October 2010, VOL. 3, NO. 7 by Green Hill Healthcare Communications, LLC

OCTOBER 2010

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VOL 3, NO 7

MODELS OF CARE

CANCER CENTER PROFILE

Breast Centers Are Changing the Cancer Landscape

Reducing Disparities in Cancer Care: St. Luke’s Mountain States Tumor Institute Embraces NCCCP Pillar

By Eileen Koutnik-Fotopoulos

he treatment of breast cancer has become more complex, and the national incidence of breast cancer is setting the stage for healthcare providers to develop a dedicated breast program to improve their quality of care. The American Cancer Society’s Cancer Facts & Figures 2010 estimates that 207,090 new cases of invasive breast cancer are expected to occur among women in the United States during 2010; about 1970 new cases are expected in men. Excluding cancers of the skin, breast can-

By Dawn Lagrosa

cer is the most frequently diagnosed cancer in women. How healthcare providers and health systems establish a dedicated breast program was the focus of a presentation by David L. Katz, MD, JD, “Next-Generation Tumor Site Strategy,” at the 2010 American College of Oncology Administrators Oncology Update: Positioning for Success conference. He discussed how to develop and implement a tumor site–specific strategic plan; assessed key operational, technological, and infraContinued on page 10

HEALTHCARE REFORM

Members of St. Luke’s Mountain States Tumor Institute, from left: Dan Zuckerman, MD; Alicia Rosales, LMSW; Jill Winschell, RN; and Paul G. Montgomery, MD, FACP.

t. Luke’s Mountain States Tumor Institute (MSTI) provides advanced cancer care to patients at clinics in Boise, Fruitland, Meridian, Nampa, and Twin Falls, Idaho. Spanning more than 180 miles across southwestern Idaho, MSTI cares for patients from rural areas and from metropolitan areas. Because of geographic isolation, many people in rural areas present at later stages of disease. In addition, large Hispanic populations in the rural counties of the state are not getting screened for cancers on recommended timelines. “Reduce cancer healthcare disparities” is the first of seven pillars with which National Cancer Institute Community Cancer Centers Program (NCCCP) sites are tasked. These inequalities of care include access to cancer screening, treatment, and research. The staff at MSTI hopes to reduce disparities in care for their patients with help from their new contract as a member of the NCCCP.

Healthcare Reform Impacts Cancer Care Delivery By Eileen Koutnik-Fotopoulos

he current economic drivers and healthcare reform initiatives are changing the landscape of cancer care. As a result, cancer care programs are being forced to reevaluate existing models of care and delivery. During the 2010 American College of Oncology Administrators Oncology Update: Positioning for Success conference, Lisa Slama, PhD, associate vice president at Sg2, presented “Optimizing Cancer Performance in a Reform Era.” The discussion focused on the drivers of optimal performance for cancer programs

related to the current healthcare reform climate and presented strategies to enhance growth and efficiency in cancer care. Sg2 is a healthcare information company that provides expert-led, future-focused systems for growth and clinical performance and works with more than 1000 hospitals and organizations worldwide. Cost of cancer Cancer care costs are rising and can be attributed to an aging population and the availability of new, expensive therapies

Continued on page 17

Inside Community Clinical Scientist Award Carl J. Minniti Jr, MD page 16

Models of Care Split Scheduling for Chemotherapy page 18

Genetics Identifying Breast Cancer Patients at Risk for Hereditary Breast Cancer

Continued on page 6

Healthcare Reform CER Will Help Guide Health Policy page 20

page 24

Clinical Pathways Promising Options page 19

Genetic Profiling Changing Clinical Practice page 25

Fostering a Dialogue to Improve Patient Care & Outcomes

Oncology Drug Codes Medications Used for the Treatment of Breast Cancer page 26

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Mouridsen HT et al. Treatment of anthracycline extravasation with savene (dexrazoxane). Results from two prospective clinical multicentre studies. Ann Oncol 2007; 18:546-550. 2 Totect® package insert. 3 Polovich M, White JM, Olsen, M (eds.). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (ed 3). Pittsburgh, PA, Oncology Nursing Society, 2009. 4 Alexander M, Corrigan A, Gorski L, Hankins J, Perucca R. (eds). Infusion Nurses Society Infusion Nursing an Evidence-Based Approach (ed 3). Boston, MA, Infusion Nurses Society, 2009. 5 Jacobsen J., et al. American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards. Oncology Nursing Forum, 2009; 36:651-658. © 2010 Topotarget USA. All rights reserved. TOT0111/7-10 Totect and its logo mark are registered trademarks of Topotarget A/S Image is copyright © Photo Researchers, Inc.

Totect® – Brief prescribing information Please refer to the package insert for full prescribing information. Each Totect carton contains 10 vials of Totect® (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent. Indication: Treatment of extravasation resulting from IV anthracycline chemotherapy. Dosage and administration: Totect is a cytotoxic drug. Vial contents must be mixed and diluted before use. Totect should not be mixed or administered with any other drug during the infusion. Administration of Totect should begin as soon as possible and within 6 hours following the anthracycline extravasation. Totect should be given as an intravenous (IV) infusion once daily for 3 consecutive days. The dose of Totect is based on the patient’s body surface area: day one, 1000 mg/m2; day two, 1000 mg/m2; day three, 500 mg/m2. For patients with a body surface area of > 2 m2, a dose of 2000 mg should be given on days 1 and 2, and a dose of 1000 mg should be given on day 3. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the first day. The Totect dose should be reduced 50% for patients with creatinine clearance values of <40 mL/minute. Cooling procedures such as ice packs should be removed from the affected area at least 15 minutes prior to Totect administration. Totect (dexrazoxane for injection) must be reconstituted with diluent supplied in the carton. The patient’s Totect dose is diluted in 0.9% 1000 mL NaCl prior to administration. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.3-5 Direct contact of Totect® with the skin or mucous membranes prior to and following reconstitution should be avoided. If contact occurs, wash immediately and thoroughly with water. Contraindications: None. Warnings and Precautions: Myelosuppression: treatment with Totect is associated with leukopenia, neutropenia, and thrombocytopenia. Hematological monitoring should be performed. Use in Pregnancy: Pregnancy Category D. Totect can cause fetal harm when administered to a pregnant woman. There is no adequate information about the use of Totect in pregnant women. 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. Adverse reactions: The most common adverse reactions (≥ 16%) are nausea, pyrexia, injection site pain and vomiting.

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Drug Interactions: No drug interactions have been identified. Based on anecdotal reports concurrent use of topical dimethyl sulfoxide (DMSO) at the site of tissue injury may reduce the benefit of Totect. Additionally, nonclinical studies using a mouse model that simulates extravasation of anthracyclines has shown that concomitant treatment with topical DMSO decreases the efficacy of systemic dexrazoxane. Use in Specific Populations: Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of drug to the mother. Renal Impairment: Reduce the Totect dose by 50% In patients with creatinine clearance values <40 mL/min. Pediatric Use: The safety and effectiveness of Totect in pediatric patients have not been established. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Overdosage: There are no data on overdosage. There is no known antidote for dexrazoxane. Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of dexrazoxane has not been investigated. Nevertheless, a study by the National Cancer Institute has reported that long term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice. Dexrazoxane was not mutagenic to bacteria in vitro (Ames assay), but caused significant chromosomal aberrations in mammalian cells in vitro. It also increased the formation of micronucleated polychromatic erythrocytes in mice. Thus, dexrazoxane is mutagenic and clastogenic. The possible adverse effects of Totect on the fertility of humans and experimental animals, male or female, have not been adequately studied. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (about 1/5 the human dose on a mg/m2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (about half the human dose on a mg/m2 basis).

