June 2011, No 1, Vol 2

Wellness-Based Healthcare: Economic Incentives and Benefit Design

ONCOLOGY PRACTICE MANAGEMENT ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE

www.OncPracticeManagement.com

JUNE 2011

Scheduling, Staffing, and Task Assignment Using Operational Dashboards for an Efficient Practice

By Elaine Kloos, RN, NE-BC, MBA

VOLUME 1 • NUMBER 2

Changing the Oncology Guidelines Market Proventys and NCCN

By Dawn Holcombe, MBA, FACMPE

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or the past 4 years, various entities, large and small, have struggled to address the question of guidelines and pathways in oncology. Thousands of hours have been spent building software solutions to the complexity of oncology decision making. A handful of companies have created versions of oncology pathways, but not one of these have been able to incorporate the recognized national gold standard for oncology clinical guide-

lines—those produced and maintained by the National Comprehensive Cancer Network® (NCCN®). This collaboration embeds the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) and NCCN Drugs and Biologics Compendium™ (NCCN Compendium™) within the Proventys CDS Oncology system, an interactive web platform that arms oncologists with trusted indications Continued on page 6

A Community-Based Practice Model for Success Steps for Collaboration Among Specialty Groups

By Dawn Lagrosa

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t goes without saying that the world of oncology has grown more complex through the years. In addition, certain nuances (eg, multiple locations, large hematology volume, space inefficiencies, treating referred-in nononcology infusion patients, utilization of nonphysician providers, clinical research in the office setting, etc) complicate the comparison of one practice with another. As a consequence, uniform industry dashboards or benchmarks are difficult to find.

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any groups have begun taking on more challenging operational strategies for success, said Har vey D. Bichkoff, MPH, CEO of Marin Specialty Care, a collaboration of specialty physician groups in Marin County, California, presenting at the 2011 annual meeting of the American Society of Clinical Oncology. To illustrate how this can be done, Bichkoff detailed the steps implemented by Marin Specialty Care.

Continued on page 4

Continued on page 8

From the publishers of ©2011 Engage Healthcare Communications, LLC

INSIDE

TECHNOLOGY

Dashboards for Hospital-Based Cancer Centers..........................10 MODELS OF CARE

Will Accountable Care Organizations Take Hold in Oncology? ..............17

Your goal is to give him a cancer treatment that’s right for him.

When you choose a Lilly Oncology product, our goal is to make sure he has access to it.

Medication Access Support.

A cancer diagnosis presents many challenges for your patients— and for those who love and care for them. That’s why PatientOne offers reimbursement support and financial assistance for eligible patients who are prescribed Lilly Oncology products. It’s the kind of support that can make access to medication easier—and make a difference in the lives of your patients.

To learn more, visit www.LillyPatientOne.com or call 1-866-4PatOne (1-866-472-8663).

MG69852 02/11 PRINTED IN USA © 2011, Lilly USA, LLC. ALL RIGHTS RESERVED.

Patient Assistance I Insurance Expertise I Claims Appeals

In This Issue

TECHNOLOGY Dashboards for Hospital-Based Cancer Centers ......10 Oncology Networks Best Practices ............................18

PUBLISHING STAFF Publisher Nicholas Englezos nick@engagehc.com 732-992-1884

LEGAL UPDATE Malpractice and Genetic Testing ..............................11

Associate Publisher Maurice Nogueira maurice@engagehc.com 732-992-1895

MODELS OF CARE Will Accountable Care Organizations Take Hold in Oncology? ..................................................................17 Medium-Margin Businesses ........................................... 21

Director, Client Services Cristopher Pires cris@engagehc.com 732-992-1896 Editorial Director Dalia Buffery

CASE STUDY Cancer Care Northwest ................................................ 20

Editor Dawn Lagrosa dawn@greenhillhc.com 732-992-1891 Production Manager Marie R. S. Borelli Quality Control Director Barbara Marino Business Manager Blanche Marchitto

EDITORIAL BOARD

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 highquality 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.

VOPM2

Editor-in-Chief Dawn Holcombe, MBA, FACMPE, ACHE President, DGH Consulting South Windsor, Connecticut Bruce A. Cutter, MD President Cutter HealthCare Consulting Spokane, Washington

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

Patrick A. Grusenmeyer, ScD, FACHE Senior Vice President, Cancer and Imaging Services Christiana Care Health System Newark, Delaware

Cindy C. Parman, CPC, CPC-H, RCC Principal CSI Coding Strategies Inc Powder Springs, Georgia

Value-Based Cancer Care®, ISSN 2153-4888 (print); ISSN 2153-4896 (online), is published 7 times a year by Engage Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. Copyright © 2011 by Engage Healthcare Communications, LLC. All rights reserved. Value-Based Cancer Care® 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 Value-Based Cancer Care® do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an advertisement or other product mentioned in Value-Based Cancer Care® 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, Value-Based Cancer Care®, 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.

June 2011

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Staffing

Scheduling, Staffing…Continued from the cover To follow are recommendations to consider in your office setting regarding scheduling, staffing, and task assignment with the hopeful intent, if implemented, to improve your practice’s operations. In addition, many of the hospital benchmarks discussed by Guidi (see pages 10-11) can be used in the practice setting as well.

Scheduling Except for fine-tuned, hardwired procedures for the revenue cycle processes, appropriate scheduling is the most important aspect for a wellrun, efficient oncology practice.

Nurses should perform duties that require an RN license.

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Consider each billable event as a revenue-generating resource, and maximize revenue by scheduling each step in the patient’s process as a separate appointment. These include lab draws and lab work, doctor’s appointment, chemotherapy, injection, etc. Direct intervention should occur when the patient is in the phlebotomy chair, examination room, or chemotherapy chair. Patients should be in a waiting room or subwaiting area when intervention is not occurring.

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Make each appointment for the amount of time the intervention takes, and build into your system a method to accommodate the maximum number of patients. For example, if a lab draw takes 5 minutes and you have 1 lab technician, the template should be built for 1 patient scheduled every 5 minutes.

Don’t schedule 5 lab draws at 8 AM if the technician can draw only one at that exact time. If the doctor

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needs 20 minutes to see a patient, review imaging and lab results, write orders, and dictate, don’t schedule patients every 15 minutes.

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Build each chemotherapy chair into the scheduling system as a resource, ensuring that all the chairs can be viewed on the computer screen. Each patient should be assigned to a chair. Develop scheduling guidelines for the scheduler, and include time to start the intravenous or port access, give premedications, and mix and give chemotherapy. Utilize appointments throughout the day, with shorter treatments after noon.

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Leave one or more chairs open as a swing chair(s), depending on your average number of sick walk-ins and add-ons. This allows add-ons to be assigned to a chair.

This also allows for fewer bottlenecks if a patient has a reaction, because an open chair is available for the next scheduled patient.

5

Consider assigning one nurse to do all injections, port access (nonchemotherapy), and, if possible, have this chair/room near the lab.

Build the schedule template with 10or 15-minute slots for this service.

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Schedule new cancer patient appointment (unless an emergency) within 5 business days or less.

Schedule new asymptomatic benign hematology patients within 3 weeks.

Symptomatic benign hematology patients, however, should be scheduled within 5 to 7 business days.

7

Reserve slots in the schedule for new patients according to provider’s preferences. Most providers prefer the last slot (11 AM to 12 NOON) before lunch and/or the last slots for the day (3 PM and/or 4 PM).

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Staffing Multiple sources (proprietary and purchased data) are used to gather data to benchmark the practice production and compare it with other medical oncology practices. As stated previously, it can be difficult, at times, to compare apples with apples. As a guide, the number of full-time equivalents (FTEs) per fulltime medical oncologist includes: • Front desk 2.4 FTE • Medical records 0.6 FTE • Phlebotomy and lab 1.0 FTE • Chemotherapy nurses (mix and administer) 2.2 FTE • Clinic support 1.0 FTE • Insurance/billing 1.2 FTE. Task Assignment As practices grow, tasks can be assigned to specific staff members and, over time, these tasks become that person’s responsibilities. It is very important that the right person performs each task, with the duty falling within his or her respective scope. For example, nurses should perform duties that require a registered nurse (RN) license. RNs should not be performing charge capture, charge entry, or scheduling.

Coders should perform charge capture and charge entry. Front office staff should perform all scheduling.

Training and accurate, up-to-date job descriptions are imperative.

In summary, as outside forces continue to impact the bottom line for oncology practices, it is imperative to operate as efficiently as possible.

Hopefully, some of these recommendations will impact and improve your operations. l Elaine Kloos is a Senior Consultant with the Oncology Management Consulting Group, where she specializes in service line development and strategic planning.

