OPM May 2012, Vol 2, No 3 by Value-Based Cancer Care

ONCOLOGY PRACTICE MANAGEMENT ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

www.OncPracticeManagement.com

efore 2005, the Centers for Medicare & Medicaid Services (CMS) reimbursed physicians for drugs administered in their offices at a percentage of the average wholesale price. In 2005, however, the payment basis was changed to a percentage of a newly created measure, the average sales price. This change resulted in a significant change to the bottom line for all physician practices that administered chemotherapy and other infused drugs. According to the National Practice Benchmark, drug margins dropped from approximately 22% in 2005 to approximately 9% in 2010 (Figure 1).1 Because 65% of all practice revenue is generated Continued on page 8

By Risë Marie Cleland Founder and Chief Executive Officer, Oplinc, Inc

udits and reviews of medical claims are nothing new. However, we are seeing an unprecedented increase in the number of these audits in the hospital and in the physician practice setting. The increase in audits is directly related to the growing numbers of entities that are auditing medical claims and the increased focus on identifying and preventing overpayments. Public and private payers alike recognize the excellent return on investment

(ROI) of medical claims audit initiatives. Yet, as good as the ROI is on the recovery of overpayments, it is even better if the overpayment can be prevented. Therefore, providers should expect to see more prepayment audits and reviews in the future.

New Tools to Reduce Fraud In fact, provisions in the massive healthcare reform legislation, the Affordable Care Act (ACA), provide Continued on page 11

Evolving Practice Standards for Cancer Programs from the Commission on Cancer By M. Asa Carter, CTR Manager of Accreditation and Standards, Cancer Programs, American College of Surgeons

hat is the most important challenge faced by a person who is diagnosed with cancer today? Opinions will differ, but most patients want to be assured that they will work with a group of multispecialty physicians who will provide recommendations for care that provide the best possible outcomes, that all options for effective treat-

ment will be available to them, that care will be provided in a safe and Continued on page 18

By Teri U. Guidi, MBA, FAAMA President and Chief Executive Officer of the Oncology Management Consulting Group, Pipersville, PA

Audits and Reviews of Medical Claims

A g N C ht om to D C PR an mu yo O ce nit u b VI rD y C y t DE ru an he g A Sh cer sso R A or C c C ta en iat C ge te io n r ES s.. s o ..3 f S

Strategies Oncology Practices Should Consider to Stay Afloat

VOLUME 2 • NUMBER 3

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MAY 2012

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From the Editor

Hospital-Based or Community-Based Practice, We All Care for Patients with Cancer Working Together to Set Common Standards By Dawn Holcombe, MBA, FACMPE, ACHE

he majority of cancer care is well known to be delivered in the community setting. We also are starting to learn that there may be cost differences based on site of service. What does that really mean to a patient with cancer, a physician, a practice administrator, and a payer or employer? The real answer is…it depends. The cancer community has at its heart a desire to serve patients and to beat cancer as often as possible, as well as to assist patients through the journey if cure is not an option. The men and women who choose to serve patients with cancer are special in their own right—no matter where they are employed, you will find specialized knowledge, expert training,

Instead of battling internally over which site is better or worse, our focus may be better spent on identifying the medical and operational standards that would be expected of any site delivering quality cancer care.

The Challenge We are being challenged every day to prove quality and value. Of note,

Continued on page 6

Editorial Advisory Board

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

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

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

Craig Deligdish, MD Medical Director Florida Comprehensive Cancer Network Melbourne, FL

Peggy Barton, RN Practice Manager Toledo Clinic, OH

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

Risë Marie Cleland President Oplinc, Inc Lawton, OK

the very medical decisions and treatment choices made by physicians for their individual patients are being challenged and held up to some interpretation of evidence-based stan-

warmth, compassion, and even love for their patients.

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

May 2012

www.OncPracticeManagement.com

In This Issue

PUBLISHING STAFF Publisher Nicholas Englezos nick@engagehc.com 732-992-1884 Editorial Director Dalia Buffery dalia@engagehc.com 732-992-1889 Associate Publisher American Health & Drug Benefits Maurice Nogueira maurice@engagehc.com 732-992-1895 Associate Publisher Cristopher Pires cris@engagehc.com 732-992-1896 Director, Client Services Lou Lesperance, Jr. lou@engagehc.com 732-992-1896 Associate Editor Lara J. Lorton Editorial Assistant Jennifer Brandt jennifer@generaladminllc.com 732-992-1536 Production Manager Marie R. S. Borelli Sales Assistant Zach Ceretelle Quality Control Director Barbara Marino Business Manager Blanche Marchitto MISSION STATEMENT Oncology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the high-quality care cancer patients deserve, providers must master the ever-changing business of oncology. Oncology Practice Management will offer process solutions for members of the cancer care team—medical, surgical, and radiation oncologists, as well as executives, administrators, and coders/billers—to assist them in reimbursement, staffing, electronic health records, REMS, and compliance with state and federal regulations.

FROM THE EDITOR Hospital-Based or Community-Based Practice, We All Care for Patients with Cancer.......................................3 By Dawn Holcombe, MBA, FACMPE, ACHE

FEATURES Strategies Oncology Practices Should Consider to Stay Afloat.............................................................................1 By Teri U. Guidi, MBA, FAAMA

Audits and Reviews of Medical Claims... ............................1 By Risë Marie Cleland

Evolving Practice Standards for Cancer Programs from the Commission on Cancer..................................................1 By M. Asa Carter, CTR

340B DRUG PRICING PROGRAM Contract Pharmacies Permitted to Manage Drugs Under 340B Program...... ............................................28 By Wayne Kuznar

DRUG CODING Medications Used for the Treatment of Colorectal Cancer..............................................................30 DEPARTMENTS Medical Legal Update Protecting from HIPAA Exposure through Compliance ....20 By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

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

Cancer Drug Shortages.........................................................34 By Sydney Abbott, JD

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

Business Disability Insurance and Your Medical Practice, Part 2...........................................................................35

Oncology Practice Management™, ISSN 2164-4403(print), is published 6 times a year by Engage Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. Copyright © 2012 by Engage Healthcare Communications, LLC. All rights reserved. Oncology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America. The ideas and opinions expressed in Oncology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an advertisement or other product mentioned in Oncology Practice Management™ should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication. Postmaster: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Oncology Practice Management™, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

ONCOLOGY PRACTICE MANAGEMENT

I May 2012

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From the Editor

Hospital-Based or Community…Continued from page 3 dards, or the thought that it may be time to change the current model for physician diagnostics and treatments. Is there a quality difference related to the site of care—hospital based versus private practice? We do not yet know. All we do know is that the cost, and possibly the length of treatment, varies, based on recent studies by Milliman (with US Oncology)1 and by Avalere Health (with Community Oncology Alliance and the National Association of Managed Care Physicians).2 Many questions remain to be answered about the depth of service elements, the consistency of the service and care, and even the scope of care across the continuum. Until those differences are known, it is impossible to delve into defining which approach is more appropriate or has greater value, let alone assessing the value given for the cost spent. Another reality is that because of the very nature of hospital–payer contracting, identifying specific cost differences may not lead to any significant change: hospital contracting is on a more unilateral basis, across the entire spectrum of inpatient and outpatient care, and individual rates may be less flexible or have less importance, because contracting is not as focused on a specialty-specific basis. Although we do need to be cognizant of information that could lead to better policy decisions on all sides, and studies like the 2 cited here contribute to the greater body of knowledge,1,2 it may be useful to reconsider the focus and intensity of the hospital-versus-community discussion. The problem is that the more we battle among ourselves—challenging one type of physician care setting against another—the more we leave ourselves open to other delivery models and oversight coming in from another direction.

Our reality is that Medicare reimbursement, and the extent to which private payers mirror its rates, make it incredibly difficult, if not impossible, for most private oncology practices to stand alone. That is not a trend that will be easily stopped; indeed, in some states almost all oncologists are already hospital based.

Although we do need to be cognizant of information that could lead to better policy decisions on all sides, and studies like the 2 cited here contribute to the greater body of knowledge, it may be useful to reconsider the focus and intensity of the hospital-versuscommunity discussion.

Identifying Standards of Care Instead of battling internally over which site is better or worse, our focus may be better spent on identifying the medical and operational standards that would be expected of any site delivering quality cancer care. This would enable those who care for patients with cancer (hospital based and private practice based) to draw the line in the sand as a challenge to other potential delivery models under consideration (eg, possible infusion clinics in retail pharmacy settings, in corporate complexes, or in free-standing commercial settings). Some of these discussions regarding standards and expectations are already under way. The National Com-

ONCOLOGY PRACTICE MANAGEMENT

I May 2012

prehensive Cancer Network (NCCN) and National Business Group on Health have a substantial project in progress that defines expectations for cancer benefit design for employers and health plans. The Community Oncology Alliance, the McKesson/ US Oncology Network, and at least 2 other major projects, are seeking to shape and define the oncology medical home concept. The American Society of Clinical Oncology has identified specific quality measures in its Quality Oncology Practice Initiative (QOPI) project and is now certifying QOPI-engaged practices. However, most of these projects are specific to the individual project–focused end goals and do not address the breadth of oncology care delivery, regardless of site of care. Some goals will be difficult to establish on a unilateral basis but will be essential as we move forward. Suggestions for categories of cancer program delivery standards may begin with expectations for monitoring and documentation in accreditation and certification programs, such as those managed by the Joint Commission and the American College of Surgeons Commission on Cancer, as well as the Oncology Nursing Society, and various laboratory and imaging oversight bodies. The USP 797 Standards for chemotherapy mixing environments will be just as important, regardless of site. The National Association of Managed Care Physicians has a membership of medical directors that crosses health plans, employers, and providers; it may offer a good start to a cross-stakeholder discussion, especially with outreach and affiliation with other key, yet diverse, oncology perspectives. Appropriate universal standards that we, as the community of oncology, can address will include not just Continued on page 10

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Practice Management

Strategies Oncology Practices Should…Continued from the cover

Drug margin, % of total revenue

Figure 1. Drug Revenue as a Percentage of Total Revenue, 2005-2010 0.25 0.25 0.20 0.20 0.15 0.15 0.10 0.10 0.05 0.05 00 2005 2005

2006 2006

2007 2007

2008 2008

2009 2009

2010 2010

2011 2011

Used with permission from Barr TR, Towle EL. National Oncology Practice

FBenchmark, 2011 Report on 2010 Data. J Oncol Pract. 2011;7(suppl 6S):67S-82S. Figure 2. Revenue Mix, by Service Line (37 Practices)

Drugs

Infusion Imaging

5% 2% 2% 2%

65%

Laboratory Nonmedical Closed-door pharmacy Radiation

Evaluation and management

8% Used with permission from Barr TR, Towle EL. National Oncology Practice Benchmark, 2011 Report on 2010 Data. J Oncol Pract. 2011;7(suppl 6S):67S-82S.

by drugs (Figure 2),1 it is clear that this payment methodology change has had a major effect on the practice’s overall profitability. Still, physicians buckled down, reducing their expenses and improving efficiency to remain financially viable and able to deliver care to their patients.