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Editorial Board EDITOR-IN-CHIEF

Mark J. Krasna, MD St. Joseph Cancer Institute Towson, MD Surgical Oncology

University of Chicago Chicago, IL Surgical Oncology

Arun Kumar, MD

Greg Pilat, MBA

VA Medical Center Huntington, WV Medical Oncology

Advocate Health Care Oak Brook, IL Oncology Administration

Shaji K. Kumar, MD

Cristi Radford, MS, CGC

Mayo Clinic Rochester, MN Hematology-Oncology

Sarasota Memorial Hospital Sarasota, FL Genetic Counseling

Ritu Salani, MD

John F. Aforismo, BSc Pharm, RPh, FASCP

Beth Faiman, RN, MSN, APRN, BC, AOCN

RJ Health Systems International Wethersfield, CT Oncology Pharmacy

Cleveland Clinic Taussig Cancer Institute Mayfield Heights, OH Oncology Nursing

Elizabeth Bilotti, RN, MSN, APNc

Mehra Golshan, MD

Terry Macarol, RT(R)(M)(QM)

John Theuer Cancer Center Hackensack University Medical Center Hackensack, NJ Oncology Nursing

Dana-Farber Cancer Institute Boston, MA Surgical Oncology

Advocate Health Care Oak Brook, IL Radiological Technology

Ohio State University Medical Center Columbus, OH Medical Oncology

Nicole A. Bradshaw, MS, CIC

Patrick A. Grusenmeyer, ScD, FACHE

Patrick Medina, PharmD, BCOP

Andrew Salner, MD

Mountain States Tumor Institute Nampa, ID Oncology Administration

Christiana Care Health System Newark, DE Oncology Administration

Oklahoma University College of Pharmacy Oklahoma City, OK Oncology Pharmacy

Hartford Radiation Oncologists Association Hartford, CT Radiation Oncology

Anna M. Butturini, MD

Marilyn Haas, PhD, CNS, ANP-BC

Patricia Molinelli, MS, RN, APN-C, AOCNS

Timothy G. Tyler, PharmD, FCSHP

CarePartners Asheville, NC Oncology Nursing

Somerset Medical Center Somerville, NJ Oncology Nursing

Comprehensive Cancer Center Desert Regional Medical Center Palm Springs, CA Oncology Pharmacy

Dawn Holcombe, MBA, FACMPE, ACHE

Judy A. Olson, RT(R), RDMS

Gary C. Yee, PharmD, FCCP, BCOP

Children’s Hospital Los Angeles Los Angeles, CA Medical Oncology

Minsig Choi, MD G. V. Montgomery VA Medical Center Jackson, MS Medical Oncology

Steven L. D’Amato, RPh, BCOP Maine Center for Cancer Medicine Scarborough, ME Oncology Pharmacy

Scott E. Eggener, MD

october 2010 I VoL 3, No 7

DGH Consulting South Windsor, CT Oncology Administration

Patricia Hughes, RN, MSN, BSN, OCN Piedmont Healthcare Atlanta, GA Oncology Nursing

St. Luke’s Mountain States Tumor Institute Boise, ID Oncology Administration

University of Nebraska Medical Center Omaha, NE Oncology Pharmacy

Nicholas Petrelli, MD

Burt Zweigenhaft, BS

Helen F. Graham Cancer Center Christiana Care Health System Newark, DE Surgical Oncology

BioPharma Partners LLC New York, NY Managed Care

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INTRODUCTION

n September 22, the Health Care and Education Reconciliation Act hit its 6-month anniversary. So, what has changed for us in cancer care? We have begun to experience the benefits promised in the first phase of this act, “the prelude” as Ms Slama and her colleagues at Sg2 call it. This Mark J. Krasna, MD includes many provisions that should help cancer patients ST. JOSEPH CANCER receive our services: banning INSTITUTE lifetime benefit caps, prohibitEditor-in-Chief ing insurance companies from removing patients who get sick, allowing adult children to remain on their parents’ insurance until age 26, requiring new policies to cover preventive services at no cost to patients, and full coverage of patients on clinical trials. We still do not know, however, how insurers and large corporations will adjust to the new regulations. These new benefits, clearly, offer us the opportunity to deliver care to

PUBLISHING STAFF Publisher Philip Pawelko phil@greenhillhc.com Editorial Director Karen Rosenberg karen@greenhillhc.com Managing Editor Dawn Lagrosa dawn@greenhillhc.com Directors, Client Services John W. Hennessy john@greenhillhc.com Cristopher Pires cris@greenhillhc.com Production Manager Marie RS Borrelli Business Manager Blanche Marchitto blanche@greenhillhc.com Executive Administrator Andrea Boylston Circulation Department circulation@greenhillhc.com Editorial Contact: Telephone: 732-992-1891 Fax: 732-656-7938

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Journal of Multidisciplinary Cancer Care® (ISSN # 19490321) is published 8 times a year by Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2010 by Green Hill Healthcare Communications, LLC. All rights reserved. Journal of Multidisciplinary Cancer Care® is a registered trademark of Green Hill 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. EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DIRECTOR, Journal of Multidisciplinary Cancer Care®, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. E-mail: karen@greenhill hc.com YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issues $17.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. The ideas and opinions expressed in Journal of Multidisciplinary Cancer Care® do not necessarily reflect those of the Editorial Board, the Editorial Director, or the Publisher. Publication of an advertisement or other product mentioned in Journal of Multidisciplinary Cancer Care® should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the Editorial Director.

october 2010 I VoL 3, No 7

CONTENTS

more patients. But how will we be able to do so in the current economic climate? This issue of Journal of Multidisciplinary Cancer Care highlights some models of care that have proven successful, that is, enhancing the quality of care delivered and the cost-effectiveness of delivering it. Whether it be establishing a dedicated tumor site–specific center, as Dr Katz describes, or reorganizing your staff’s schedule, as Ms Maxwell discusses, many improvement can be made in how we deliver care. Payers are involved as well; clinical pathways are an example of how evidencebased decision making offers an opportunity for physicians to work with payers on keeping costs down and quality up. Ms Holcolmbe details the available options. Of course, more is happening in cancer care than just economics. One exciting direction is the field of genetics: the testing, the counseling, the targeted drugs. This issue touches upon how these components of care can be implemented in our practices. In addition, we will detail how to be involved in clinical research in your community. Again, I hope this issue benefits your practice and provides ideas on how to move it forward. We look forward to your feedback.

october 2010 • VoL 3, No 7

FEATURE ARTICLES 12 Conference News: ASCO The rising cost of cancer care: who takes responsibility? Surgery the most cost-effective prevention in BRCA mutation carriers Clinical research in the community setting 16 Clinical Research Clinical research leader wins King Award 18 Models of Care Split scheduling for chemotherapy increases efficiency, reduces costs New approach to helping patients deal with the unknown 19 Clinical Pathways Clinical pathways programs: confusing choices for payers and physicians. Part 2: promising options 20 Healthcare Reform CER will help guide health policy 22 Supportive Care Revisiting the use of IV iron in patients with cancer Simple intervention boosts sperm cryopreservation in male cancer patients 24 Genetics Identifying newly diagnosed individuals with breast cancer at risk for hereditary breast cancer Genetic profiling changing clinical practice in some areas of oncology 32 Hematologic Cancers New “tip sheets” help NHL patients communicate with the oncology team DEPARTMENTS 9 Recent FDA Approval 26 Oncology Drug Codes Medications used for the treatment of breast cancer 32 International News www.jomcc.com

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Healthcare Reform Healthcare Reform Impact... continued from cover that are appropriate for a reimbursement for many broader range of patients. cancer services is shrinking. The National Institutes of Slama highlighted three key Health estimates overall areas in her presentation. costs of cancer in 2010 at 1. Radiation oncology will $263.8 billion with $102.8 see a 5% reduction in billion for direct medical physician fees over 4 costs, according to the years, with a 1% cut in American Cancer Society’s 2010. Cancer Facts & Figures 2. There will be a 5% reduc2010. A recent study found tion in physician fees in Lisa Slama, PhD that the cost of treating 2010 for chemotherapy; cancer in the United States has more cuts will increase throughout 2010 than doubled over the past 20 years, and and are expected to reach 20%. cancer costs have shifted away from 3. Reimbursement for computed toinpatient treatment to outpatient care. mography scan and magnetic resoFurthermore, cancer costs are impacting nance imaging (MRI) will drop in providers, public and private payers, 2011 due to an increase in the utiand patients (Tangka FK, et al. Cancer. lization rate used to calculate reim2010;116:3477-3483). In a 2006 survey bursement. That is, the assumed of adult households affected by cancer, utilization rate will increase from 25% of insured cancer patients reported 50% to 75%. using most or all of their savings during treatment (Elkin EB, Bach PB. JAMA. Healthcare reform The Health Care and Education 2010;303:1086-1087). Whereas cancer costs are increasing, Reconciliation Act, signed into law