VELCADE and Millennium are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners.

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

Printed in USA

V-10-0196

11/10

Technology

Oncology Guidelines…Continued from the cover of evidence and other key information needed for fully informed medical decision making.

Oncology Guidelines as DecisionSupport Tools One of the hottest topics in oncology management is variation, and how implementation of clinical care guidelines or the evenmore-streamlined pathways programs might enforce greater consistency of care and more predictability in the costs of care. Payers seek reduction of variation both as an indicator of “best practices” and as confirmation that oncologists are not straying from evidence-based treatments without reasons. Increasingly, payers need assurance that physicians are not only looking at the status of each patient and his or her disease, but also that medical decisions incorporate full cognizance of the diagnostics, targeted therapies, alternative choices, and full impact of a given treatment for a specific clinical situation.

Most oncology information systems can manage specific regimens tightly, but there is limited ability to track through the medical decisionmaking process leading to the se lection of a regimen in a way that measures and reports even simple concordance with the national standards set forth for oncology care.

Savvy payers are seeking proof of high levels of concordance with NCCN Guidelines™ and the NCCN Com pendium™ as an essential measure of quality for oncology care.

Payer expectations for benchmarking care against NCCN Guidelines are problematic for practices, because current claims and practice

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management (PM) systems have limited medical decision-making processes or can’t integrate those processes with the details of the recognized standards for clinical care for tracking and reporting.

Available electronic health record (EHR) or PM systems have not had broad access to integrate the details of the clinical NCCN Guidelines into real-time, active decision-making algorithms. Some systems do allow reference to the Guidelines in a static manner. Consequently, even oncology practices with very sophisticated EHR or PM systems either start their data entry at the point where the medical treatment decision already has been made (which is too late for payer interest or needs) or have some type of shadow decision-making process that works around reference to the NCCN Guidelines.

Practices, therefore, are not able to report concordance with NCCN Guidelines or track variation from them through their existing technology systems. Most physicians state high levels of reliance and concordance with NCCN Guidelines and NCCN Compendium indications in practice, but have limited ability to track or report on the actual experience in their practice. Often available is the ability to report on concordance with other clinical decision points, which can vary and lead to inconsistency on aggregated platforms beyond the individual practice.

NCCN Guidelines versus Other Guideline Models When there is a consistent, nationally recognized gold standard for clinical care, such as the NCCN Guidelines, it is referred to as the benchmark for quality and evidencebased decision making by physicians, patients, payers, and employers alike.

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All comparisons for quality treatment decisions are made against that standard.

NCCN has built that reputation by conducting rigorous reviews of new information about drugs and treatment, and through regular and timely updates to the clinical care guidelines. The Centers for Medicare & Medicaid Services (CMS) has set forth specific standards for the conduct and documentation of transparency in organizations that set forth care guidelines and compendia, and has approved NCCN as a primary source that is fully compliant with the CMS standards: • Tracking of changes considered and made for not less than 5 years • Listing all evidence considered • Listing all participating individuals in review (credentials, disclosures) • Keeping minutes and voting records • Clear decision making, with no agenda other than care.

Patients, physicians, payers, and employers should expect the same transparency of other guidelines and pathways, but are not usually able to see those standards met. Despite the recent buzz about pathways and the proliferation of shadow guidelines before the NCCN/Proventys collaborative algorithm was available, most physicians still resist the idea that these allow for appropriate medical decision making for the individual patient and disease that sits in front of them.

Pathways narrow physician choices further than guidelines, and some are drawing increasing criticism for potential liability and challenge by patients and physicians who question the validity and evidence that lead to the narrowed options rather than those found in the nationally recognized evidence-based NCCN

Technology

Guidelines. It may be more useful to take a step back and record consistency and utilization against the national evidence-based standards, which in turn will quickly lead to informationdriven narrowing of selected choices based on real-time practice and patient experience instead of negotiated narrowing of choices.

Likely Challenges to “Other” Guidelines and Pathways Until the NCCN Guidelines were accessible electronically and in a web platform for easy use, the only expectations of electronic care guidelines were that some payer or some physician accepts them. Now that the nationally recognized gold standard of care is readily accessible and usable, challenges will be made on all fronts to other proposed guidelines or pathways.

Common questions and challenges now are being heard about other proposed guidelines or pathways from patients, payers, employers, and physicians: • Why are these not the NCCN Guidelines?

• How can I convince my [patients, physicians, payers, employers] that these are better when they expect that NCCN Guidelines are the gold standard?

• What decisions drove the choices that are different from the NCCN Guidelines?

• Can you prove the evidence behind those decisions?

• Were certain drugs and regimens selected based on costs or available rebates, and given preference over other options?

• Can you meet the CMS expectations for transparency in your activities?

• What is the update and maintenance process, and how does it compare with the NCCN com mittees, processes, and updates and reviews?

• How can I defend your recom-

Cancer Care. Feb 2011:30) will not only allow physicians to see the NCCN Guidelines recommendations for a specific state and stage of disease, it also will allow that physician to see the levels of evidence for each choice, and potentially also the patient’s payer policy for each regimen (approved coverage, needs prior authorization, not covered), any internal practice pathways that may have been developed regarding each choice and, eventually, benchmarks showing utilization rates of each choice for other physicians across the country for patients with the same state and stage of disease.

The aggregation of this level of information in a consistent manner will spark expanded real-time, realworld, evidence-based treatment decisions and activity, thus leading to true evidence-based care management in oncology, grounded, as most believe it should be, in the medical decision making of the physician. Payers and physicians will quickly reap the benefits of universally applied evidencebased treatment, and progress to collection of treatment outcomes to support conversations about oncology disease management.

Preserving and supporting physician autonomy to (1) make individualized care decisions; (2) use the evidence they trust; (3) base treatment on the needs of the patient; and (4) be able to track and proved the quality of that decision. This harkens back to the core of the medical profession, the Hippocratic Oath…where physicians promise to treat patients to the “best of their ability and judgment” —not someone else’s best judgment. l

mendations/decisions if they differ from the choices on the NCCN Guidelines, especially if the patient, employer, or the physician is comparing those options to what is on the NCCN Guidelines?

Common national platforms do evolve in clinical care standards, and it will be far more acceptable to physicians to adopt the detailed electronic algorithms of the NCCN Guidelines now that they are available than to go through the onerous

The aggregation of this level of information in a consistent manner will spark expanded real-time, real-world evidence-based treatment decisions and activity. time and effort to create or validate a different set of shadow guidelines, accept other guidelines created by any entity that is not NCCN out of concern for risk or potential bias in the decision-making process, or accept from a payer or external vendor other portals or processes that are not NCCN Guidelines and therefore not part of their normal clinical decision-making process.

True Evidence-Based Treatment, and Beyond Payers, physicians, employers, and patients will demand only clinical care guidelines that incorporate the NCCN Guidelines, now that they are available, as the basic platform for oncology management. Use of the Proventys CDS Oncology platform (see description in Value-Based

June 2011

Dawn Holcombe is President of DGH Consulting, which provides consulting and speaking services to practices, pharma, and payers in strategy development, MD/payer negotiations and relationships, and oncology management and pathways.

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Models of Care

Practice Model for Success…Continued from the cover Know Your Market Before embarking on their collaboration efforts, the group—initially 6 medical oncologists—investigated the current marketplace in which they practiced. Bichkoff explained that 4 years ago in Marin County, Kaiser Permanente covered 30% to 40% of patients and Sutter Health ran more than 25 hospitals, using a strategy of forming medical foundations through which physicians are employed and are affiliated tightly with the local hospital.

At first, his group considered building their own cancer center, going so far as to design the facility with consultants. Research, however, revealed that Sutter Health was not a strong player in the marketplace, and during its transition period Marin General Hospital became county owned. The hospital then developed a large primary care network, which it termed PRIMA Medical Group, and its new administration expressed interest in a joint venture or strategic partnership with local medical oncologists, Bichkoff told attendees.

Design Your Collaboration Marin Specialty Care worked in concert with Marin General Hospital to develop an organizational structure that would benefit both. The current arrangement consists of the medical oncologists, 4 urologists, 3 radiation oncologists, and 1 breast surgeon.

The breast surgeon is a member of PRIMA Medical Group, which according to Bichkoff removes the risk of her salary from the oncology group because she is employed through PRIMA’s foundation.