In 2008, CMS instituted a coverage policy change that effectively limited the clinical indications approved for payment for use of erythropoiesis-stimulating agents. These drugs had been prescribed heavily based on the labeled clinical indications, but their use dropped dramatically when the new policy

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I May 2012

was launched. This reduction in utilization resulted in a dramatic decline in the practice’s total revenue, once again challenging physicians in their efforts to remain open and able to serve patients. At that point, many practices began to seek alternate means of survival, including merging with other practices to gain economies of scale, expanding services to generate sufficient revenue to remain viable, and entering into new relationship models with other groups and with hospitals. But other practices have steadfastly held to the independent private practice model. We have recently received a number of inquiries for consulting help from such independent practices as they continue to struggle to stay afloat. We have noted that these groups fall into 2 basic groups, which we characterize as (1) “We are being starved out by the new market alignments,” and (2) “We survived the rest, why are we still sinking?” In this article, we offer suggestions to these 2 groups on possible approaches to meet the challenges they now face.

Starved Out: Band Together or Join a Hospital As the trend toward alternative alignment and integration models between office-based and hospitalbased oncology has grown, there are often political or other circumstances that have prevented such shifts from taking place. Many hospitals and health systems, however, have moved forward in acquiring physician practices of various disciplines, including those that refer directly to medical oncology, thereby gaining heavy influence on the referral patterns for cancer care. In markets where there are multiple oncology practice options, the Continued on page 9

Practice Management

Strategies Oncology Practices Should…Continued from page 8 hospital often “chooses sides,” effectively squeezing the others out. Furthermore, in many markets, the hospital has decided to acquire or closely align with an existing oncology practice, or to directly employ competing medical oncologists. This clearly can result in a dramatic constriction of referrals to any medical oncologists who remain outside of the circle. In these situations, the medical oncology group that finds itself on the outside has few options that offer a strong likelihood for success. In general, there are 2 basic approaches for oncology practices. One option is for the practice to band together with the remaining independent practices of referring and treating disciplines (likely expanding services to compete more effectively) to capture the market share that the hospital has not already gathered up. The second option is to knock on the hospital’s door and seek admission.

Still Sinking: Pay Attention to Details We recently received an alarming number of calls from practices that are sinking. What they seem to have in common—assuming that they are not in the “starved-out” group—is a lapse in attention to details. The most frequent lapses are: 1. Poor management of drug purchasing and inventory 2. Failure to monitor key statistics 3. Failure to remain attentive to providing customer service 4. Poor management of staff 5. Drug management. Using a group purchasing organization (GPO) is the most common means of purchasing drugs, and there are many reputable GPOs to choose from. Select a GPO that offers tools to help manage your spending through analysis of use of the following elements:

Dashboards provide an at-a-glance view of key performance indicators that can help healthcare professionals identify and monitor the most important information needed to think, reason, and make informed healthcare decisions. Yet few practices actually use them in any manner, even though they need not be complicated to create and to monitor. A regular review of some key statistics in looking for changes and trends over a 3- to 4-month period should include: The number of new patients monthly. If you note downward trends, dig deeper to see which referring physicians have changed, or what type of patients are on the decline

1 We recently received an alarming number of calls from practices that are sinking. What they seem to have in common is a lapse in attention to details.

Monthly billed charges and total receipts. Explore downward trends to be sure that charges are not being missed or delayed, and to check for changes in payer policy or other collection problems

Monthly drug spending and drug revenue. As long as they keep pace, there is no problem

• Which drugs are used in the greatest quantity or with the greatest frequency • What vial and/or package sizes will minimize unbillable waste and outdated inventory • Which therapeutic equivalents are options, which regimens offer comparable clinical performance with less financial risk, and the determination of whether there is a dangerous pattern of off-label use that could result in frequent denials. It is generally inappropriate to expect nursing staff to monitor these things, and smaller practices usually do not have sufficient additional staff to do so effectively.

Monthly operating costs. Most operating costs should be relatively stable unless there is significant growth. If you have had measurable declines in volume, review your expenses for reduction opportunities

Customer service. It is only human to eventually slide into complacency. Remain attentive to the experience that is delivered to patients (eg, friendliness of staff, bedside manner, wait times, etc), as well as to the experience provided to referring physicians (eg, copies of notes, fast track phone lines for referral, helpful staff)

Key Statistics Everyone has heard of dashboards.

May 2012

Continued on page 10

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From the Editor

Hospital-Based or Community…Continued from page 6 clinical expectations (eg, all or specific levels of evidence from nationally accepted guidelines, such as produced by the NCCN), but also operational (ie, staffing, expertise, regulatory compliance) and service (ie, patient satisfaction, all types of patient assessments and counseling, financial transparency and counseling, and multidisciplinary patient assessment and support).

Moving Beyond Site of Care It is also important not to focus on such questions and standards internally, or locally. We have already seen that “if you build it, they will come” is not a concept that has worked well for some practices that have led the curve in terms of creating content and standards but are now having difficulty finding health plans willing to pay for what they have developed. This will become a national discussion that of necessity will engage many stakeholders. We are making

Whether you are in a hospital-based practice, in private practice, or are considering a change from one to the other, patients with cancer and those who pay for their care have a right to certain standard levels of expectations—clinical, operational, and service related. progress, and do have some discussions under way, none of which yet addresses the totality of what we may need, but may provide useful build-

ing blocks for discussion over the next few years. Whether you are in a hospitalbased practice, in private practice, or are considering a change from one to the other, patients with cancer and those who pay for their care have a right to certain standard levels of expectations—clinical, operational, and service related. We are not likely to be able to affect how the hospital or the private practice situation shapes out in different communities—there are many other variables that shape that future—but we can work together to shape expectations and assessment of appropriate care, regardless of site. l

References 1. Fitch K, Pyenson B. Site of service cost differences for Medicare patients receiving chemotherapy. Milliman, Inc. October 19, 2011. http://publications. milliman.com/publications/health-published/pdfs/siteof-service-cost-differences.pdf. Accessed May 3, 2012. 2. Avalere Health. Total cost of cancer care by site of service: physician office versus outpatient hospital. Avalere Health, LLC. March 2012. http://www.avale rehealth.net/news/2012-04-03_COA/Cost_of_Care. pdf. Accessed May 4, 2012.

Practice Management

Strategies Oncology Practices Should…Continued from page 9

Managing staff. All the items above involve some staffing issues that need to be monitored. With the economy being still somewhat weak, we have seen a rise in unethical staff behavior, such as minor theft and “creative” accounting. In addition, when staff members are under pressure or are unhappy, performance can suffer and result in poor customer service and failure to complete work in a timely fashion. The staff represents the practice, so it is important that staff members are

projecting the image that the practice wants to maintain.

Conclusion Whether a practice is facing market pressures from competitors or is struggling to keep heads above water, the wise keep an open mind and look carefully at the details. For practices looking to align with others, those details are as much quantitative (eg, market share and financial arrangements) as they are qualitative (eg, the right fit, control,

ONCOLOGY PRACTICE MANAGEMENT

I May 2012

quality of life). For those who are trying to stick it out, the same applies. The quantitative details (eg, volumes, dollars) must be carefully monitored, and the qualitative details (eg, customer service) influence not only the measurable results but also the physicians’ ability to remain happy in their work. l

Reference 1. Barr TR, Towle EL. National Oncology Practice Benchmark, 2011 Report on 2010 Data. J Oncol Pract. 2011;7(suppl 6S):67S-82S.

Claim Audits

Audits and Reviews…Continued from the cover strengthened the reverse false claims provision of the False Claims Act. The ACA established a new section 1128J(d) of the act titled, “Reporting and Returning of Overpayments,” which requires providers to report and return any Medicare overpayment by the later of 60 days after the identification of the overpayment or the date the applicable cost report is due. Failure to refund promptly could result in a violation of the False Claims Act, which includes civil penalties between $5500 and $11,000 per violation, plus 3 times the government’s losses. In addition to liability under the False Claims Act, a determination that an individual or entity knowingly concealed overpayments from federal healthcare programs may constitute grounds for additional civil money penalties, criminal penalties (including fines, imprisonment, or both), as well as exclusion from the Medicare and Medicaid programs.

Tips to Avoid Overpayments • Know the billing and coding rules • Know what you should be paid • Ensure medical record documentation supports services billed • Document medical necessity for services • Follow incident to supervision, billing, and documentation rules • Comply with Medicare signature requirements • Put processes in place to avoid duplicate claims • Perform internal prepayment reviews • Develop, implement, and monitor a billing compliance program • Check the Office of Inspector General exclusion databases before hiring new enforcement tools and resources for identifying and preventing overpayments as a result of fraud, abuse, and billing errors. The ACA provides an additional $350 million over 10 years to increase antifraud activity through more prepayment audits and reviews and new highly sophisticated data analytics. The ACA also expands the successful Recovery Audit Contractor (RAC) program to Medicaid, Medicare Advantage (Part C), and Medicare Part D programs. The Centers for Medicare & Medicaid Services (CMS) reports that it expects to save $2.5 billion over the next 5 years in the Medicaid RAC program alone. False Claims Act Reducing fraud is a high priority for CMS; nevertheless, the identification and recovery of overpayments resulting from errors remains a key initiative. Because of the recent changes to the False Claims Act, inadvertent claims errors, the lack of adequate documentation to support billed claims, or inattention to billing errors or overpayments can rapidly snowball and threaten a clinic’s financial viability. In 2009, Congress amended the federal civil False Claims Act to

include the concealment or the knowing and improper avoidance of an obligation to pay or transmit money to the government. This is

Because of the recent changes to the False Claims Act, inadvertent claims errors, the lack of adequate documentation to support billed claims, or inattention to billing errors or overpayments can rapidly snowball and threaten a clinic’s financial viability.