Select Initatives Within Health Reform Law, 2010-2013 The Prelude

Payment

Insurance

Taxes

• Market basket • Lifetime benefit • Increase reductions Medicare caps banned payroll tax • Coverage of preventive and • 2.5% tax on medical screening devices services mandated; no cost-sharing

Pilots and initiatives • CER institute • Readmission penalties • Bundled payment pilots • Hospital-acquired infection penalty • Medical home model

Figure 1. 2010-2013: Market Prepares for Expanded Access

Select Initatives Within Health Reform Law, 2014-2017 Market Expansion

Hospital payment cuts

Insurance market reforms

Taxes

• Fees on • Medicare DSH • Guaranteed issue/renewability health payments cut • Essential benefit insurers by 75% package defined

Figure 2. 2014-2017: Increased Access Will Drive Demand

october 2010 I VoL 3, No 7

Coverage expansion • Medicaid expanded to 133% of FPL • Individual mandate to purchase (subsidies up to 400% of FPL) • State-based insurance exchanges

March 2010, “does not provide a lot of detail for cancer patients and providers. We have had to take 1000+ pages of legislative language and interpret what we think will happen,” said Slama. Sg2 put together a special report, “The Impact of Health Reform,” to help its clients and business partners understand specific provisions. The new legislation will expand health insurance coverage, impose new rules on the insurance markets, and fund a variety of pilot projects. How does the new legislation affect cancer care? Slama explained that the new legislation drives cancer care trends in six key areas. 1. Tight budgets and cost cutting will persist in healthcare and cancer specifically, despite US economic improvement. 2. Demand for cancer screening will rise with the elimination of costsharing and, further, with coverage expansion. 3. Increased comparative effectiveness research (CER) will offer better guidance on which cancer therapies are most effective. 4. Insurance reforms guaranteeing issue and banning lifetime caps will directly affect the coverage of cancer patients and cancer survivors. 5. Coverage expansion will strain cancer care providers with implications on workforce issues, capacity, payer mix, and profitability. 6. Care model innovation will be necessary and rewarded within the new healthcare landscape. 2010-2013: The prelude To help stakeholders treating cancer understand the scope of healthcare reform, Slama said the timing of reform provisions is key and can be divided into three time periods. During 20102013, reform provisions will make minor adjustments to the insurance markets, raise new revenues, and set the stage for the big changes starting in 2014. Initiatives include hospital payment cuts and incentives for Medicare, a ban on lifetime benefit caps, coverage of preventive and screening services mandated with the elimination of costsharing (eg, copays), increased Medicare payroll tax, and the introduction of pilot programs examining the feasibility of alternative care delivery and payment models (Figure 1). CER “CER is not a new concept in its terminology,” said Slama. However, CER has gained attention because of the $500 million in research funds allocated from the healthcare reform bill, which is in addition to the $1.1 billion in CER

funding earmarked from the stimulus package known as the American Recovery and Reinvestment Act of 2009. CER compares screening modalities, diagnostics, drugs, devices, etc, to identify technologies or interventions that improve patient management, and then structures payment for the more effective technologies. In its 100 initial priority topics for CER, the Institute of Medicine identified numerous cancer-specific initiatives. Examples include: • Management strategies for localized cancers • Imaging technologies for diagnosis, staging, and monitoring • Genetic/biomarker testing versus usual care in preventing and treating breast, colorectal, prostate, lung, and ovarian cancers • New screening technologies versus standard care in preventing colorectal cancer • Film-screen or digital mammography alone versus mammography plus MRI. Bundled payment model Bundled payment is one of the strategies that the Centers for Medicare & Medicaid Services is piloting to slow the rapid growth of healthcare spending. Currently, patients receive bills for services from the hospital, from the physician, and from both parties if unplanned hospital readmission occurs. Bundled payment works by combining all three variables for an episode of care into one payment that must be shared among the hospital and providers.

Payment for cancer care could start by bundling certain treatment modalities, like chemotherapy infusions and radiation therapy fractions.

“This represents a huge change in how we think of getting paid for services,” said Slama. “Bundled payment for cancer is a challenge because of the various comorbidities associated with cancer and the different stages at which the disease is diagnosed, but it is not out of the realm of possibility. Payment for cancer care could start by bundling certain treatment modalities, like chemotherapy infusions and radiation therapy fractions.” Continued on page 8

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Healthcare Reform Healthcare Reform Impact... continued from page 6 To remain successful, health systems must learn to thrive in this more regulated, budget-driven market.

Select Initatives Within Health Reform Law, 2018-2020 Regulation and restructuring Taxes

Other

• Excise tax on “Cadillac” plans • TBD Impact of Reform in 2018-2020: • Budget pressures drive rate regulations, risk shifting, and government involvement • Capacity constraints drive innovation (eg, nonphysician-led models) • Hospitals and insurer payment rates become public record • New payment structures (bundling, accountable care organizations) reward performance across the System of CARE • Successful health systems must thrive in a more regulated, budget-driven market CARE indicates Clinical Alignment and Resource Effectiveness. Reprinted with permission. © 2010 Sg2.

Figure 3. 2018-2020: Regulation and Restructuring Will Evolve from Changes

Table Reform Will Directly Impact Cancer Provider Reform impact Increased cancer patient volumes

Key considerations • Select markets will see moderate increases in screening volume (eg, mammography and colonoscopy) • Growth is expected in cancer-related evaluations and management visits

Quality care mandates

• Incentives for physician performance excellence from payers will emerge • Hospitals must prepare to track metrics and publish results

Focus on costs

• Lack of strong cost-control measures in reform bill, combined with reduced payments, will place added pressure on margins • Expect an increase in Medicare and Medicaid patient volumes, where margins are slimmer

Payment and care model innovation

• Significant changes in care delivery will be driven by market forces favoring coordination, quality, and efficiency • Small pilot programs in reform bill will spur innovation • Providers must be prepared to build their System of CARE

2014-2017: Market expansion The health reform law’s full financial impact will become evident on January 1, 2014, when an estimated 19 million uninsured individuals will be covered, including Medicaid patients and individuals under the newly established state-level insurance exchanges, according to Sg2’s report. This will be achieved by expanding Medicaid to all individuals with incomes up to 133% of the federal poverty level (FPL), and providing subsidies for the purchase of policies through an exchange for individuals, up to 400% of FPL (Figure 2).

october 2010 I VoL 3, No 7

2018-2020: Regulation and restructuring The one major provision during the regulation and restructuring phase will be the excise tax on high-cost health plans, according to Sg2’s report. Another factor that likely will impact reform during this period is increased budget pressures. This includes regulatory scrutiny by the government as it acts to contain costs, mandating that hospital and insurer payments become public record, and instituting new payment structures that reward performance (Figure 3).

Next steps for providers Concern exists among cancer patients and providers about how healthcare reform directly affects them. Patients without insurance who have preexisting conditions will be covered, and family coverage will be extended to the age of 26. “The extended family coverage is particularly beneficial for pediatric oncology survivors,” said Slama. Patients with insurance but who cannot afford care will see payment relief with the removal of lifetime and annual caps on coverage. Also, preventive care and screenings will be offered without copays. Patients with affordable but poor-quality insurance should see improvements in care with the integration of pilot projects and coverage for standard medical services if participating in clinical trials. “Coverage of care during clinical trial participation can be significant for cancer patients because many seek top cancer centers in the country due to their access to clinical trials,” she added. From the cancer provider side, reform will be a challenge because of additional pressure to meet mandates. “There is not a lot of language in the bill right now on how we will sustain payment for expanded coverage. How are we going to do this in an environment where costs are rising and reimbursement is shrinking?” she said. Slama discussed four crucial areas and key considerations for providers based on Sg2 analysis (Table). Reform is only one of the factors pressuring leaders to improve performance. “The economic landscape has reshaped how we deliver cancer care. We are coming into a performance era in cancer care,” said Slama. “Furthermore, cancer patients are more informed today and demanding highquality expert care.” Increasing payer demands and policy changes are shaping and complicating the performance environment. Therefore, metrics based on these performance drivers are critical. Optimal performance requires an integrated care delivery system, according to Slama. To help providers deliver optimal performance and thrive in the postreform era, organizations must build out their care continuum, what Sg2 refers to as their System of CARE (Clinical Alignment and Resource Effectiveness). This approach links them to communitybased and postacute care and enables them to improve the handoffs across care sites. The framework for this model:

• Creates an integrated clinical platform • Defines a common brand promise to the market • Defines a common clinical standard and patient experience • Provides a vehicle to measure, manage, and prove performance. As the focus shifts toward metrics to measure value in the performance era, Sg2 offers systems that enable providers to plan growth strategies and clinical performance improvement across the complete care continuum. The Sg2 INSIGHT™ Clinical Performance Management System improves performance with a focus on changes introduced in the healthcare reform bill. By tracking key metrics—including potentially avoidable admissions, 30-day readmissions, length of stay (LOS), and cost per case—and benchmarking performance against peer hospitals, the system identifies specific areas of improvement at the enterprise, service line, disease, and physician levels. The clinical integra-

The economic landscape has reshaped how we deliver cancer care. We are coming into a performance era in cancer care.

tion tool identifies performance changes that drive financial improvement across the care continuum. INSIGHT helps solve issues including reducing potentially avoidable admissions and readmissions, improving margins on Medicare, developing hospital–physician alignment, and meeting leading practice benchmarks. Metrics can measure value of cancer care in community-based, acute care, and postacute care settings. In community-based care, outpatient financials are a key indicator of overall cancer performance. “In cancer, 95% of services take place in the outpatient arena,” she said. Therefore, one reason providers should pay attention to their outpatient contribution margin is that high-margin therapies can be areas an organization will want to invest in or build experience around. Another area in which providers can deliver high-quality care while managing costs in the acute care setting is reducing LOS in hospitals. Slama stressed that keeping LOS low is an important metric because it generates a higher margin and correlates with a

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Healthcare Reform

reduction in direct costs. “Providers need to look at strategies to reduce LOS without sacrificing quality of patient care,” she added. Postacute care metrics can assess discharge effectiveness and patient management. Slama discussed how reducing 30-day readmission rates can improve patient care quality. She said this is an important metric because 30-day readmissions are currently being scrutinized by Medicare. Providers need to manage transition gaps to reduce 30-day readmissions; for example, they should reevaluate discharge orders and explore options for improving patient education at discharge. Also, providers should ensure all cancer patients are given a care plan and that this plan is shared with caregivers. Outpatient costs, LOS, and 30-day readmissions are not the only metrics to prove performance and value. Providers should also consider various clinical quality metrics and their significance, such as time from patient screening to diagnosis, cancer diagnosis by tumor stage, adherence to the National Comprehensive Cancer Network core measures, clinical trial enrollment, and patient satisfaction.

Recent FDA Approval FDA Approves Docetaxel Injection One-vial Formulation The US Food and Drug Administration (FDA) has approved a new one-vial formulation of docetaxel injection concentrate (Taxotere, sanofi-aventis). This new formulation eliminates the initial dilution step, as well as the second vial containing the diluent. With the one-vial formulation, the pharmaceutical ingredients and the 1-hour intravenous infusion administration remain unchanged. Docetaxel is approved for use in treating patients at specific stages of metastatic and adjuvant breast cancer, metastatic androgenindependent prostate cancer, advanced non–small-cell lung cancer, advanced gastric adenocarcinoma, and locally advanced squamous cell carcinoma of the head and neck. l

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Slama concluded her presentation by offering strategies to outperform benchmarks and become a top performer: • Remember that metrics are just the beginning—providers should turn performance opportunities into

strategies and actions. • Compare performance trends over time and not just when they occur. • Strengthen alignment with physicians to stay coordinated across the care continuum.

• Keep in mind that benchmarks are a moving target; performance improvement should be a continuous process. • Prove performance to all stakeholders to truly excel. l

In the treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible

Making the Case for INFeD ®

Broad usage1 • Allows FDA-approved treatment of a wide range of patients with documented iron deficiency anemia

Proven safety profile of iron dextran • In a retrospective analysis of 841,252 doses, dyspnea, hypotension, and neurological symptoms were the most common major adverse drug events (ADEs)2 — The most common minor ADEs were nausea, vomiting, flushing, and pruritus2 • Serious adverse events are rare — In a nonuremic population, 3 serious adverse events occurred in 481 patients (0.6%) receiving 2099 iron dextran injections (0.1%), with no fatalities reported3 — In a retrospective analysis of 61,950 hemodialysis patients, the incidence of reactions requiring resuscitative medications was 0.0016% (7 episodes in 440,406 exposures)4 • Iron dextran products are not clinically interchangeable1 — Differ in chemical characteristics and may differ in clinical effects Important Safety Information1 Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. A test dose should be administered prior to the first therapeutic dose, followed by the full therapeutic dose if no signs or symptoms of anaphylactic-type reactions are seen. Resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions must be readily available during all INFeD® administrations. Patients should be observed for signs or symptoms of anaphylactic-type reactions during all INFeD® administrations. Fatal reactions have followed the test dose and have also occurred in situations where the test dose was tolerated. Use INFeD® only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactictype reactions. INFeD® should be used with caution in individuals with histories of significant allergies and/or asthma, and is contraindicated in patients with hypersensitivity to the product and patients with all anemias not associated with iron deficiency. INFeD® should be used with extreme care in patients with serious impairment of liver function, and should not be used during the acute phase of infectious kidney disease. Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis, which is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias. Please see next page for references and brief summary of full Prescribing Information.

www.infed.com

october 2010 I VoL 3, No 7

Models of Care Breast Centers... continued from cover structure requirements; and profiled progressive breast cancer programs. Katz serves as the executive director and national/international physician director for The Advisory Board Company. The Advisory Board Company, with corporate headquarters in Wash-

ington, DC, is a provider of comprehensive improvement services to healthcare and educational centers, including operational best practices and insights, business intelligence and analytic tools, management training, and consulting support. More than 2800

organizations are members, including preeminent hospitals, health systems, and universities. Why is a next-generation breast cancer strategy vital to the healthcare team and patients? Katz explained, “First you need to understand how breast cancer

References: 1. INFeD® full Prescribing Information. Watson Pharma, Inc. September 2009. 2. Fletes R, Lazarus JM, Gage J, Chertow GM. Suspected iron dextran-related adverse drug events in hemodialysis patients. Am J Kidney Dis. 2001;37:743-749. 3. Hamstra RD, Block MH, Schocket AL. Intravenous iron dextran in clinical medicine. JAMA. 1980;243:1726-1731. 4. Walters BAJ, Van Wyck DB. Benchmarking iron dextran sensitivity: reactions requiring resuscitative medication in incident and prevalent patients. Nephrol Dial Transplant. 2005;20:1438-1442.

BRIEF SUMMARY: For full Prescribing Information, see package insert. WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Administer a test INFeD dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose. During all INFeD administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have followed the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated. Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to INFeD. INDICATIONS AND USAGE: Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible. CONTRAINDICATIONS: Hypersensitivity to the product. All anemias not associated with iron deficiency. WARNINGS: Risk for Anaphylactic-type Reactions: Anaphylactic-type reactions, including fatalities have followed the parenteral administration of iron dextran. Always have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Prior to the first therapeutic dose, administer a test INFeD dose of 0.5 mL. (See DOSAGE AND ADMINISTRATION.) Although reactions are usually evident within a few minutes, observe patients for at least one hour before administering the therapeutic dose. During all INFeD administrations, observe patients for signs or symptoms of anaphylactictype reactions. Fatal reactions have followed the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. Iron dextran products differ in chemical characteristics and may differ in clinical effects. Iron dextran products are not clinically interchangeable. Delayed Reactions: Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse effects. The adverse effects frequently are delayed (1-2 days) reactions typified by one or more of the following symptoms: arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting. The onset is usually 24-48 hours after administration and symptoms generally subside within 3-4 days. The etiology of these reactions is not known. The potential for a delayed reaction must be considered when estimating the risk/benefit of treatment. The maximum daily dose should not exceed 2 mL undiluted iron dextran. Risk in Patients with Underlying Conditions: INFeD should be used with extreme care in patients with serious impairment of liver function. It should not be used during the acute phase of infectious kidney disease. Adverse reactions experienced following administration of INFeD may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. Carcinogenesis: A risk of carcinogenesis may attend the intramuscular injection of iron-carbohydrate complexes. Such complexes have been found under experimental conditions to produce sarcoma when large doses or small doses injected repeatedly at the same site were given to rats, mice, and rabbits, and possibly in hamsters. The long latent period between the injection of a potential carcinogen and the appearance of a tumor makes it impossible to measure accurately the risk in man. There have, however, been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes. PRECAUTIONS: General: Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Therefore, administer a test dose prior to the first therapeutic dose of INFeD. (See BOXED WARNING and DOSAGE AND ADMINISTRATION: Administration.) Epinephrine should be immediately available in the event of acute hypersensitivity reactions. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.) Note: Patients using beta-blocking agents may not respond adequately to epinephrine. Isoproterenol or similar beta-agonist agents may be required in these patients. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli. Information For Patients: Patients should be advised of the potential adverse reactions associated with the use of INFeD. Drug/Laboratory Test Interactions: Large doses of iron dextran (5 mL or more) have been reported to give a brown color to serum from a blood sample drawn 4 hours after administration. The drug may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of iron dextran. Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of INFeD and slowly returns to baseline after about 3 weeks.