For radiation oncology, Bichkoff explained that the 2 organizations developed a lease structure that allows the department to be owned and run by the hospital in the mornings and the oncology group in the afternoons. For medical oncology, a

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comanagement agreement was put in place, which requires the oncology group to be involved in all aspects of the service line and manage the department with the hospital. In addition, a block lease was set up for positron-emission tomography/computed tomography.

Shareholders meet every 2 weeks, which helps overcome the silo situation.

To set up the new arrangement, Bichkoff, as the lead administrator of the oncology group, worked with hospital administration on the deal points. “Instead of duplicating service in the market, we brought in an independent group to do a fair market value analysis on space, equipment, and staff,” said Bichkoff.

Consider the Operational Aspects It is important to plan for myriad operational elements, Bichkoff cautioned. At Marin Specialty Care, they considered not only medical oncology overhead but also the culture change for the radiation oncologists and surgeons. These practitioners “are not used to large executive pay scale for accounting administrators, finance people, or millions of dollars in drug spend,” said Bichkoff.

In addition, payer contracts will need to be renegotiated. Bichkoff gave this example: “It took 2 years to renegotiate contracts. The PPO [preferred provider organization] contracts, which are 40% of the business, were more weighted toward drug reimbursement.” The group had to renegotiate with procedural bases in mind for urologists’ services and

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radiation global fees.

Another aspect Bichkoff reminded attendees to consider is branding.

For his group, which now contained urologists and breast surgeons with nononcology (benign disease) clientele, a new name was in order: from Marin Oncology Associates to Marin Specialty Care. Bichkoff also cautioned not to overlook the difficulty in integrating 2 electronic health record systems.

A board of directors and physician committees also need to be selected.

At Marin Specialty Care, shareholders meet every 2 weeks, which according to Bichkoff helps overcome the silo situation that is common in multispecialty practices.

Selection of other key personnel is important as well. In his experience, “active participation and buy in from members of each group…[and] a lot of time and dedication is needed.”

To keep the new venture successful, use of outside personnel—consultants for business planning, lawyers who understand Stark laws and mergers, payer contracting consultants, human resource and benefits consultants, pension experts, billing experts, and accounting experts—needs to be included in the operational design. He recommended ensuring the group budgets adequately for consultants.

Reap the Rewards Although this collaboration took 4 years of hard work, the partners can now offer their patients the highest quality of care. From a business perspective, the group enjoys “more bargaining clout with payers and better rates for all, a diversified revenue stream with ‘low’ investment, positioning for ACOs [accountable care organizations] and alignment with referral sources, and ability to test relationships before moving to tighter affiliations.” l

Technology

Dashboards for Hospital-Based Cancer Centers Constructing the Right One for Your Success

By Teri U. Guidi, MBA, FAAMA

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anaging a hospitalbased cancer center is a complex task and it is all too easy to become consumed putting out the daily fires, losing sight of the larger responsibility of maintaining an efficient and financially viable service line. A dashboard is an important tool in ensuring that the bigger picture is not neglected.

Like the dashboard in a car, the purpose of the dashboard is to provide important information on a reg-

ular basis in a manner that can be quickly digested and allows for appropriate actions. A dashboard should not be cluttered with information that is interesting but that does not provide valuable knowledge or opportunities for action. In other words, don’t measure something just because it can be measured.

In running a cancer program, there are 2 main types of information requiring periodic review: operational information and strategic information. Each category may have 1 or more key indicators that any given administrator wants to monitor, and the indicators may change over time. Further, the indi-

Table 1. Common Volume Indicators and Review Timeline

Indicator Number of new tumor registry cases (look at Class 0, Class 1, and Class 2 for migration patterns), by major site of disease if you are developing/running a site-specific clinic or program New radiation treatment starts Patients accrued to clinical trials (separated for cooperative groups and commercial studies) New patients to any specialized service/ program, such as an employed physician or a multidisciplinary lung clinic Number of patients referred to departments/services/programs, segmented by referring physician Clinical/quality measures such as percent of negative breast biopsies, turnaround times, adherence to guidelines, etc

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Review Schedule No more than quarterly

Quarterly or monthly Quarterly (monthly for very large programs) Monthly until well established, then quarterly Monthly for new services/ programs, then quarterly until well established, then annually Monthly or quarterly depending on the level of concern

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cators may be volume oriented or they may be financially oriented. In either case, the most important reason to use a dashboard is to track performance over time and thus identify important changes in time to take any appropriate action. It is also useful to compare dashboard results with benchmarks, when those are available.

The most important reason to use a dashboard is to track performance over time and thus identify important changes in time to take any appropriate action.

Choosing Your Information To construct your dashboard, begin by answering 2 questions: • What do I need to know to be sure that we are not losing ground?

• What do I need to know to be sure that we are progressing toward our goals?

For each answer, determine the measurable indicators. For example, if you define “losing ground” as decreasing volumes, then the volumes become your indicators: number of new registry cases, number of billed procedures, charges or revenue for a particular department, etc.

These may be more specific if you are launching a disease-specific program or a new clinical service. If

Legal Update

your goals are numeric, put those on the dashboard (eg, increased clinical trial enrollment, decreased negative biopsies). If those goals relate to progress of a nonnumeric project (eg, strategic plan initiatives such as developing multidisciplinary clinics), devise a milestone schedule and track your progress.

For most indicators, it is sufficient to review the dashboard monthly.

That gives enough time to see the early results of any changes you have made. More frequent dashboard review is generally not advised, because it can place too much importance on small fluctuations.

Some indicators, like tracking progress on strategic plan initiatives, may need only quarterly or even annual review (Tables 1 and 2).

To the maximum extent possible, a dashboard should be populated by data that are electronically available

Table 2. Common Financial Indicators and Review Timeline

Indicator Paid overtime hours by staff category Billed charges for each department Expenses for each department, segmented by expense category Claims denied/appealed (number and dollars), segmented by payer Accounts receivable (dollars and days) in each department

rather than requiring hand counts, and ideally the dashboard should update itself automatically through information technology systems.

The discussed indicators should serve as examples and should not limit your focus or creativity. A useful dashboard will show you, in a quick table or graph, exactly where

Review Schedule Monthly or quarterly Monthly Monthly Monthly or quarterly Monthly

you stand on the things that matter most to your success. l Teri Guidi is President & CEO of The Oncology Management Consulting Group, an oncology consulting firm that helps practices devise and implement the strategies and processes to remain competitive and solvent.

LEGAL UPDATE

Malpractice and Genetic Testing Review of Malpractice Claims Finds Physicians Vulnerable

By Dawn Lagrosa

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ourts are ruling in favor of plaintiffs in malpractice cases claiming that physicians are negligent in their use and application of genetic testing methods, according to an abstract presented at the 2011 annual meeting of the American Society of Clinical Oncology.

Researchers with the College of Law at Arizona State University in Tempe and the Mayo Medical School in Rochester, Minnesota, identified factors for which physicians have been held liable: • Failing to take an adequate family history • Not recommending the appro-

priate testing • Failing to refer to a geneticist or genetic counselor • Misinterpretation of test results • Not interpreting results in a timely manner • Failing to recommend the appropriate risk mitigation strategies • Failing to disclose a patient’s test results to at-risk family members.

Although the number of cases relating to hereditary cancer remains low, just 3 of more than 50 total cases identified through Westlaw, the researchers believe that the “causes of action” ruled on by the courts can be applied in cases involving hereditary cancer.

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These actions are important.

With responsibilities related to genetic testing continually evolving, physicians’ legal position remains dependent on the courts’ rulings. And with genetic technologies being adopted into clinical practice slower than the public realizes, their role as jurors can impact legal outcomes negatively for members of the healthcare team, especially physicians. The researchers concluded that, with the field of genetics continuing to grow along with the public’s expectations for genetic testing, the number of lawsuits filed against physicians is likely to increase. l

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Models of Care

Will Accountable Care Organizations Take Hold in Oncology?

Fervor Fading Fast

By Dawn Holcombe, MBA, FACMPE

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hen accountable care organizations (ACOs) were first proposed as part of healthcare reform possibilities, many in the healthcare industry jumped all over the term. An ACO is a group of healthcare providers who contract with Medicare to be responsible for taking care of the needs of 5000 or more patients under the terms of Medicare’s new ACO payment program that will begin on January 1, 2012.

According to the outline of this program, the providers (who may or may not be owned by hospitals) agree to adhere to certain “quality of care” requirements while they take care of these patients for a 3year period. For each year, Medicare will compare the amount that it actually spent caring for these patients with some predicted amount that it expected to spend. If less is spent on these patients than expected—while still adhering to government-mandated quality standards—the Centers for Medicare & Medicaid Services (CMS) would share the savings with the members of the ACO. If more is spent on the patients than predicted, the ACO shares the losses.

