule, any impermissible use or disclosure of PHI is presumed a breach, unless a low probability that information has been compromised can be demonstrated.

Oncology practices are now tasked with the arduous effort of implementing what the HHS is calling “the most sweeping changes to the HIPAA privacy and security rules since they were first implemented.” l Ross D. Margulies, JD, MPH, is an Associate at Foley Hoag, LLP, Washington, DC. Jayson Slotnik, JD, MPH, is a Partner, Health Policy Strategies, LLC, Washington, DC.

WCMC_2013Conf_horizontal2_31213_Layout 1 3/12/13 4:10 PM Page 1

SECOND ANNUAL CONFERENCE

2013 WORLD CUTANEOUS MALIGNANCIES CONGRESS

TM

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

22

I

• Squamous Cell Carcinoma • Merkel Cell Carcinoma

ONCOLOGY PRACTICE MANAGEMENT

I March 2013

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

ANNUAL CONFERENCE

"! !

!

!

Professor Rob Coleman, MBBS, MD, FRCP Yorkshire Cancer Research Professor of Medical Oncology Director, Sheffield Cancer Research Centre Associate Director, National Institute for Health Research Cancer Research Network Department of Oncology, Weston Park Hospital Sheffield, United Kingdom

*

3:00 pm - 7:00 pm

Registration

5:30 pm - 7:30 pm

Welcome Reception and Exhibits

7:00 am - 8:00 am

Symposium/Product Theater

8:15 am - 8:30 am

Welcome to the Second Annual Conference of the Global Biomarkers Consortiumâ&#x20AC;&#x201D;Setting the Stage for the Meeting Professor Rob Coleman, MBBS, MD, FRCP

8:15 am - 11:45 am

General Session I â&#x20AC;˘ Personalized Medicine in Oncology: Evolution of Cancer Therapy from Nonspecific Cytotoxic Drugs to Targeted Therapies â&#x20AC;˘ Taking Stock of Molecular Oncology Biomarkers â&#x20AC;˘ Genomics â&#x20AC;˘ Bioinformatics â&#x20AC;˘ Validating Biomarkers for Clinical Use in Solid Tumors - Professor Rob Coleman, MBBS, MD, FRCP â&#x20AC;˘ Validating Biomarkers for Clinical Use in Hematologic Malignancies Jorge E. Cortes, MD â&#x20AC;˘ The Challenges of Biomarker-Based Clinical Trials â&#x20AC;˘ Keynote Lecture: Understanding Cancer at the Molecular Level

12:00 pm - 1:00 pm

Symposium/Product Theater/Exhibits

1:15 pm - 4:30 pm

This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

General Session II â&#x20AC;˘ Introduction to Case Studies - Jorge E. Cortes, MD â&#x20AC;˘ Case Studies: Optimal, Value-Based Use of Molecular Biomarkers in Oncology: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients, Part I â&#x20AC;˘ Lung Cancer â&#x20AC;˘ Breast Cancer â&#x20AC;˘ Multiple Myeloma â&#x20AC;˘ Prostate Cancer â&#x20AC;˘ Leukemia â&#x20AC;˘ Lymphoma â&#x20AC;˘ Panel Discussion: Management Controversies and Accepted Guidelines for the Personalized Management of Solid Tumors and Hematologic Malignancies â&#x20AC;˘ Keynote Lecture: The Medical-Legal Issues Surrounding the Use of Biomarkers in Oncology

4:30 pm - 6:30 pm

Meet the Experts/Networking/Exhibits

Jorge E. Cortes, MD Chair, CML and AML Sections D.B. Lane Cancer Research Distinguished Professor for Leukemia Research Department of Leukemia, Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX

The only global meeting dedicated to advancing the understanding of value and clinical impact of biomarker research in oncology. Guided by the expertise of leaders in this field, participants will receive a thorough understanding of the current and future landscape of the relevance of tumor biomarkers and how to effectively personalize cancer care in the clinical setting.

This meeting will be directed toward medical oncologists and hematologists, pathologists, geneticists, advanced practice oncology nurses, research nurses, clinical oncology pharmacists, and genetic counselors involved in the management of patients with solid tumors or hematologic malignancies, and interested in the use of molecular tumor biomarkers to help optimize patient care.

Upon completion of this activity, the participant will be able to: â&#x20AC;˘ Assess emerging data and recent advances in the discovery of molecular biomarkers and their impact on the treatment of patients with solid tumors or hematologic malignancies â&#x20AC;˘ Discuss the role of molecular biomarkers in designing personalized therapy for patients with solid tumors or hematologic malignancies â&#x20AC;˘ Outline the practical aspects of integrating molecular biomarkers into everyday clinical practice in the treatment of patients with cancer

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

7:00 am - 8:00 am

Symposium/Product Theater

8:15 am - 11:45 am

General Session III â&#x20AC;˘ Review of Saturdayâ&#x20AC;&#x2122;s Presentations and Preview of Today - Jorge E. Cortes, MD â&#x20AC;˘ Case Studies: Optimal, Value-Based Use of Molecular Biomarkers in Oncology: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients, Part II â&#x20AC;˘ Melanoma â&#x20AC;˘ Colorectal Cancer and Other GI Malignancies â&#x20AC;˘ MDS â&#x20AC;˘ Myeloproliferative Neoplasms â&#x20AC;˘ Keynote Lecture: Promises and Challenges of Personalized Medicine in Improving Cancer Care â&#x20AC;˘ Tumor Board: Challenging Cases in the Use of Biomarkers in Managing Solid Tumors (attendee-contributed cases) â&#x20AC;˘ Tumor Board: Challenging Cases in the Use of Biomarkers in Managing Hematologic Malignancies (attendee-contributed cases)

