OPM April 2013 by Value-Based Cancer Care

Oncology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

www.OncPracticeManagement.com

APRIL 2013

VOLUME 3 • NUMBER 3

Three Steps to Better New Federal Reporting Profiles Reimbursement for Physicians and Hospitals Oncology Practices By Gail Thompson By Elaine Kloos, RN, NE-BC, MBA, and Teri U. Guidi, MBA, FAAMA

he American healthcare system is clearly evolving. Although dramatic changes are likely, these changes will be neither instant nor universal. Thus, Elaine Kloos to optimize revenue, it remains extremely important to understand the current reimbursement situation.

Step 1. Know Thy Payer There are currently 2 major types of insurance contracts—fee for service and percent of charges. The latter usually only exists for hospitals. To achieve optimal reimbursement under either type of contract, the provider must understand the payer’s rules and policies. Edits. These rules, established by the Continued on page 10

Orlando, FL—At the Community Oncology Alliance (COA)’s 2013 annual conference on March 22, 2013, David Eagle, MD, from Lake Norman Hematology Oncology Specialists in North Carolina, presented an illuminating program on the rapid growth of federal reporting on physicians and hospitals in the name of quality. Provocatively entitled, “You Won’t

Believe What CMS Will Be Reporting on Your Oncologists,” Dr Eagle presented the challenges and the details of the information that the federal government is now collecting and reporting. Key federal quality initiatives are now involved in comparing hospitals, comparing physicians, and also building quality and resource-use reports as well as a physician value-based payment modifier. Continued on page 18

Meaningful Use Stage 1 Now Met by Majority of Hospitals By Caroline Helwick

New Orleans, LA—The majority of healthcare “leaders,” primarily hospitals, have qualified for Meaningful Use Stage 1, according to the 24th Annual Health Information and Management Systems Society (HIMSS) Leadership Survey (http://himss.files.cms-plus.com/HIMSS org/Content/files/leadership_FINAL_RE

PORT_022813.pdf.). The survey, released at the HIMSS annual conference, indicates that the government’s efforts to impact provider investments in information technologies (ITs) to qualify for Meaningful Use and International Classification of Diseases, Tenth Revision (ICD-10) conversions are paying off. Continued on page 23

From the publishers of

of n it o s D ia ter d VI ssocCen vide O Ar i 4 PR y thenceally Ds...3 n a D N ou bity CntinuMea A y T t to mun Coress N h m a g TIE roug Co hatCon A B W

INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM

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

Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients 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, Randomized to PROVENGE controlled clinical trials. The control was non-activated autologous peripheral blood PROVENGE (N = 601) Control* (N = 303) 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)

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

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

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.

GBC_2013Conf_vertical_62512_Layout 1 7/11/12 11:38

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. I n 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.

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From the Editor

With Policy and Management, Are We Gaining or Losing Ground in the War on Cancer? By Dawn Holcombe, MBA, FACMPE, ACHE

n 1971, President Nixon declared the war on cancer. Millions of dollars flooded into research facilities, and by the early 1990s, we reaped the benefits of those investments as new anticancer agents and supportive care drugs arrived to help us better manage the disease and its side effects. Cancer treatment rapidly migrated to physician offices designed as acute care facilities that allowed patients to receive cutting-edge care in a comfortable and focused environment, with highly trained, specialized professional staff and physicians leading the care teams. Through the evolution of the community care model and the new arsenal of cancer treatments, patients found ways to integrate their treatment with their daily lives, often continuing to work and function as part of their families. However, rising pric-

es on new treatments and increasing combination treatment options posed new questions about the clinical and financial oversight and management of the cancer treatment process. It has not been easy for the clinical community to answer those questions and concerns, especially because the technological systems to support and track patient clinical care and status did not evolve as quickly as the treatment and, in many settings, still track only the basic information needed to process and administer a billing claim for treatment. Many groups within the oncology community are starting to build technology solutions and data collection that will help us to answer challenges to medical treatment choices and the resulting patient outcomes. The nature of oncology is such that the US Food and Drug Administration

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

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

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

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

Risë Marie Cleland President Oplinc, Inc Lawton, OK

Continued on page 8

Editorial Advisory Board

Editor-in-Chief

Peggy Barton, RN Practice Manager Toledo Clinic, OH

(FDA) approves new drugs, but ongoing research and studies often discover applications for these drugs that extend beyond the initial “FDA label.” We have a strong culture and process for considering treatment options that are so-called off-label in relation to the original FDA indication, but have been established through oncology compendia and peer-reviewed literature to offer additional value in battling cancer since the first FDA approval of that drug. Payers and employers commonly express concern about needing better guidance regarding appropriateness of “off-label” cancer treatments, and more frequently challenge the care a physician might recommend as lacking sufficient evidence for approval to pay.

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

April 2013

www.OncPracticeManagement.com

In This Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nick@engagehc.com Vice President, Director of Sales & Marketing Joe Chanley joe@engagehc.com Publisher Cristopher Pires cris@engagehc.com Director, Client Services Lou Lesperance lou@greenhillhc.com Editorial Director Dalia Buffery dalia@engagehc.com Managing Editor Lisa Neuman Associate Editor Lara J. Lorton

By Dawn Holcombe, MBA, FACMPE, ACHE

Features

Three Steps to Better Reimbursement for Oncology Practices........................1 By Elaine Kloos, RN, NE-BC, MBA, and Teri U. Guidi, MBA, FAAMA

New Federal Reporting Profiles Physicians and Hospitals...................................1 By Gail Thompson

Meaningful Use Stage 1 Now Met by Majority of Hospitals...............................1 By Caroline Helwick

The Value of Community Oncology: Proximity, Availability, Access, and Cost....................................................................................................24 By Lisa Neuman

A Plan to Fix Cancer Care.....................................................................................38 By Ezekiel Emanuel

Production Manager Marie RS Borrelli

FDA-Approved Medications Used for the Treatment of Colorectal Cancer............................................................................. 28

Chief Operating Officer Pam Rattanonont Ferris Vice President of Finance Andrea Kelly Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Travean Digital Programmer Michael Amundsen Senior Project Manager Andrea Boylston Project Coordinators Deanna Martinez Jackie Luma Business Manager Blanche Marchitto Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

With Policy and Management, Are We Gaining or Losing Ground in the War on Cancer?…....................................................................................... 5

Editorial Assistants Jennifer Brandt Cara Guglielmon

The Lynx Group President/CEO Brian Tyburski

From the Editor

Drug Coding

Departments

MEDICAL LEGAL UPDATE Understanding the National Practitioner Data Breach Notification Requirements.....................................................................32 By Jennifer Kirschenbaum, Esq

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

What a Continually Divided Congress Means for Community Oncology……….......................................................................... 34 By Sydney Abbott, JD

PHYSICIAN WEALTH MANAGEMENT Joint Tenants with Rights of Survivorship: Planning Pitfalls to Consider............36 By Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF 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 reimbursment, staffing, electronic health records, REMS, and compliance with state and federal regulations.

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

From the Editor

With Policy and Management Are We…Continued from page 5 It now sometimes seems that we are embroiled in a race for control of medical decision-making and costs that could dramatically change the face of cancer care and the “war on cancer” in future decades. Although most treatments are still delivered in physician offices and outpatient centers, organizational relationships are changing. Increasingly, cancer care is delivered in larger, integrated settings (whether hospital-based or large group practices) that can serve to either enhance the sharing of clinical information and care parameters, or possibly increase the opportunities for communication gaps and possibly higher costs in more complex settings. At the same time, we are pushing for better information systems to yield the data we need to improve our own internal oversight and management of cancer care, and some of the new delivery sites utilize legacy systems with more limited oncology specialization than previous sites possessed. Many hospital-based systems are notorious for multispecialty capabilities with little strength in oncology-specific needs, which can create integration and management difficulties when formerly private oncology practices, with oncology-specific systems, are acquired. Federal policy is increasing the pressure for the development of accountable care organizations that, although not yet focused on oncology, are geared to support patient support systems and infrastructures that are likely to break down traditional care “silos” and move oversight and clinical decision-making into a more collaborative team environment. This, in turn, may make it more difficult for the private physician practice to function independently, and it may very likely evolve into bundled payment reforms that will present challenges to a freestanding physician practice. Cost pressures and the

reduction of variation to meet bundled payment restrictions could then lead to the shrinking of innovation in care and in treatment, and possibly even a reduction of innovation in research and drug development—the exact opposite effect created when President Nixon declared the war on cancer just 40+ years ago.

Many groups within the oncology community are starting to build technology solutions and data collection that will help us to answer challenges to medical treatment choices and the resulting patient outcomes. Oncology management and oversight are proposed by external companies in the specialty pharmacy and oncology guidelines markets, even management of care delivered in the medical benefit (physician-delivered care and drugs), not just the pharmaceutical benefit. At the same time, the oncology community is ramping up its own individual and collective forays into oncology management, monitoring, tracking, and reaching out to payers and employers for new relationships and negotiations. These external companies are also reaching out to payers and employers to offer a single point of contact and solution to the challenge of complex oncology management. Will we resolve these information technology and data collection demands quickly enough to retain

ONCOLOGY PRACTICE MANAGEMENT

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our ownership of the clinical management and decision-making for cancer care? Will we collaborate across diverse healthcare organizations and agree on policy and standards for oncology management and delivery originating from the healthcare professionals who have specifically trained for oncology management in time to bring these clinically driven solutions to the table with payers and employers, without falling into the traditional differences of practice and opinion that could undermine our negotiating position and presence? Will we be able to scale up on a more universal basis some of the projects and pilots that have been developed in recent years in the oncology community across organizations as diverse as outpatient centers and private oncology practices, leaving the competition between those groups to differences of geography and service but keeping agreement on process and clinical decision-making? Or will we find ourselves, in the near future—no matter what our own organizational structure is—following the universal policies and approval mechanisms of an external vendor that has contracted with payers and employers to run the approval processes, collecting clinical data in support of authorization requests that is then housed outside of the patient medical record and used to justify future clinical decisions for similar patients? Although many payers and employers would like to engage individual practices, cancer centers, or multiple representatives in the oncology community, these are large organizations with responsibility for millions of covered lives and contracts, only a fraction of which are from the oncology community. The more unified the oncology community is regarding clinical decisions and processes and

From the Editor

“evidence” for treatment choices and alternatives, the harder it will be for payers or employers to embrace an external vendor solution that is likely to use different parameters and choices. The less unified we are, the more attractive single oncology policy and oversight services from an external vendor may be to the payers who are beleaguered by rising costs and pressures, even in a complex field such as oncology. So, it may be important to consider how you relate clinically to other cancer groups in your area and in

your state. Is everyone seeking their “own” solutions? Is everyone going individually to payers and employers with different proposals? The clinical decision-making process should be—but has not been—fairly consistent across the oncology community, and that variation has weakened our ability to advocate for our patients with payers and with employers. Your state oncology associations may prove very useful in housing these types of central clinical discussions across the diverse providers in the community.