Overpayment On February 16, 2012, CMS published the “proposed rule,” Medicare Program; Reporting and Returning of Overpayments, in which CMS provides definitions and clarifications on the reporting and returning of overpayments. The proposed rule defines an overpayment as “any funds that a person receives or retains under title XVIII or XIX to which the person, after applicable reconciliation, is not entitled under such title.” The proposed rule would also clarify that an overpayment is “identified” (and therefore subject to the 60-day deadline) when a provider or supplier has actual knowledge or acts in “reckless disregard” or “deliberate ignorance” of the existence of the overpayment. CMS states that this

referred to as the “reverse false claims” provision, because it is the knowing retention and failure to refund federal funds that were paid in error that triggers violation of the False Claims Act. In 2010, Section 6402(a) of the ACA further

May 2012

Continued on page 16

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38% 53% ▼ Starting VELCADE® (bortezomib) subcutaneously may be considered for patients with preexisting PN or patients at high risk for PN. Patients with preexisting severe neuropathy should be treated with VELCADE only after careful risk-benefit assessment ▼ Treatment with VELCADE may cause PN that is predominantly sensory. However, cases of severe sensory and motor PN have been reported. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain, or weakness ▼ Patients experiencing new or worsening PN during therapy with VELCADE may require a decrease in the dose, a less-dose-intense schedule, or discontinuation. Please see full Prescribing Information for dose modification guidelines for PN

WARNINGS, PRECAUTIONS AND DRUG INTERACTIONS CONTINUED ▼ Women should avoid becoming pregnant while being treated with VELCADE. Pregnant women should be apprised of the potential harm to the fetus ▼ Closely monitor patients receiving VELCADE in combination with strong CYP3A4 inhibitors. Concomitant use of strong CYP3A4 inducers is not recommended

ADVERSE REACTIONS Most commonly reported adverse reactions (incidence ≥30%) in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia, and anemia. Other adverse reactions, including serious adverse reactions, have been reported

Please see Brief Summary for VELCADE on next page. For Patient Assistance Information or Reimbursement Assistance, call 1-866-VELCADE (835-2233), Option 2, or visit VELCADEHCP.com Reference: 1. Moreau P, Pylypenko H, Grosicki S, et al. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011;12(5):431-440.

Brief Summary INDICATIONS: VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE is contraindicated for intrathecal administration.

WARNINGS AND PRECAUTIONS: VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE. Peripheral Neuropathy: VELCADE treatment causes a peripheral neuropathy that is predominantly sensory. However, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥ Grade 3) during treatment with VELCADE. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. In the Phase 3 relapsed multiple myeloma trial comparing VELCADE subcutaneous vs. intravenous the incidence of Grade ≥ 2 peripheral neuropathy events was 24% for subcutaneous and 41% for intravenous. Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group. Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy. Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may benefit from a decrease in the dose and/or a less dose-intense schedule. In the single agent phase 3 relapsed multiple myeloma study of VELCADE vs. Dexamethasone following dose adjustments, improvement in or resolution of peripheral neuropathy was reported in 51% of patients with ≥ Grade 2 peripheral neuropathy in the relapsed multiple myeloma study. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥ Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Hypotension: The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 13%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/ postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics. Cardiac Disorders: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have been reported, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing heart disease should be closely monitored. In the relapsed multiple myeloma study of VELCADE vs. dexamethasone, the incidence of any treatment-emergent cardiac disorder was 15% and 13% in the VELCADE and dexamethasone groups, respectively. The incidence of heart failure events (acute pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock, pulmonary edema) was similar in the VELCADE and dexamethasone groups, 5% and 4%, respectively. There have been

isolated cases of QT-interval prolongation in clinical studies; causality has not been established. Pulmonary Disorders: There have been reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome (ARDS) in patients receiving VELCADE. Some of these events have been fatal. In a clinical trial, the first two patients given high-dose cytarabine (2 g/m2 per day) by continuous infusion with daunorubicin and VELCADE for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. There have been reports of pulmonary hypertension associated with VELCADE administration in the absence of left heart failure or significant pulmonary disease. In the event of new or worsening cardiopulmonary symptoms, a prompt comprehensive diagnostic evaluation should be conducted. Reversible Posterior Leukoencephalopathy Syndrome (RPLS): There have been reports of RPLS in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing RPLS, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing RPLS is not known. Gastrointestinal Adverse Events: VELCADE treatment can cause nausea, diarrhea, constipation, and vomiting sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur. Fluid and electrolyte replacement should be administered to prevent dehydration. Thrombocytopenia/Neutropenia: VELCADE is associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remained consistent over the 8 cycles of twice weekly dosing, and there was no evidence of cumulative thrombocytopenia or neutropenia. The mean platelet count nadir measured was approximately 40% of baseline. The severity of thrombocytopenia was related to pretreatment platelet count. In the relapsed multiple myeloma study of VELCADE vs. dexamethasone, the incidence of significant bleeding events (≥Grade 3) was similar on both the VELCADE (4%) and dexamethasone (5%) arms. Platelet counts should be monitored prior to each dose of VELCADE. Patients experiencing thrombocytopenia may require change in the dose and schedule of VELCADE. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. The incidence of febrile neutropenia was <1%. Tumor Lysis Syndrome: Because VELCADE is a cytotoxic agent and can rapidly kill malignant cells, the complications of tumor lysis syndrome may occur. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken. Hepatic Events: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic events include increases in liver enzymes, hyperbilirubinemia, and hepatitis. Such changes may be reversible upon discontinuation of VELCADE. There is limited re-challenge information in these patients. Hepatic Impairment: Bortezomib is metabolized by liver enzymes. Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with VELCADE at reduced starting doses and closely monitored for toxicities. (continued)

Use in Pregnancy: Pregnancy Category D. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE (bortezomib). Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses.

ADVERSE EVENT DATA: Safety data from phase 2 and 3 studies of single-agent VELCADE 1.3 mg/m2/dose administered intravenously twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously treated multiple myeloma (N=1008, not including the phase 3, VELCADE plus DOXIL® [doxorubicin HCI liposome injection] study) and previously treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma. In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness); (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated); (39%), thrombocytopenia and appetite decreased (including anorexia); (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo); (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of ≥Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%). In the phase 3 VELCADE + melphalan and prednisone study in previously untreated multiple myeloma, the safety profile of VELCADE administered intravenously in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/ prednisone. The most commonly reported adverse events in this study (VELCADE+melphalan/prednisone vs melphalan/prednisone) were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal pain (14% vs 7%), paresthesia (13% vs 4%), herpes zoster (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%). In the phase 3 VELCADE subcutaneous vs. intravenous study in relapsed multiple myeloma, safety data were similar between the two treatment groups. The most commonly reported adverse events in this study were peripheral neuropathy NEC (38% vs 53%), anemia (36% vs 35%), thrombocytopenia (35% vs 36%), neutropenia (29% vs 27%), diarrhea (24% vs 36%), neuralgia (24% vs 23%), leukopenia (20% vs 22%), pyrexia (19% vs 16%), nausea (18% vs 19%), asthenia (16% vs 19%), weight decreased (15% vs 3%), constipation (14% vs 15%), back pain (14% vs 11%), fatigue (12% vs 20%), vomiting (12% vs 16%), insomnia (12% vs 11%), herpes zoster (11% vs 9%), decreased appetite (10% vs 9%), hypertension (10% vs 4%), dyspnea (7% vs 12%), pain in extremities (5% vs 11%), abdominal pain and headache (each 3% vs 11%), abdominal pain upper (2% vs 11%). The incidence of serious adverse events was similar for the subcutaneous treatment group (36%) and the intravenous treatment group (35%). The most commonly reported SAEs

were pneumonia (6%) and pyrexia (3%) in the subcutaneous treatment group and pneumonia (7%), diarrhea (4%), peripheral sensory neuropathy (3%) and renal failure (3%) in the intravenous treatment group.

DRUG INTERACTIONS: Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2. Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Therefore, patients should be closely monitored when given bortezomib in combination with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir). Co-administration of omeprazole, a strong inhibitor of CYP2C19, had no effect on the exposure of bortezomib in 17 patients. Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when VELCADE (bortezomib) is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving VELCADE. St. John’s Wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided. Co-administration of dexamethasone, a weak CYP3A4 inducer, had no effect on the exposure of bortezomib in 7 patients. Co-administration of melphalan-prednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant.

USE IN SPECIFIC POPULATIONS: Nursing Mothers: It is not known whether bortezomib 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 VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: The safety and effectiveness of VELCADE in children has not been established. Geriatric Use: No overall differences in safety or effectiveness were observed between patients ≥age 65 and younger patients receiving VELCADE; but greater sensitivity of some older individuals cannot be ruled out. Patients with Renal Impairment: The pharmacokinetics of VELCADE are not influenced by the degree of renal impairment. Therefore, dosing adjustments of VELCADE are not necessary for patients with renal insufficiency. Since dialysis may reduce VELCADE concentrations, VELCADE should be administered after the dialysis procedure. For information concerning dosing of melphalan in patients with renal impairment, see manufacturer’s prescribing information. Patients with Hepatic Impairment: The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment. Starting dose should be reduced in those patients. Patients with Diabetes: During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication. Please see full Prescribing Information for VELCADE at VELCADEHCP.com.

VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners. Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2012, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA

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Claim Audits

Audits and Reviews…Continued from page 11

gives providers and suppliers an incentive to undertake reasonable diligence to determine whether overpayments exist, “such as self-audits, compliance checks, and other additional research.” Under the proposed rule, identified overpayments would be reported using the existing voluntary refund process, which CMS renamed the “self-reported overpayment refund process.” The current voluntary refund process (as described in Publication 100-06, Chapter 4 of the Medicare Financial Management Manual) requires providers to report overpayments using a form made available from the Medicare contractor. However, CMS plans to develop a uniform reporting form, thereby enabling overpayments to be reported and returned in a consistent manner across all Medicare contractors.

of the federal False Claims Act statute of limitations. CMS is also suggesting amending the rules to provide for a 10-year reopening time frame consistent with the proposed lookback period.

Extension Period Finally, CMS proposes extending the “lookback” period for reporting and returning overpayments to 10 years. CMS reports that the proposed 10-year lookback period was selected because it is the outer limit

Implications for Practices and Suppliers In summary, Medicare’s reporting and returning of overpayments proposed rule will have a profound impact on Medicare providers and suppliers, and it would greatly

An effective compliance plan can assist in the identification of overpayments and the avoidance of future errors that might otherwise lead to overpayments.