12:00 pm - 1:00 pm

Symposium/Product Theater/Exhibits

1:15 pm - 3:00 pm

General Session IV â&#x20AC;˘ Keynote Lecture: Making Personalized Medicine a Reality: The Realization of Genomic Medicine â&#x20AC;˘ The Future of Personalized Medicine: Measuring Clinical Outcomes â&#x20AC;˘ Cost-Effective Technologies That Can Drive Therapeutic Decision Making â&#x20AC;˘ Regulatory Perspectives on PMO â&#x20AC;˘ PMO: The Payerâ&#x20AC;&#x2122;s Perspective â&#x20AC;˘ Panel Discussion: Can We Afford PMO? A Value-Based Analysis â&#x20AC;˘ Practical Considerations in Incorporating PMO into Everyday Cinical Management â&#x20AC;˘ Reimbursement Challenges

â&#x20AC;˘ Closing Remarks

3:00 pm

Departures

The Medical Learning Institute Inc designates this live activity for a maximum of 12.5 AMA PRA Category 1 Creditsâ&#x201E;˘. 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.

Medical Learning Institute Inc Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 12.5 contact hours.

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 12.5 contact hours (1.25 CEUs) of continuing pharmacy education credit.

The Universal Activity Number for this activity is (To be determined).

CONFERENCE REGISTRATION

EARLY BIRD REGISTRATION NOW OPEN! $175.00 until June 30, 2013

www.globalbiomarkersconsortium.com

*Agenda is subject to change.

PMPMERSONALIZED EDICINE IN ONCOLOGY O

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

Second Circuit Okays Off-Label Promotion: What Will Be the Impact on Provider/Rep Interaction?

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

S

24

ince 2004, un‑­ der the False Claims Act, whis­­­­­­­­­tleblowers have fueled numerous fed­­­­ eral investigations into fraudulent claims for reimbursement from federal programs, such as Medicare, that violated the Food, Drug, & Cosmetic (FD&C) Act. But now the long-held understanding that a pharmaceutical representative may not discuss any off-label use of a US Food and Drug Administration (FDA)-approved drug with a provider has been turned on its head by a federal appellate court in Manhattan.

The controversial decision to allow pharmaceutical sales representatives to promote drugs for off-label use was recently determined in a 2-1 decision by a 3-judge panel in the Court of Appeals for the Second Circuit, in United States v. Caronia. However, because of the Second Circuit’s jurisdiction, this ruling is only applicable for New York, Connecticut, and Vermont.

1 2 3 4

Protecting Consumers Everyone knows that the First Amendment protects free speech in most situations. However, to protect consumers—in this case, providers and patients—commercial speech is more closely regulated. To regulate commercial speech, the government would have to pass a series of questions:

Most likely, this ruling will not impact the conversations pharmaceutical representatives have with providers immediately. However, there are certain things that cancer care providers should know about this important decision.

This ruling is a complete reversal of the way the FDA views the issue. The government justifies its

I

Is the speech false or misleading?

Does the restriction support a substantial government interest?

Does the restriction directly advance that interest?

Is the restriction narrowly tailored to serve that purpose?

In the case of off-label promotion of FDA-approved medications, the Court determined that:

1

Promoting a medication for off-label uses, when supported by compendia, is not misleading, but

2

Protection of patients is a substantial government interest, but that

3

The regulation of off-label promotion does not necessarily protect patients, therefore

4

Regulation of off-label promotion where the promotion is supported by recognized compendia is not appropriate.

ONCOLOGY PRACTICE MANAGEMENT

I March 2013

crackdown on off-label promotion on the grounds that it is protecting the integrity of the FDA’s drug approval process. The FDA wants to discourage manufacturers from seeking approval for only a narrow—and easily approvable— claim while intending to actually promote the drug for much wider uses. However, providers need not fear that pharmaceutical representatives will soon start to promote drugs recklessly, primarily because of other potential state and federal litigation that drug manufacturers could face, not to mention the harm it could do to the manufacturer’s reputation.

The FDA has stated that it will not appeal the Second Circuit’s decision to the Supreme Court of the United States. The FDA feels that because the decision is limited to just a few states and because the ruling does not strike the provision of the FD&C Act or impact any misbranding provisions, further advancement of this case is not necessary. While the decision determines that some off-label promotion is permitted, the Court’s analysis still leaves questions, such as the scope of off-label promotion. Is it limited to drugs only, or can it extend to anything else the FDA has its hand in, such as medical devices, tobacco, or even diet aids? The Court also did not define what constitutes false or misleading speech, or address the impact this could have on civil suits for offlabel promotion.

The primary takeaway for canContinued on page 26

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

“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

Value-BasedCare IN Myeloma

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RESOURCE CENTER FOR PAYERS, PROVIDERS, AND THE ENTIRE CANCER CARE TEAM

Value-Based Care in Myeloma delivers exclusive interviews and perspectives related to cost, quality, and access issues.

Special sections for VA-based clinicians, advanced practice nurses, and pharmacists will also focus on the unique challenges in the management of multiple myeloma.

www.ValueBasedMyeloma.com Value-Based Care in Myeloma is a publication of Engage Healthcare Communications, a member of The Lynx Group. © 2012 All rights reserved.