october 2010 I VoL 3, No 7

Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells. Bone scans involving 99m Tc-diphosphonate have been reported to show a dense, crescentic area of activity in the buttocks, following the contour of the iliac crest, 1 to 6 days after intramuscular injections of iron dextran. Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following iron dextran infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation. Carcinogenesis, Mutagenesis, Impairment Of Fertility: See WARNINGS. Pregnancy: Pregnancy Category C: Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose. No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs and monkeys at doses of 50 mg iron/kg or less. Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. The animals used in these tests were not iron deficient. There are no adequate and well-controlled studies in pregnant women. INFeD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Placental Transfer: Various animal studies and studies in pregnant humans have demonstrated inconclusive results with respect to the placental transfer of iron dextran as iron dextran. It appears that some iron does reach the fetus, but the form in which it crosses the placenta is not clear. Nursing Mothers: Caution should be exercised when INFeD is administered to a nursing woman. Traces of unmetabolized iron dextran are excreted in human milk. Pediatric Use: Not recommended for use in infants under 4 months of age. (See DOSAGE AND ADMINISTRATION.) ADVERSE REACTIONS: Severe/Fatal: Anaphylactic reactions have been reported with the use of iron dextran injection; on occasions these reactions have been fatal. Such reactions, which occur most often within the first several minutes of administration, have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. Because fatal anaphylactic reactions have been reported after administration of iron dextran injection, the drug should be given only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available. (See BOXED WARNING and PRECAUTIONS: General, pertaining to immediate availability of epinephrine.) Cardiovascular: Chest pain, chest tightness, shock, cardiac arrest, hypotension, hypertension, tachycardia, bradycardia, flushing, arrhythmias. (Flushing and hypotension may occur from too rapid injections by the intravenous route.) Dermatologic: Urticaria, pruritus, purpura, rash, cyanosis. Gastrointestinal: Abdominal pain, nausea, vomiting, diarrhea. Hematologic/lymphatic: Leucocytosis, lymphadenopathy. Musculoskeletal/soft tissue: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis – See PRECAUTIONS: General), myalgia; backache; sterile abscess, atrophy/fibrosis (intramuscular injection site); brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites; cellulitis; swelling; inflammation; local phlebitis at or near intravenous injection site. Neurologic: Convulsions, seizures, syncope, headache, weakness, unresponsiveness, paresthesia, febrile episodes, chills, dizziness, disorientation, numbness, unconsciousness. Respiratory: Respiratory arrest, dyspnea, bronchospasm, wheezing. Urologic: Hematuria. Delayed reactions: Arthralgia, backache, chills, dizziness, fever, headache, malaise, myalgia, nausea, vomiting. (See WARNINGS.) Miscellaneous: Febrile episodes, sweating, shivering, chills, malaise, altered taste. OVERDOSAGE: Overdosage with iron dextran is unlikely to be associated with any acute manifestations. Dosages of iron dextran in excess of the requirements for restoration of hemoglobin and replenishment of iron stores may lead to hemosiderosis. Periodic monitoring of serum ferritin levels may be helpful in recognizing a deleterious progressive accumulation of iron resulting from impaired uptake of iron from the reticuloendothelial system in concurrent medical conditions such as chronic renal failure, Hodgkins disease, and rheumatoid arthritis. The LD50 of iron dextran is not less than 500 mg/kg in the mouse. Rx Only Revised: September 2009 Address medical inquiries to: WATSON Medical Communications P.O. Box 1953 Morristown, NJ 07962-1953 800-272-5525

Distributed by: Watson Pharma, Inc. Morristown, NJ 07962 Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013 251279 S0909

care is currently delivered, and how next-generation breast cancer strategy can help healthcare teams and patients. Multidisciplinary care is vital, and it is a huge advantage for patients in getting the best care.” A dedicated breast program should include designated physician leadership, appropriate subspecialized physicians (ie, dedicated breast surgeon) when relevant, a comprehensive multidisciplinary care model (clinic or virtual clinic), a nurse navigator or care coordinator, quality and outcomes tracking, and comprehensive support services, according to the results of The Advisory Board Company’s 2009 Oncology Roundtable Tumor Site Survey.

“Multidisciplinary care is vital, and it is a huge advantage for patients in getting the best care.” —David L. Katz, MD, JD In its 12th year, the Oncology Roundtable serves administrators, physicians, and clinical staff dedicated to exceptional practice at America’s leading academic medical centers, dedicated cancer facilities, and community hospital oncology programs. The current membership comprises more than 600 hospital-based cancer programs, as well as freestanding centers. Approximately 65% of members are community-based programs; the remainder are large teaching hospitals, including comprehensive cancer centers. NAPBC sets the standards for program performance The National Accreditation Program for Breast Centers (NAPBC) is a voluntary 3-year accreditation program for breast centers in the United States. The NAPBC encourages hospitals, treatment centers, physician practices, and other facilities committed to breast healthcare to improve the quality of care available through various breastrelated programs. These programs focus on prevention, early detection, diagnosis, pretreatment evaluation, staging, optimal treatment, rehabilitation, surveillance for recurrent disease, support services, and end-of-life care. The NAPBC application fee is $4000. The interest in NAPBC is growing, according to Katz. “Among The Advisory Board members, more than 50% are pursuing accreditation. Patients and providers have welcomed this as the next steps in comprehensive breast care.”

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Models of Care

NAPBC includes 17 components and 27 standards of care. A center cannot receive accreditation without meeting three standards, which have been identified as critical: • Standard 1.1: Level of responsibility and accountability. The organizational structure of the breast center gives the breast program leadership (BPL) responsibility and accountability for provided breast center services. • Standard 1.2: Interdisciplinary breast cancer conference. The BPL establishes, monitors, and evaluates the interdisciplinary breast cancer conference frequency, multidisciplinary attendance, prospective case presentation, and total care presentation annually. • Standard 2.1: Interdisciplinary patient management. After a diagnosis of breast cancer, patient management is conducted by an interdisciplinary team. Physician team members are board certified or in the process of board certification. Each breast center must undergo a rigorous evaluation and review of its performance and compliance of NAPBC standards. For example, Katz explained that St. John Providence Health Sys tem, a seven-hospital system headquartered in Southeast Michigan, tackled the accreditation process in distinct phases with clear ownership over each component (Figures 1 and 2), which resulted in gaining full accreditation. Assessing the pros and cons of common breast center types As healthcare moves toward an even greater multidisciplinary approach to care, healthcare team members need to evaluate the pros and cons of establishing a comprehensive breast center and screening/diagnostic center. “The advantage of a comprehensive breast center for patients is that it is a ‘one-stop shop’ for patients with everything in one centralized location. Additionally, patients have a greater likelihood of getting cutting-edge technology,” said Katz. “Healthcare providers do not have to push for multidisciplinary collaboration because it’s already happening. “Screening/diagnostic centers offer patients multiple locations to create easier patient access with everything under one roof and healthcare providers gain efficiency,” added Katz. Katz also noted several drawbacks for both centers. “A comprehensive breast center will require more space for the healthcare providers. In rural areas, having only one comprehensive breast center will require more travel time for patients, compared with urban areas