There will always be competitive differences in service, access, and environment between the medical communities, but if we allow clinical decision-making processes to vary significantly, we are opening the door wide for external vendor solutions to be imposed on us. In the process, we may just start losing the war on cancer. If innovation and clinical advances are restricted by external company parameters on medical decision-making, a slippery slope may be created—one that will be difficult to slow. l

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April 2013

www.OncPracticeManagement.com

Reimbursement in Oncology

Three Steps to Better Reimbursement…Continued from page 1 payer, restrict the specific items that may be billed and under what circumstances. For example, most payers will not accept charges for a port flush on the same day as an infusion, and many payers will only accept Teri U. Guidi, MBA, intensity-modulated FAAMA radiation therapy (IMRT) charges for selected diagnoses. Utilization limits. These rules may limit the number of times that a particular service may be billed either at a single encounter or over a complete course of treatment. Port films would be an example of this type of rule. Coding details. Most payers accept the traditional Healthcare Common Procedure Coding System (HCPCS) and Current Procedural Terminology (CPT) codes, but in some cases payers require the use of alternate codes—for example, J2405 ondansetron 1 mg versus S0119 ondansetron 4 mg. Using the payer’s preferred codes is vital to avoiding nonpayment. In addition, modifiers can be payer-specific, as with the use of the JW modifier to indicate billable drug waste or the use of a modifier for twice-daily radiation treatment. Time limits. All payers have established limits for the timely filing of claims. Medicare permits billing (either initial or amended) for up to 1 year from the date of service. Other payers are often far less generous. Coverage. Payers are largely at liberty to determine what services will be reimbursed, so it is crucial for physicians’ office staff and hospital staff to check first by obtaining precertification and/or preauthori-

zations. Approvals may stipulate limits on items such as the number of treatments or the number of days that are approved. Payer processes. Because each payer is unique, all staff handling the payer process must be familiar with the various processes for filing, amending, and appealing claims. In terms of billing and reimburse-

Payers are largely at liberty to determine what services will be reimbursed, so it is crucial for physicians’ office staff and hospital staff to check first by obtaining precertification and/ or preauthorizations. Approvals may stipulate limits on items such as the number of treatments or the number of days that are approved. ment, much remains to be seen. Although the emerging “bundled payment” systems may not retain many of the current requirements and payer-specific rules, the use of HCPCS/CPT codes is not likely to cease, because they provide a means of tracking the kind of details that would be necessary in shared savings or in similar approaches. Documentation Clear, complete, and compliant documentation is also de rigueur

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

under the current system. Without appropriate documentation, an external “unfriendly” audit could easily result in significant repayment and/or substantial penalties. Orders. Even when the ordering physician is external to the treatment department (eg, infusion or radiation), the treating entity’s chart must include documentation that the treatment was ordered by a qualified provider, and that it is medically necessary. For infusion therapy, this includes drug, dose, route, and duration. For radiation therapy, this includes prescriptions and requests for special physics consults. Furthermore, the documentation for specific radiation modalities (eg, IMRT, image-guided radiation therapy) must include sufficient patient-specific information to ensure that medical necessity is clearly established. Whether for infusion or radiation, there must be “source documentation” (ie, something directly from or signed by a qualified physician) of all applicable clinical diagnoses, as well as backup documentation explaining the medical necessity, such as a history and physical examination or progress notes. Drugs and infusions. In cases where it is acceptable to bill for wasted drug (Table 1, page 12), the patient’s medical record must include documentation (by either pharmacy or nursing) of the amount of drug wasted and the reason for the waste. Nursing documentation of the actual drug delivery must include the drug name, the dose administered, the route, and the duration of administration. The latter should always note both the start and stop times for all intravenous infusions, regardless of the drug (eg, chemotherapy, biologics, supportive medications) and regardless of

Continued on page 12

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

Reimbursement in Oncology

Three Steps to Better Reimbursement…ontinued from page 10 Table 1. Billing for Waste • The billing of drug waste is appropriate only to a single-use vial or a single-use package • The provider must make a good-faith effort to schedule patients so that the use of drugs is efficient and medically appropriate (ie, administering an unused portion of a drug package to another patient) • Any waste reimbursed by Medicare must not be billed for use on any other patient • Coverage does not apply if the provider chooses to purchase larger packages (for a lower per-unit cost) when smaller, more appropriate packaging is available • In terms of documentation, the discarded drugs must be noted in the medical record, including the date and time of discharge, the amount of product used, the amount of product wasted, and the reason for the waste • Check with your fiscal intermediaries and/or Medicare Administrative Contractors to determine if the JW modifier is required on the claim

the total duration (even for short infusions of less than 15 minutes).

Step 2. Reduce Nonpayment The provider’s processes can make or break the provider’s financial performance. The 2 most im portant processes at the front end are the chemotherapy/radiation pause and the financial advocate. Chemotherapy/radiation pause. Before a patient receives any services, there must be time for staff to verify that the patient has insurance, and that the planned care is covered. This includes obtaining preauthorizations and precertifications at the most detailed level possible so that the staff can keep track of when the patient’s insurance benefits run out. Whenever possible, these preapprovals should be obtained in writing to reduce the risk of future misunderstandings. Financial advocate. Even with insurance coverage, patients generally must bear some financial responsibility for their treatment. Addressing this responsibility with the patient before the therapy begins is not only good business but

is a courtesy to the patient. In addition, if the patient’s responsibility is large, the provider and the patient can benefit by working together to obtain financial assistance for the patient. That assistance can come from numerous sources, such as

Before a patient receives any services, there must be time for staff to verify that the patient has insurance, and that the planned care is covered. charitable patient-assistance foundations, application for Medicaid or other supplemental insurance, and pharmaceutical drug replacement programs. Recognizing the importance of the role of a financial advocate, the Association of Community Cancer Centers (ACCC) has developed an educational program and tool kit for

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

financial advocates for its members (accessible to members at http:// accc-cancer.org/education/Finan cialCounseling-Toolkit.asp). Back-end processes. Of equal importance, the back-end processes include monitoring and tracking payments to ensure that insurers are adhering to the contract and to identify any patterns of nonpayment that can be altered by a change in processes, such as ensuring that the correct diagnosis code finds its way to the claim. Note that many payers use the term “not covered” on the explanation of benefits or remittance advice rather than using the term “denied.” Any unpaid item on a claim should be examined before simply writing it off. If the nonpayment can be corrected by providing more accurate information, the claim should be resubmitted. If the nonpayment seems inappropriate upon a review of the payer’s policies, an appeal should be filed. The ACCC tool kit mentioned above includes sample letters and other information regarding appeals, as well as tracking forms, sample scripts, job descriptions, and more.

Step 3. Eliminate Missed Charges Excellent documentation not only ensures compliance, it is also the source of information for charge entry. If billable items and related information is not well documented, the appropriate charges cannot be captured and charged. Furthermore, if the automated software (ie, a claim-scrubbing program) rejects charges entered into the system, billers need to be able to research the issue and perhaps add a modifier or obtain an additional physician-assigned diagnosis. Therefore, it behooves providers Continued on page 14

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Reimbursement in Oncology

Three Steps to Better Reimbursement…Continued from page 12 Table 2. Most Frequently Missed Radiation Charges Medicare outpatient prospective payment system payment, $

Medicare freestanding global payment, $

Dose calculations/77300

109.73

66.69

Treatment devices/77332

201.76

80.29

Treatment devices/77333

201.76

51.03

Treatment devices/77334

201.76

150.04

Treatment devices/77338

290.88

501.16

Weekly physics checks/77336

109.73

43.89

Special treatment procedure/77470

392.41

151.40

Description/code

Table 3. Most Frequently Missed/Erroneous Infusion Charges Medicare outpatient prospective payment system payment, $

Medicare freestanding global payment, $

Confusing chemo additional hours/96415 with Sequential chemo drug/96417

74.69

58.52

74.69

71.11

Improperly billing for hydration/96360 Improperly billing for hydration/96361

74.69

58.52

27.01

15.31

Missing additional intravenous (chemo) hours/96415

39.13

30.62

Varies widely

Description/code

Billing for single-dose drug waste

to pay close attention to their processes, to ensure that each task is assigned to the most knowledgeable individual. In our experience, we find that the selection of billing codes is best assigned to coders who know how to read clinical documentation rather than having clinical staff members identify the billable codes. Most providers believe that they

are doing their utmost to ensure perfect results, but an independent external audit will nearly always find items that, although seemingly small, can add up to substantial missed revenue given the recurring nature of oncology services. Table 2 lists the most frequently missed radiation charges. For example, when we reviewed 16 radiation treatment courses for

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

one of our clients, we found erroneous charges representing $2663 of Medicare reimbursement that should be corrected. If these errors were corrected, the missed charges would total $9640 (again, defined as Medicare reimbursements). Alone, this does not seem particularly significant. However, assuming that these 16 treatment courses were relatively representative of all the courses delivered in 1 year, and with an annual volume of 832 treatment courses, this represents an opportunity to improve revenue by $501,280 annually. The most frequently missed or most erroneous infusions are listed in Table 3. For example, consider a recent audit of 32 treatment encounters. With $291 in erroneous charges/payments and $1390 in missed and corrected charges/ payments at a very busy center (with more than 15,500 encounters annually), the annual revenue increase totaled $673,281. In addition, for just these 32 encounters, the unbilled drug waste totaled $4417. In short, even the smallest “systemic” glitch, such as missing an injection charge 1 time in 4 encounters, can add up very quickly: the Medicare payment for an injection is $39.13 in the hospital outpatient department and $75.87 in the freestanding office, so a hospital-based center providing just 1000 treatment encounters annually misses out on $9782.50 each year and a freestanding center misses out on $18,967.50 annually. l Elaine Kloos is a Senior Consultant, and Teri Guidi is President and CEO of Oncology Management Consulting Group, in Pipersville, PA.