Consultants were advising hospi-

6, 2011. Already some of the comments are being made public through press releases and articles, and most are very apprehensive.

The American Medical Group Association warned CMS in its letter of May 13, 2011, that the proposed rules are “overly prescriptive” and “operationally burdensome.”

In a 2011 HealthLeaders Media Impact Analysis on ACOs, many key healthcare leaders from companies including Scripps Health, Alegent Health, Kaiser Foundation Hospitals, and Dean Health System expressed their reservations (www. healthleadersmedia.com/impactanalysis/265335). In this report, George Halvorson, CEO of Kaiser Foundation Hospitals—an organization that many may have expected to participate as an ACO—stated that his system, with 8.8 million members nationally, would not be participating, but would continue to participate in Medicare Advantage.

With comments unfolding up until the deadline, spokespersons for CMS have indicated that the proposed rule is receiving intense criticism, and that a high volume of comments and significant reaction could affect the final role of ACOs in oncology. l

tals, physician groups, and other organizations how to prepare to become an ACO before the clarifications and proposed rules were issued by the government. Now that CMS has issued its 429-page proposed rule and groups have gotten a solid look at the expectations for risk, savings, and both the rewards and penalties attached to Medicare spending, reality has started setting in.

According to CMS, the program is voluntary, but there is a downside risk to participation. Participants will be paid as usual under “original” Medicare, but their performance as an ACO will be measured by CMS on an annual basis over a 3-year period.

CMS assumes that 75 to 150 ACOs could participate, and that aggregated start-up investments and first-year operating expenses for all of these organizations could range from $131.6 million to $263.3 million. Participating ACOs can choose 1 of 2 shared savings and risk models (Table).

Participants also will not know which beneficiaries are assigned to them until the care-year has ended, which increases the uncertainty and risk.

Apprehension Growing Comments were due back to CMS on the proposed rule by June

Table. Proposed Savings and Risk Models

Model 1-Sided Risk

Terms Years 1 and 2: Shared savings Year 3: Shared savings and losses

2-Sided Risk

Years 1, 2, and 3: Shared savings and losses

Rationale Offers experience for organizations less familiar with population management before transitioning to a risk-based model Offers opportunity for organizations with experience in population management to receive greater savings

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Reward Less risk

Greater share of savings

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Technology

Oncology Networks Best Practices A Study of Governance, Resources, and Clinical Coordination

By Gerard M. Nussbaum; Laura Rehfeld

enhancing the network now can create an opportunity for growth and value in the future.

Best Practices The study was conducted to better understand current levels of development and best practices in 3 areas: organization and governance, systems and resources, and clinical

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s cancer prevalence continues to rise in the United States, demand increases for highly coordinated oncology networks that provide the best possible patient care closest to home.

A Kurt Salmon study conducted in the fall of 2010 found that although all regional oncology networks surveyed are in the process of increasing coordination of services and resources, most networks remain at a low or intermediate level of development.

Because many networks remain underdeveloped in certain key areas, investing resources in

The most advanced oncology networks have governance administered through a central oncology network leadership council. care coordination. Examined together, these areas create a broad picture of the maturity of oncology networks. Table 1 lists some of the best practices in each area.

• Organization and governance.

The most advanced oncology networks have governance ad ministered through a central oncology network leadership council consisting of key administrative, physician, and nursing leadership. This body has defined authority over network resources across all sites and is coordinated with other governance structures (CEOs of individual sites).

• Systems and resources. Leading networks have developed highly coordinated centralized systems and resources supporting the network. The network has a central administrator and staff who lead, coordinate, direct, and support network development.

Leading oncology networks are distinguished by their increased dedication to developing electronic health records (EHRs) and common information technology (IT) systems across network sites. Network planning and budgeting are completed across multiyear cycles.

Table 1. Oncology Best Practices

Organization and Governance

Systems and Resources

Clinical Care Coordination

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• Governance through a strong, centralized oncology leadership council • Authority defined through an oncology network charter • A dyadic leadership structure with an administrative and physician leader • Dedicated oncology network administrative support group • Dedicated oncology network functional support staff • Use of common information technology systems across all sites • Stable funding sources for network goals and initiatives • Standard treatment protocols and care processes across all sites • Coordination of the clinical care information flow •Adding provider–patient information flow into clinical care delivery

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Technology

• Clinical care coordination. This area represents the most underdeveloped aspect of the oncology networks studied. The best practices are implementation of common clinical care protocol sets across all sites, instantaneous access to patient records at any point of care, and demonstration of improved clinical outcomes. All participants envision this as their future state, even though few have achieved it in practice.

Strengthening Clinical Care Coordination The study also identified 8 lessons about the interplay between the 3 areas studied and potential priorities for future development (Table 2). Oncology networks interested in strengthening their clinical care coordination can take 3 actions to prepare for future models of care:

1

Ensure the network has a strong central leadership body that is able to prioritize initiatives and secure resources across sites.

The ability of the network to conduct coordinated planning and multiyear budgeting is essential to advancing EHR and clinical care initiatives as well as balancing oncology priorities with alternate service line investments within hospitals and systems.

2

Evaluate current EHR re sources and plans to understand how they support or hinder clinical care coordination and quality treatment delivery regardless of where the patient accesses care. The free flow of clinical information among providers is the key differentiating feature of leading oncology networks. This may be accomplished in a number of ways (eg, single oncology EHR or multiple interfaced systems); however, greater integration

Table 2. Eight Lessons Learned

1. Governance development determines network strength 2. Clinical care coordination is not as prevalent as many perceive 3. Clinical care coordination benefits from strong governance and dedicated resources 4. Physician leadership is a critical element of success 5. Paper still permeates clinical care documentation 6. IT is viewed as a critical enabler of improved patient care 7. Tumor boards remain mostly a locally focused forum 8. A vision for use of tumor registry and electronic health record information to support research is coming into focus of clinical information will be required for future success.

cols and standardizing treatment processes across the network.

Leading networks see advancing clinical care coordination as the next important area for network development and are creating multiyear plans and budgets to support this goal.

We expect many networks to address the key challenges and barriers to coordinating care over the next few years by engaging physicians; developing dedicated staff assignment; and investing in information technology systems, interfaces, and health information exchange. Achievement of clinical care coordination will significantly improve the network’s value and prepare the organization for the future healthcare environment.

For more information, please refer to the Kurt Salmon white paper at www.kurtsalmon.com/ oncology. l

3

Create staff roles that support current clinical information needs. The realities of living in a largely paper-based care environment can be greatly improved by

The free flow of clinical information among providers is the key differentiating feature of leading oncology networks. defining functional support roles, such as tumor registrars, clinical coordinators, and tumor board coordinators. These functional staff members provide expertise to smooth clinical information flow and ensure providers have access to all necessary care records.

Gerard M. Nussbaum and Laura Rehfeld have more than 30 years of experience advising hospital and health system leaders. Kurt Salmon offers strategic planning for clinical programs; developing cutting-edge, operationally efficient facilities; and designing agile information management environments.

Over the past decade, the major focus of oncology networks has been on forming the organization and developing basic resources. To date, little progress has been made in coordinating clinical care proto-

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Case Study

Cancer Care Northwest Consolidation and Integration

By Bruce Cutter, MD, MMM

C

ancer Care Northwest (CCNW) is an approximately 20-physician multispecialty oncology group in Spokane, Washington, that has undergone several consolidations over the past 15 years. In this article I would like to outline these efforts, hoping to share the experiences and assist others who may be facing such events.

CCNW’s experience with consolidations and integrations began in 1995. At that time, the practice, consisting of 7 medical oncologists, became part of Physicians Reliance Network, a precursor to US Oncology. This consolidation is best described as horizontal integration. The practice affiliated with other oncology groups around the country to gain advantages associated with such specialty integration.

The next phase, in 1999, involved adding radiation oncology and imaging, with the practice moving into free-standing outpatient cancer centers. Surgical and gynecologic oncologists were added in 2002, and breast surgeons a short time after.

These details are less important than the leadership, analysis, and decision making that underlain the organizational change. A full exploration of these issues is beyond the scope of this article; however, I encourage leaders and organizations to delve more deeply into these topics. These decisions offer the opportunity to shape, for better or worse, the course and welfare of your organization for years to come.

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Consolidation should be a solution, a means to an end and not an end itself, and be designed to address a specific problem or set of problems. More broadly, it should be used as a strategy meant to realize a vision and organizational goals. Two good questions to ask yourselves continuously are: “What are we doing?” and “Why are we doing it?”