VBCC0112_VBMAsizeGH

Patient and Provider Access

Second Circuit Okays Off-Label Promotion: What Will Be the Impact…Continued from page 24 The primary takeaway for cancer care providers is to know that most likely nothing will change in your interaction with pharmaceutical representatives in the near term. In every state besides New York, Connecticut, or Vermont, any discussion of off-label uses by drug representatives is still prohibited by law.

cer care providers is to know that most likely nothing will change in your interaction with pharmaceutical representatives in the near term. In every state besides New York, Connecticut, or Vermont, any discussion of off-label uses by drug representatives is still prohibited by law. Certainly as this policy evolves, ACCC will keep its members informed of its implications for cancer care providers. l

presents

Defining and Creating Clinical Excellence

April 10-12, 2013 Bally’s Hotel & Casino • Las Vegas, NV

www.aameda.org

3 Conferences – Oncology, Cardiovascular, Neuroscience – 1 Dynamic Location

Oncology track highlights: • Quality Metrics • Developing a Cancer Program • • 2013 Contracting Strategies • Building a Dashboard • • Rural Cancer Care • Multidisciplinary Clinical Care • • Growing Clinical Trial Enrollment • AAMA JOP Ad.indd 1

26

I

ONCOLOGY PRACTICE MANAGEMENT

12/12/12 11:40 AM

I March 2013

â&#x20AC;˘ Melanoma â&#x20AC;˘ Basal Cell Carcinoma â&#x20AC;˘ Cutaneous T-Cell Lymphoma â&#x20AC;˘ Squamous Cell Carcinoma â&#x20AC;˘ Merkel Cell Carcinoma

July 26-28, 2013

Hyatt Regency La Jolla â&#x20AC;˘ San Diego, California

PROGRAM OVERVIEW

CONFERENCE CO-CHAIRS

A 2-day congress dedicated to informing, educating, and fostering the exchange of clinically relevant information in the field of cutaneous malignancies on topics in melanoma, basal cell carcinoma, cutaneous T-cell lymphoma, squamous cell carcinoma, and Merkel cell carcinoma, including: â&#x20AC;˘ Epidemiology and genetic/environmental factors â&#x20AC;˘ Molecular biology and cytogenetics related to the pathogenesis of cutaneous malignancies â&#x20AC;˘ Risk stratification based on patient and tumor characteristics â&#x20AC;˘ Principles of cancer prevention of melanoma and basal cell carcinoma â&#x20AC;˘ Current treatment guidelines â&#x20AC;˘ Emerging treatment options for personalized therapy â&#x20AC;˘ Future strategies in management based on translational data from current clinical trials and basic research

LEARNING OBJECTIVES Upon completion of this activity, the participant will be able to: â&#x20AC;˘ Review the molecular biology and pathogenesis of cutaneous malignancies as they relate to the treatment of cutaneous T-cell lymphoma, basal cell carcinoma, Merkel cell tumors, and malignant melanoma â&#x20AC;˘ Compare risk stratification of patients with cutaneous malignancies, and how to tailor treatment based on patient and tumor characteristics â&#x20AC;˘ Summarize a personalized treatment strategy that incorporates current standards of care and emerging treatment options for therapy of patients with cutaneous malignancies

TARGET AUDIENCE This activity was developed for medical and surgical oncologists, dermatologists, radiation oncologists, and pathologists actively involved in the treatment of cutaneous malignancies. Advanced practice oncology or dermatololgy nurses, oncology pharmacists, and researchers interested in the molecular biology and management of cutaneous malignancies are also encouraged to participate.

DESIGNATION OF CREDIT STATEMENTS SPONSORS This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

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

Sanjiv S. Agarwala, MD Professor of Medicine Temple University School of Medicine Chief, Oncology & Hematology St. Lukeâ&#x20AC;&#x2122;s Cancer Center Bethlehem, Pennsylvania

REGISTERED NURSE DESIGNATION Medical Learning Institute Inc Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 12.0 contact hours.

REGISTERED PHARMACY DESIGNATION 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 12.0 contact hours (1.2 CEUs) of continuing pharmacy education credit. The Universal Activity Number for this activity is (To be determined).

CONFERENCE REGISTRATION EARLY BIRD REGISTRATION NOW OPEN! $175.00 UNTIL APRIL 30, 2013

www.CutaneousMalignancies.com

Professor Dr. Med. Axel Hauschild Professor, Department of Dermatology University of Kiel Kiel, Germany

AGENDA* FRIDAY, JULY 26, 2013 3:00 pm â&#x20AC;&#x201C; 7:00 pm

Registration

5:30 pm â&#x20AC;&#x201C; 7:30 pm

Welcome Reception/Exhibits

SATURDAY, JULY 27, 2013 7:00 am â&#x20AC;&#x201C; 8:00 am

Breakfast Symposium/Product Theater/Exhibits

8:00 am â&#x20AC;&#x201C; 8:15 am

BREAK

8:15 am â&#x20AC;&#x201C; 8:30 am

Welcome to the Second Annual World Cutaneous Malignancies Congress â&#x20AC;&#x201D; Setting the Stage for the Meeting - Sanjiv S. Agarwala, MD

8:30 am â&#x20AC;&#x201C; 11:45 am General Session I: A Clinicianâ&#x20AC;&#x2122;s Primer on the Molecular Biology of Cutaneous Malignancies â&#x20AC;˘ Keynote Lecture Understanding the Basic Biology and Clinical Implications of the Hedgehog Pathway â&#x20AC;˘ Keynote Lecture Pathogenesis of Merkel Cell Carcinoma: An Infectious Etiology? - Paul Nghiem, MD, PhD 12:00 pm â&#x20AC;&#x201C; 1:00 pm Lunch Symposium/Product Theater/Exhibits 1:00 pm â&#x20AC;&#x201C; 1:15 pm

BREAK

1:15 pm â&#x20AC;&#x201C; 4:30 pm

General Session II: Current Treatment Guidelines in Cutaneous Malignancies â&#x20AC;˘ Case Studies Optimal, Value-Based Therapy of Cutaneous Malignancies: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients â&#x20AC;˘ Panel Discussion Management Controversies and Accepted Guidelines for the Personalized Management of Cutaneous Malignancies â&#x20AC;˘ Keynote Lecture New Combinations in Melanoma: A Role for MEK + BRAF and Antiâ&#x20AC;&#x201C;PD-1

4:30 pm â&#x20AC;&#x201C; 6:30 pm

Meet the Experts/Networking/Exhibits

PHYSICIAN CREDIT DESIGNATION The Medical Learning Institute Inc designates this live activity for a maximum of 12.0 AMA PRA Category 1 Credits â&#x201E;˘. 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.