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increase the liabilities of billing and coding errors. Moreover, regardless of the outcome of this proposed rule, providers need to have policies and processes in place for avoiding billing errors and identifying and returning overpayments in a timely manner. An effective compliance plan can assist in the identification of overpayments and the avoidance of future errors that might otherwise lead to overpayments. Furthermore, effective compliance plans and the development of compliance policies and procedures will help protect the practice from whistleblower claims. The ACA requires providers to have a compliance program in place as a condition of enrollment in Medicare, Medicaid, or the Children’s Health Insurance Program. The details for the new mandatory provider compliance plan are not yet finalized. CMS sought comments on 7 core elements, stating that they will work with the Office of Inspector General to establish the required core elements of the program. CMS will publish specific proposals in the future. l

“Quality care is everyone’s business.” Beth Faiman, RN, MSN, APRN, BC, AOCN Nurse Practitioner, Multiple Myeloma Program Cleveland Clinic Taussig Cancer Institute Cleveland, OH

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Practice Standards

Evolving Practice Standards…Continued from the cover

M. Asa Carter, CTR

comfortable hospital or other facility, and that the healthcare staff will care about their problems and concerns with managing treatment, professional issues, and family issues. How did we come to expect this level of care, and what can patients expect in

the future? The Commission on Cancer (CoC) of the American College of Surgeons is dedicated to improving survival and quality of life for patients with cancer through setting of standards, prevention, research, education, and the monitoring of comprehensive quality care. Beginning with the first standards for cancer clinics created in 1930, the CoC has taken the lead to ensure that patients will receive high-quality cancer care in US hospitals and freestanding, nonhospital facilities. The goal of the CoC is to ensure that every patient with cancer can access the full scope of diagnostic and treatment services needed to manage their cancer in a setting that is close to their home. Today, more than 1500 facilities across the country are members of the CoC Accreditation Program, which provides external evaluation and recognition of performance to each participating facility.

The Commission’s Focus The first iterations of the CoC standards focused on surgical care, the only treatment option available to patients with cancer at that time. Over time, the CoC standards have been revised to include radiation and medical oncology treatments, as well as quality improvement activities, among others. The 4 corner-

stone requirements for the committee are: To address the cancer committee’s leadership of the program

1 2

To hold cancer conferences for multidisciplinary discussion of treatment options

To have a cancer registry that provides diagnostic and treatment information on each patient

To include patient care and quality evaluations that evaluate and improve performance.

More than 1500 facilities across the country are members of the CoC Accreditation Program, which provides an external evaluation and recognition of performance to each participating facility.

The Evolving Standards The updated standards for cancer programs released in 2004, which were revised in 2005 and again in 2009, took the first major step forward to require true improvements in patient care. The standards required that cancer committees in CoC-accredited programs must ensure that the stage of disease; sitespecific prognostic factors, such as histology and tumor-specific markers; and nationally accepted treatment guidelines are used to plan the

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treatment for patients with cancer. The treatment guidelines developed by recognized and authoritative national organizations, such as the National Comprehensive Cancer Network and the American Society of Clinical Oncology, were designed to achieve the best possible treatment outcome for patients. Pathologists were expected to follow the cancer protocols developed by the College of American Pathologists. These protocols required that specific information needed for treatment decisions were to be included in the pathology reports. The commission created tools to facilitate an evaluation of the CoCaccredited programs’ performance based on the accountability measures that are endorsed by the National Quality Forum. For the first time in the commission’s history, the performance at each CoCaccredited program was compared with care practices that have proved effective through clinical research. The commission also introduced a set of standardized quality improvement measures that evaluate each program’s performance based on care accepted as good clinical practice. Although all of these changes are important steps forward in promoting high-quality care for cancer programs, physicians, and patients, the CoC standards did not address patient needs outside of direct intervention to cure or control the cancer. In 1999, a joint publication of the National Cancer Policy Board, National Institute on Medicine and Commission on Life Sciences, and the National Research Council (Ensuring Quality Cancer Care. Washington, DC: National Academy Press; 1999) described the state of cancer care in the United States. Continued on page 19

Practice Standards

Evolving Practice Standards…Continued from page 18 The findings can be summed up as “for many Americans with cancer, there is a wide gulf between what could be construed as the ideal and the reality of their experience with cancer care.” The publication cited issues regarding: • Poor access to care • Excessive use of tests, examinations, and treatments • Limited use of some of the same tests, examinations, and treatments • Nonstandard treatment decisions • Measuring and assessing the quality of care • Ensuring that patients are informed about all aspects of and options for their treatment • Providing services that support patients and their needs beyond direct cancer intervention • Ensuring care for patients who are approaching the end of life.

The New Standards Although the 2004 edition of the CoC’s Cancer Program Standards already addressed some of these issues, gaps still existed in many areas. Therefore, the commission undertook to revise and rebuild the standards to address the patient-centered issues identified in the 1999 joint report mentioned above. The outcomes of this 2-year project are the new standards that address many of the patient-centered issues identified in that report. The Cancer Program Standards 2012: Ensuring Patient-Centered Care includes standards that address:

1 2

A patient navigation process to identify and address barriers to care

to learn from their peers. The CoC encourages programs to submit their best practice examples and tools to

Genetic assessment and counseling for patients who are at risk of family or hereditary syndromes, thus guiding informed decision-making

The CoC standards are designed to allow for significant latitude and customization so that activities meet the needs of the CoCaccredited facilities and the patients and communities that they serve.

Expected performance rates that will be met for each of the 6 performance measures

A treatment summary and survivor plan for each patient who is completing initial treatment

5 6

Psychosocial distress screening and intervention

A palliative care team to ensure that patients have access to pain management, hospice care, and other services during and after treatment. As cancer programs implement the new standards, they are looking to the CoC for guidance, assistance, and best practice examples that can assist their work. The CoC standards are designed to allow for significant latitude and customization so that activities meet the needs of the CoCaccredited facilities and the patients and communities that they serve.

the best practice repository so that all programs can benefit from the successful experiences of others.

Conclusion The CoC is a longstanding leader in the effort to improve the care of patients with cancer. Its historical work created the first standards for cancer diagnosis and treatment. The standards have evolved over time to address advances in care and bring a new focus on addressing patient needs. The new standards put the CoC in a unique position to establish quantitative and qualitative benchmarks that can be used to measure performance and ensure that highquality care is provided to every patient with cancer. l

Best Practices The CoC is working with its member organization partners to provide examples of policies, procedures, and tools, as well as successful strategies developed by CoC-accredited programs that have already implemented the standards to enable programs

May 2012

www.OncPracticeManagement.com

Medical Legal Update

Protecting from HIPAA Exposure through Compliance By Jennifer Kirschenbaum, Esq, and Erica Youngerman, Esq

he Office for Civil Rights (OCR)—the arm of the US Department of Health and Human Services (HHS) that is responsible for enforcing Health Insurance Portability and Accountability Act (HIPAA) compliance— has historically taken a passive role on its mandate. This is why news that Klynveld Peat Marwick Goerdeler (KPMG)—a global audit giant—has been retained to begin auditing “covered entities” is noteworthy. The contract that KPMG has entered into with the OCR looks to begin small by providing for the audit of 150 “covered entities.” It is designed to be “self-funded,” with the auditors being compensated on a contingency basis based on what they recover. Similar to the Medicare Recovery Audit Contractors program, the OCR’s contract with KPMG looks like a test-case scenario to see how positive the results are for the OCR before rolling out a national program to systematically audit “covered entities.” However, it is difficult to conceive of KPMG’s findings not reaping positive monetary results for the OCR, because the OCR has the authority to levy huge fines against entities in noncompliance (up to $50,000 per violation; each individual privacy breach is considered a separate violation), as well as to seek criminal penalties. There are numerous policy requirements that each entity is required to have on file to remain in compliance with HIPAA and other statutes overseen by the OCR. Moreover, the OCR has already seen returns on its efforts in previous investigations. A recent settlement

between the University of California at Los Angeles Health System and the HHS resulted from an OCR investigation of complaints received by 2 celebrity patients who received care at the health system and for whom employees of the health system repeatedly and without reason looked at their electronic health information.1 During the investiga-

Having language in your HIPAA privacy policy stating that you charge for copies was not enough; the OCR stated that every practice must have a separate specific policy addressing charging for records.

tion, the OCR established that inappropriate access to protected health information was a common practice at the health system.1 The University of California at Los Angeles Health System agreed to pay $865,500 to settle the matter.1 Similarly, Massachusetts General has been slapped with 7-figure fines for inadvertent security breaches resulting in the disclosure of protected health information.2 OCR activity with big players is typically what we read about in the news; however, the lack of coverage does not mean that solo providers or small group practices are not sub-

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ject to review. In fact, the OCR is required to investigate each and every complaint that is made to its office. Complaints vary from inappropriate disclosures of protected information pursuant to HIPAA to mismanagement of records and potential violations of the statutes OCR is ordered to protect. A recent situation our office handled on behalf of a doctor was an OCR investigation into a solo provider’s office requesting that doctor’s policy on charging for medical records. A patient had requested copies of her x-rays and the doctor had charged the patient $60—$54 was the fee the doctor paid to the company making the copies, and $6 was charged by the doctor to recover a minimal amount of office time obtaining the copies. The patient thought that the charge was excessive, and although she had agreed to pay the $60 at the time that she requested the copies, she still reported the doctor to the OCR. This matter was interesting, because the OCR took the position that having language in your HIPAA privacy policy stating that you charge for copies was not enough; the OCR stated that every practice must have a separate specific policy addressing charging for records. Also, the OCR took the position that although an office may charge an “administrative fee” for locating and copying its own records, it was inappropriate for this doctor to charge the extra $6, because his office did not make the actual copies. In the end, no fine was assessed; however, time was spent defending the practice for failure to Continued on page 22

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

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Medical Legal Update

Protecting from HIPAA…Continued from page 20 maintain the medical records copy charge policy, and the doctor was required to refund the $6. How you are using patient information also extends to the way you are communicating with your patients. Many practices are using e-mail to correspond and to transmit information, policies, and forms over the internet and through their websites. A main concern with the increase of e-mail communications is that people are often much more casual in their email communications, and the formalities put in place to protect patient confidentiality in the office may be forgotten or ignored. An example of this happened to our client when the client’s boyfriend—who had accompanied the patient to several office visits and was known by the practitioner—sent an e-mail in the middle of the night to the vigilant provider, who checked it and believed this was an emergent situation requiring disclosure of a sensitive medication. The patient, who had been in a medical facility against her will, submitted a complaint against the provider for an unauthorized disclosure after the fact, because the boyfriend was not listed on her HIPAA consent form for authorized access as a third party. The patient was moderately famous, and her boyfriend, although seemingly well intentioned, inadvertently leaked the information on the medication to the media. Sanctions were taken against the provider after OCR determined that the situation preceding the disclosure was not an emergency, and that access was not warranted or authorized. To better understand where potential exposure may originate from in your practice, it is essential to review the basic patient rights that the OCR is looking to protect. The OCR is responsible for enforcing adherence to HIPAA, and now, as of 2010, to

the Health Information Technology for Economic and Clinical Health (HITECH) Act, as well as to the Patient Safety and Quality Improvement Act (PSQIA). So, what does that mean?