Consolidation should be a solution, a means to an end and not an end itself, and be designed to address a specific problem.

The (idealized) process by which CCNW decided to undertake its consolidations and integrations is instructive. We spent significant time understanding what we wanted the organization to look like in the future and assessing where we were currently. We looked within as well as without, assessing our strengths and weaknesses as well as opportunities and threats, and trying to understand the external environment (including the local and national market and trends) and where oncology was headed. From this process, decisions were made; for example, we would need a partner to help us to “get to where we wanted to go.” A subsequent analysis looked at the various partners available and, ultimately, a formal decision was made. Whether the issue was horizontal integration or the addition of other oncologic spe-

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cialties, we had to make sure these strategic moves were consistent with our vision, that they supported both our clinical and business goals, and that we undertook a careful and thorough analysis of the environment, our competitive position, and our capabilities before making a final decision. An additional important part of the analysis relates to legal and regulatory issues. In the case of CCNW, we planned to bring the other specialty physicians into a single legal and operational entity, with a single tax identification number. This was relatively straightforward, although there were legal regulations that we had to follow regarding Stark and antikickback statutes. Expert legal assistance is strongly advised.

Consolidations and integrations such as described are difficult and time-consuming. There are many challenges to overcome, including issues of trust, compensation, governance, and especially the merging of different cultures; the need for skilled physician leadership is great.

Despite these issues, given the state of the industry, consolidations among various entities are sure to increase. The likelihood of such an effort succeeding can be improved by assuring a rigorous and well-done evaluation and analytic process, making sure that you have quality decision making, and making very clear you understand exactly what it is you are doing and why you are doing it. l

Bruce Cutter is President, Cutter HealthCare Consulting, where he works with oncology practices on consolidations and mergers.

Models of Care

Medium-Margin Businesses Assessing and Implementing Ancillary Services

By Dawn Lagrosa

O

ncology is evolving from a high-margin infusion business into diversified medium-margin businesses, according to Jeffrey Patton, MD, medical oncologist and CEO, Tennessee Oncology, Nashville. At the 2011 annual meeting of the American Society of Clinical Oncology, Patton discussed how to assess the potential for future revenue, before you commit to adding an ancillary service.

Begin by developing a pro forma statement. This statement projects future returns of a new venture. In appearance, a pro forma statement is similar to an income statement; but instead of detailing past revenue, the financial tool creates a way to decide if the new venture will be worthwhile.

that business line can help, according to Patton, who recommended asking about their costs, volumes, and pro forma projections.

Medium-Margin Businesses for Potential Revenue • Pharmaceuticals • Administration codes • Laboratory services • Retail pharmacy • Pathology • Radiation oncology • Clinical research

2

Estimate cost. This estimate will need to include any lease payments, additional employee costs (ie, will an additional person need to be hired to operate the new technology), wholesale cost of goods needed to successfully operate a new technology (eg, contrast agents or lab serums), and, if new space is required, rent payments.

by your patients’ insurance?

Patton recommended only integrating services that can be reimbursed.

• Is the vender’s pro forma accurate for your situation? It is important to realize that the vendor is selling you a product; therefore, a vendor will show you a “very aggressive pro forma statement.”

• Will the practice’s doctors/partners embrace/support the service? The human element should not be overlooked, stressed Patton. For a new technology, consider the likely adoption curve; and for an established line of service, remember that doctors have an established referral pattern that may need to change.

3

Estimate net income. It is important to project ahead for 2, 3, 4, and 5 years, although in his experience the estimates get murkier the further out you get, noted Patton.

Income = Revenue – Expenses

1

Estimate revenue. First, estimate your potential volume, for example, the number of tests taken and/or procedures performed. Second, multiply that volume by the estimated revenue per test. To calculate your per-test revenue, Patton suggested averaging your commercial rates with your Medicare rates.

To keep the estimate as accurate as possible, he stressed the importance of factoring in any “cannibalizing” of a current revenue stream, such as if you install a magnetic resonance imaging machine, remember that its use will likely decrease the use of and revenue from a current computed tomography scanner.

Be conservative in your estimates, Patton warned. You do not want to create a financial cost center instead of a profit center.

Talking to colleagues who are in

4

Question your decision making, and plan ahead.

• What is your current versus your future volume? For a new technology, adoption is likely and your volume is likely to increase over time, believes Patton. For a mature technology, however, he cautioned that volume may decrease because its use is more aggressively managed by payers.

• What is your current versus future reimbursement? Reimbursement trends follow those of volume trends. A new technology takes time to “show up on the radar” of payers, which translates to a stable, and possibly increasing, revenue stream. An established line of business, however, will be under pressure from payers and your reimbursement will probably decrease over time, said Patton.

• Will the new business be covered

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Implement. Once you decide to move forward with a new service, choose a staff member to “own” the project. This project manager will be the one working with you to develop a project plan. Be sure to develop hard, but reasonable timelines, emphasized Patton. As a team, you need to identify resources both inside and outside of the practice, as well as look at capital—both human and financial. l

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DOXIL® (doxorubicin HCl liposome injection) for intravenous infusion BRIEF SUMMARY. Please see Full Prescribing Information.

WARNING: INFUSION REACTIONS, MYELOSUPPRESSION, CARDIOTOXICITY, LIVER IMPAIRMENT, ACCIDENTAL SUBSTITUTION 1. The use of DOXIL (doxorubicin HCl liposome injection) may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2. In a clinical study in patients with advanced breast cancer, 250 patients received DOXIL at a starting dose of 50 mg/m2 every 4 weeks. At all cumulative anthracycline doses between 450-500 mg/m2 or between 500-550 mg/m2, the risk of cardiac toxicity for patients treated with DOXIL was 11%. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. Cardiac toxicity may also occur at lower cumulative doses in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy [see Warnings and Precautions]. 2. Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with DOXIL. In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction has resolved with slowing of the infusion rate. Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. DOXIL should be administered at an initial rate of 1 mg/min to minimize the risk of infusion reactions [see Warnings and Precautions]. 3. Severe myelosuppression may occur [see Warnings and Precautions]. 4. Dosage should be reduced in patients with impaired hepatic function [see Full Prescribing Information]. 5. Accidental substitution of DOXIL for doxorubicin HCl has resulted in severe side effects. DOXIL should not be substituted for doxorubicin HCl on a mg per mg basis [see Full Prescribing Information].

INDICATIONS AND USAGE: Ovarian Cancer: DOXIL (doxorubicin HCl liposome injection) is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. AIDS-Related Kaposi’s Sarcoma: DOXIL is indicated for the treatment of AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.

Multiple Myeloma: DOXIL in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

CONTRAINDICATIONS: DOXIL (doxorubicin HCl liposome injection) is contraindicated in patients who have a history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of DOXIL [see Warnings and Precautions]. DOXIL is contraindicated in nursing mothers [see Full Prescribing Information].

WARNINGS AND PRECAUTIONS: Cardiac Toxicity: Special attention must be given to the risk of myocardial damage from cumulative doses of doxorubicin HCl. Acute left ventricular failure may occur with doxorubicin, particularly in patients who have received a total cumulative dosage of doxorubicin exceeding the currently recommended limit of 550 mg/m2. Lower (400 mg/m2) doses appear to cause heart failure in patients who have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents such as cyclophosphamide. Prior use of other anthracyclines or anthracenodiones should be included in calculations of total cumulative dosage. Congestive heart failure or cardiomyopathy may be encountered after discontinuation of anthracycline therapy. Patients with a history of cardiovascular disease should be administered DOXIL only when the potential benefit of treatment outweighs the risk. Cardiac function should be carefully monitored in patients treated with DOXIL. The most definitive test for anthracycline myocardial injury is endomyocardial biopsy. Other methods, such as echocardiography or multigated radionuclide scans, have been used to monitor cardiac function during anthracycline therapy. Any of these methods should be employed to monitor potential cardiac toxicity in patients treated with DOXIL. If these test results indicate possible cardiac injury associated with DOXIL therapy, the benefit of continued therapy must be carefully weighed against the risk of myocardial injury. In a clinical study in patients with advanced breast cancer, 250 patients received DOXIL at starting dose of 50 mg/m2 every 4 weeks. At all cumulative anthracycline doses between 450-500 mg/m2, or between 500–550 mg/m2, the risk of cardiac toxicity for patients treated with DOXIL was 11%. In this study, cardiotoxicity was defined as a decrease of >20% from baseline if the resting left ventricular ejection fraction (LVEF) remained in the normal range, or a decrease of >10% if the resting LVEF became abnormal (less than the institutional lower limit of normal). The data on left ventricular ejection fraction (LVEF) defined cardiotoxicity and congestive heart failure (CHF) are in the table below.