Fourth Annual Navigation and Survivorship Conference Memphis, Tennessee â&#x20AC;˘ The Peabody Memphis

NOVEMBER 15-17, 2013 CONFERENCE CO-CHAIRS Lillie D. Shockney, RN, BS, MAS AONN Program Director University Distinguished Service Associate Professor of Breast Cancer Departments of Surgery and Oncology Administrative Director, Johns Hopkins Clinical Breast Programs Administrative Director, Johns Hopkins Cancer Survivorship Programs Department of Surgery and Oncology Associate Professor, JHU School of Medicine Departments of Surgery, Oncology, and Gynecology Associate Professor, JHU School of Nursing Johns Hopkins Avon Foundation Breast Center Baltimore, MD

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

www.AONNonline.org AONNAsize31413

HalavenReimbursem Your source for reimbursement information related to Halaven

CODING & BILLING Coding & Pricing

Billing Forms

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

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

COVERAGE POLICY Physician Office

Hospital Outpatient

Medicare Medicaid Commercial Payors

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 Communicatio may be reproduced or transmitted in any form or by any means now or recording, or any informational storage and retrieval system, without wr

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

ment.com

速

(eribulin mesylate) Injection

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

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

NAVIGATOR

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98% of calls answered within 10 seconds or less Full-time pharmacists on duty during hours of operation (Monday through Friday, 8AM to 8PM ET) Dedicated EAP team with an average of more than 9 years of healthcare, reimbursement, and/or call center experience On-staff Certified Professional Coders (CPCs) provide an additional level of expertise Regionally aligned EAP hotline agents are well-versed in local payor and plan knowledge Insurance verification and coverage options with an approximate 24- to 48-hour turnaround for all queries

Community Oncology Alliance

New Federal Reporting Profiles…Continued from page 1 Hospital reporting has been ongoing since 2005, when the Centers for Medicare & Medicaid Services (CMS) launched the “Hospital Compare” website (www.medicare. gov/hospitalcompare), which shows comparative data on approximately 4000 Medicare-certified hospitals. Using data analyses of Medicare patient claims, as well as a patient survey administered by the Consumer Assessment of Healthcare Providers and Systems (CAHPS), Hospital Compare pre sents specific measurements intended to provide patients with a platform to compare local hospitals. Detailed reporting is made available on 3 primary categories: timely and effective care (ie, time to treatment for specific diseases); readmissions, complications, and deaths; and the use of medical imaging. Additional information is shared from CAHPS patient surveys on the number of Medicare patients served as well as whether the costs of care to the Medicare program were higher, lower, or about the same compared with other hospitals.

Value-Based Comparison Systems Like any of the reporting and “grades” programs that have cropped up in recent years for consumer comparisons of healthcare choices, Hospital Compare faces many challenges. Dr Eagle reported on a 2007 study that found that rating systems often varied significantly from each other, and “for any given diagnosis, the ratings demonstrated little overall agreement.” Despite the variation, the fact that reporting and measurement is being done at all does appear to yield some degree of performance improvement for process-of-care measurements and risk-adjusted mortality. With that marginal success

behind them, CMS then turned to a program mandated by the Affordable Care Act (ACA) to create a pay-for-performance program for hospitals. The “Hospital ValueBased Purchasing Program,” which began in October 2012, involves a pool of $850 million set aside for making patient incentives in the initial year. That funding pool will double in 2017.

Key federal quality initiatives are now involved in comparing hospitals, comparing physicians, and also building quality and resource-use reports as well as a physician value-based payment modifier. This program feeds off the data collected and reported in the Hospital Compare database, and it has the potential to redistribute reimbursement from those hospitals judged to be “poor” performers to “higher” performers. Initial payment changes have been calculated to range from -0.25% to +0.25% for affected hospitals. Dr Eagle noted that these rather modest incentives and penalties will probably pale in comparison to the impact on hospitals from the 2% sequester cut, thereby undermining the intent of these performance incentives from their beginning. After hospitals, physicians moved into the spotlight of federal reporting. The CMS “Physician Compare” website (www.medicare.gov/find-adoctor) was initially launched in

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

December 2010, but it has been populated with basic information on about 932,000 physicians through early 2013. Current reporting is limited to demographic information, such as name, features, and contact/ office information; whether the physician is accepting new Medicare patients; the physician’s training and affiliations; any unique languages spoken; and whether the physician accepts Medicare assignments. CMS plans to add “robust and reliable quality of care data no earlier than 2014” on the website. The data for the Physician Compare assessments will come from Medicare claims; the Medicare Provider Enrollment, Chain, and Ownership System (PECOS); as well as the results from various physician-reporting programs that are now ongoing (including the Physician Quality Reporting System [PQRS], the e-Prescribing program, the Electronic Health Records Incentive Program, and others). By 2014, CMS plans to include reports of the measures tracked through current group and accountable care organization reports and patient satisfaction surveys for large groups (ie, ≥100 physicians). By 2015, it is expected that detailed “quality” data and measures will be available on individual physicians in groups of any size, including the measures developed by specialty societies for individual specialties.

Verifying Reliability Dr Eagle then addressed the reliability of these public comparison sites. He noted that CMS is supposed to be ensuring that the data supporting the comparisons are statistically valid and include riskadjustment methodology to reflect an accurate portrayal of a physician’s performance. However, he looked up his own personal information

Community Oncology Alliance

on the Physician Compare website, and explained what he found by saying, “I searched the website for oncology providers within 1 mile of my practice zip code. Of the 7 providers found, none were my partners or myself. When I expanded the search to within 5 miles of my practice zip code, we all appeared, but only 1 of my 2 hospital affiliations was noted and only 1 of my 2 practice office locations. In addition, my specialty was incorrectly listed as “Hematology Oncology.” Dr Eagle highly recommended that physicians check their listings and address any errors by logging into their CMS PECOS accounts now. The ACA also required that CMS develop a “Quality and Resource Use Report” (QRUR) to provide confidential feedback reports to physicians compiled from Medicare claims data. The QRUR is being phased in and tried with physicians in Iowa, Kansas, Missouri, and Nebraska. The initial purpose of the QRUR is to enable physicians to compare the quality and cost of their care both within their specialty and with all physicians in a geographic region. However, CMS is moving toward ways to pay for quality as an alternative to the current fee-for-service model, and the plan is to use these reports to identify possible components of a payment modifier (that could be used in 2015) to provide differential payment amounts to physicians

based on measures of quality and cost. Further details and sample reports for the QRUR are available at www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ PhysicianFeedbackProgram/Report Template.html.

all leading up to this differentiation process for payment. The Value-Based Payment Modi fier will first affect physicians in groups of 100 or more in 2015, but by 2017, it will apply to all physicians. The modifier will determine payment to physicians based on quality and cost-of-care measures. More information on this program may be found at www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ PhysicianFeedbackProgram/index. html. Physicians will soon see their payments directly affected by the information collected and reported about them through not only the CMS Medicare system but, by extension, possibly through private payers as well. The law of averages says that half of all physicians will perform above the average, and half will perform below the average. Soon, that means that half may receive better reimbursement for Medicare patients and half will receive worse reimbursement. These are matters that are critical to the future of the cancer care delivery system, and to each individual physician in the United States. Making sure that practices and physicians understand the measures against which they are being judged, and the details of the reports now being generated about them and the care they provide, will be an essential practice survival tool, now and in the future. l

Physicians will soon see their payments directly affected by the information collected and reported about them through not only the CMS Medicare system but, by extension, possibly through private payers as well. The concept of the ValueBased Payment Modifier was first introduced in the 2008 Medicare Improvements for Patients and Providers Act and was expanded in the 2010 ACA. Differential payment for physicians is coming, and it is coming quickly. Each of the activities noted earlier—the launch of the PQRS on top of the current fee-for-service payment model, and the current expansion into Physician Feedback Reporting—are

AVBCC_2013Conf_horizontal_62512_Layout 1 7/9/12 1:10 PM Page 1

THIRD ANNUAL CONFERENCE Influencing the Patient-Impact Factor

May 2-5, 2013 Westin Diplomat Hollywood, Florida

April 2013

www.OncPracticeManagement.com

Making

PRO gress with patient-reported outcomes How PROs were successfully integrated into the Jakafi® (ruxolitinib) drug development program1 A novel approach to engage clinicians and FDA

TAILORING a PRO tool for myelofibrosis

PROs are an important means to demonstrate treatment

Myelofibrosis (MF) is a life-threatening, progressive disease

benefits in clinical trials.2,3 Use of a PRO instrument can

characterized by splenomegaly, debilitating symptoms and

evaluate symptoms best judged by the patient, whether

cytopenias.5-7 Measures to assess both the splenomegaly

caused by the disease or treatment toxicity. Assessment

and core symptoms of MF were incorporated into the phase III,

of symptom burden is important because it can be a major

double-blind placebo-controlled study, COMFORT-I, for Jakafi.

indicator of disease severity, progression or improvement.

Spleen reduction, as measured by imaging (MRI or CT), was the

Incorporating PROs into a clinical trial program provides a

primary and biologic endpoint, and a reduction in total symptom

means for evaluating the impact of therapy from the patient’s

score (TSS), the PRO measure, was a key secondary endpoint.8,9

perspective and helps patients and clinicians make better-

The TSS encompassed the following symptoms: abdominal

informed decisions.4

discomfort, pain under left ribs, early satiety, pruritus, night sweats and bone/muscle pain.9 To include PROs in the trial, a novel instrument had to be specifically developed. After patient interviews, advice from clinical experts and extensive input from the FDA, the modified Myelofibrosis Symptom Assessment Form, version 2.0 (modified MFSAF v2.0) was finalized as part of the Special Protocol Assessment prior to the initiation of COMFORT-I. Ultimately, Jakafi was approved by the FDA for the treatment of intermediate or high-risk MF.1,8 This became Incyte’s first approved drug and also the first oncology medicine approved with symptom data in its label since the FDA’s draft guidance on PROs was finalized in 2009.2,4

Indications and Usage Jakafi is indicated for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis and post–essential thrombocythemia myelofibrosis. Important Safety Information • Treatment with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia. A complete blood count must be performed before initiating therapy with Jakafi. Complete blood counts should be monitored as clinically indicated and dosing adjusted as required • The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache • Patients with platelet counts <200 × 109/L at the start of therapy are more likely to develop thrombocytopenia

during treatment. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If clinically indicated, platelet transfusions may be administered • Patients developing anemia may require blood transfusions. Dose modifications of Jakafi for patients developing anemia may also be considered • Neutropenia (ANC <0.5 × 109/L) was generally reversible and was managed by temporarily withholding Jakafi • Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections. Active serious infections should have resolved before starting Jakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection (including herpes zoster) and initiate appropriate treatment promptly • A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or in patients with

JAKAFI endpoints included both biologic and patient-reported outcomes8,9 COMFORT-I: Percent Change in Spleen Volume in Individual Patients From Baseline to Week 24 or Last Observation9,a

COMFORT-I: Percent Change in TSS in Individual Patients From Baseline to Week 24 or Last Observation9,a,b 150

-20 -40

35% Reduction

-60 -80

Upper 50th Percentile

Jakafi (n = 155)

Upper 50th Percentile

Placebo (n = 153)

Each bar represents an individual patient’s response.