Steven J. Oâ&#x20AC;&#x2122;Day, MD Hematology/Oncology Director of Clinical Research Director of Los Angeles Skin Cancer Institute at Beverly Hills Cancer Center Clinical Associate Professor of Medicine USC Keck School of Medicine Los Angeles, California

SUNDAY, JULY 28, 2013 7:00 am â&#x20AC;&#x201C; 8:00 am

Breakfast Symposium/Product Theater/Exhibits

8:00 am â&#x20AC;&#x201C; 8:15 am

BREAK

8:15 am â&#x20AC;&#x201C; 8:30 am

Review of Saturdayâ&#x20AC;&#x2122;s Presentations and Preview of Todayâ&#x20AC;&#x2122;s Sessions

8:30 am â&#x20AC;&#x201C; 11:45 am General Session III: Review of Emerging Treatment Options for Cutaneous Malignancies General Session IV: Challenges for the Cutaneous Malignancies Clinician â&#x20AC;˘ Panel Discussion How Can the Healthcare Team Work Best Together to Deliver Value-Based Care in Cutaneous Malignancies?

12:00 pm â&#x20AC;&#x201C; 1:00 pm Lunch Symposium/Product Theater/Exhibits 1:00 pm â&#x20AC;&#x201C; 1:15 pm

BREAK

1:15 pm â&#x20AC;&#x201C; 2:45 pm

General Session V: â&#x20AC;&#x153;Hot Dataâ&#x20AC;? â&#x20AC;&#x201D; What I Learned at Recent Meetings: Focus on Cutaneous Malignancies

2:45 pm â&#x20AC;&#x201C; 3:00 pm

Closing Remarks - Steven J. Oâ&#x20AC;&#x2122;Day, MD

*Agenda is subject to change.

For complete agenda please visit www.CutaneousMalignancies.com

Drug Coding Supplied by RJ Health Systems

FDA-Approved 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 treatment of multiple myeloma.

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

28

I

FDA-approved for multiple myeloma

Compendia listed off-label uses for multiple myeloma

Generic (brand) name

HCPCS code: code description

arsenic trioxide (Trisenox)

J9017: Injection, arsenic trioxide, 1 mg

√

96413, 96415

betamethasone acetate and sodium phosphate (Celestone Soluspan)

J0702: Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg

√

11900, 11901, 20600, 20605, 20610, 96372

bortezomib (Velcade)

J9041: Injection, bortezomib, 0.1 mg

√

96409

carfilzomib (Kyprolis)

C9295: Injection, carfilzomib, 1 mg

√

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

ONCOLOGY PRACTICE MANAGEMENT

I March 2013

√

√

Possible CPT® administration codes

96409, 96413, 96415

N/A

Drug Coding Supplied by RJ Health Systems

FDA-approved for multiple myeloma

Compendia listed off-label uses for multiple myeloma

Generic (brand) name

HCPCS code: code description

dexamethasone (Decadron)

J1100: Injection, dexamethasone sodium phosphate, 1 mg

√

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

doxorubicin HCl (Adriamycin)

J9000: Injection, doxorubicin hydrochloride, 10 mg

√

96409

doxorubicin HCl liposomal (Doxil)

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

epirubicin (Ellence)

J9178: Injection, epirubicin HCl, 2 mg

√

96409, 96413

etoposide (Vepesid)

J8560: Etoposide, oral, 50 mg

√

N/A

etoposide (Etopophos, Toposar)

J9181: Injection, etoposide, 10 mg

√

96413, 96415

hydrocortisone (Solu-Cortef)

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

√

96365, 96366, 96372, 96374

hydrocortisone (Cortef)

J8499a: Prescription drug, oral, nonchemotherapeutic Not otherwise specified

√

N/A

ifosfamide (Ifex)

J9208: Injection, ifosfamide, 1g

√

96413, 96415

interferon alfa-2b (Intron-A)

J9214: Injection, interferon, alfa-2b, recombinant, 1 million units

√

96372, 96401

interferon alfa-n3 (Alferon-N)

J9215: Injection, interferon, alfa-n3 (human leukocyte derived), 250,000 IU

√

11900, 11901

lenalidomide (Revlimid)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

lomustine (CeeNu)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

√

N/A

lomustine (CeeNu)

S0178: Lomustine, oral, 10 mg

√

N/A

melphalan (Alkeran)

J8600: Melphalan, oral, 2 mg

√

N/A

melphalan (Alkeran)

J9245: Injection, melphalan hydrochloride, 50 mg

√

96409, 96413

methylprednisolone (Medrol)

J7509: Methylprednisolone, oral, per 4 mg

√

N/A

methylprednisolone (Depo-Medrol)

J1020: Injection, methylprednisolone acetate, 20 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Depo-Medrol)

J1030: Injection, methylprednisolone acetate, 40 mg

√

11900, 11901, 20600, 20605, 20610, 96372

96413

√

N/A

√

March 2013

Possible CPT® administration codes

I

www.OncPracticeManagement.com

I

29

Drug Coding Supplied by RJ Health Systems

FDA approved for multiple myeloma

Compendia listed off-label uses for multiple myeloma

Generic (brand) name

HCPCS code: code description

Possible CPT® administration codes

methylprednisolone (Depo-Medrol)

J1040: Injection, methylprednisolone acetate, 80 mg

√

11900, 11901, 20600, 20605, 20610, 96372

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

pomalidomide (Pomalyst)

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

√

N/A

pomalidomide (Pomalyst)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

√

N/A

prednisone (eg, Deltasone, Orasone)

J7506: Prednisone, oral, per 5 mg

√

N/A

procarbazine (Matulane)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

√

N/A

procarbazine (Matulane)

S0182: Procarbazine HCl, oral, 50 mg

√

N/A

thalidomide (Thalomid)

J8999a: Prescription drug, oral, chemotherapeutic Not otherwise specified

teniposide (Vumon)

Q2017: Injection, teniposide, 50 mg

√

96413, 96415

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

√

96413

vinCRIStine (Vincasar PFS)

J9370: Vincristine sulfate, 1 mg

√

96409

N/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 or 24A to ensure appropriate reimbursement.