Under HITECH, each practice that is capable of using computers or electronic transmission for protected health information is required to have protection in place for that information.

You are most likely familiar with HIPAA, and you understand that any individually identifiable information of a patient must be protected and may not be disclosed unless for an authorized or permitted reason. “Individually identifiable” includes, but is not limited to, a patient’s full name, social security number, and image. HITECH acknowledges and brings to the forefront issues regarding transacting with protected health information electronically. Under HITECH, each practice that is capable of using computers or electronic transmission for protected health information is required to have protection in place for that information. The required protection starts with having a proper policy with regard to the treatment of electronic-protected health information. Under PSQIA, the government created a voluntary reporting system for medical errors in patient

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care. Because the OCR requires policies for all statutes that it governs, having a policy on file acknowledging the PSQIA and its reporting procedures should suffice. The bottom line when preparing for the HIPAA policy is that you have a choice between taking preventive action and adopting appropriate policies that will work with your practice to ensure that you are in compliance, or you have the option to risk that you will not be targeted for a review or have a complaint made to the OCR about your practice. It has been my experience that the practices that do partake in preventive planning have cleaner operations and less exposure, as well as much lower legal fees should they be targeted for investigation. l

References 1. US Department of Health and Human Services. University of California settles HIPAA Privacy and Security case involving UCLA Health System facilities. July 7, 2011. www.hhs.gov/news/press/2011pres/ 07/20110707a.html. Accessed May 2, 2012. 2. US Department of Health and Human Services. Massachusetts General Hospital settles potential HIPAA violations. February 24, 2011. www.hhs.gov/ news/press/2011pres/02/20110224b.html. Accessed May 2, 2012.

This article is for education and discussion purposes only and does not constitute legal advice. Jennifer Kirschenbaum, Esq, manages Kirschenbaum & Kirschenbaum’s healthcare practice, which specializes in representing healthcare practitioners in regulatory compliance, audit defense, licensure, and transactional matters. Erica Youngerman, Esq, is an associate in Kirschenbaum & Kirschenbaum healthcare practice. If you have a question for Jennifer or if you would like to discuss ways to protect your practice, she can be reached at 516-747-6700 x302 or by e-mail at Jennifer@kirschen baumesq.com. For updates on changes in documentation requirements, and general healthcare updates visit www.nyhealthcareattorneys.com.

Announcing: J-code for YERVOYâ&#x201E;˘ (ipilimumab) J9228 Indication

Replaces J9999, J99 999,, J3490,, J3590,, and C9284.

Product Description

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

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

10-digit

0003-2327-11

0003-2328-22

11-digit

00003-2327-11

00003-2328-22

NDC Number

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

Important Safety Information WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

1. 2.

to 8:00

Important Safety Information (cont) Recommended Dose Modifications t

Immune-mediated Hepatitis: t

t t

Immune-mediated Enterocolitis: t

t Immune-mediated Dermatitis: t

t t t

t t

Important Safety Information (cont) t

Immune-mediated Neuropathies: t t t t

Other Immune-mediated Adverse Reactions, Including Ocular Manifestations: t

t t Immune-mediated Endocrinopathies: t t

t t

Pregnancy & Nursing: t

t t

Common Adverse Reactions: t

YERVOYâ&#x201E;˘ (ipilimumab) Injection, for intravenous infusion Brief Summary of Prescribing Information. For complete prescribing information consult official package insert. WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY (ipilimumab) can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. [See Dosage and Administration (2.2) in Full Prescribing Information] Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose. [See Warnings and Precautions] INDICATIONS AND USAGE YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS YERVOY can result in severe and fatal immune-mediated reactions due to T-cell activation and proliferation. [See Boxed Warning] Immune-mediated Enterocolitis In Study 1, severe, life-threatening, or fatal (diarrhea of 7 or more stools above baseline, fever, ileus, peritoneal signs; Grade 3â&#x20AC;&#x201C;5) immune-mediated enterocolitis occurred in 34 (7%) YERVOY-treated patients, and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) YERVOY-treated patients. Across all YERVOY-treated patients (n=511), 5 (1%) patients developed intestinal perforation, 4 (0.8%) patients died as a result of complications, and 26 (5%) patients were hospitalized for severe enterocolitis. The median time to onset was 7.4 weeks (range 1.6â&#x20AC;&#x201C;13.4) and 6.3 weeks (range 0.3â&#x20AC;&#x201C;18.9) after the initiation of YERVOY for patients with Grade 3â&#x20AC;&#x201C;5 enterocolitis and with Grade 2 enterocolitis, respectively. Twenty-nine patients (85%) with Grade 3â&#x20AC;&#x201C;5 enterocolitis were treated with high-dose (â&#x2030;Ľ40 mg prednisone equivalent per day) corticosteroids, with a median dose of 80 mg/day of prednisone or equivalent; the median duration of treatment was 2.3 weeks (ranging up to 13.9 weeks) followed by corticosteroid taper. Of the 28 patients with moderate enterocolitis, 46% were not treated with systemic corticosteroids, 29% were treated with <40 mg prednisone or equivalent per day for a median duration of 5.1 weeks, and 25% were treated with high-dose corticosteroids for a median duration of 10 days prior to corticosteroid taper. Infliximab was administered to 5 of the 62 patients (8%) with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids. Of the 34 patients with Grade 3â&#x20AC;&#x201C;5 enterocolitis, 74% experienced complete resolution, 3% experienced improvement to Grade 2 severity, and 24% did not improve. Among the 28 patients with Grade 2 enterocolitis, 79% experienced complete resolution, 11% improved, and 11% did not improve. Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms. Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least one month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients. Withhold YERVOY dosing for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for more than one week, initiate systemic corticosteroids at a dose of 0.5 mg/kg/day prednisone or equivalent. [See Dosage and Administration (2.2) in Full Prescribing Information] Immune-mediated Hepatitis In Study 1, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations of more than 5 times the upper limit of normal or total bilirubin elevations more than 3 times the upper limit of normal; Grade 3â&#x20AC;&#x201C;5) occurred in 8 (2%) YERVOY-treated patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4% of YERVOY-treated patients. An additional 13 (2.5%) patients experienced moderate hepatotoxicity manifested by liver function test abnormalities (AST or ALT elevations of more than 2.5 times but not more than 5 times the upper limit of normal or total bilirubin elevation of more than 1.5 times but not more than 3 times the upper limit of normal; Grade 2). The underlying pathology was not ascertained in all patients but in some instances included immune-mediated hepatitis. There were insufficient numbers of patients with biopsyproven hepatitis to characterize the clinical course of this event.

The median time to onset of moderate, severe, or life-threatening immune-mediated dermatitis was 3.1 weeks and ranged up to 17.3 weeks from the initiation of YERVOY (ipilimumab). Seven (54%) YERVOY-treated patients with severe dermatitis received high-dose corticosteroids (median dose 60 mg prednisone/day or equivalent) for up to 14.9 weeks followed by corticosteroid taper. Of these 7 patients, 6 had complete resolution; time to resolution ranged up to 15.6 weeks. Of the 63 patients with moderate dermatitis, 25 (40%) were treated with systemic corticosteroids (median of 60 mg/day of prednisone or equivalent) for a median of 2.1 weeks, 7 (11%) were treated with only topical corticosteroids, and 31 (49%) did not receive systemic or topical corticosteroids. Forty-four (70%) patients with moderate dermatitis were reported to have complete resolution, 7 (11%) improved to mild (Grade 1) severity, and 12 (19%) had no reported improvement. Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated. Permanently discontinue YERVOY in patients with Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations. Administer systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent. When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. Withhold YERVOY dosing in patients with moderate to severe signs and symptoms. [See Dosage and Administration (2.2) in Full Prescribing Information] For mild to moderate dermatitis, such as localized rash and pruritus, treat symptomatically. Administer topical or systemic corticosteroids if there is no improvement of symptoms within 1 week. Immune-mediated Neuropathies In Study 1, one case of fatal Guillain-BarrĂŠ syndrome and one case of severe (Grade 3) peripheral motor neuropathy were reported. Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-BarrĂŠ syndrome have been reported. Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-BarrĂŠ-like syndromes. Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids at a dose of 1 to 2 mg/kg/day prednisone or equivalent for severe neuropathies. Withhold YERVOY dosing in patients with moderate neuropathy (not interfering with daily activities). [See Dosage and Administration (2.2) in Full Prescribing Information] Immune-mediated Endocrinopathies In Study 1, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3â&#x20AC;&#x201C;4) occurred in 9 (1.8%) YERVOY-treated patients. All 9 patients had hypopituitarism and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies. Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and one case each of hyperthyroidism and Cushingâ&#x20AC;&#x2122;s syndrome. The median time to onset of moderate to severe immune-mediated endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the initiation of YERVOY. Of the 21 patients with moderate to life-threatening endocrinopathy, 17 patients required long-term hormone replacement therapy including, most commonly, adrenal hormones (n=10) and thyroid hormones (n=13). Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism. Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms of endocrinopathies should be considered immune-mediated. Monitor thyroid function tests and clinical chemistries at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland. Withhold YERVOY dosing in symptomatic patients. Initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent, and initiate appropriate hormone replacement therapy. [See Dosage and Administration (2.2) in Full Prescribing Information] Other Immune-mediated Adverse Reactions, Including Ocular Manifestations The following clinically significant immune-mediated adverse reactions were seen in less than 1% of YERVOY-treated patients in Study 1: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia. Across the clinical development program for YERVOY, the following likely immune-mediated adverse reactions were also reported with less than 1% incidence: myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, and autoimmune thyroiditis. Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids at a dose of 1 to 2 mg/kg/day prednisone or equivalent for severe immunemediated adverse reactions.