50 0 -50

-100

WORSENING

100

IMPROVEMENT

Change From Baseline (%)

WORSENING

IMPROVEMENT

Change From Baseline (%)

50% Improvement

Upper 50th Percentile

Jakafi (n = 145)

Upper 50th Percentile

Placebo (n = 145)

Each bar represents an individual patient’s response. Worsening of TSS is truncated at 150%.

PROVIDING proof of patient benefit MF is progressive, and spleen size and symptoms can become increasingly burdensome to patients over time.5-7 Jakafi is proven to decrease total symptom score in patients with intermediate or high-risk MF—this is an important consideration when evaluating and treating patients.9 The FDA approval included patients with intermediate-2 risk and high risk, as well as patients with intermediate-1 risk, since intermediate-1 patients may also have symptoms that require treatment. Clinical experience with Jakafi has shown that with the right process, manufacturers can successfully collaborate with regulatory agencies and academic experts to develop relevant and validated PRO instruments that can be incorporated into clinical trials.1,8 The approval of Jakafi marks a significant milestone in which validated PRO instruments can provide symptom data and demonstrate clinical benefit. The experience with Jakafi may provide a model for the future use of PROs in marketing applications.8

renal or hepatic impairment [see Dosage and Administration]. Patients should be closely monitored and the dose titrated based on safety and efficacy • There are no adequate and well-controlled studies of Jakafi in pregnant women. Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus • Women taking Jakafi should not breast-feed. Discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother References: 1. McCallister E, et al. BioCentury. Reprint from December 5, 2011. 2. Haley S. The Pink Sheet. November 21, 2011;73:47. Symptom Measurement in Clinical Trials. 3. US Department of Health and Human Services Guidance for Industry: Patientreported outcome measures: Use in medical product development to support labeling claims. December 2009. 4. Basch E, et al. Issue brief from Conference on Clinical Cancer Research, November 2011. 5. Cervantes F, et al. Blood. 2009;113:2895-2901. 6. Mesa RA, et al. Leuk Res. 2009;33:1199-1203. 7. Verstovsek S, et al. N Engl J Med. 2012;366:799-807. 8. Deisseroth AB, et al. Clin Cancer Res. 2012 Apr 27. (Epub ahead of print). 9. Jakafi Prescribing Information. Incyte Corporation. November 2011. 10. Data on File, Incyte Corporation.

a As studied in COMFORT-I, a randomized, double-blind, placebo-controlled phase III

study with 309 total patients (United States, Canada, Australia). The primary endpoint was the proportion of subjects achieving a ≥35% reduction in spleen volume from baseline to Week 24 as measured by MRI or computed tomography (CT). A secondary endpoint was the proportion of subjects with a ≥50% reduction in TSS from baseline to Week 24 as measured by the daily patient diary, the modified MFSAF v2.0.9,10 b Symptom scores were captured by a daily patient diary recorded for 25 weeks. TSS encompasses debilitating symptoms of MF: abdominal discomfort, pain under left ribs, early satiety, pruritus, night sweats and bone/muscle pain. Symptom scores ranged from 0 to 10 with 0 representing symptoms “absent” and 10 representing “worst imaginable” symptoms. These scores were added to create the daily total score, which has a maximum of 60. At baseline, mean TSS was 18.0 in the Jakafi group and 16.5 in the placebo group.9,10

Please see Brief Summary of Full Prescribing Information on the following page.

Table 2: Worst Hematology Laboratory Abnormalities in the Placebo-controlled Studya Jakafi Placebo (N=155) (N=151) Laboratory All All b Grade 3 Grade 4 Grades Grade 3 Grade 4 Parameter Grades BRIEF SUMMARY: For Full Prescribing Information, see package insert. (%) (%) (%) (%) (%) (%) INDICATIONS AND USAGE Jakafi is indicated for treatment of patients with intermediate or high-risk Thrombocytopenia 69.7 9.0 3.9 30.5 1.3 0 myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential Anemia 96.1 34.2 11.0 86.8 15.9 3.3 thrombocythemia myelofibrosis. Neutropenia 18.7 5.2 1.9 4.0 0.7 1.3 CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia and Neutropenia Treatment a Presented values are worst Grade values regardless of baseline b National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia. A complete blood count must be performed before initiating therapy with Jakafi [see Dosage and Additional Data from the Placebo-controlled Study 25.2% of patients treated with Jakafi and 7.3% of Administration (2.1) in Full Prescribing Information]. Patients with platelet counts of less than 200 X 109/L patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transat the start of therapy are more likely to develop thrombocytopenia during treatment. Thrombocytopenia was aminase (ALT). The incidence of greater than or equal to Grade 2 elevations was 1.9% for Jakafi with 1.3% Grade 3 and no Grade 4 ALT elevations. 17.4% of patients treated with Jakafi and 6.0% of patients treated generally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase clinically indicated, platelet transfusions may be administered [see Dosage and Administration (2.2) in Full (AST). The incidence of Grade 2 AST elevations was 0.6% for Jakafi with no Grade 3 or 4 AST elevations. Prescribing Information, and Adverse Reactions]. Patients developing anemia may require blood trans16.8% of patients treated with Jakafi and 0.7% of patients treated with placebo developed newly occurring or fusions. Dose modifications of Jakafi for patients developing anemia may also be considered. Neutropenia worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was 0.6% for (ANC less than 0.5 X 109/L) was generally reversible and was managed by temporarily withholding Jakafi Jakafi with no Grade 3 or 4 cholesterol elevations. [see Adverse Reactions]. Complete blood counts should be monitored as clinically indicated and dosing DRUG INTERACTIONS Drugs That Inhibit or Induce Cytochrome P450 Enzymes Ruxolitinib adjusted as required [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse is predominantly metabolized by CYP3A4. Strong CYP3A4 inhibitors: The C max and AUC of ruxolitinib Reactions]. Infections Patients should be assessed for the risk of developing serious bacterial, mycobac- increased 33% and 91%, respectively, with Jakafi administration (10 mg single dose) following ketoconazole terial, fungal and viral infections. Active serious infections should have resolved before starting therapy with 200 mg twice daily for four days, compared to receiving Jakafi alone in healthy subjects. The half-life was also Jakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection and prolonged from 3.7 to 6.0 hours with concurrent use of ketoconazole. The change in the pharmacodynamic initiate appropriate treatment promptly. Herpes Zoster Physicians should inform patients about early signs marker, pSTAT3 inhibition, was consistent with the corresponding ruxolitinib AUC following concurrent adminand symptoms of herpes zoster and advise patients to seek treatment as early as possible [see Adverse istration with ketoconazole. When administering Jakafi with strong CYP3A4 inhibitors a dose reduction is Reactions]. recommended [see Dosage and Administration (2.4) in Full Prescribing Information]. Patients should be ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under closely monitored and the dose titrated based on safety and efficacy. Mild or moderate CYP3A4 inhibitors: widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly There was an 8% and 27% increase in the Cmax and AUC of ruxolitinib, respectively, with Jakafi administration compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The (10 mg single dose) following erythromycin, a moderate CYP3A4 inhibitor, at 500 mg twice daily for 4 days, safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 compared to receiving Jakafi alone in healthy subjects. The change in the pharmacodynamic marker, pSTAT3 months, including 301 patients with myelofibrosis in two Phase 3 studies. In these two Phase 3 studies, inhibition was consistent with the corresponding exposure information. No dose adjustment is recommended patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 88.7% of when Jakafi is coadministered with mild or moderate CYP3A4 inhibitors (eg, erythromycin). CYP3A4 patients treated for more than 6 months and 24.6% treated for more than 12 months. One hundred and inducers: The Cmax and AUC of ruxolitinib decreased 32% and 61%, respectively, with Jakafi administration eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In (50 mg single dose) following rifampin 600 mg once daily for 10 days, compared to receiving Jakafi alone in a double-blind, randomized, placebo-controlled study of Jakafi, 155 patients were treated with Jakafi. The healthy subjects. In addition, the relative exposure to ruxolitinib’s active metabolites increased approximately most frequent adverse drug reactions were thrombocytopenia and anemia [see Table 2]. Thrombocytopenia, 100%. This increase may partially explain the reported disproportionate 10% reduction in the pharmacoanemia and neutropenia are dose related effects. The three most frequent non-hematologic adverse reactions dynamic marker pSTAT3 inhibition. No dose adjustment is recommended when Jakafi is coadministered with were bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless of a CYP3A4 inducer. Patients should be closely monitored and the dose titrated based on safety and efficacy. causality, was observed in 11.0% of patients treated with Jakafi and 10.6% of patients treated with placebo. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: There are no adequate Following interruption or discontinuation of Jakafi, symptoms of myelofibrosis generally return to and well-controlled studies of Jakafi in pregnant women. In embryofetal toxicity studies, treatment with pretreatment levels over a period of approximately 1 week. There have been isolated cases of patients discon- ruxolitinib resulted in an increase in late resorptions and reduced fetal weights at maternally toxic doses. tinuing Jakafi during acute intercurrent illnesses after which the patient’s clinical course continued to worsen; Jakafi should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. however, it has not been established whether discontinuation of therapy contributed to the clinical course in Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses these patients. When discontinuing therapy for reasons other than thrombocytopenia, gradual tapering of the of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There was no evidence of teratodose of Jakafi may be considered [see Dosage and Administration (2.6) in Full Prescribing Information]. genicity. However, decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times Table 1 presents the most common adverse reactions occurring in patients who received Jakafi in the doublethe clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights blind, placebo-controlled study during randomized treatment. of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of Table 1: Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlled 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In Study During Randomized Treatment a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implanJakafi Placebo tation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for (N=155) (N=151) fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest Adverse All All dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). a Reactions Grades Grade 3 Grade 4 Grades Grade 3 Grade 4 Nursing Mothers It is not known whether ruxolitinib is excreted in human milk. Ruxolitinib and/or its metabolites were excreted in the milk of lactating rats with a concentration that was 13-fold the maternal (%) (%) (%) (%) (%) (%) plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse Bruisingb 23.2 0.6 0 14.6 0 0 reactions in nursing infants from Jakafi, a decision should be made to discontinue nursing or to discontinue Dizzinessc 18.1 0.6 0 7.3 0 0 the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effecHeadache 14.8 0 0 5.3 0 0 tiveness of Jakafi in pediatric patients have not been established. Geriatric Use Of the total number of Urinary Tract Infectionsd 9.0 0 0 5.3 0.7 0.7 myelofibrosis patients in clinical studies with Jakafi, 51.9% were 65 years of age and older. No overall differWeight Gaine 7.1 0.6 0 1.3 0.7 0 ences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in Flatulence 5.2 0 0 0.7 0 0 healthy subjects [CrCl 72-164 mL/min (N=8)] and in subjects with mild [CrCl 53-83 mL/min (N=8)], Herpes Zosterf 1.9 0 0 0.7 0 0 moderate [CrCl 38-57 mL/min (N=8)], or severe renal impairment [CrCl 15-51 mL/min (N=8)]. Eight (8) a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 b includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site additional subjects with end stage renal disease requiring hemodialysis were also enrolled. The pharmacokinetics of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with hematoma, increased tendency to bruise, petechiae, purpura c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis normal renal function. However, plasma AUC values of ruxolitinib metabolites increased with increasing d includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria severity of renal impairment. This was most marked in the subjects with end stage renal disease requiring urine, bacteria urine identified, nitrite urine present hemodialysis. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the e includes weight increased, abnormal weight gain corresponding increase in metabolite exposure. Ruxolitinib is not removed by dialysis; however, the removal f includes herpes zoster and post-herpetic neuralgia of some active metabolites by dialysis cannot be ruled out. When administering Jakafi to patients with Description of Selected Adverse Drug Reactions Anemia In the two Phase 3 clinical studies, median moderate (CrCl 30-59 mL/min) or severe renal impairment (CrCl 15-29 mL/min) with a platelet count time to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks. One patient (0.3%) between 100 X 109/L and 150 X 109/L and patients with end stage renal disease on dialysis a dose reduction discontinued treatment because of anemia. In patients receiving Jakafi, mean decreases in hemoglobin is recommended [see Dosage and Administration (2.5) in Full Prescribing Information]. Hepatic reached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in gradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This pattern healthy subjects (N=8) and in subjects with mild [Child-Pugh A (N=8)], moderate [Child-Pugh B (N=8)], or was observed in patients regardless of whether they had received transfusions during therapy. In the severe hepatic impairment [Child-Pugh C (N=8)]. The mean AUC for ruxolitinib was increased by 87%, 28% randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving and 65%, respectively, in patients with mild, moderate and severe hepatic impairment compared to patients placebo received red blood cell transfusions during randomized treatment. Among transfused patients, the with normal hepatic function. The terminal elimination half-life was prolonged in patients with hepatic median number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebo impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours). The change in the pharmacotreated patients. Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3 dynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in ruxolitinib exposure or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was except in the severe (Child-Pugh C) hepatic impairment cohort where the pharmacodynamic activity was generally reversible with dose reduction or dose interruption. The median time to recovery of platelet counts more prolonged in some subjects than expected based on plasma concentrations of ruxolitinib. When above 50 X 109/L was 14 days. Platelet transfusions were administered to 4.7% of patients receiving Jakafi administering Jakafi to patients with any degree of hepatic impairment and with a platelet count between and to 4.0% of patients receiving control regimens. Discontinuation of treatment because of thrombo- 100 X 109/L and 150 X 109/L, a dose reduction is recommended [see Dosage and Administration (2.5) in cytopenia occurred in 0.7% of patients receiving Jakafi and 0.9% of patients receiving control regimens. Full Prescribing Information]. Patients with a platelet count of 100 X 109/L to 200 X 109/L before starting Jakafi had a higher frequency of Grade 3 or 4 thrombocytopenia compared to patients with a platelet count greater than 200 X 109/L (16.5% Jakafi is a registered trademark of Incyte Corporation. All rights reserved. versus 7.2%). Neutropenia In the two Phase 3 clinical studies, 1.0% of patients reduced or stopped Jakafi U.S. Patent No. 7,598,257 because of neutropenia. Table 2 provides the frequency and severity of clinical hematology abnormalities © 2011-2012 Incyte Corporation. All rights reserved. reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study. Issued: June 2012 RUX-1040a