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The Carol Milgard Breast Center took 2 years to open. The 25,000-square-foot center incorporates screening mammography, diagnostic mammography (all digital), ultrasound, breast invasive, and dedicated magnetic resCarol Milgard Breast onance imaging (MRI). The Center: a model to center sees 150 to 200 paDavid L. Katz, MD, JD follow tients per day and performs During his presentation, 60,000 imaging studies per year. Katz profiled progressive breast center Before the Carol Milgard Breast programs. “The Advisory Board did a Center opened, patients were waiting 6 case study of the Tacoma, Washington, to 8 weeks from screening to a definiarea to look at the market for breast tive diagnosis. Patients being treated at screening centers,” explained Katz. the Breast Center receive same-day “What we found was access to screening screening mammography results, biopcenters was limited and patients were not sies are performed within 24 to 36 hours getting screened in a timely manner.” of diagnostic mammogram, and patholMultiCare Health System, Franciscan ogy is turned around in 24 hours. Health System, and TRA Medical “In our modern era of competition, Imaging took notice of the problem and the fact these three groups got together formed a joint venture. Each group con- in a joint venture to leverage their tributed $6.5 million in capital budget resources is a great example of what and an additional $5 million was con- could be done anywhere in putting a tributed by the Carol Milgard family. center together.” where easier access to these centers is available.” As for screening/diagnostic centers, Katz pointed out it creates additional patient transitions for healthcare providers.”

Technology is vital for breast centers Technology is a critical component for any breast center. “If a technology exists, that is an advantage most people are going to want access to,” said Katz. Breast MRI is increasingly becoming “must-have” technology. The cost is approximately $60,000 for coil and $1.3 million to $1.5 million for a dedicated system. Breast MRI provides superior exam sensitivity compared with mammography and ultrasound, is recommended for high-risk screening, and offers potential benefit in treatment planning. However, “technology requires extensive training for technicians and radiologists, and it gives a high number of false positives, leading to unnecessary and more radical interventions,” explained Katz. He noted that more than 90% of Oncology Roundtable members have adopted the technology. Katz also included analog mammography and full-field digital mammography (FFDM) as “must-have” technologies. “Analog mammography, which Continued on page 24

Creating Granular To-dos Allows Distribution of Work Assign documentation ownership

Generate individual line items • Break each standard into its components to create checklist-style document • Sample: Standard 1.1 Level of Responsibility and Accountability document includes: • Organizational chart, details regarding roles and responsibilities • Roster of steering committees • Minutes from recent meetings • Copy of bylaws • Concurrently outline discussion points for day of surgery

Designate point person • Key roles supporting leadership/program director include administrative directors, navigators, or breast cancer working groups • Offload targeted sections (ultrasonography, diagnostic imaging) to appropriate departmental leadership • Breast program leadership involved in each step as quality check • Distinguish between those parties responsible for gathering documentation, leading discussion during survey visit

Sources: St. John Providence Health System, Detroit, Michigan; Oncology Roundtable interviews and analysis. Reprinted with permission. © The Advisory Board Company.

Figure 1. Turning Standards into Action

Theoretical benefits Quality tracking, performance improvement

St. John Providence Health System’s results Database realignment to demonstrate center’s performance; adherence to quality standards of accreditation serves as platform for future quality initiatives

Staff alignment

Elevated pride, sense of community across all; reinforced dedication to breast subspecialization and continuing medical education in physicians

Marketing cache

In the process of developing targeted marketing campaign to capitalize on status as one of first 50 accredited programs in the nation and the first multicenter program to receive approval

Source: Oncology Roundtable interviews and analysis. Reprinted with permission. © The Advisory Board Company.

Figure 2. Bringing Home the Benefits

october 2010 I VoL 3, No 7

Conference News ASCO

The following articles are based on presentations at the 46th Annual Meeting of the American Society of Clinical Oncology held in Chicago, Illinois, June 4-8, 2010.

The Rising Cost of Cancer Care: Who Takes Responsibility? By Caroline Helwick

CHICAGO—Direct medical spending for cancer amounts to $104 billion per year, which when adjusted for inflation represents a 222% increase over the past 20 years. Controlling these rising costs will be the responsibility of government, payers, and providers, but there remains little direction for these entities to control these costs at this point, according to Michael J. Hassett, MD, MPH, of Dana-Farber Cancer Institute’s Breast Oncology Center, Boston, who spoke at the session “Controversies in Metastatic Breast Cancer Treatment.” A study reported at the 2008 annual meeting (Wiley VJ, et al. J Clin Oncol. 2008;26[May 20 suppl]:Abstract 6503) evaluated trends in medical payments and patient out-of-pocket spending for 74,630 privately insured patients with breast cancer, colorectal cancer, and lung cancer, and non-Hodgkin lymphoma. All medical payments increased over 4 years, but out-of-pocket payments increased the most (Table 1). These figures are undoubtedly underestimates, Table 1

because they come from an insurance database and do not include expenditures not reported to payers, Hassett added. “Healthcare expenditures are substantial and they are increasing. Resources are not unlimited and we need to decide how to allocate them,” he told attendees. Confusion will be part of cost control “In the past, as long as the patient was insured, there was little reason to consider cost. But like it or not, costs are becoming more of a factor, and efforts to control costs are only likely to increase,” Hassett said. “The question is not whether costs should be considered but rather how cost decisions will be made and who will be responsible for doing that.” The federal government, private insurers, providers, and patients all should bear responsibility, he maintained. There is no uniform approach to cost control from the government, which can set payments but is constrained by both

Comparison of Medical Costs Overall with Patient Out-of-pocket Expenses 2003

2004

2005

2006

Mean increase/year

Medical payments

$24,335

$25,554

$25,949

$27,044

3.6%

Patient payments

$1937

$2097

$2172

$2648

11.4%

Costs

Table 2 Survey of Oncologists’ Attitudes: How Cost Influences Treatment Question

Percent agreeing

Patients’ out-of-pocket costs influence my treatment recommendations

Costs of new cancer drugs influence my treatment recommendations

More cost-sharing by patients for cancer drug costs is needed

More use of cost-effectiveness data in coverage and payment decisions is needed

Who should determine whether a drug provides good value? • Physicians • Nonprofit entity • Patients • Government • Insurance company

60 57 37 21 6

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Costs in Cancer Care • Costs are increasing and resources are limited; therefore, factoring costs into decision-making seems inevitable • Who should be making decisions about cost, versus who is making decisions, is often discordant, and there is no consensus about these roles • An open and frank discussion is needed regarding how costs should be considered and who should be responsible for these decisions • Personalized medicine could help direct costly therapies to smaller subsets of patients and thereby conserve costs, but more research is needed • Providers should contribute to the creation of consistent policies and guidelines that focus primarily on benefits, but secondarily consider costs —Michael J. Hassett, MD, MPH Dana-Farber Cancer Institute

federal law and policy. By law, coverage decisions are based on what is medically “reasonable and necessary, and cost is usually not a factor in this process,” Hassett said. Private insurers’ approach to controlling cost is to set payment rates, for example, negotiate reimbursement rates for computed tomography scans; to make coverage decisions, for example, refuse to cover a biologic; do carve-outs, that is, identify a subset of services (specialty-care pharmacy benefits, mental health) that can be provided at lower cost by an independent entity; shift costs to patients via copayments and deductibles; and reduce costs by discouraging utilization, although it is difficult to control quantity of services due to the fee-for-service nature of the current reimbursement system, Hassett said. The fact that insurers can make independent decisions means that providers must deal with a variety of policies. This paradoxically leads to increases in the administrative burden and consequently the cost of providing healthcare overall, he noted. On the provider side, rising cancer costs are clearly beginning to influence clinical practice, he observed. In a 2010 national survey of medical oncologists, 84% said patients’ out-of-pocket spending influences their treatment recommendations (Neumann PJ, et al. Health Aff [Millwood]. 2010;29: 196202) (Table 2). The results also suggested that physicians support federally funded compara-

tive effectiveness research but they wish to retain a central role in making decisions about how and when to use expensive cancer treatments. The results also support educating physicians about cost-effectiveness and how to communicate with patients about cost, the authors stated. “Most clinicians believe they have a duty to offer a patient any treatment that yields a net benefit, regardless of the cost to our society. To be an effective patient advocate in the future, will oncologists need to get into the question of value—that is, provide patients with information on what treatments cost, and discuss expected differences in outcomes for low-cost versus high-cost treatments?” he questioned. Should oncologists begin considering costs when making treatment decisions, they will inevitably have to deal with multiple, potentially conflicting responsibilities as taxpayers, business owners, and patient advocates, Hassett predicted. “Despite these potentially conflicting responsibilities, it is important that providers think and function independently in different settings. As patient advocates, they must focus on which treatment is best for the patient and consider costs only if incurred directly by a patient. But as taxpayers, they have to acknowledge that some elements of cost control are inevitable, and they must advocate for a principled, consistent, societal approach to the problem,” he said. l