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

Administer corticosteroid eye drops to patients who develop uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease that is unresponsive to local immunosuppressive therapy. [See Dosage and Administration (2.2) in Full Prescribing Information]

Permanently discontinue YERVOY in patients with Grade 3â&#x20AC;&#x201C;5 hepatotoxicity and administer systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent. When liver function tests show sustained improvement or return to baseline, initiate corticosteroid tapering and continue to taper over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients who have persistent severe hepatitis despite high-dose corticosteroids. Withhold YERVOY in patients with Grade 2 hepatotoxicity. [See Dosage and Administration (2.2) in Full Prescribing Information]

ADVERSE REACTIONS

Immune-mediated Dermatitis In Study 1, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3â&#x20AC;&#x201C;5) occurred in 13 (2.5%) YERVOY-treated patients. One (0.2%) patient died as a result of toxic epidermal necrolysis and one additional patient required hospitalization for severe dermatitis. There were 63 (12%) patients with moderate (Grade 2) dermatitis.

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

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

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

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

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

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

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

Clinical Trials Experience

Immunogenicity

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

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

The clinical development program excluded patients with active autoimmune disease or those receiving systemic immunosuppression for organ transplantation. Exposure to YERVOY (ipilimumab) 3 mg/kg for four doses given by intravenous infusion in previously treated patients with unresectable or metastatic melanoma was assessed in a randomized, double-blind clinical study (Study 1). [See Clinical Studies (14) in Full Prescribing Information] One hundred thirty-one patients (median age 57 years, 60% male) received YERVOY as a single agent, 380 patients (median age 56 years, 61% male) received YERVOY with an investigational gp100 peptide vaccine (gp100), and 132 patients (median age 57 years, 54% male) received gp100 peptide vaccine alone. Patients in the study received a median of 4 doses (range 1 to 4 doses). YERVOY was discontinued for adverse reactions in 10% of patients. The most common adverse reactions (â&#x2030;Ľ5%) in patients who received YERVOY at 3 mg/kg were fatigue, diarrhea, pruritus, rash, and colitis. Table 1 presents selected adverse reactions from Study 1, which occurred in at least 5% of patients in the YERVOY-containing arms and with at least 5% increased incidence over the control gp100 arm for all-grade events and at least 1% incidence over the control group for Grade 3â&#x20AC;&#x201C;5 events. Table 1:

YERVOY 3 mg/kg n=131

YERVOY 3 mg/kg+gp100 n=380

gp100 n=132

Any Grade

Grade 3â&#x20AC;&#x201C;5

Any Grade

Grade 3â&#x20AC;&#x201C;5

Any Grade

Grade 3â&#x20AC;&#x201C;5

32 8

5 5

37 5

4 3

20 2

1 0

31 29

0 2

21 25

<1 2

11 8

0 0

Table 2 presents the per-patient incidence of severe, life-threatening, or fatal immune-mediated adverse reactions from Study 1. Severe to Fatal Immune-mediated Adverse Reactions in Study 1 Percentage (%) of Patients

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

No formal drug-drug interaction studies have been conducted with YERVOY (ipilimumab). USE IN SPECIFIC POPULATIONS Pregnancy

In a combined study of embryo-fetal and peri-postnatal development, severe toxicities including increased incidences of third-trimester abortion, stillbirth, premature delivery, low birth weight, and infant mortality occurred following intravenous administration of ipilimumab to pregnant cynomolgus monkeys every 21 days from the onset of organogenesis through parturition at doses of 2.6 or 7.2 times the recommended human dose of 3 mg/kg (by AUC). [See Nonclinical Toxicology (13.2) in Full Prescribing Information] In genetically engineered mice in which the gene for CTLA-4 has been deleted (a â&#x20AC;&#x153;knockout mouseâ&#x20AC;?), offspring lacking CTLA-4 were born apparently healthy, but died within 3â&#x20AC;&#x201C;4 weeks due to multi-organ infiltration and damage by lymphocytes. Human IgG1 is known to cross the placental barrier and ipilimumab is an IgG1; therefore, ipilimumab has the potential to be transmitted from the mother to the developing fetus. Nursing Mothers

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

Table 2:

DRUG INTERACTIONS

There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Percentage (%) of Patientsa

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

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

Pregnancy Category C

Selected Adverse Reactions in Study 1

System Organ Class/ Preferred Term

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

YERVOY 3 mg/kg n=131

YERVOY 3 mg/kg+gp100 n=380

15 7 1 2 1 4 4 0

12 7 2 3 <1 1 1 1

0 0 1 1 0

<1 <1 0 0 <1

It is not known whether ipilimumab is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from YERVOY, a decision should be made whether to discontinue nursing or to discontinue YERVOY, taking into account the importance of YERVOY to the mother. Pediatric Use Safety and effectiveness of YERVOY have not been established in pediatric patients. Geriatric Use Of the 511 patients treated with YERVOY at 3 mg/kg, 28% were 65 years and over. No overall differences in safety or efficacy were reported between the elderly patients (65 years and over) and younger patients (less than 65 years). Renal Impairment No formal studies of YERVOY in patients with renal impairment have been conducted. [See Clinical Pharmacology (12.3) in Full Prescribing Information] Hepatic Impairment No formal studies of YERVOY in patients with hepatic impairment have been conducted. [See Clinical Pharmacology (12.3) in Full Prescribing Information] OVERDOSAGE There is no information on overdosage with YERVOY. PATIENT COUNSELING INFORMATION See MEDICATION GUIDE in Full Prescribing Information. t *OGPSN QBUJFOUT PG UIF QPUFOUJBM SJTL PG JNNVOF NFEJBUFE BEWFSTF SFBDUJPOT t "EWJTF QBUJFOUT UP SFBE UIF :&370: .FEJDBUJPO (VJEF CFGPSF FBDI :&370: JOGVTJPO t "EWJTF XPNFO UIBU :&370: NBZ DBVTF GFUBM IBSN t "EWJTF OVSTJOH NPUIFST OPU UP CSFBTU GFFE XIJMF UBLJOH :&370:

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

Including fatal outcome. Including intestinal perforation. Underlying etiology not established.

Across clinical studies that utilized YERVOY doses ranging from 0.3 to 10 mg/kg, the following adverse reactions were also reported (incidence less than 1% unless otherwise noted): urticaria (2%), large intestinal ulcer, esophagitis, acute respiratory distress syndrome, renal failure, and infusion reaction. Based on the experience in the entire clinical program for melanoma, the incidence and severity of enterocolitis and hepatitis appear to be dose dependent.

1281558A2

IP-B0001A-03-11

Issued: March 2011

340B Drug Pricing Program

Contract Pharmacies Permitted to Manage Drugs Under 340B Program By Wayne Kuznar

Chicago, IL—The ability to use contract pharmacies to deliver drugs for covered entities is one provision of the 340B drug pricing program. This provision allows for the use of an inhouse pharmacy and/or an external retail pharmacy or mail-order pharmacies with the use of virtual inventories, according to Kent Nicaud, Vice President, Physician Administrative Services, Memorial Hospital at Gulfport, MS.

“Covered entities must have detailed accounting, so that they maintain your covered entity requirement.” — Kent Nicaud

Mr Nicaud and Martin Shenk, CMPE, Chief Operating Officer, the Medical Oncology Group, Gulfport, MS, participated in a discussion on this topic during last year’s Cancer Center Business Summit annual meeting.

Detailed Accounting Contract pharmacies must provide the covered entity with financial statements, a detailed report of collections, and a summary of receiving and dispensing records, and must work with the covered entity to establish and maintain a tracking

system to prevent diversion, suggested Mr Nicaud. “Covered entities must have detailed accounting so that they maintain your covered entity requirement,” he said. Any records maintained that pertain to compliance with the 340B program requirements are subject to audit by a participating manufacturer and/or the Office of Pharmacy Affairs to protect against diversion.

340B Drugs Covered Drugs covered under the 340B program are outpatient prescription drugs provided to patients of the covered entity, and over-the-counter drugs if a prescriber writes a prescription for the drug. Vaccines given in inpatient settings and orphan drugs for newly eligible entities are excluded. New guidelines, which have been in place since April 5, 2010, now allow the use of multiple pharmacies as a standard option for 340Bcovered entities. Covered entities may also contract with mail-order pharmacies. When using contract pharmacies, there is no need to maintain separate inventories. Contract Review Covered entity contract pharmacy agreements must include covered entity compliance agreements. The Office of Pharmacy Affairs will not review contracts, and it recommends that covered entities engage their legal counsel to review all contracts or other legal documents to ensure that all federal, state, and local

ONCOLOGY PRACTICE MANAGEMENT

I May 2012

requirements are met. “Not only can you benefit from your 340B infusion center, you can also benefit from 340B from all of your employee physicians. Any physician that works in your hospital

“Not only can you benefit from your 340B infusion center, you can also benefit from 340B from all of your employee physicians. Any physician that works in your hospital system who writes a prescription for oral, as well as infusible, medications now qualify for 340B pricing.” —Martin Shenk, CMPE

system who writes a prescription for oral, as well as infusible, medications now qualifies for 340B pricing,” said Mr Shenk. “The hospital can, by contracting through the virtual pharmacies, get a benefit from all the prescription medications that are prescribed by their affiliated physicians,” Mr Shenk added. l

We Will

exhaust all possibilities.

We will…because patients are our priority. Celgene Patient Support® provides free and personalized assistance with patients’ access and reimbursement needs. With continual communication and consistent follow-through, your dedicated Celgene Patient Support® Specialist will streamline access to Celgene products by helping you and your patients with: t Benefits investigation

To Contact Celgene Patient Support®:

t Prior authorization

Call: 1-800-931-8691

t Appeal support

E-mail: patientsupport@celgene.com

t Medicare

Fax: 1-800-822-2496

t Co-pay assistance – Celgene Commercial Co-pay Program – Co-pay assistance through third-party organizations

Visit: www.CelgenePatientSupport.com Monday through Friday, 8:00 AM to 7:00 PM ET

t Prescription status t Celgene free medication program t Celgene products and restricted distribution programs

4 out of 5 patients who requested assistance from Celgene Patient Support ® received their medication.