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

References HCPCS Level II Expert 2013 • Current Procedural Terminology (CPT ®) 2013 (CPT copyright 2013 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Volumes 1 & 2, 2013 • FDAapproved 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) a

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

30

I

ONCOLOGY PRACTICE MANAGEMENT

I March 2013

RJ Health Systems The Creators of ReimbursementCodes.com

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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.

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

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Your source for reimbursement information related to Halaven

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RESOURCES Patient Assistance Program Coverage Scenarios FAQ FDA Approval Letter

Prescribing Information Eisai Assistance Program Enrollment Form Insurance Verification Form

Navigator is a registered trademark of Engage Healthcare Communicat may be reproduced or transmitted in any form or by any means now o recording, or any informational storage and retrieval system, without w

Halaven is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. Š 2012 Eisai Inc. All rights reserved. Printed in USA/September 2012 HALA0137 Ž

Eisai cannot guarantee payment of any claim. Coding, coverage, an and setting of care. Actual coverage and reimbursement decisions For additional information, customers should consult with their requirements. It is the sole responsibility of the provider to select seeking reimbursement. All services must be medically appropria

ment.com

n (eribulin mesylate) Injection 速

tions, LLC, an affiliate of The Lynx Group. No part of these materials or hereafter known, electronic or mechanical, including photocopy, written permission from the Publisher.

nd reimbursement may vary significantly by payor, plan, patient, s are made by individual payors following the receipt of claims. payors for all relevant coding, reimbursement, and coverage the proper code and ensure the accuracy of all claims used in ate and properly supported in the patient medical record.

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Physician Wealth Management With Lawrence B. Keller

Think You Earn Too Much Money to Contribute to a Roth IRA? Guess Again Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

A

lthough it has been a r o u n d since 1998 and is one of the best financial tools available, most oncologists, as high-income taxpayers, were unable to take advantage of the Roth IRA because Lawrence B. Keller of income limitations. However, as of January 1, 2010, that all changed when the income limit for Roth IRA conversions was eliminated. As a result, taxpayers earning more than $100,000 were suddenly eligible to convert their IRAs and other eligible retirement accounts to a Roth IRA. What Is a Roth IRA? A Roth IRA is an individual retirement account named after the late senator William V. Roth, Jr (R-Delaware) that allows you and your spouse to make nondeductible contributions to save for retirement. However, rather than growing on a tax-deferred basis, all qualified distributions are made on an income tax–free basis.

For 2012, an individual may directly contribute the lesser of $5000 or 100% of his or her annual compensation to a Roth IRA. For 2013, an individual may directly contribute the lesser of $5500 or 100% of his or her annual compensation to a Roth IRA. For a married couple, an additional $5000 or $5500, respectively, may be contributed on behalf of a lesser earning (or nonworking) spouse using a spousal account (Table).

In addition, if an IRA owner is

34

I

aged ≥50 years, he or she may contribute an additional $1000 (or $2000 if a spouse is also aged ≥50 years).

As with many tools that offer tax advantages, Congress has limited who can contribute to a Roth IRA based on income. A taxpayer can only contribute the maximum amount if his or her modified adjusted gross income (MAGI) is below a certain level. Otherwise, a phase out of allowed contributions

For 2013, an individual may directly contribute the lesser of $5500 or 100% of his or her annual compensation to a Roth IRA. For a married couple, an additional $5000 or $5500, respectively, may be contributed on behalf of a lesser earning (or nonworking) spouse.

runs throughout the MAGI ranges that are shown in the Table. Once the MAGI meets or exceeds the maximum of the range, no contribution is allowed at all.

Although it is true that individuals cannot make a direct contribution to a Roth IRA if their MAGI exceeds the published limits, they can still contribute through a loophole known as the “backdoor” Roth

ONCOLOGY PRACTICE MANAGEMENT

I March 2013

IRA, which effectively allows them to legally circumvent the limits and take advantage of the valuable benefits provided by a Roth IRA. How to Contribute to a Roth IRA If Your Income Exceeds These Limits Individuals can make a nondeductible (posttax) contribution to a traditional IRA. As soon as the contribution posts, they subsequently convert their nondeductible traditional IRA to a Roth IRA. The only additional tax that is due would be if their account increased in value from the time of the contribution until the time of the conversion.

The individual would then repeat these steps year after year until the backdoor Roth IRA loophole is closed by the government and is no longer available.

A Word of Caution If an individual has any other IRAs (including SEP-IRAs, SIMPLE IRAs, and/or rollover IRAs) that were funded with pretax dollars, the taxable portion of any conversion made is prorated over all of the IRAs. For example, if one had an IRA balance of $100,000 and only $5000 (5%) was funded with posttax contributions, then only 5% of any conversion would be income tax free, and the balance would be subject to ordinary income taxes.

The higher the percentage of posttax dollars (which are tracked

by Form 8606, a form that is attached to one’s federal income tax return) to the total value of the IRAs, the smaller the tax burden on the amount converted. Therefore, to really benefit from the backdoor Roth IRA, one must either con-

Physician Wealth Management

vert his or her other IRAs as well or transfer IRA contributions that were funded with pretax dollars to an employer-sponsored plan that accepts IRA rollovers so that all that remains are IRAs funded with posttax dollars.

Roth IRA Strengths Qualified Distributions Are Completely Income Tax Free A withdrawal from a Roth IRA (including both contributions and investment earnings) is completely income tax free and penalty free if (1) the withdrawal is made at least 5 years after a person first established any Roth IRA, and (2) if 1 of the following also applies: • You have reached age 59.5 years by the time of the withdrawal • The withdrawal is made as a re­ sult of a qualifying disability • The withdrawal is made for firsttime homebuyer expenses ($10,000 lifetime limit) • The withdrawal is made by your beneficiary or your eswtate after your death.