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Conference News

Surgery the Most Cost-effective Prevention in BRCA Mutation Carriers By Caroline Helwick

CHICAGO—In a simulated cohort of women with BRCA1 and BRCA2 mutations, which places them at high risk for breast and ovarian cancer, investigators determined that prophylactic surgery is the most cost-effective means of cancer prevention. “No research has compared prophylactic surgery, chemoprevention, and imaging for their benefit in BRCA mutation carriers,” said Victor Grann, MD, MPH, of Herbert Irving Comprehensive Cancer Center of Columbia University, New York City. The researchers used a simulated cohort of women aged 30 to 65 years who tested positive for BRCA mutations and were without cancer at baseline. They compared mammography with and without magnetic resonance imaging (MRI), prophylactic oophorectomy or mastectomy (at age 35) or both surgeries, and chemoprevention. They developed Markov models and conducted probabilistic sensitivity analyses using mutation penetrance rates, breast and ovarian cancer incidence and mortality rates based on published studies, and data from the SEER-Medicare Linked Database. They projected that prophylactic oophorectomy reduces the risk of ovarian cancer by 85% in BRCA1 carriers and 96% in BRCA2 carriers, and reduces the risk of breast cancer before age 50 by 54% in BRCA1 and BRCA2 carriers. Prophylactic mastectomy reduces the risk in each group by 90%, and by 95% when done along with oophorectomy. Tamoxifen reduces the risk by 49%, and by 84% when done with oophorectomy. Oral contraceptives reduce the risk by 54%. Investigators calculated the qualityadjusted life-years (QALYs) saved two ways: based on preferences of women without known high risk and on preferences of women with BRCA mutations. For the first analysis, for BRCA1 mutation carriers, prophylactic oophorectomy, at $1741/QALY, was more cost-effective than both surgeries and dominated all other interventions. Mammography, as an example, cost $681,000/QALY. For BRCA2 carriers, prophylactic mastectomy, at $5062/QALY, was more cost-effective than both surgeries. MRI and mammography combined cost $247,000/QALY. With QALYs based on preferences of mutation carriers, prophylactic oophorectomy was most cost-effective at $1677 for BRCA1 carriers, whereas mastectomy won out for BRCA2 carriers, at $13,960/QALY.

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Screening modalities had the highest preference ratings but were very costly, he added. “Mammography plus MRI

was the most effective strategy because it was associated with the longest quality-adjusted survival in both groups, but

it was also the most expensive strategy,” noted Grann, primarily because of the high cost of MRI. l

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october 2010 I VoL 3, No 7

Conference News

Clinical Research in the Community Setting By Charles Bankhead

CHICAGO—Taking part The Institute of Medicine Berman Cancer Institute at work space, telephone/telein clinical research poses (IOM) published a report Greater Baltimore Medical communication support, and administrative, financial, that addresses needs, goals, Center in Maryland. “Our computer equipment and and logistic challenges to and initiatives to “reinvigo- time has value, and we software. community oncology pracrate” the National Cancer don’t want to give it away. The considerable overtices, but also presents Institute’s (NCI) clinical tri- If we are going to do clinihead associated with operatthese organizations with als cooperative group pro- cal trials, we certainly want ing a clinical research site opportunities for a more gram.2 Among other recom- to manage our time properrequires income to offset mendations, the IOM called ly, and having a team allows active role in shaping those expenses. A site may on the NCI to increase us to get that done in the patient care. So communinot make money, but it also reimbursement to trial sites most efficient way.” ty practices that venture should not lose money, Robin Zon, MD Dee Anna Smith and urges the American into clinical research The titles and responsiwhich necessitates a “costshould strive to follow emerging guide- Medical Association to develop a bilities of the other members of the neutral” financial balancing act, said lines aimed at establishing exemplary Current Procedural Terminology clinical research team may vary some- Cohen. clinical trial sites, said speakers at an (CPT)-4 code that would increase re- what from site to site, but most teams American Society of Clinical Oncology imbursement to providers who enroll share several key members and respon- Budgeting and paying for clinical trials patients and participate in clinical tri- sibilities (Table 2). (ASCO) education program. Contract negotiation is the fulcrum Considerations involved in develop- als. The IOM also called on the NCI to Operating a clinical research site work with a nonprofit foundation to requires a substantial financial commit- in the balancing act, and the negotiaing an exemplary research site include: • Structuring and marketing a pro- develop a certification program for clin- ment, Cohen noted, and personnel tion process has no hard-and-fast rules. “Sponsors will not pay more than fair ical trial sites. gram for success costs usually represent the largest out• Organizing a team that recognizes its lay. At his institution, salary and bene- market value for services,” said Dee critical role in the program’s success Good teams make for good fits for various members of the research Anna Smith, chief executive officer of • Knowing the costs to budget effec- research team can range from $39,000 for a med- the Sarah Cannon Research Institute in The path to exemplary status as a ical assistant to $98,000 for a research Nashville, Tennessee. Although “there tively and negotiate contracts. Community oncology practices have research site begins with the creation of nurse, accounting for about three is no clear mechanism in the law or rega vested interest in participating in clin- a research team that understands and fourths of expenditures for the site’s ulations for determining fair market ical research, according to Robin Zon, strives to create a culture that is sup- research program. Equally important, value in the clinical research context,” MD, a principal investigator with the portive to clinical research. the clinical research team must have she said, “well-documented justification Physicians participating in clinical the resources necessary to carry out [of costs] increases the likelihood that a Northern Indiana Cancer Research Consortium in South Bend. “The ‘com- research must have a strong commit- their work, Cohen added, including Continued on page 16 munity,’ as a partnership between the ment to research and be willing to physician and the patient, has the spend the extra time required to explain potential to make an enormous impact the trial process to patients, discuss Table 1 Exemplary Attributes of Clinical Trial Sites on the algorithm of cancer care by treatment options, and obtain appropri• Diversification in mix of clinical trials increasing participation in clinical tri- ate consent. Most steps in the research als,” said Zon. Yet, a clear disconnect process, including forms and documen• High accrual activity tation, require the participating physiseparates interest and participation. • Active participation in the clinical trial process Community oncology practices care cian to sign off. Research physicians • Maintenance of high educational standards for 85% of oncology patients and 50% also must be prepared to attend instituto 60% of patient accrual in clinical tri- tional and investigator meetings related • Quality assurance als comes from the community setting. to the clinical research program and • Multidisciplinary involvement in the research program However, fewer than 20% of oncolo- specific clinical trials. “The main thing physicians have to gists and 2% to 7% of all cancer • Programs to promote clinical trial awareness among healthcare colleagues, in the offer is our time,” said Gary I. Cohen, patients participate in clinical trials. community, and among oncology patients MD, director of clinical research at the Ingredients for success Successful clinical research sites have Table 2 The Clinical Research Team several common traits, Zon outlined, including a committed staff, financial Team member Duties resources, accessible ancillary services, Clinical research associate Screens patients and determines eligibility for trial participation; prepares duplicate institutional support, respect for pamedical charts for each trial participant; handles pathology and radiology submissions, tients, and an overarching commitment coordinates data collection, and assures or verifies insurance coverage. (Sometimes to patient safety. Those principles are called data manager or coordinator.) embodied in ASCO’s statement on Clinical research nurse Works with physicians to verify patient eligibility for a trial and assists in the consent minimum standards for exemplary clin1 process. Other responsibilities include scheduling patient contacts, reviewing treatment ical trial sites, which Zon helped write. protocols and physician orders, and documenting adverse events; assessing patient Key attributes cited in the ASCO statequality of life; following clinical and laboratory data to assess the need for treatment ment are listed in Table 1. modification; and facilitating tissue, laboratory, and pharmacology studies. First and foremost, exemplary clinical trial sites adhere to the clinical practice Clinical research pharmacist Reviews treatment protocols, ensures standardization, monitors dosing, and makes guidelines of the International Conadjustments for changes in hepatic or renal function or patient weight; logs and ference on Harmonisation, said Zon. monitors storage and use of investigational drugs and distributes assigned study Adherence to the guidelines is a requiremedications; and maintains the integrity of the clinical trial blinding process. ment for participation in federally fundAdministrative assistant Performs various administrative duties. ed and industry-sponsored clinical research.