Table 1: Number of Patients With Advanced Breast Cancer Patients who Developed Cardiotoxicity (LVEF Defined) Cardiotoxicity (With Signs & Symptoms of CHF) Cardiotoxicity (no Signs & Symptoms of CHF) Patients With Signs and Symptoms of CHF Only

DOXIL (n=250) 10 0 10 2

In the randomized multiple myeloma study, the incidence of heart failure events (ventricular dysfunction, cardiac failure, right ventricular failure, congestive cardiac failure, chronic cardiac failure, acute pulmonary edema and pulmonary edema) was similar in the DOXIL+bortezomib group and the bortezomib monotherapy group, 3% in each group. LVEF decrease was defined as an absolute decrease of 15% over baseline or a 5% decrease below the institutional lower limit of normal. Based on this definition, 25 patients in the bortezomib arm (8%) and 42 patients in the DOXIL+bortezomib arm (13%) experienced a reduction in LVEF. Infusion Reactions: Acute infusion-related reactions were reported in 7.1% of patients treated with DOXIL in the randomized ovarian cancer study. These reactions were characterized by one or more of the following symptoms: flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in the chest and throat, fever, tachycardia, pruritus, rash, cyanosis, syncope, bronchospasm, asthma, apnea, and hypotension. In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction resolved when the rate of infusion was slowed. In this study, two patients treated with DOXIL (0.8%) discontinued due to infusion-related reactions. In clinical studies, six patients with AIDS-related Kaposi’s sarcoma (0.9%) and 13 (1.7%) solid tumor patients discontinued DOXIL therapy because of infusion-related reactions. Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. The majority of infusion-related events occurred during the first infusion.

Similar reactions have not been reported with conventional doxorubicin and they presumably represent a reaction to the DOXIL liposomes or one of its surface components. The initial rate of infusion should be 1 mg/min to help minimize the risk of infusion reactions [see Full Prescribing Information].

Myelosuppression: Because of the potential for bone marrow suppression, careful hematologic monitoring is required during use of DOXIL, including white blood cell, neutrophil, platelet counts, and Hgb/Hct. With the recommended dosage schedule, leukopenia is usually transient. Hematologic toxicity may require dose reduction or delay or suspension of DOXIL therapy. Persistent severe myelosuppression may result in superinfection, neutropenic fever, or hemorrhage. Development of sepsis in the setting of neutropenia has resulted in discontinuation of treatment and, in rare cases, death. DOXIL may potentiate the toxicity of other anticancer therapies. In particular, hematologic toxicity may be more severe when DOXIL is administered in combination with other agents that cause bone marrow suppression. In patients with relapsed ovarian cancer, myelosuppression was generally moderate and reversible. In the three single-arm studies, anemia was the most common hematologic adverse reaction (52.6%), followed by leukopenia (WBC <4,000 mm3; 42.2%), thrombocytopenia (24.2%), and neutropenia (ANC <1,000; 19.0%). In the randomized study, anemia was the most common hematologic adverse reaction (40.2%), followed by leukopenia (WBC <4,000 mm3; 36.8%), neutropenia (ANC <1,000; 35.1%), and thrombocytopenia (13.0%) [see Adverse Reactions]. In patients with relapsed ovarian cancer, 4.6% received G-CSF (or GM-CSF) to support their blood counts [see Full Prescribing Information]. For patients with AIDS-related Kaposi’s sarcoma who often present with baseline myelosuppression due to such factors as their HIV disease or concomitant medications, myelosuppression appears to be the dose-limiting adverse reaction at the recommended dose of 20 mg/m2 [see Adverse Reactions]. Leukopenia is the most common adverse reaction experienced in this population; anemia and thrombocytopenia can also be expected. Sepsis occurred in 5% of patients; for 0.7% of patients the event was considered possibly or probably related to DOXIL. Eleven patients (1.6%) discontinued study because of bone marrow suppression or neutropenia.

Table 10 presents data on myelosuppression in patients with multiple myeloma receiving DOXIL and bortezomib in combination [see Adverse Reactions].

Hand-Foot Syndrome (HFS): In the randomized ovarian cancer study, 50.6% of patients treated with DOXIL at 50 mg/m2 every 4 weeks experienced HFS (developed palmar-plantar skin eruptions characterized by swelling, pain, erythema and, for some patients, desquamation of the skin on the hands and the feet), with 23.8% of the patients reporting HFS Grade 3 or 4 events. Ten subjects (4.2%) discontinued treatment due to HFS or other skin toxicity. HFS toxicity grades are described in Dosage and Administration section [see Full Prescribing Information]. Among 705 patients with AIDS-related Kaposi’s sarcoma treated with DOXIL at 20 mg/m2 every 2 weeks, 24 (3.4%) developed HFS, with 3 (0.9%) discontinuing. In the randomized multiple myeloma study, 19% of patients treated with DOXIL at 30 mg/m2 every three weeks experienced HFS. HFS was generally observed after 2 or 3 cycles of treatment but may occur earlier. In most patients the reaction is mild and resolves in one to two weeks so that prolonged delay of therapy need not occur.

However, dose modification may be required to manage HFS [see Full Prescribing Information]. The reaction can be severe and debilitating in some patients and may require discontinuation of treatment.

Radiation Recall Reaction: Recall reaction has occurred with DOXIL administration after radiotherapy.

Fetal Mortality: Pregnancy Category D: DOXIL can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If DOXIL is to be used during pregnancy, or if the patient becomes pregnant during therapy, the patient should be apprised of the potential hazard to the fetus. If pregnancy occurs in the first few months following treatment with DOXIL, the prolonged half-life of the drug must be considered. Women of childbearing potential should be advised to avoid pregnancy during treatment with Doxil. [see Full Prescribing Information].

Toxicity Potentiation: The doxorubicin in DOXIL may potentiate the toxicity of other anticancer therapies.

Exacerbation of cyclophosphamide-induced hemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported with the conventional formulation of doxorubicin HCl. Radiationinduced toxicity to the myocardium, mucosae, skin, and liver have been reported to be increased by the administration of doxorubicin HCl. Monitoring: Laboratory Tests: Complete blood counts, including platelet counts, should be obtained frequently and at a minimum prior to each dose of DOXIL [see Warnings and Precautions].

ADVERSE REACTIONS: Overall Adverse Reactions Profile: The following adverse reactions are discussed in more detail in other sections of the labeling. • Cardiac Toxicity [see Warnings and Precautions] • Infusion reactions [see Warnings and Precautions] • Myelosuppression [see Warnings and Precautions] • HandFoot syndrome [see Warnings and Precautions] The most common adverse reactions observed with DOXIL are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia and anemia. The most common serious adverse reactions observed with DOXIL are described in Section Adverse Reactions in Clinical Trials. The safety data described below reflect exposure to DOXIL in 1310 patients including: 239 patients with ovarian cancer, 753 patients with AIDS-related Kaposi’s sarcoma and 318 patients with multiple myeloma.

Adverse Reactions in Clinical Trials: Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates on other clinical trials and may not reflect the rates observed in clinical practice. The following tables present adverse reactions from clinical trials of DOXIL in ovarian cancer, AIDS-Related Kaposi’s sarcoma, and multiple myeloma.

Patients With Ovarian Cancer: The safety data described below are from 239 patients with ovarian cancer treated with DOXIL (doxorubicin HCl liposome injection) at 50 mg/m2 once every 4 weeks for a minimum of 4 courses in a randomized, multicenter, open-label study. In this study, patients received DOXIL for a median number of 98.0 days (range 1-785 days). The population studied was 27-87 years of age, 91% Caucasian, 6% Black and 3% Hispanic and other. Table 2 presents the hematologic adverse reactions from the randomized study of DOXIL compared to topotecan.

Table 2: Ovarian Cancer Randomized Study Hematology Data Reported in Patients With Ovarian Cancer DOXIL Topotecan Patients Patients (n = 239) (n = 235) Neutropenia 19 (7.9%) 33 (14.0%) 500 - <1000/mm3 10 (4.2%) 146 (62.1%) <500/mm3 Anemia 6.5 - <8 g/dL 13 (5.4%) 59 (25.1%) <6.5 g/dL 1 (0.4%) 10 (4.3%) Thrombocytopenia 3 3 (1.3%) 40 (17.0%) 10,000 - <50,000/mm <10,000/mm3 0 (0.0%) 40 (17.0%) Table 3 presents a comparative profile of the non-hematologic adverse reactions from the randomized study of DOXIL compared to topotecan.