Withdrawals that meet these conditions are referred to as “qualified distributions.” If the above conditions are not met, any portion of a withdrawal that represents investment earnings will be subject to federal income tax and may also be subject to a 10% premature distribution tax if you are aged <59.5 years.

No Required Minimum Distributions Starting at Age 70.5 Years The IRS requires you to take annual required minimum distributions from traditional IRAs beginning when you reach age 70.5 years.

These withdrawals are calculated to dispose of all of the money in the traditional IRA over a given period of time. Roth IRAs are not subject to the required minimum distribution rule. In fact, you are not required to take a single dis-

Table.

Roth IRA contribution limits MAGI phase-out ranges

2012

2013

Single individuals

$110,000-$125,000

$112,000-$127,000

Married filing a joint income tax return

$173,000-$183,000

$178,000-$188,000

$0-$10,000

$0-$10,000

Married filing separate tax returns

MAGI indicates modified adjusted gross income.

tribution from a Roth IRA during your life (although distributions are generally required after your death).

not have to pay any federal income tax on postdeath distributions. Even if you have not satisfied the 5-year holding period at the time of your death, distributions to your beneficiary will still be tax free if he or she waits until the date you would have satisfied the 5-year holding period before taking the distributions. This can be a significant advantage in terms of your estate planning.

You Can Contribute to a Roth IRA after Age 70.5 Years Unlike traditional IRAs, you can contribute to a Roth IRA for every year that you have taxable compensation, including the year in which you reach age 70.5 years and every year thereafter.

Conclusion A backdoor Roth IRA might be a good option for oncologists who want to save more money for retirement and are already taking full advantage of employer-sponsored retirement plans. However, if you have any other IRAs, including SEP-IRAs and/or SIMPLE IRAs, that were funded with pretax dollars, the taxable portion of any conversion you make is prorated over all of your IRAs. As a result, collaboration between your financial advisor and your tax professional is essential. l

A backdoor Roth IRA might be a good option for oncologists who want to save more money for retirement and are already taking full advantage of employer-sponsored retirement plans.

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.

No Income Taxation to Your Beneficiary on Withdrawals from Inherited Roth IRAs As long as any Roth IRA you have established has been in existence for at least 5 years at the time of your death, your beneficiary will

March 2013

I

www.OncPracticeManagement.com

I

35

ZYTIGA® (abiraterone acetate) Tablets Brief Summary of Prescribing Information.

INDICATIONS AND USAGE ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

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

WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1) in full Prescribing Information]. In the two randomized clinical trials, grade 3 to 4 hypertension occurred in 2% of patients, grade 3 to 4 hypokalemia in 4% of patients, and grade 3 to 4 edema in 1% of patients treated with ZYTIGA [see Adverse Reactions].

Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in the incidence and severity of these adverse reactions. Use caution when treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, e.g., those with heart failure, recent myocardial infarction or ventricular arrhythmia. Use ZYTIGA with caution in patients with a history of cardiovascular disease. The safety of ZYTIGA in patients with left ventricular ejection fraction < 50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials [see Clinical Studies (14) in full Prescribing Information]. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with ZYTIGA. Adrenocortical Insufficiency: Adrenal insufficiency occurred in the two randomized clinical studies in 0.5% of patients taking ZYTIGA and in 0.2% of patients taking placebo. Adrenocortical insufficiency was reported in patients receiving ZYTIGA in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations [see Warnings and Precautions].

Hepatotoxicity: In the two randomized clinical trials, grade 3 or 4 ALT or AST increases (at least 5X ULN) were reported in 4% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. Patients whose baseline ALT or AST were elevated were more likely to experience liver test elevation than those beginning with normal values. Treatment discontinuation due to liver enzyme increases occurred in 1% of patients taking ZYTIGA. No deaths clearly related to ZYTIGA were reported due to hepatotoxicity events.

Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced ZYTIGA dose of 250 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt ZYTIGA treatment and closely monitor liver function.

Re-treatment with ZYTIGA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [see Dosage and Administration (2.2) in full Prescribing Information].

The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown.

Increased ZYTIGA Exposures with Food: ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. The safety of these increased exposures when multiple doses of abiraterone acetate are taken with food has not been assessed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

ZYTIGA® (abiraterone acetate) Tablets ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Hypertension, Hypokalemia, and Fluid Retention due to Mineralocorticoid Excess [see Warnings and Precautions].

• Adrenocortical Insufficiency [see Warnings and Precautions].

• Hepatotoxicity [see Warnings and Precautions].

• Increased ZYTIGA Exposures with Food [see Warnings and Precautions].

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

Two randomized placebo-controlled, multicenter clinical trials enrolled patients who had metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy. In both Study 1 and Study 2 ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arms. Placebo plus prednisone 5 mg twice daily was given to control patients.

The most common adverse drug reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) reported in the two randomized clinical trials that occurred more commonly (≥2%) in the abiraterone acetate arm were anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Study 1: Metastatic CRPC Following Chemotherapy: Study 1 enrolled 1195 patients with metastatic CRPC who had received prior docetaxel chemotherapy. Patients were not eligible if AST and/or ALT ≥ 2.5X ULN in the absence of liver metastases. Patients with liver metastases were excluded if AST and/or ALT > 5X ULN. Table 1 shows adverse reactions on the ZYTIGA arm in Study 1 that occurred with a ≥2% absolute increase in frequency compared to placebo or were events of special interest. The median duration of treatment with ZYTIGA was 8 months.