Drug Coding Supplied by RJ Health Systems

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 management of colorectal cancer. The following sections include: • Associated ICD-9-CM codes used for the classification of colorectal cancer • Drugs that have been FDA-approved in the treatment of colorectal cancer • Drugs that are Compendia listed for off-label use for colorectal cancer based on clinical studies that suggest beneficial use in some cases. Please note: if a check mark appears in the FDA column it will NOT appear in the Compendia off-label use column • Corresponding HCPCS/CPT® codes and code descriptions

Associated ICD-9-CM codes for colorectal cancer: 153 Malignant neoplasm of colon Excludes: benign carcinoid tumor of colon (209.50-209.56) malignant carcinoid tumor of colon (209.10-209.16) 153.0 Hepatic flexure 153.1 Transverse colon 153.2 Descending colon Left colon 153.3 Sigmoid colon Sigmoid (flexure) Excludes: rectosigmoid function (154.0) 153.4 Cecum Ileocecal valve 153.5 Appendix 153.6 Ascending colon Right colon 153.7 Splenic flexure 153.8 Other specified sites of large intestine Malignant neoplasm of contiguous or overlapping sites of colon whose point of origin cannot be determined Excludes: ileocecal valve (153.4) rectosigmoid junction (154.0) 153.9 Colon, unspecified Large intestine NOS 154 Malignant neoplasm of rectum, rectosigmoid junction, and anus Excludes: benign carcinoid tumor of rectum (209.57) malignant carcinoid tumor of rectum (209.17) 154.0 Rectosigmoid junction Colon with rectum Rectosigmoid (colon) 154.1 Rectum Rectal ampulla 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 May 2012

Drug Coding Supplied by RJ Health Systems

FDA-approved for colorectal cancer

Compendia listed off-label use for colorectal cancer

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

bevacizumab (Avastin)

J9035: Injection, bevacizumab, 10 mg

✓

96413, 96415

capecitabine (Xeloda)

J8520: Capecitabine, oral, 150 mg

✓

N/A

capecitabine (Xeloda)

J8521: Capecitabine, oral, 500 mg

✓

N/A

carmustine (BiCNU)

J9050: Injection, carmustine, 100 mg

cetuximab (Erbitux)

J9055: Injection, cetuximab, 10 mg

cisplatin (Platinol AQ)

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

✓

96409, 96413, 96415

doxorubicin (Adriamycin)

J9000: Injection, doxorubicin hydrochloride, 10 mg

✓

96409

floxuridine (FUDR)

J9200: Injection, floxuridine, 500 mg

✓

96422, 96423, 96425

fluorouracil (Adrucil)

J9190: Injection, fluorouracil, 500 mg

✓

96409

irinotecan (Camptosar)

J9206: Injection, irinotecan, 20 mg

✓

96413, 96415

leucovorin calcium (Wellcovorin)

J0640: Injection, leucovorin calcium, per 50 mg

✓

96372, 96374, 96409

levoleucovorin calcium (Fusilev)

J0641: Injection, levoleucovorin calcium, 0.5 mg

✓

96365, 96366

lomustine (CeeNu)

J8999*: Prescription drug, oral, chemotherapeutic 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

✓

96409

topotecan (Hycamtin)

J8705: Topotecan, oral, 0.25 mg

✓

N/A

✓

96413, 96415

✓

May 2012

96413, 96415

www.OncPracticeManagement.com

Drug Coding Supplied by RJ Health Systems

FDA-approved for colorectal cancer

Compendia listed off-label use for colorectal cancer

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

✓

96413

vincristine (Vincasar PFS)

J9370: Vincristine sulfate, 1 mg

✓

96409

*When billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code in Column 24D and the drug name, strength, and NDC (National Drug Code) in Box 19 to ensure appropriate reimbursement. References HCPCS Level II Expert 2012 • Current Procedural Terminology (CPT®), 2012 (CPT® copyright 2012 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Vol 1, 2, 2012 • FDA-approved indication (from product prescribing information) • 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 May 2012

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:

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

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

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

very day, increasing numbers of patients learn that a chemotherapy has been developed that could save their lives, but the drug they need is unavailable, because no one is manufacturing it. Expensive to manufacture, yet priced very low, generic sterile injectable chemotherapies are some of the drugs that are the most vulnerable to production shortages. However, thanks in part to the efforts of physicians, patient groups, and provider groups such as the Association of Community Cancer Centers (ACCC), critical drug shortages have received much-needed attention from the media and by Congress. The ACCC recently signed a coalition letter with other stakeholders, urging the US Congress to act now to stem the crisis. Many ACCC members have submitted letters to their legislators on Capitol Hill, and some have even had letters to the editor published in their local newspapers. With our current hyperpartisan Congress—where only the most necessary legislation moves—the volume on the drug shortage crisis has risen to a level where Congress agrees that action must be taken. A few approaches have been put forward as potential solutions to alleviate the drug shortage crisis. First, Senator Amy Klobuchar (D-MN) introduced the S. 296 bill in the Senate, which gained bipartisan support from 30 cosponsors. This bill shifts the responsibility for reporting drug shortages from physicians to manufacturers. The legislation

would require manufacturers to report impending drug shortages to the US Food and Drug Administration (FDA). The bill is designed to give providers more notice of upcoming shortages and encourage manufacturers to avoid unnecessary production stoppages.

We will not see a significant reduction in the shortage crisis until we address how the manufacturers producing these critical drugs are reimbursed.

The House of Representatives soon followed with its own version of the bill, H.R. 2245, introduced by Rep Diana DeGette (D-CO). In addition, H.R. 3839, introduced by Rep John Carney (D-DE) and Rep Larry Bucshon (R-IN), is legislation that would grant the FDA authority and resources to expedite the approval process for new companies that manufacture drugs facing shortages. Although these bills treat some of the symptoms of drug shortages, most experts agree that these bills do not reach the root cause of the problem. Many believe that we will not see a significant reduction in the shortage crisis until we address how the manufacturers producing these critical drugs are reimbursed. Senator Orrin Hatch (R-UT), member of the Senate Finance Health Subcommittee and ranking member on the Finance Committee, is expected

ONCOLOGY PRACTICE MANAGEMENT

I May 2012

to introduce legislation that seeks to alleviate shortages through economic incentives. This legislation defines drugs in critical shortage as being generic sterile injectable drugs with less than 5 active manufacturers. This bill would grant 5 years of exclusivity to manufacturers that produce drugs to alleviate a shortage and would alter the reimbursement structure for those drugs. For drugs with only a single manufacturing source, Medicare reimbursement would be based on the wholesale acquisition cost. For drugs with multiple production sources, payment would be based on a volume-weighted average of the wholesale acquisition cost. Because of the difficulty of moving independent legislation to passage in Congress, elements of these bills are expected to be incorporated into the Prescription Drug User Fee Act (PDUFA) reauthorization. Because the PDUFA regulates how manufacturers bring drugs to market, it is one of the few bills that must pass in 2012. Legislators generally view the drug shortage issue as germane to the PDUFA as a whole, so it is probable that we will see language that shifts reporting requirements, and grants the FDA the necessary resources to have manufacturers that produce drugs in short supply continue to manufacture those drugs. Although the oncology provider community remains hopeful that components of Senator Hatch’s approach will make it into broader FDA regulation, at this point it is still unclear what will happen. The ACCC has been on the forefront of the drug shortage crisis, and it continues to work with providers and legislators to find a meaningful solution to this critical issue. l

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

Business Disability Insurance and Your Medical Practice, Part 2

y last article published in the March 2012 issue of Oncology Practice Management described the benefits of Key Person Replacement insurance and how it can benefit a medical practice. This article focuses on 2 additional types of disability insurance that are often used to protect a medical practice— Disability Business Overhead Expense insurance and Disability BuyOut insurance. Few business partners have a plan in place to help protect their practice in the event of a prolonged or permanent disability of a partner, and few business owners realize that an illness or accident could cause such a disability. If you or one of your partners became disabled, the effect on your business could be devastating.

Disability Business Overhead Expense Insurance As the owner of a medical practice, you are the key to its success. Your patients and staff rely on you. If you become disabled, you may be unable to provide the services your patients expect or the leadership that your employees need. Overhead Expense Disability insurance is a cost-effective way to ensure that your practice can meet its ongoing expenses during a period of disability. Protecting your practice from financial loss is important, whether you eventually return to work or decide to sell your practice. Just as individual disability income insurance can help you pay your living expenses while you recover from a serious injury or illness, Overhead Expense Disability insurance can help you to keep your medical practice healthy. Business Overhead Expense Disability insurance is a cost-effective

way to ensure that your business can meet its ongoing expenses during a period of disability by reimbursing the owner(s) of a practice up to 100% of the normal ongoing business expenses incurred during a disability. Items include: • Rent • Electricity • Telephone • Heat • Water • Laundry, janitorial, and maintenance services • Employee salaries • Employee benefits

• Other taxdeductible business expenses • Salary for your replacement (depending on insurance carrier). Typically, monthly benefits up to $50,000 are available with benefit periods up to 30 months. Although this may be a substantial amount of coverage, it is not uncommon to find medical practices with overhead expenses that far exceed this limit. As a result, special risk insurers, such as Lloyd’s of London, are able to supplement the traditional market with monthly benefits in excess of $250,000. Premium payments for Overhead Expense Disability insurance are tax deductible as a reasonable and necessary business expense (Rev. Rul 55-264, 1955-1 C.B. 11). As such, benefits received during disability, while taxable on receipt, are used to pay practice-related expenses, which are tax deductible. The net tax result is a “wash,” so the net tax impact is neutral.

The buy-sell agreement ensures that the business interest of a deceased, a disabled, or a departing owner is effectively transferred in accordance with predetermined, mutually agreed upon guidelines.

Disability Buy-Out Insurance If you or one of your partners become disabled, the healthy partner(s) would be faced with the task of running the business and deciding how long the practice could continue paying the disabled physician. In all likelihood, the disabled partner would want to recover the capital he or she has invested in the business. The remaining partner(s) will be challenged to come up with the money to buy the disabled partner’s share while remaining in practice.