Meaningful Use

Meaningful Use Stage 1 Now Met by…Continued from page 1 “We found this year that healthcare organizations are making strong progress toward federal mandates,” said Jennifer Horowitz, CPHIMS, FHIMSS, Senior Director of Research at HIMSS Analytics, speaking at a press briefing. “It seems we have reached a tipping point.” The Annual HIMSS Leadership Survey covers a range of topics crucial to health IT. The survey included 298 respondents, primarily senior IT executives representing almost 600 hospitals in the United States. Data were collected via a web-based survey from December 2012 to February 2013. Survey results showed that 66% of the respondents have already qualified for Meaningful Use Stage 1 and 75% expect to qualify for Stage 2 in 2014. ICD-10 conversion is expected to be completed on time by 87% of the respondents, Ms Horowitz reported. Other key survey results included: • Health information exchanges: 51% reported their organization participates in at least 1 in their area • ICD-10: 47% indicated that implementing Current Procedural Terminology-10/ICD-10 continues to be the top focus for their financial IT systems • Impact of IT on patient care: Most respondents felt that IT can impact patient care by improving clinical and quality outcomes, reducing medical errors, or helping to standardize care by allowing for the use of evidence-based medicine • Organization infrastructure: 22% indicated that a focus on security systems was their current key infrastructure priority • Security concerns: A security

breach in the past year was reported by 19% of respondents. Current concerns largely pertain to ensuring that information delivered on mobile devices is secure.

ed by 7% of the respondents. For Meaningful Use Stage 2, most of those surveyed (38%) expected to see less than a $2 million return on investment. Approximately 50% of the respondents said the primary financial IT focus is on implementing ICD-10, which is due by October 2014. One in 5 respondents planned to invest less than $250,000 for this purpose, but 33% did not know how much this effort would cost. In addition, 15% planned to devote funds to upgrading their financial analytics systems. A definite increase in IT budgets was predicted by 47% of the respondents, and a probable increase by 29%, primarily owing to the overall growth in IT systems and the need for additional staff.

Level of Investment Only 5% of the organizations surveyed made no investment in Meaningful Use Stage 1 last year. Most (17%) invested $1 million to $2 million, 11% invested $3 million

Survey results showed that 66% of hospitals have already qualified for Meaningful Use Stage 1 and 75% expect to qualify for Stage 2 in 2014. ICD-10 conversion is expected to be completed on time by 87% of the respondents.

Lingering Concerns As the role of IT in healthcare grows, respondents continued to express concerns about IT staffing shortages. Approximately 50% of those surveyed indicated that they plan to increase their IT staff over the next year, but 21% were concerned that their IT objectives could not be sufficiently met because of a lack of staff. The greatest staffing need was in the area of clinical application support, 33% of respondents indicated. A lack of adequate financial support was a potential barrier for 15% of the respondents, and 13% worried that the vendor would be unable to deliver the product. Difficulty in end-user acceptance, however, was rarely a concern, as was difficulty proving return on investment as this concept matures, expressed by only 7% and 4% of users, respectively. l

to $4 million, and 6% invested $5 million to $9 million. An investment of $20 million or more was reported by 5% of the respondents. The expected return on this investment was less than $2 million for 30% of the respondents, whereas 23% expected a return of $2 million to $3 million and 16% expected to see $4 million to $5 million. Of note, a return on investment of at least $10 million was expect-

April 2013

www.OncPracticeManagement.com

ACCC

The Value of Community Oncology: Proximity, Availability, Access, and Cost By Lisa Neuman

Washington, DC—“While our country has been fixated on the fiscal cliff, the profession of oncology has been facing, quietly, its own survival cliff,” said Barry V. Fortner, PhD, Senior Vice President of Payer Strategy and Sales at ION Solutions in Frisco, Texas, at the Association of Community Cancer Centers’ annual meeting. Yet, according to Dr Fortner, regardless of the politically charged atmosphere in which all of healthcare currently finds itself, there is a legislated march toward a concept of value, with physician payments based not on production but on services rendered to the patient. Community oncology now finds itself needing to evolve with the new concepts of accountable care organizations, health insurance exchanges, clinical pathways, and medical home models. In particular, Dr Fortner explained, community oncology—defined as privately owned, local community practices—faces new levels of stress that have never been seen before, which has been caused by the continued downward spiral of drug reimbursement and encroachments on oncology practices’ ability to buy, bill, and dispense the drugs they need for their patients’ treatments. “While I’m sure The New York Times can find one,” Dr Fortner quipped, “I’ve never met an oncologist who was not pro-quality. I’ve never met an oncology nurse who was not pro-patient centeredness. I’ve never met an oncology practice administrator who was not pro-cost effectiveness,” he said. “The issue is not whether we pursue these things. The issue is how do we pursue them so that while we reach for new lev-

els of value, we don’t destroy the value we currently have?” The First 3 Elements of Value According to Dr Fortner, the first 3 qualities that define value for patients with cancer are proximity to care, availability of care, and access to care, and these qualities matter especially in vulnerable populations, such as rural and

“If we’re going to create a value story, we have to talk about access to care, which is predicated on a fundamental dynamic in which there is an array of sites of care, in which there is a foundation of community practices that represent frontline care, and where care can be triaged to other areas depending on the clinical needs—and even the location—of the patient.” —Barry V. Fortner, PhD low-income patients. This is where he says the private community oncology practice can create value for these patients. “Having a local

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

practitioner matters to the widowed patient, to the low socioeconomic patient,” Dr Fortner explained. “That 5, 10, or 15 miles of drive time has implications—real, practical implications in patients’ lives that translate into delaying care, experiencing less intensive care, or, ultimately, receiving less care than they actually require.” He cited a study on chemotherapy recession within 3 months of resection in patients with colon cancer that was published in the Journal of Oncology Practice which found that when compared with service areas where there was no medical oncologist, patients were 1.451 times more likely to receive chemotherapy in that 3-month window if there were 1 to 3 medical oncologists available, 1.5 times more likely to receive chemotherapy if there were 4 to 8 medical oncologists available, and 1.3 times more likely to receive chemotherapy if there were more than 9 medical oncologists available in their geographic area. “Proximity matters. Availability of care matters. We simply can’t talk about value if we’re going to restrict access to care,” Dr Fortner said. “If we’re going to create a value story, we have to talk about access to care, which is predicated on a fundamental dynamic in which there is an array of sites of care, in which there is a foundation of community practices that represent frontline care, and where care can be triaged to other areas depending on the clinical needs—and even the location—of the patient.” The Last Element of Value The last critical part of the value Continued 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.