Table 1: Adverse Reactions due to ZYTIGA in Study 1 ZYTIGA with Placebo with Prednisone (N=791) Prednisone (N=394) 1 System/Organ Class All Grades Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % Musculoskeletal and connective tissue disorders 29.5 4.2 23.4 4.1 Joint swelling/discomfort2 Muscle discomfort3 26.2 3.0 23.1 2.3 General disorders Edema4 26.7 1.9 18.3 0.8 Vascular disorders Hot flush 19.0 0.3 16.8 0.3 Hypertension 8.5 1.3 6.9 0.3 Gastrointestinal disorders Diarrhea 17.6 0.6 13.5 1.3 Dyspepsia 6.1 0 3.3 0 Infections and infestations Urinary tract infection 11.5 2.1 7.1 0.5 Upper respiratory tract infection 5.4 0 2.5 0 Respiratory, thoracic and mediastinal disorders Cough 10.6 0 7.6 0 Renal and urinary disorders Urinary frequency 7.2 0.3 5.1 0.3 Nocturia 6.2 0 4.1 0 Injury, poisoning and procedural complications Fractures5 5.9 1.4 2.3 0 Cardiac disorders Arrhythmia6 7.2 1.1 4.6 1.0 Chest pain or chest 7 discomfort 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.3 1 Adverse

events graded according to CTCAE version 3.0 terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness

2 Includes 3 Includes

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

4 Includes

1 Adverse

edema

terms Edema, Edema peripheral, Pitting edema, and Generalized

5 Includes 6 Includes

all fractures with the exception of pathological fracture terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia 7 Includes terms Angina pectoris, Chest pain, and Angina unstable.

Myocardial infarction or ischemia occurred more commonly in the placebo arm than in the ZYTIGA arm (1.3% vs. 1.1% respectively).

8 Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction, Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased Table 2 shows laboratory abnormalities of interest from Study 1. Grade 3-4 low serum phosphorus (7%) and low potassium (5%) occurred at a greater than or equal to 5% rate in the ZYTIGA arm.

Table 2: Laboratory Abnormalities of Interest in Study 1 Abiraterone (N=791) Placebo (N=394) Laboratory All Grades Grade 3-4 All Grades Grade 3-4 Abnormality (%) (%) (%) (%) Hypertriglyceridemia 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Hypokalemia 28.3 5.3 19.8 1.0 Hypophosphatemia 23.8 7.2 15.7 5.8 High ALT 11.1 1.4 10.4 0.8 High Total Bilirubin 6.6 0.1 4.6 0 Study 2: Metastatic CRPC Prior to Chemotherapy Study 2 enrolled 1088 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥ 2.5X ULN and patients were excluded if they had liver metastases.

Table 3 shows adverse reactions on the ZYTIGA arm in Study 2 that occurred with a ≥ 2% absolute increase in frequency compared to placebo.

The median duration of treatment with ZYTIGA was 13.8 months.

Table 3: Adverse Reactions in ≥5% of Patients on the ZYTIGA Arm in Study 2 ZYTIGA with Placebo with Prednisone (N=542) Prednisone (N=540) 1 System/Organ Class All Grades Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % General disorders Fatigue 39.1 2.2 34.3 1.7 Edema2 25.1 0.4 20.7 1.1 Pyrexia 8.7 0.6 5.9 0.2 Musculoskeletal and connective tissue disorders Joint swelling/ discomfort3 30.3 2.0 25.2 2.0 Groin pain 6.6 0.4 4.1 0.7 Gastrointestinal disorders Constipation 23.1 0.4 19.1 0.6 Diarrhea 21.6 0.9 17.8 0.9 Dyspepsia 11.1 0.0 5.0 0.2 Vascular disorders Hot flush 22.3 0.2 18.1 0.0 Hypertension 21.6 3.9 13.1 3.0 Respiratory, thoracic and mediastinal disorders Cough 17.3 0.0 13.5 0.2 Dyspnea 11.8 2.4 9.6 0.9 Psychiatric disorders Insomnia 13.5 0.2 11.3 0.0 Injury, poisoning and procedural complications Contusion 13.3 0.0 9.1 0.0 Falls 5.9 0.0 3.3 0.0 Infections and infestations Upper respiratory tract infection 12.7 0.0 8.0 0.0 Nasopharyngitis 10.7 0.0 8.1 0.0 Renal and urinary disorders Hematuria 10.3 1.3 5.6 0.6 Skin and subcutaneous tissue disorders Rash 8.1 0.0 3.7 0.0

events graded according to CTCAE version 3.0 terms Edema peripheral, Pitting edema, and Generalized edema 3 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 2 Includes

Table 4 shows laboratory abnormalities that occurred in greater than 15% of patients, and more frequently (>5%) in the ZYTIGA arm compared to placebo in Study 2. Grade 3-4 lymphopenia (9%), hyperglycemia (7%) and high alanine aminotransferase (6%) occurred at a greater than 5% rate in the ZYTIGA arm.

Table 4: Laboratory Abnormalities in > 15% of Patients in the ZYTIGA Arm of Study 2 Abiraterone (N = 542) Placebo (N = 540) Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Laboratory Abnormality % % % % Hematology Lymphopenia 38.2 8.7 31.7 7.4 Chemistry Hyperglycemia1 56.6 6.5 50.9 5.2 High ALT 41.9 6.1 29.1 0.7 High AST 37.3 3.1 28.7 1.1 Hypernatremia 32.8 0.4 25.0 0.2 Hypokalemia 17.2 2.8 10.2 1.7 1Based on non-fasting blood draws Cardiovascular Adverse Reactions: In the combined data for studies 1 and 2, cardiac failure occurred more commonly in patients treated with ZYTIGA compared to patients on the placebo arm (2.1% versus 0.7%). Grade 3-4 cardiac failure occurred in 1.6% of patients taking ZYTIGA and led to 5 treatment discontinuations and 2 deaths. Grade 3-4 cardiac failure occurred in 0.2% of patients taking placebo. There were no treatment discontinuations and one death due to cardiac failure in the placebo group.