• Real estate taxes • Property, liability, and malpractice insurance • Interest on debt • Depreciation • Rent or lease expense of furniture or equipment • Legal and professional services • Professional, trade, and association dues • Licensing fees • Billing and collection fees

May 2012

Continued on page 36

www.OncPracticeManagement.com

Physician Wealth Management

Business Disability Insurance…Continued from page 35 The first step in business continuation planning is to set up a buy-sell agreement. A buy-sell agreement is a contract for persons engaged in a business. Buy-sell agreements are generally entered into between shareholders of a corporation, partners of a partnership, members of a limited liability company, or among any of these members and a key employee (physician), or an acceptable outside buyer (another licensed physician in your medical specialty). The buy-sell agreement ensures that the business interest of a deceased, a disabled, or a departing owner is effectively transferred in accordance with predetermined, mutually agreed upon guidelines. Buy-sell arrangements take many forms, and each has its own legal, tax, and financial ramifications. The key is to find the agreement that best fits the needs of your business and family. The disability clause in your buysell agreement and disability insurance funding provide income protection for your family. Your buy-sell agreement establishes the buyer for your interest, as well as the conditions under which they must buy. When you become sick or hurt, the disability insurance provides the buyer with the money to pay for your share of the business.

Once disabled under the terms of the policy, you must satisfy the policy’s elimination period, typically 365, 540, or 730 days. The policy owner will then receive either monthly pay-

are not income tax deductible. It does not matter if the payments are made by the business itself or by the individual owners. Disability Buy-Out insurance ensures business succession by reimbursing money used to purchase a disabled owner’s interest. Although many fund buy-sell agreements with life insurance, the potential for disability is greater—and most often overlooked.

Although most physicians are keenly aware of the need to purchase individual Summary disability insurance Although most physicians are coverage, few are keenly aware of the need to purchase individual disability insurance covcognizant of the erage, few are cognizant of the varivariety of disability ety of disability insurance policies insurance policies designed to help meet the needs of designed to help meet self-employed physicians and/or the shareholders of a medical practice. the needs of selfThese include, but are not limited to, Key Person Replacement insuremployed physicians ance, Disability Business Overhead and/or the Expense insurance, and Disability Buy-Out insurance. l shareholders of a medical practice.

ments and/or a lump sum benefit at the end of the elimination period or the date the buy-out expense is incurred, whichever is later. The premiums for disability insurance to fund your buy-sell agreement

ONCOLOGY PRACTICE MANAGEMENT

I May 2012

Lawrence B. Keller, CLU, ChFC, CFP®, is the founder of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 516-6776211 or Lkeller@physicianfinancialser vices.com for comments or questions.

ZYTIGA® (abiraterone acetate) Tablets Brief Summary of Prescribing Information. INDICATIONS AND USAGE ZYTIGA in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel. CONTRAINDICATIONS Pregnancy: ZYTIGA may cause fetal harm when administered to a pregnant woman. 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, the patient should be apprised of the potential hazard to the fetus. WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: Use ZYTIGA with caution in patients with a history of cardiovascular disease. ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Adverse Reactions and Clinical Pharmacology (12.1) in full Prescribing Information]. 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. The safety of ZYTIGA in patients with left ventricular ejection fraction <50% or NYHA Class III or IV heart failure has not been established because these patients were excluded from the randomized clinical trial. 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: Adrenocortical insufficiency has been reported in clinical trials 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: Marked increases in liver enzymes leading to drug discontinuation or dosage modification have occurred [see Adverse Reactions]. 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. Food Effect: 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 17- and 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]. 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]. Food effect [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

ZYTIGA® (abiraterone acetate) Tablets directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a placebo-controlled, multicenter phase 3 clinical trial of patients with metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy, ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arm (N = 791). Placebo plus prednisone 5 mg twice daily was given to control patients (N = 394). The median duration of treatment with ZYTIGA was 8 months. The most common adverse drug reactions (≥5%) reported in clinical studies were joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection. The most common adverse drug reactions that resulted in drug discontinuation were aspartate aminotransferase increased, alanine aminotransferase increased, urosepsis and cardiac failure (each in <1% of patients taking ZYTIGA). Adverse reactions and laboratory abnormalities related to mineralocorticoid effects were reported more commonly in patients treated with ZYTIGA than in patients treated with placebo: hypokalemia 28% versus 20%, hypertension 9% versus 7% and fluid retention (edema) 27% versus 18%, respectively (see Table 1). In patients treated with ZYTIGA, grades 3 to 4 hypokalemia occurred in 5% of patients and grades 3 to 4 hypertension was reported in 1% of patients [see Warnings and Precautions]. Table 1 shows adverse reactions due to ZYTIGA that occurred with either a ≥ 2% absolute increase in frequency compared to placebo, or were events of special interest (mineralocorticoid excess, cardiac adverse reactions, and liver toxicities). Table 1: Adverse Reactions due to ZYTIGA in a Placebo-Controlled Phase 3 Trial ZYTIGA with Placebo with Prednisone Prednisone (N=791) (N=394) System/Organ All Grades1 Grade 3-4Class 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 7.2 1.1 4.6 1.0 Arrhythmia6 Chest pain or 7 3.8 0.5 2.8 0 chest discomfort 2.3 1.9 1.0 0.3 Cardiac failure8 1

Adverse events graded according to CTCAE version 3.0 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 3 Includes terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness 4 Includes 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 2

ZYTIGA® (abiraterone acetate) Tablets

USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications]. 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, the patient should be apprised of the potential hazard to the fetus and the potential risk for pregnancy loss. Women of childbearing potential should be advised to avoid becoming pregnant during treatment with ZYTIGA. 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: ZYTIGA is not indicated in children. Geriatric Use: Of the total number of patients in a phase 3 trial of ZYTIGA, 71% of patients were 65 years and over and 28% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients. 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 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F 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].

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 Cardiovascular Adverse Reactions: Cardiovascular adverse reactions in the phase 3 trial are shown in Table 1. The majority of arrhythmias were grade 1 or 2. Grade 3-4 arrhythmias occurred at similar rates in the two arms. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arm. No patients had sudden death or arrhythmia associated with death in the placebo arm. Cardiac ischemia or myocardial infarction led to death in 2 patients in the placebo arm and 1 death in the ZYTIGA arm. Cardiac failure resulting in death occurred in 1 patient on both arms. Hepatotoxicity: Drug-associated hepatotoxicity with elevated ALT, AST, and total bilirubin has been reported in patients treated with ZYTIGA. Across all clinical trials, liver function test elevations (ALT or AST increases of > 5X ULN) were reported in 2.3% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. In the phase 3 trial, patients whose baseline ALT or AST were elevated were more likely to experience liver function test elevations than those beginning with normal values. When elevations of either ALT or AST > 5X ULN, or elevations in bilirubin > 3X ULN were observed, ZYTIGA was withheld or discontinued. In two instances marked increases in liver function tests occurred [see Warnings and Precautions]. These two patients with normal baseline hepatic function, experienced ALT or AST elevations 15 to 40X ULN and bilirubin elevations 2 to 6 X ULN. Upon discontinuation of ZYTIGA, both patients had normalization of their liver function tests and one patient was re-treated with ZYTIGA without recurrence of the elevations. In clinical trials, the following patients were excluded: patients with active hepatitis, patients with baseline ALT and/or AST ≥ 2.5X ULN in the absence of liver metastases, and patients with ALT and/or AST > 5X ULN in the presence of liver metastases. Abnormal liver function tests developing in patients participating in clinical trials were managed by treatment interruption, dose modification and/or discontinuation [see Dosage and Administration (2.2) in full Prescribing Information and Warnings and Precautions]. Patients with elevations of ALT or AST > 20X ULN were not re-treated. Other Adverse Reactions: Adrenal insufficiency occurred in two patients on the abiraterone arm of the phase 3 clinical trial (< 1%). Laboratory Abnormalities of Interest: Table 2 shows laboratory values of interest from the phase 3 placebo-controlled clinical trial. Grade 3-4 low serum phosphate (7.2%) and potassium (5.3%) occurred more frequently in the ZYTIGA arm. Table 2: Laboratory Abnormalities of Interest in a Phase 3 Placebo-Controlled Clinical Trial Abiraterone (N=791) Placebo (N=394) All Grades Grade 3-4 All Grades Grade 3-4 Laboratory Abnormality (%) (%) (%) (%) High Triglyceride 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Low Potassium 28.3 5.3 19.8 1.0 Low Phosphorus 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 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]. 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].

Manufactured by: Patheon Inc. Mississauga, Canada Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044 Issued: December 2011 08Z11205B

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

Please see brief summary of Prescribing Information on adjacent pages.

2/12

08Z12026

08Z11121R3

Contraindications ZYTIGA® (abiraterone acetate) may cause fetal harm (Pregnancy Category X) and is contraindicated in women who are or may become pregnant. Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in hypertension, hypokalemia, and fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure because these patients were excluded from the randomized clinical trial. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly. Adrenocortical Insufficiency (AI) AI has been reported in clinical trials in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations. Hepatotoxicity Increases in liver enzymes have led to drug interruption, dose modification, and/or discontinuation. Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient's baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function. Food Effect ZYTIGA® must be taken on an empty stomach. Exposure of abiraterone increases up to 10-fold when abiraterone acetate is taken with meals. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. Adverse Reactions The most common adverse reactions (≥5%) are joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection. Drug Interactions ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. Additionally, abiraterone is a substrate of CYP3A4 in vitro. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution. Use in Specific Populations The safety of ZYTIGA® in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA®.

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

Support for your patients:

Benefit Investigation

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

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

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1-855-ZYTIGA-1 (998-4421) Monday–Friday, 8:00 AM–8:00 PM ET

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Please see Indication, Important Safety Information, and Brief Summary of Prescribing Information on adjacent pages. Patient insurance benefit investigation is provided as a service by TheraCom, LLC and The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, TheraCom, LLC, and The Lash Group, Inc., assist healthcare professionals in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer and patient information provided by the healthcare provider under appropriate authorization following the provider’s exclusive determination of medical necessity. Importantly, insurance verification is the ultimate responsibility of the provider. Third-party reimbursement is affected by many factors. Therefore, TheraCom, LLC, The Lash Group, Inc., and Janssen Biotech make no representation or guarantee that full or partial insurance reimbursement or any other payment will be available. This information is provided as an information service only. While TheraCom, LLC, and The Lash Group, Inc., try to provide correct information, they and Janssen Biotech make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall TheraCom, LLC, The Lash Group, Inc., or Janssen Biotech or its employees or agents be liable for any damages resulting from or relating to the services. All providers and other users of this information agree that they accept responsibility for the use of this service. Janssen Biotech assumes no responsibility for, and does not guarantee the quality, scope, or availability of the services including but not limited to reimbursement support services, patient education, and other support services. Each provider, not Janssen Biotech, is responsible for the services they provide. These support services have no independent value to providers apart from the product and are included within the cost of the product. © Janssen Biotech, Inc. 2012

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