ACCC

The Value of Community Oncology…Continued from page 24 equation, of course, is cost. Dr Fortner told the audience there is no denying that the cost of cancer care over the past several decades has increased exponentially, to the point that it has now reached a threshold that has made society start paying attention. He explained that before 1990, oncologists only had “3 double fistfuls of drugs” with which to treat their patients, and it was the therapeutic discoveries of the 1970s and 1980s that led to the explosion of clinical trials and US Food and Drug Administration (FDA) approvals that began in the late 1980s and continued into the 1990s. “That resulted in what I would say is nothing short of an evolutionary burst in oncology,” Dr Fortner said. “It’s no wonder that cost increased as we began to see scientifically validated, FDA-approved treatments for most lines of therapy within the major disease categories. This in turn created a supportive care portfolio that let us take cancer care from an inpatient setting, to a contiguous outpatient setting, and, finally, to a detached, community-based infusion center model—the birth of a delivery system known today as community oncology.” Now, Dr Fortner noted, the argument on value is a bit more subtle. All of the drugs that came to market in the 1990s are coming to maturity in the next decade. Whereas the rest of the pharmaceutical industry has already faced its generic cliff, oncology is just now reaching the precipice of its own generic cliff. By 2022, virtually the entire drug portfolio that oncologists rely on today as the mainstays of their chemotherapy armamentarium will turn over to generic chemotherapeutic drugs, which will fundamentally

change the way a drug is tested, approved, and brought to market. There will be new drugs, Dr Fortner says, and they will be expensive. However, there will also be an existing foundation of cancer drugs that cost substantially less than the new, innovative drugs that will just be coming to market. In fact, he

“It’s no wonder that cost increased as we began to see scientifically validated, FDA-approved treatments for most lines of therapy within the major disease categories.” —Barry V. Fortner, MD told the audience, it is happening already, because when a cancer drug “goes generic,” the price of that drug plummets. “In fact,” Dr Fortner noted, “there is actually a positive incentive under ‘buy and bill’—at least during the period in which the price of the drug is declining—for physicians to use the generic drug. We all look for new ways to create incentives for the use of generics but we already have a way—with no external pressure, no external control. Again, we’re looking for value dynamics, as this is one of them.” Although the new cancer drugs that are either currently or will be in research and development may be tremendously expensive

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

when they finally hit the market over the next decade and beyond, Dr Fortner reminded the audience that it behooves all of oncology that the pharmaceutical industry keeps innovating, saying that the future of pharmacogenomics has huge potential to be disruptively innovative. “That’s value, and with the maturity of our drug portfolio, with the development of targeted therapy, with accessible care, where evolutionary pressures have forced efficiency amongst our predominant delivery system, we are poised to produce even greater levels of value,” he said. Yet, he continued, the untold value story is that the predominant cancer care delivery system in the United States is, actually, a good deal. According to IMS Health, the overall spending on cancer pharmaceuticals through 2016 is projected to be 3.8%; however, by putting the value of 1 year of life at a conservative European level of $150,000 a year, the US cancer care system delivered more than $600 billion in value above what was delivered by the European system. In other words, Dr Fortner explained, from 1995 to 2000, for every additional $20,000 that US oncologists spent on a patient with cancer than their European counterparts, the US patient’s life expectancy increased by 2.3 years. “The fact is that the data and the arguments are on our side. If we cooperate and we tell the story, and if our patients understand it, if the payers understand it, if the government understands it, if society at large understands it, then someday we may look back on this cliff we’re facing right now and see it as a triumphant summit,” Dr Fortner finished. l

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

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

PHYSICIAN CREDIT DESIGNATION

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

REGISTERED NURSE DESIGNATION

Simultaneous Symposia/Product Theaters

8:15 am - 8:30 am

12:00 pm - 1:00 pm

Exclusive Lunch Symposium/Product Theater

1:15 pm - 3:00 pm

Session 12: Meet the Experts Networking Roundtable Session

3:00 pm - 3:45 pm

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

3:45 pm - 4:15 pm

Summary/Wrap-Up of Day 2

4:30 pm - 6:30 pm

Cocktail Reception in the Exhibit Hall

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

SUNDAY, MAY 5, 2013

REGISTERED PHARMACY DESIGNATION

8:15 am - 8:30 am

Opening Remarks

8:30 am - 9:15 am

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

9:15 am - 10:00 am

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

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).

CONFERENCE $375.00 until March 15, 2013 REGISTRATION $425.00 after March 15, 2013 REGISTER TODAY AT

www.regonline.com/avbcc2013

7:00 am - 8:00 am

Simultaneous Symposia/Product Theaters

10:00 am - 10:15 am

Break

10:15 am - 11:00 am

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

11:00 am - 11:45 am

Session 17: Perspectives from 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

Drug Coding Supplied by RJ Health Systems

FDA-Approved Medications Used for the Treatment of Colorectal Cancer The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with the treatment of colorectal cancer. The following sections include: • Associated ICD-9-CM codes used for the classification of colorectal cancer • Drugs that have been FDA-approved for the treatment of colorectal cancer • Drugs that are Compendia listed for off-label use for colorectal cancer based on clinical studies that suggest beneficial use in some cases. Please note: If a check mark appears in the FDA column it will NOT appear in the Compendia off-label use column • Corresponding HCPCS/CPT® codes and code descriptions

Associated ICD-9-CM codes for the treatment of colorectal cancer: 153 Malignant neoplasm of colon Excludes: benign carcinoid tumor of colon (209.50-209.56) malignant carcinoid tumor of colon (209.10-209.16) 153.0 Hepatic flexure 153.1 Transverse colon 153.2 Descending colon Left colon 153.3 Sigmoid colon Sigmoid (flexure) Excludes: rectosigmoid function (154.0) 153.4 Cecum Ileocecal valve 153.5 Appendix vermiformis 153.6 Ascending colon Right colon 153.7 Splenic flexure 153.8 Other specified sites of large intestine Malignant neoplasm of contiguous or overlapping sites of colon whose point of origin cannot be determined Excludes: ileocecal valve (153.4) rectosigmoid junction (154.0) 153.9 Colon, unspecified Large intestine NOS 154

Malignant neoplasm of rectum, rectosigmoid junction, and anus Excludes: benign carcinoid tumor of rectum (209.57) malignant carcinoid tumor of rectum (209.17) 154.0 Rectosigmoid junction Colon with rectum Rectosigmoid (colon) 154.1 Rectum Rectal ampulla 154.8 Other Anorectum Cloacogenic zone Malignant neoplasm of contiguous or overlapping sites of rectum, rectosigmoid junction, and anus whose point of origin cannot be determined

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

Drug Coding

FDA-approved for colorectal cancer

Compendia listed off-label uses for colorectal cancer

Generic (brand) name

HCPCS code: code description

bevacizumab (Avastin)

J9035: Injection, bevacizumab, 10 mg

√

96413, 96415

capecitabine (Xeloda)

J8520: Capecitabine, oral, 150 mg

√

N/A

capecitabine (Xeloda)

J8521: Capecitabine, oral, 500 mg

√

N/A

carmustine (BiCNU)

J9050: Injection, carmustine, 100 mg

cetuximab (Erbitux)

J9055: Injection, cetuximab, 10 mg

cisplatin (Platinol-AQ)

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

√

96409, 96413, 96415

doxorubicin (Adriamycin)

J9000: Injection, doxorubicin hydrochloride, 10 mg

√

96409

floxuridine (FUDR)

J9200: Injection, floxuridine, 500 mg

√

96422, 96423, 96425

fluorouracil (Adrucil)

J9190: Injection fluorouracil, 500 mg

√

96409

irinotecan (Camptosar)

J9206: Injection, irinotecan, 20 mg

√

96413, 96415

leucovorin calcium (Wellcovorin)

J0640: Injection, leucovorin calcium, per 50 mg

√

96372, 96374, 96409

levoleucovorin calcium (Fusilev)

J0641: Injection, levoleucovorin calcium, 0.5 mg

√

96365, 96366

lomustine (CeeNu)

J8999a: Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

lomustine (CeeNu)

S0178: Lomustine, oral, 10 mg

√

N/A

methotrexate

J9250: Methotrexate sodium, 5 mg

√

96372, 96374, 96401, 96409, 96450

methotrexate

J9260: Methotrexate sodium, 50 mg

√

96372, 96374, 96401, 96409, 96450

mitomycin (Mutamycin)

J9280: Mitomycin, 5 mg

√

96409

mitoxantrone (Novantrone)

J9293: Injection, mitoxantrone hydrochloride, per 5 mg

√

96409, 96413

oxaliplatin (Eloxatin)

J9263: Injection, oxaliplatin, 0.5 mg

√

96413, 96415

panitumumab (Vectibix)

J9303: Injection, panitumumab, 10 mg

√

96413, 96415

pemetrexed (Alimta)

J9305: Injection, pemetrexed, 10 mg

√

Possible CPT® administration codes

96413, 96415 96413, 96415

√

April 2013

96409

www.OncPracticeManagement.com

Drug Coding

FDA-approved for colorectal cancer

Compendia listed off-label uses for colorectal cancer

Generic (brand) name

HCPCS code: code description

Possible CPT® administration codes

topotecan (Hycamtin)

J8705: Topotecan, oral, 0.25 mg

√

N/A

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

√

96413

vincristine (Vincasar PFS)

J9370: Vincristine sulfate, 1 mg

√

96409

ziv-aflibercept

C9296: Injection, ziv-aflibercept, 1 mg

ziv-aflibercept

J9999a: Not otherwise classified, antineoplastic drugs

96413 √

96413

When billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code in Column 24D and the drug name, strength, and NDC (National Drug Code) in Box 19 or 24A to ensure appropriate reimbursement. Please note: Payer NDC requirements and placement may vary; check with payer. a

References HCPCS Level II Expert 2013 • Current Procedural Terminology (CPT®) 2013 (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 • FDA-approved indication (from product prescribing information) • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Rocky Hill, Connecticut • CMS (Centers for Medicare and Medicaid Services) CPT® indicates Current Procedural Terminology; HCPCS, Healthcare Common Procedure Coding System.