In Study 1 and 2, the majority of arrhythmias were grade 1 or 2. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arms and no deaths in the placebo arms. There were 7 (0.5%) deaths due to cardiorespiratory arrest in the ZYTIGA arms and 3 (0.3%) deaths in the placebo arms. Myocardial ischemia or myocardial infarction led to death in 3 patients in the placebo arms and 2 deaths in the ZYTIGA arms.

DRUG INTERACTIONS Effects of Abiraterone on Drug Metabolizing Enzymes: ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) in full Prescribing Information].

In vitro, ZYTIGA inhibits CYP2C8. There are no clinical data on the use of ZYTIGA with drugs that are substrates of CYP2C8. However, patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Avoid or use with caution, strong inhibitors and inducers of CYP3A4 during ZYTIGA treatment [see Clinical Pharmacology (12.3) in full Prescribing Information].

USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications].: ZYTIGA can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. While there are no adequate and well-controlled studies with ZYTIGA in pregnant women and ZYTIGA is not indicated for use in women, it is important to know that maternal use of a CYP17 inhibitor could affect development of the fetus. Abiraterone acetate caused developmental toxicity in pregnant rats at exposures that were lower than in patients receiving the recommended dose. ZYTIGA is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with ZYTIGA.

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

In an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6-17). Findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/ day. Doses ≥10 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 0.03, 0.1 and 0.3 times, respectively, the AUC in patients.

Nursing Mothers: ZYTIGA is not indicated for use in women. It is not known if abiraterone acetate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ZYTIGA, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

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

Geriatric Use: Of the total number of patients receiving ZYTIGA in phase 3 trials, 73% of patients were 65 years and over and 30% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Patients with Hepatic Impairment: The pharmacokinetics of abiraterone were examined in subjects with baseline mild (n = 8) or moderate (n = 8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone after a single oral 1,000 mg dose of ZYTIGA increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function.

No dosage adjustment is necessary for patients with baseline mild hepatic impairment. In patients with baseline moderate hepatic impairment (ChildPugh Class B), reduce the recommended dose of ZYTIGA to 250 mg once daily. If elevations in ALT or AST >5X ULN or total bilirubin >3X ULN occur in patients with baseline moderate hepatic impairment, discontinue ZYTIGA treatment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

The safety of ZYTIGA in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA. For patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Clinical Pharmacology (12.3) in full Prescribing Information].

Patients with Renal Impairment: In a dedicated renal impairment trial, the mean PK parameters were comparable between healthy subjects with normal renal function (N=8) and those with end stage renal disease (ESRD) on hemodialysis (N=8) after a single oral 1,000 mg dose of ZYTIGA. No dosage adjustment is necessary for patients with renal impairment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

OVERDOSAGE There have been no reports of overdose of ZYTIGA during clinical studies.

There is no specific antidote. In the event of an overdose, stop ZYTIGA, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function.

Storage and Handling: Store at 20oC to 25oC (68oF to 77oF); excursions permitted in the range from 15oC to 30oC (59oF to 86°F) [see USP controlled room temperature].

Based on its mechanism of action, ZYTIGA may harm a developing fetus.

Therefore, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves [see Use in Specific Populations].

• Patients receiving GnRH agonists should be informed that they need to maintain this treatment during the course of treatment with ZYTIGA and prednisone.

• Patients should be informed that ZYTIGA must not be taken with food and that no food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. They should be informed that the tablets should be swallowed whole with water without crushing or chewing. Patients should be informed that taking ZYTIGA with food causes increased exposure and this may result in adverse reactions.

• Patients should be informed that ZYTIGA is taken once daily and prednisone is taken twice daily according to their physician’s instructions.

• Patients should be informed that in the event of a missed daily dose of ZYTIGA or prednisone, they should take their normal dose the following day. If more than one daily dose is skipped, patients should be told to inform their physician.

• Patients should be apprised of the common side effects associated with ZYTIGA, including peripheral edema, hypokalemia, hypertension, elevated liver function tests, and urinary tract infection. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. • Patients should be advised that their liver function will be monitored using blood tests.

• Patients should be informed that ZYTIGA may harm a developing fetus; thus, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves. Patients should also be informed that it is not known whether abiraterone or its metabolites are present in semen and they should use a condom if having sex with a pregnant woman. The patient should use a condom and another effective method of birth control if he is having sex with a woman of child-bearing potential. These measures are required during and for one week after treatment with ZYTIGA.

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) • Patients should be informed that ZYTIGA and prednisone are used together and that they should not interrupt or stop either of these medications without consulting their physician.

Manufactured by: Patheon Inc. Mississauga, Canada Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044 © Janssen Biotech, Inc. 2012 Revised: December 2012 2000005445 K08Z121174A

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

IMPORTANT SAFETY INFORMATION

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Contraindications ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant.

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

Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.

Adrenocortical Insufficiency (AI) AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®.

Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

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

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

Adverse Reactions The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Drug Interactions ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on its use with drugs that are substrates of CYP2C8. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors or inducers on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution during treatment with ZYTIGA®.

Use in Specific Populations Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).

Please see Brief Summary of Prescribing Information on adjacent pages.

© Janssen Biotech, Inc. 2013

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

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1-855-ZYTIGA-1 (998-4421) Monday–Friday, 8:00 AM–8:00 PM ET ACCESS TO ZYTIGA® SIMPLIFIED FOR YOU AND YOUR PATIENTS Also available online at janssenaccessone.com

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

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

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

Janssen Biotech assumes no responsibility for, and does not guarantee the quality, scope, or availability of the services including but not limited to reimbursement support services, patient education, and other support services. Each provider, not Janssen Biotech, is responsible for the services they provide. These support services have no independent value to providers apart from the product and are included within the cost of the product. © Janssen Biotech, Inc. 2013

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