Table 3: Ovarian Cancer Randomized Study Non-Hematologic Adverse Reaction 10% or Greater

Body as a Whole Asthenia Fever Mucous Membrane Disorder Back Pain Infection Headache Digestive Nausea Stomatitis Vomiting Diarrhea Anorexia Dyspepsia Nervous Dizziness Respiratory Pharyngitis Dyspnea Cough increased Skin and Appendages Hand-foot syndrome Rash Alopecia

DOXIL (%) treated (n = 239) All Grades grades 3-4

Topotecan (%) treated (n =235) All Grades grades 3-4

40.2 21.3 14.2

7.1 0.8 3.8

51.5 30.6 3.4

8.1 5.5 0

11.7 11.7 10.5

1.7 2.1 0.8

10.2 6.4 14.9

0.9 0.9 0

46.0 41.4 32.6 20.9 20.1 12.1

5.4 8.3 7.9 2.5 2.5 0.8

63.0 15.3 43.8 34.9 21.7 14.0

8.1 0.4 9.8 4.2 1.3 0

4.2

0

10.2

0

15.9 15.1 9.6

0 4.1 0

17.9 23.4 11.5

0.4 4.3 0

50.6 28.5 19.2

23.8 4.2 N/A

0.9 12.3 52.3

0 0.4 N/A

The following additional adverse reactions (not in table) were observed in patients with ovarian cancer with doses administered every four weeks.

Incidence 1% to 10%: Cardiovascular: vasodilation, tachycardia, deep thrombophlebitis, hypotension, cardiac arrest. Digestive: oral moniliasis, mouth ulceration, esophagitis, dysphagia, rectal bleeding, ileus.

Hemic and Lymphatic: ecchymosis. Metabolic and Nutritional: dehydration, weight loss, hyperbilirubinemia, hypokalemia, hypercalcemia, hyponatremia. Nervous: somnolence, dizziness, depression. Respiratory: rhinitis, pneumonia, sinusitis, epistaxis. Skin and Appendages: pruritus, skin discoloration, vesiculobullous rash, maculopapular rash, exfoliative dermatitis, herpes zoster, dry skin, herpes simplex, fungal dermatitis, furunculosis, acne. Special Senses: conjunctivitis, taste perversion, dry eyes. Urinary: urinary tract infection, hematuria, vaginal moniliasis.

Patients With AIDS-Related Kaposi’s Sarcoma: The safety data below is based on the experience reported in 753 patients with AIDS-related Kaposi’s sarcoma enrolled in four studies. The median age of the population was 38.7 years (range 24-70 years), which was 99% male, 1% female, 88% Caucasian, 6% Hispanic, 4% Black, and 2% Asian/other/unknown. The majority of patients were treated with 20 mg/m2 of DOXIL every two to three weeks. The median time on study was 127 days and ranged from 1 to 811 days. The median cumulative dose was 120 mg/m2 and ranged from 3.3 to 798.6 mg/m2. Twenty-six patients (3.0%) received cumulative doses of greater than 450 mg/m2. Of these 753 patients, 61.2% were considered poor risk for KS tumor burden, 91.5% poor for immune system, and 46.9% for systemic illness; 36.2% were poor risk for all three categories. Patients’ median CD4 count was 21.0 cells/mm3, with 50.8% of patients having less than 50 cells/mm3. The mean absolute neutrophil count at study entry was approximately 3,000 cells/mm3. Patients received a variety of potentially myelotoxic drugs in combination with DOXIL. Of the 693 patients with concomitant medication information, 58.7% were on one or more antiretroviral medications; 34.9% patients were on zidovudine (AZT), 20.8% on didanosine (ddI), 16.5% on zalcitabine (ddC), and 9.5% on stavudine (D4T). A total of 85.1% patients were on PCP prophylaxis, most (54.4%) on sulfamethoxazole/trimethoprim. Eighty-five percent of patients were receiving antifungal medications, primarily fluconazole (75.8%). Seventy-two percent of patients were receiving antivirals, 56.3% acyclovir, 29% ganciclovir, and 16% foscarnet. In addition, 47.8% patients received colonystimulating factors (sargramostim/filgrastim) sometime during their course of treatment. Adverse reactions led to discontinuation of treatment in 5% of patients with AIDS related Kaposi’s sarcoma. Those that did so included bone marrow suppression, cardiac adverse reactions, infusion-related reactions, toxoplasmosis, HFS, pneumonia, cough/dyspnea, fatigue, optic neuritis, progression of a non-KS tumor, allergy to penicillin, and unspecified reasons.

Table 4: Hematology Data Reported in Patients With AIDS-Related Kaposi’s Sarcoma Patients With Total Patients Refractory or Intolerant With AIDS-Related AIDS-Related Kaposi’s Sarcoma Kaposi’s Sarcoma (n = 74) (n = 720) Neutropenia 1000/mm3 34 (45.9%) 352 (48.9%) 500/mm3 8 (10.8%) 96 (13.3%) Anemia 10 g/dL 43 (58.1%) 399 (55.4%) 8 g/dL 12 (16.2%) 131 (18.2%) Thrombocytopenia 150,000/mm3 45 (60.8%) 439 (60.9%) 25,000/mm3 1 (1.4%) 30 (4.2%) Table 5: Probably and Possibly Drug-Related Non-Hematologic Adverse Reactions Reported in of Patients With AIDS-Related Kaposi’s Sarcoma Adverse Patients With Total Patients Reactions Refractory or Intolerant With AIDS-Related AIDS-Related Kaposi’s Sarcoma Kaposi’s Sarcoma (n = 77) (n = 705) Nausea 14 (18.2%) 119 (16.9%) Asthenia 5 (6.5%) 70 (9.9%) Fever 6 (7.8%) 64 (9.1%) Alopecia 7 (9.1%) 63 (8.9%) Alkaline Phosphatase 1 (1.3%) 55 (7.8%) Increase Vomiting 6 (7.8%) 55 (7.8%) Diarrhea 4 (5.2%) 55 (7.8%) Stomatitis 4 (5.2%) 48 (6.8%) Oral Moniliasis 1 (1.3%) 39 (5.5%)

5%

The following additional (not in table) adverse reactions were observed in patients with AIDS-related Kaposi’s sarcoma. Incidence 1% to 5%: Body as a Whole: headache, back pain, infection, allergic reaction, chills. Cardiovascular: chest pain, hypotension, tachycardia. Cutaneous: herpes simplex, rash, itching. Digestive: mouth ulceration, anorexia, dysphagia. Metabolic and Nutritional: SGPT increase, weight loss, hyperbilirubinemia. Other: dyspnea, pneumonia, dizziness, somnolence. Incidence Less Than 1%: Body As A Whole: sepsis, moniliasis, cryptococcosis. Cardiovascular: thrombophlebitis, cardiomyopathy, palpitation, bundle branch block, congestive heart failure, heart arrest, thrombosis, ventricular arrhythmia. Digestive: hepatitis. Metabolic and Nutritional Disorders: dehydration.

Respiratory: cough increase, pharyngitis. Skin and Appendages: maculopapular rash, herpes zoster.

Special Senses: taste perversion, conjunctivitis.

Patients With Multiple Myeloma: The safety data below are from 318 patients treated with DOXIL (30 mg/m2 as a 1-hr i.v. infusion) administered on day 4 following bortezomib (1.3 mg/m2 i.v. bolus on days 1, 4, 8 and 11) every three weeks, in a randomized, open-label, multicenter study. In this study, patients in the DOXIL + bortezomib combination group were treated for a median number of 138 days (range 21-410 days). The population was 28-85 years of age, 58% male, 42% female, 90% Caucasian, 6% Black, and 4% Asian and other. Table 6 lists adverse reactions reported in 10% or more of patients treated with DOXIL in combination with bortezomib for multiple myeloma.

Table 6: Frequency of treatment emergent adverse reactions reported in 10% patients treated for multiple myeloma with DOXIL in combination with bortezomib, by Severity, Body System, and MedDRA Terminology.