This information was supplied by:

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

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

RJ Health Systems The Creators of ReimbursementCodes.com

RJ Health Systems â&#x20AC;&#x201D; the pharmaceutical specialists that healthcare professionals have turned to since 1983 for their drug information. We work with over 170 Payor organizations that touch approximately 110 million lives. RJ Health Systems has established and continuously maintains a Library of Drug Intelligence that provides the most comprehensive, trusted, and up-to-date coding and reimbursement information in the industry. ReimbursementCodes.com incorporates the CMS HCPCS and AMA CPT Drug codes into a system that crosswalks each drug code with the drugâ&#x20AC;&#x2122;s NDC and brand/generic name. Please visit www.rjhealthsystems.com to learn more about our products and services listed below:

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

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

rjhealthsystems.com

Medical Legal Update

Breach Notification Requirements By Jennifer Kirschenbaum, Esq

t should be no surprise to read that medical practices have an obligation to maintain protected health information in certain ways, and to only use and disclose such protected health information as authorized by the patient or otherwise by law. Such requirements are set forth under the Privacy Rule. What you may be surprised to read is that when protected health information is not maintained by a medical practice in accordance with HIPAA, notification to the patient or other sources may be required pursuant to the Breach Notification Rule (45 CFR Part 164). You may not be aware of the Breach Notification Rule because it was part of proposed modifications set forth several years ago, and many practices did not adopt the requirements of the rule because the statute at that time had not been written with teeth. However, the Final Rule promulgated on January 25, 2013, not only modifies the Breach Notification Rule, it incorporates significant enforcement provisions should a breach occur and not be dealt with appropriately by the practice. Effective September 23, 2013, every medical practice is required to notify an individual of an acquisition, access, use, or disclosure of protected health information in a manner not permitted under the Privacy Rule, otherwise known as a breach. Pursuant to the statute, a breach excludes:

Any unintentional acquisition, access, or use of protected health information by a workforce member

or person acting under the authority of the practice or a business associate, if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under the practice’s privacy policy.

Any inadvertent disclosure by a person who is authorized to access protected health information at the practice, or a business associate, to another person authorized to access protected health information

When protected health information is not maintained by a medical practice in accordance with HIPAA, notification to the patient or other sources may be required pursuant to the Breach Notification Rule. at the same practice, or business associate, or organized healthcare arrangement in which the practice participates, and the information received as a result of such disclosure is not further used or disclosed in a manner not permitted under the practice’s privacy policy.

A disclosure of protected health information where the practice, or business associate, has a goodfaith belief that an unauthorized person to whom the disclosure was

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

made would not reasonably have been able to retain such information.

Where the practice has demonstrated that there is a low probability that the protected health information has been compromised based on a risk assessment of at least the following factors: A. The nature and extent of the protected health information involved, including the types of identifiers and the likelihood of re-identification B. The unauthorized person who used the protected health information or to whom the disclosure was made C. Whether the protected health information was actually ac quired or viewed D. The extent to which the risk to the protected health information has been mitigated (45 CFR 164.402). Notification is required at several levels: (1) to the individual; (2) to the media; and (3) to the Secretary of the US Department of Health and Human Services (HHS). Each requirement will be addressed in turn below. To the Individual Notification to the individual is required where, after a risk assessment, it has been determined that protected health information has been—or is reasonably believed by the practice to have been— accessed, acquired, used, or disclosed as a result of a breach. A breach shall be treated as being discovered by the practice on the first day that the breach is actually known to the practice or, by exercising reasonable diligence, would have been known to the practice, meaning that, if

Medical Legal Update

such breach is known—or by exercising reasonable diligence would have been known—to any person who is a workforce member or agent of the covered entity other than the person committing the breach. Notification to the individual is required no later than 60 calendar days after the discovery of a breach, and in the notification the practice is required to provide, to the extent possible, the following information: • A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if the date is known • A description of the types of unsecured protected health information that were involved in the breach (such as whether the individual’s full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved) • Any steps that the individual should take to protect himself or herself from potential harm resulting from the breach • A brief description of what the covered entity involved is doing to investigate the breach, to mitigate harm to the individual, and to protect against any further breaches • Contact procedures for the individual to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, website, and/or postal address. Notification is required to be sent in writing by first-class mail to the individual at the last known address of the individual or, if the individual agrees to electronic notice and such agreement has not been withdrawn, by electronic mail. The notification may be provided in 1

or more mailings as information is available. If the practice knows that the individual is deceased and has the address of his or her next of kin or personal representative, written notification by first-class mail to either the next of kin or personal representative must be made. Again, the notification may be provided in 1 or more mailings as information is available. In a case where there is insufficient or out-of-date contact information that precludes written notification to the individual, substitute notice may be provided. In a breach where more than 10 individuals are affected, substitute notice may take the form of either a conspicuous posting on the home page of the practice’s website for a period of 90 days, or a conspicuous notice in major print and/or broadcast media outlets in the geographic areas where the affected individuals likely reside, that includes a toll-free phone number that remains active for at least 90 days where individuals can learn whether their unsecured protected health information may be included in the breach. (See 45 CFR 164.404.)

tice shall maintain a log or other documentation of such breaches and, no later than 60 days after the end of each calendar year, provide notification to the Secretary in the manner specified on the HHS website. (See 45 CFR 164.408.) Additional Concerns In addition to the foregoing, business associates are required to report the discovery of a breach to the practice within 60 calendar days. (See 45 CFR 164.410.) Failure to abide by the Breach Notification Rule may open up the practice to substantial liability. The recent modifications to HIPAA allow for the imposition of civil monetary penalties for any entity or individual in violation of any HIPAA requirement, including the Breach Notification Rule, which is why it is imperative to understand and implement the requirements of the rule. Implementation requires that the policies, procedures, and contracts of the practice reflect the requirements of the Breach Notification Rule. To discuss your practice’s compliance needs to prepare for September 23, 2013, check out available HIPAA policies at www.healthcarepractice compliance.com, or contact Jennifer at 516-747-6700 x302 or Jennifer@ Kirschenbaumesq.com. Prior to Sept ember 2013, all practices will be required to adopt new Notice of Privacy Practices, as well as accompanying documents, such as a Breach Notification Policy. l

To the Media When more than 500 residents of a state or jurisdiction are involved in a protected health information breach, the practice is required to notify prominent media outlets serving the state or jurisdiction within 60 calendar days after the discovery of the breach. (See 45 CFR 164.406.)

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.

To the HHS Secretary The practice must also notify the Secretary of HHS when a breach has occurred that involves 500 or more individuals, in the manner and form specified on the HHS website. For all breaches involving less than 500 individuals, the prac-

April 2013

www.OncPracticeManagement.com

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

What a Continually Divided Congress Means for Community Oncology By Sydney Abbott, JD, Manager of Provider Economics and Public Policy, Association of Community Cancer Centers

he Association of Community Cancer Cen ters (ACCC) held its 39th Annual National Meeting for members March 6-8, 2013. The day after ACCC members went to Capitol Hill to participate in nearly 120 scheduled meetings with members of Congress, a panel of 3 policy specialists discussed the current political climate and the probability of oncology-related legislation moving forward in a continually divided Congress. Led by moderator Matt Farber of the ACCC, Joseph Hill of the American Society of Health-System Pharmacists, Cara Tenenbaum of the Ovarian Cancer National Alliance, and myself, we discussed some of the most pressing current issues in health policy, starting with the sequester. Although there were varying degrees of optimism between the panelists on the elimination of the sequester as a whole, we all did agree that it is likely to cause long-term effects even if it is repealed relatively quickly. The Effects of the Sequester Although the sequester was originally designed to be a blunt budget-cutting tool so devastating that no one in Congress would actually allow it to happen, we now know that it did happen and the sequester is in full effect. Now, no one believes that the sequester will be eliminated before the end of the year, and that means there will be a significant impact on the oncology community. Besides the 2% across-

the-board reduction to Medicare re imbursement, the panel also talked about the less-direct impacts to the provision of cancer care, such as reduced funding for research and clinical trials, and the difficulty in maintaining the drug approval process timeline in the face of dramatic cuts to the budgets of the National

Although the sequester was originally designed to be a blunt budget-cutting tool so devastating that no one in Congress would allow it to happen, we now know that it did happen and the sequester is in full effect. No one believes that the sequester will be eliminated before the end of the year, and that means there will be a significant impact on the oncology community. Institutes of Health and the US Food and Drug Administration. Considering the current state of Congress, as well as what is expected over the next 2 years, the panel expressed concern over healthcare

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

legislation moving independently. Instead, Mr Hill noted that legislation concerning drug shortages, such as track-and-trace or pedigree bills, may not be introduced or see any kind of movement until a larger, more broad-sweeping piece of healthcare legislation is introduced. With Congress in the mindset to only pass bills that are considered “must-pass”—bills that must pass to avoid a government shutdown—Mr Hill believes that a continuing resolution on the budget may be the best vehicle for some of the drug shortage legislation that may be introduced. By contrast, I felt that there is still an opportunity to see bills move independently of larger vehicles, particularly bills that have no (or a very low) fiscal note and a large groundswell of bipartisan support, such as legislation to create parity between oral anticancer medications and their intravenous-infused counterparts. In this budget-conscious climate, bills that do not require additional federal funds will have the greatest likelihood for movement. Fixing the Sustainable Growth Rate Next, the panelists addressed the probability that the sustainable growth rate (SGR) formula would finally be permanently fixed in the 113th Congress. Each panelist agreed that it may be too early to tell, but if Congress seriously plans to address the issue, now is the time. The Congressional Budget Office (CBO) recently rescored the 10-year SGR fix at $138 billion. This is a relative “bargain,” down from $240 billion in previous CBO estimates. Continued on page 37

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.

P O

PERSONALIZED MMEDICINE IN ONCOLOGY

Physician Wealth Management With Lawrence B. Keller

Joint Tenants with Right of Survivorship: Planning Pitfalls to Consider Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

ou work hard to accumulate assets for yourself and your family. However, you probably have never given much thought to how you should own your assets or how ownership arrangements can impact your overall estate plan. One common form of property ownership is Joint Tenants with Right of Survivorship (JTWROS), which results in the automatic transfer of a jointly owned asset to a surviving owner upon another owner’s death. Although JTWROS is often looked upon favorably, it can cause a variety of estate planning problems. Joint Tenants with Right of Survivorship In the United States, property may be owned in several different ways, and the form of property ownership is very important in estate planning. It determines how and to whom a property passes upon the death of an owner, and the extent to which the value of the property is included in the deceased owner’s gross estate for federal estate tax purposes. The unique feature of JTWROS is that, by law, ownership of the property passes automatically to the surviving joint owner(s), not according to the deceased owner’s last will and testament or his or her trust. Therefore, regardless of the terms of your estate plan, any property you own as JTWROS will pass automatically to the surviving joint tenant.

Inadvertent Disinheritance The first planning pitfall associated with this form of ownership is inadvertently disinheriting someone that you meant to benefit from the property upon your death.

The unique feature of JTWROS is that, by law, ownership of the property passes automatically to the surviving joint owner(s), not according to the deceased owner’s last will and testament or his or her trust. Therefore, regardless of the terms of your estate plan, any property you own as JTWROS will pass automatically to the surviving joint tenant.

For example, Drs Michael and Terri Smith are married and own all of their property jointly. Michael has a child from a previous marriage, and he wants to make sure that his child receives a vacation home that has been in his family for 3 generations. When Michael and Terri met with their estate planning attorney, Michael left the vaca-

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

tion home to his child in his will. However, Michael added Terri to the deed when they were married, and they currently own the property jointly with rights of survivorship. What happens if Michael predeceases Terri? Terri will receive the vacation property automatically, regardless of the terms of Michael’s will. The result is that Michael will have unintentionally disinherited his child from a deeply cherished family asset. If Terri remarries, she and her new husband could own the property jointly. Then, the property would automatically pass to Terri’s new husband if she predeceases him. Exposure to Claims of Joint Creditors When property is owned jointly with right of survivorship, the property may be subject to the claims of creditors of each joint owner. This can be a significant issue, especially when parents own property with their children. For example, a parent may find his or her property subject to a divorce or bankruptcy proceeding, or subject to other creditor claims involving his or her children. Unintentional Taxable Gifts When an individual owner of an asset decides to name another individual as a joint owner of a property, that individual has made a gift to the joint owner. If the new joint owner happens to be someone other than the original owner’s spouse, a taxable gift may result, depending on the value of the property. Taxation of Jointly Owned Property Generally, when nonspouses own

Physician Wealth Management

property as JTWROS, the entire value of the property is included in the gross estate of the first joint owner to die. To avoid this result, the estate of the first joint owner to die must prove that the surviving joint tenant(s) contributed toward all or part of the cost of acquiring the property. Without doing so, the full value of the asset will be included in the first owner’s taxable estate. Thus, if a parent owns property jointly with a child, the full value of the property will be included in the parent’s taxable estate if the child did not contribute anything toward the purchase price. This is not the case where the joint owners are spouses. Under these circumstances, only 50% of the value of the property is included in the gross estate of the first owner to die. It is not necessary that a spouse contribute toward purchasing the property. Estate Tax Allocation Problem Jointly owned property can also

cause significant tax allocation problems. If estate taxes are due at your death, the estate tax burden is allocated to your assets under the terms of your will. Typically, an individual’s will states that all taxes are to be paid from the residue of the estate. If so, then the individuals who inherit the residuary estate will bear the estate tax burden associated with those assets. The result is that a surviving joint tenant will not be responsible for any portion of the estate tax for any jointly owned property that passes to the surviving joint tenant, unlike other beneficiaries of your estate. Thus, careful planning is required to determine if estate taxes at your death should be allocated to any jointly owned property or other assets that pass outside the terms of your will.

property held this way will avoid the expense, delay, and publicity of probate proceedings. As a result, you may be unduly biased in favor of forming a joint tenancy when you may be better served by using another planning strategy. Therefore, you should make sure that you fully understand the advantages—as well as the disadvantages—of a joint tenancy compared with alternative strategies, and/or consult with an attorney or tax professional to discuss how titling assets this way may affect your overall estate plan. l Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF, is the founder of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached for comments or questions at 516-677-6211, or by e-mail at Lkeller@physicianfinancialservices. com.

Conclusion Because taking title to property as JTWROS is simple and inexpensive, it is a very common way to own property—especially because

Patient and Provider Access

What a Continually Divided Congress…Continued from page 34 It was discussed that the health subcommittees of the House Ways and Means and the House Energy and Commerce committees are floating ideas for legislation to fix the fundamentally flawed formula. All of the panelists have heard rumblings that this may be the year that we actually see legislation introduced, but the particulars of such legislation—and how it will be paid for—are

Get Involved The 39th Annual National Meeting was a great success thanks to the participation of ACCC’s members and supporters. Members are encouraged to get involved in grassroots advocacy to help shape the policies impacting cancer care. For more information and ways to get involved, please visit www. accc-cancer.org/advocacy. l

still unknown. However, each panelist did stress the importance of advocacy and the impact that the provider community could have on this issue. As committee members on both sides of the aisle float ideas on repeal, it will be vitally important that ACCC members let their members of Congress know how the flawed SGR formula impacts them and their ability to care for their patients.

April 2013

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Provider Perspective

A Plan to Fix Cancer Care By Ezekiel J. Emanuel

his year, more than 1.6 million Americans—0.5 percent of the population— will receive a diagnosis of cancer. Their treatment will consume at least 5 percent of the country’s health care spending, at a cost that is growing faster than all other areas of medicine. Doctors and patients recognize that this is unsustainable and that we need to change the way we deliver care. But we need help, and that is why more than 20 prominent members of the oncology community contributed to the drafting of this essay (their names appear below). Many cancer patients, after getting a diagnosis of a terrifying disease, pursue any potentially promising therapy, regardless of the price. But the main cost driver is the fee-for-service payment system. The more doctors do for patients, the more reimbursement they receive. Surgeons earn more for every procedure. Oncologists typically make more money if they use newly approved drugs and the latest radiation treatments than if they use cheaper, older alternatives that work just as well. (This is because they get paid back the cost of the drug, in addition to an extra 6 percent of that cost—the more expensive the drug, the higher the compensation.) Some of these new therapies are rightly heralded as substantial advances, but others provide only marginal benefit. Of the 13 anticancer drugs the Food and Drug Administration approved in 2012, only one may extend life by more than a median of six months. Two extended life for only four to six

Reprinted with permission from The New York Times, March 23, 2013.

weeks. All cost more than $5,900 per month of treatment. Significant costs also come from hospitalizations and emergency room visits that could be prevented with better management of common symptoms. Unfortunately, doctors earn more treating patients for serious problems in the hospi-

Of the 13 anticancer drugs the Food and Drug Administration approved in 2012, only one may extend life by more than a median of six months. Two extended life for only four to six weeks. All cost more than $5,900 per month of treatment. tal than they do preventing those problems from occurring in the first place. Five major changes need to occur: First, over the next few years, the payment system needs to move away from fee-for-service toward a system of bundled payments, in which doctors are paid one fee for all the treatments involved in caring for a cancer patient. This would remove the incentive to prescribe more expensive drugs when older generics are equally effective. Second, insurers have to give physicians information about where they are spending money. As crazy as it sounds, most physicians have

ONCOLOGY PRACTICE MANAGEMENT

I April 2013

little ability to track the care they deliver, or how they compare with other physicians who care for similar patients. Costs vary wildly for patients with identical cancers. One study of patients with cancers that had spread throughout their bodies showed that the costs of four months of scans varied from $1,800 to $6,400 per patient. Doctors don’t have a clear sense of whether the money is going to chemotherapy, hospitalizations or follow-up M.R.I. scans. Armed with better data, physicians can learn how to improve care at lower cost. Third, any change in payment methods must be accompanied by rigorous quality monitoring to ensure that there is neither undernor over-utilization of care. Fourth, we need more “high touch” oncology practices. In these practices, nurses manage common symptoms before they escalate to the point that they require visits to the emergency room, and doctors talk with patients about palliative-care services and end-of-life preferences early on—not in the weeks before death. These services are frequently not paid for by insurers but can improve the quality of care and save significant money by averting repeated tests, hospitalizations and futile, toxic chemotherapy. Insurers need to share the resulting savings, enabling physicians to invest in providing these services. Fifth, we need better incentives for research. Many expensive tests and treatments are introduced without evidence that they improve survival or reduce side effects, and with poor information about which patients should receive them. For instance, while more than 800,000 Continued on page 39

Provider Perspective

robotic surgeries, mostly for cancer, have been performed in the last two years, there is no reliable evidence that the robots either improve survival or reduce side effects—despite the fact that they cost more than traditional surgery. Once interventions are paid for, the incentive for research disappears. The oncology community cannot make these changes alone. The government is deeply involved and has to help. Today, 60 percent of cancer diagnoses are made in patients who are eligible for Medicare. By 2030, that number will rise to over 70 percent. Medicare and the other payers need to work with oncologists. The secretary of health and human services should organize a working group representing Medicare, pri-

vate insurers, oncologists, quality experts and patients to figure out how to develop these proposals— with no increase in costs—and start implementing them by the end of 2015. Everyone engaged in cancer care needs to help improve it. l

Ph.D., Texas Oncology, United States Oncology; John Mendelsohn, M.D., MD Anderson Cancer Center; Lee N. Newcomer, M.D., UnitedHealth Group; Jeffrey M. Peppercorn, M.D., M.P.H., Duke University; Scott D. Ramsey, M.D., Ph.D., Fred Hutchinson Cancer Research Center; Lowell E. Schnipper, M.D., Beth Israel Deaconess Medical Center; Frederick M. Schnell, M.D., Central Georgia Cancer Care; Deborah Schrag, M.D., DanaFarber Cancer Institute; Ya-Chen Tina Shih, Ph.D., University of Chicago; John D. Sprandio, M.D., Consultants in Medical Oncology and Hematology; Thomas J. Smith, M.D., Johns Hopkins University; Arthur P. Staddon, M.D., Pennsylvania Oncology Hematology Associates; Jennifer S. Temel, M.D., Massachusetts General Hospital

Written with: Amy P. Abernethy, M.D., Duke University; Justin E. Bekelman, M.D., University of Pennsylvania; Otis W. Brawley, M.D., American Cancer Society; Robert L. Erwin, Marti Nelson Cancer Foundation; Patricia Ganz, M.D., U.C.L.A.; James S. Goodwin, M.D., University of Texas Medical Branch; Robert J. Green, M.D., Palm Beach Cancer Institute; Jesse Gruman, President, Center for Advancing Health; J. Russell Hoverman, M.D.,

WCMC_2013Conf_horizontalV491212_Layout 1 9/13/12 4:32 PM Page 2

SAVE THE DATE SECOND ANNUAL CONFERENCE

2013 WORLD CUTANEOUS MALIGNANCIES CONGRESS

July 26-28, 2013 Hyatt Regency La Jolla at Aventine 3777 La Jolla Village Drive San Diego, California Melanoma • Basal Cell Carcinoma • Cutaneous T-Cell Lymphoma Squamous Cell Carcinoma • Merkel Cell Carcinoma

April 2013

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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 Joint swelling/discomfort2 29.5 4.2 23.4 4.1 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

4 Includes

1 Adverse

terms Edema, Edema peripheral, Pitting edema, and Generalized edema 5 Includes all fractures with the exception of pathological fracture 6 Includes 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

2 Includes 3 Includes

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

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

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.

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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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