Adverse DOXIL + bortezomib Bortezomib Reaction (n=318) (n=318) Any Grade Grade Any Grade Grade (%) 3 4 (%) 3 4 Blood and lymphatic system disorders Neutropenia 36 22 10 22 11 5 Thrombocytopenia 33 11 13 28 9 8 Anemia 25 7 2 21 8 2 General disorders and administration site conditions Fatigue 36 6 1 28 3 0 Pyrexia 31 1 0 22 1 0 Asthenia 22 6 0 18 4 0 Gastrointestinal disorders Nausea 48 3 0 40 1 0 Diarrhea 46 7 0 39 5 0 Vomiting 32 4 0 22 1 0 Constipation 31 1 0 31 1 0 Abdominal pain Infections and infestations Herpes zoster Herpes simplex Investigations Weight decreased Metabolism and Nutritional disorders

11

1

0

8

1

0

11 10

2 0

0 0

9 6

2 1

0 0

12

0

0

4

0

0

17

3

0

20

4

1

Respiratory, thoracic and mediastinal disorders Cough 18 Skin and subcutaneous tissue disorders Rash** 22

0

0

12

0

0

1

0

18

1

0

Nervous system disorders Neuralgia

*Peripheral neuropathy includes the following adverse reactions: peripheral sensory neuropathy, neuropathy peripheral, polyneuropathy, peripheral motor neuropathy, and neuropathy NOS. **Rash includes the following adverse reactions: rash, rash erythematous, rash macular, rash maculopapular, rash pruritic, exfoliative rash, and rash generalized.

Post Marketing Experience: The following additional adverse reactions have been identified during post approval use of DOXIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Musculoskeletal and Connective Tissue Disorders: rare cases of muscle spasms. Respiratory, Thoracic and Mediastinal Disorders: rare cases of pulmonary embolism (in some cases fatal). Hematologic disorders: Secondary acute myelogenous leukemia with and without fatal outcome has been reported in patients whose treatment included DOXIL. Skin and subcutaneous tissue disorders: rare cases of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

DRUG INTERACTIONS: No formal drug interaction studies have been conducted with DOXIL. DOXIL may interact with drugs known to interact with the conventional formulation of doxorubicin HCl. USE IN SPECIFIC POPULATIONS: Pediatric Use: The safety and effectiveness of DOXIL in pediatric patients have not been established.

Geriatric Use: Of the patients treated with DOXIL in the randomized ovarian cancer study, 34.7% (n=83) were 65 years of age or older while 7.9% (n=19) were 75 years of age or older. Of the 318 patients treated with DOXIL in combination with bortezomib for multiple myeloma, 37% were 65 years of age or older and 8% were 75 years of age or older. No overall differences in safety or efficacy were observed between these patients and younger patients.

OVERDOSAGE: Acute overdosage with doxorubicin HCl causes increases in mucositis, leucopenia, and thrombocytopenia. Treatment of acute overdosage consists of treatment of the severely myelosuppressed patient with hospitalization, antibiotics, platelet and granulocyte transfusions, and symptomatic treatment of mucositis.

0016716-5B Manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Distributed by: Ortho Biotech Products, LP Raritan, NJ 08869-0670

TM

An ALZA STEALTH® Technology Product

STEALTH® and DOXIL® are registered trademarks of ALZA Corporation.

For your patients receiving or about to start treatment with DOXIL® for recurrent ovarian cancer or relapsed/refractory multiple myeloma…

DOXIL® C.A.R.E.S. Provides Help and Support DOXIL ® C.A.R.E.S. Complements the Efforts of the Healthcare Team With: ◗ Treatment follow-up — Regularly scheduled telephone calls from oncology nurses to review lifestyle tips to help manage potential side effects of DOXIL® therapy such as hand-foot syndrome and stomatitis ◗ Patient education materials Invite your patients to enroll in DOXIL® C.A.R.E.S.: 1-877-CARES-49 (1-877-227-3749) Monday to Friday, 9:30 AM to 10:00 PM (ET). To learn more, visit www.doxil.com.

INDICATIONS ◗ DOXIL® is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy ◗ DOXIL® in combination with VELCADE® (bortezomib) is indicated for the treatment of patients with multiple myeloma who have not previously received VELCADE and have received at least one prior therapy

IMPORTANT SAFETY INFORMATION BOXED WARNINGS Cardiotoxicity, infusion reaction, myelosuppression, liver impairment, substitution ◗ The use of DOXIL® may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2 — Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dose — Cardiac toxicity may also occur at lower cumulative doses (400 mg/m2) in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy ◗ Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with DOXIL®. In most patients, these reactions have resolved within several hours to a day once the infusion is terminated. In some patients, reactions resolved with slowing of the infusion rate — Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have occurred. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use — The initial rate of infusion should be 1 mg/min to minimize the risk of infusion reactions ◗ Severe myelosuppression may occur ◗ DOXIL® dosage should be reduced in patients with impaired hepatic function ◗ Accidental substitution has resulted in severe side effects. Do not substitute for doxorubicin HCl on a mg per mg basis CONTRAINDICATIONS ◗ Patients with a history of hypersensitivity reactions to a conventional doxorubicin formulation or the components of DOXIL® ◗ Nursing mothers

ADDITIONAL SAFETY INFORMATION ◗ Cardiac function should be carefully monitored — Congestive heart failure or cardiomyopathy may occur after discontinuation of anthracycline therapy — For patients with a history of cardiovascular disease, or if the results of cardiac monitoring indicate possible cardiac injury, the benefit of therapy must be weighed against the risk of myocardial injury — In the randomized multiple myeloma study, 25 patients (8%) in the VELCADE arm and 42 patients (13%) in the DOXIL® plus VELCADE arm experienced left ventricular ejection fraction decrease (defined as absolute decrease 15% over baseline or a 5% decrease below institutional lower limit of normal)

◗ Myelosuppression may occur; frequently monitor complete blood count (including platelet count), at least prior to each dose of DOXIL® — In patients with recurrent ovarian cancer, hematologic toxicity (based on platelet count or absolute neutrophil count) may require dose reduction or delay in administration of DOXIL® — In patients with multiple myeloma, hematologic toxicity (based on platelet count, absolute neutrophil count, hemoglobin level, or neutropenia with fever) may require dose reduction, delay in administration, or suspension of DOXIL® and/or VELCADE — Persistent severe myelosuppression may result in superinfection, neutropenic fever, or hemorrhage — Sepsis occurring during neutropenia has resulted in discontinuation of treatment and in rare cases of death ◗ DOXIL® may potentiate the toxicity of other anticancer therapies, especially hematologic toxicities, when used in combination with other therapies that suppress bone marrow ◗ Hand-foot syndrome (HFS) may occur during therapy with DOXIL® — Based on HFS toxicity grade, dose reduction, delay in administration, or discontinuation of DOXIL® may be required — HFS was generally observed after 2 to 3 cycles of treatment, but may occur earlier • The reaction was mild in most patients, resolving in 1 to 2 weeks • The reaction can be severe and debilitating in some patients, resulting in discontinuation of therapy ◗ DOXIL® is an irritant, not a vesicant; use precautions to avoid extravasation ◗ DOXIL® can cause fetal harm when used during pregnancy ◗ Recall reaction has occurred with DOXIL® administration after radiotherapy ◗ DOXIL® may interact with drugs known to interact with the conventional formulation of doxorubicin HCl ◗ In patients with recurrent ovarian cancer, the most common all-grade adverse reactions (ARs) 20% (DOXIL® vs topotecan, respectively) included: asthenia (40% vs 51%), fever (21% vs 31%), nausea (46% vs 63%), stomatitis (41% vs 15%), vomiting (33% vs 44%), diarrhea (21% vs 35%), anorexia (20% vs 22%), dyspnea (15% vs 23%), HFS (51% vs 1%), and rash (29% vs 12%) — In addition, 19% vs 52.3% reported alopecia (all grades) — Grade 3/4 hematologic ARs reported in 5% (DOXIL® vs topotecan, respectively) were neutropenia (12% vs 76%) and anemia (6% vs 29%) ◗ In patients with multiple myeloma, the most common all-grade ARs 20% (DOXIL® plus VELCADE vs VELCADE, respectively) included: neutropenia (36% vs 22%), thrombocytopenia (33% vs 28%), anemia (25% vs 21%), fatigue (36% vs 28%), pyrexia (31% vs 22%), asthenia (22% vs 18%), nausea (48% vs 40%), diarrhea (46% vs 39%), vomiting (32% vs 22%), constipation (31% vs 31%), mucositis/ stomatitis (20% vs 5%), peripheral neuropathy (42% vs 45%), neuralgia (17% vs 20%), and rash (22% vs 18%) — In addition, 19% vs <1% reported HFS Please see brief summary of Prescribing Information, including Boxed WARNINGS, on adjacent pages.

VELCADE is a registered trademark of Millennium Pharmaceuticals, Inc.

Distributed by: Centocor Ortho Biotech Products, L.P., Horsham, Pennsylvania 19044-3607 © Centocor Ortho Biotech Products, L.P. 2010 9/10 08D10019B