october 2010 I VoL 3, No 7

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A Friday Satellite Symposium preceding the 52nd ASH Annual Meeting

Challenging Cases in Multiple Myeloma A Dialogue Between Community and Academic Clinicians to Improve Patient Care and Outcomes December 3, 2010 Rosen Centre Hotel Ballrooms A & B, Orlando, Florida

PROGRAM AGENDA

This continuing medical education symposium will serve as a forum for discussion of current questions and concerns regarding the treatment and management of patients through the multiple myeloma (MM) life cycle. A panel of domestic and international myeloma experts will be joined by representatives from community cancer care facilities and private oncology practices. By thoroughly engaging participants with interactive cases and physician point-counterpoint-style discussions, this symposium will provide evidence-based treatment and management recommendations and address new treatment regimens and management strategies based on recent clinical trials and emerging data. In addition to considering differences in domestic and international care, barriers and/or limitations faced by community cancer centers and private-practice oncologists will be debated.

12:30 -

1:00 PM

Registration and Lunch Service

1:00 -

1:10 PM

Welcome and Introduction Sundar Jagannath, MD - Chair

CASE PRESENTATIONS Each case will be presented by an expert faculty member and discussed by the international and community panel. 1:10 – 1:40 PM

Case 1: Difficult diagnosis G. David Roodman, MD, PhD

1:40 – 2:10 PM

Case 2: Newly diagnosed, stem cell transplant eligible patient Sundar Jagannath, MD

2:10 – 2:40 PM

Case 3: First-line therapy in a non-SCT eligible patient Stefan Knop, MD

2:40 – 3:10 PM

Case 4: Multiple risk factors Jonathan L. Kaufman, MD

3:10 – 3:40 PM

Case 5: Treatment of MM across the life cycle Noopur Raje, MD

3:40 -

3:50 PM

Question & Answer Session

3:50 -

4:00 PM

Closing Remarks Sundar Jagannath, MD

LEARNING OBJECTIVES At the end of this activity participants will be able to: • Apply early management strategies that consider new diagnostic and staging criteria for SMM, MGUS, and MM and new imaging studies in order to improve prognosis for your patients. • Evaluate novel therapeutic regimens as induction therapy for your patients considering an SCT in order to provide the most rapid response and allow the largest amount of stem cell collection, while maintaining safety and tolerance. • Integrate novel agent-based regimens that provide optimal outcomes and a survival benefit into your management strategy for patients ineligible for SCT after appraising emerging data from clinical trials. • Identify patient- and disease-associated factors that impact choice of therapeutic agent and formulate management strategies using a risk-adapted approach to treatment of MM. • Construct optimal treatment regimens based on novel combinations and make informed treatment decisions in order to improve the long-term outlook for myeloma patients across the life cycle of the disease.

TARGET AUDIENCE This activity has been developed for hematologists and medical oncologists, as well as nurses, pharmacists, and other allied health professionals who are interested in meeting the challenges faced when treating patients with multiple myeloma in academic and community settings.

ACCREDITATION INFORMATION Physician Accreditation The University of Cincinnati designates this activity for a maximum of 3 AMA PRA Category 1 Credits ™. The University of Cincinnati is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Physicians should only claim credit commensurate with the extent of their participation in the activity. Registered Nurse Designation Medical Learning Institute, Inc. (MLI) Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 3.0 contact hours. Registered Pharmacy Designation Medical Learning Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Completion of this activity provides for 3.0 contact hours (0.3 CEUs) of continuing education credit. The universal activity number for this activity is 0468-9999-10-058-L01-P.

FACULTY CHAIR: Sundar Jagannath, MD Professor, Hematology and Medical Oncology Mount Sinai School of Medicine’s Tisch Cancer Institute Director of the Multiple Myeloma Program, The Mount Sinai Medical Center New York, NY Leon Dragon, MD, FACP Medical Director Kellogg Cancer Center Northshore University HealthSystem Highland Park, IL Charles M. Farber, MD, PhD Section Chief of Hematology and Oncology Department of Medicine Carol G. Simon Cancer Center, Morristown, NJ Shoba Kankipati, MD Associate Physician EPIC Care East Bay Partners in Cancer Care San Francisco Bay Area, CA Jonathan L. Kaufman, MD Assistant Professor Blood and Marrow Transplantation Department of Hematology and Medical Oncology Emory University School of Medicine Member, Winship Cancer Institute Emory University, Atlanta, GA

ACKNOWLEDGMENT This activity is supported by an educational grant from Millennium Pharmaceuticals, Inc.

This activity is jointly sponsored by the University of Cincinnati, Medical Learning Institute, Inc., a nonprofit medical accreditation company, and Center of Excellence Media, LLC.

Stefan Knop, MD University Hospital Würzburg Würzburg, Germany Noopur Raje, MD Associate Professor of Medicine Harvard Medical School Director, Center for Multiple Myeloma Massachusetts General Hospital Boston, MA G. David Roodman, MD, PhD Professor of Medicine Vice Chair for Research Department of Medicine Director, Myeloma Program Director, Bone Biology Center University of Pittsburgh Medical Center Pittsburgh, PA Ari Umutyan, MD Redwood Regional Medical Group Hematology and Medical Oncology Napa, CA

Conference News Clinical Research... continued from page 14 sponsor will agree to your budget.” The budget for a clinical trial serves to allocate and document financial responsibility among the sponsor, the research site, the patient, and insurance. An effective budget process should include a thorough review of the protocol and informed consent, careful justification of all costs, determination of institutional requirements, and a careful delineation of all overhead costs and identification of hidden costs. One of the most difficult aspects of the process involves estimating or accounting for inflation in multiyear projects, Smith noted. However, estimation of the cost of future required procedures must include an allowance for inflation. Identifying hidden costs is more problematic for new research sites than for experienced sites. Often overlooked are costs associated with site selection and visits, staff training, attendance at investigator meetings, development of study tools, and regulatory document filing.

Other costs that should be taken into account include recruitment, pharmacy review, lab setup, quality assurance, radi-

emergent and long-term care and may include a monetary cap. Most contracts do not have allowances for incidental

An effective budget process should include a thorough review of the protocol and informed consent, careful justification of all costs, determination of institutional requirements, and a careful delineation of all overhead costs and identification of hidden costs. ology setup, monitoring, administration of study drug, and pathology fees. A research contract should clearly address indemnification, patient injury, and payment terms, said Smith. Indemnification typically includes protection for the sponsor, institution, and research site; use of study results; and product liability. Allowances for patient injury typically include direct medical costs and

expenses resulting from the injury, lost wages, pain and suffering, or punitive damages. Payment terms will vary from site to site and sponsor to sponsor, but many agreements include some common traits. Smith suggests that the terms stipulate advance payment of a nonrefundable fee for start-up costs, which most sponsors expect. Other issues commonly addressed in the agreement

include provisions for payment disputes and defined escalation procedures. Operational issues commonly include information needed to process invoices, electronic payment versus use of paper checks, payment frequency or schedule, pass-through allowances, and a process for dealing with insurance denials. “Understand the protocol, understand and document your costs, understand billing coverage, and understand when you will get cash,” said Smith. “Don’t be mesmerized by the initial perpatient amount offered. Look for what is not in your contract, and don’t be afraid to negotiate. Finally, deliver on the study requirements.” l References 1. Zon R, Meropol NJ, Catalano RB, Schilsky RL. American Society of Clinical Oncology statement on minimum standards and exemplary attributes of clinical trial sites. J Clin Oncol. 2008;26:2562-2567. 2. Nass SJ, Moses HL, Mendelsohn J; for the Institute of Medicine, eds. A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. Washington, DC: National Academies Press; 2010.

CLINCAL RESEARCH

Clinical Research Leader Wins King Award By Daniel Denvir

arl J. Minniti Jr, MD, was the 2010 recipient of the Association of Community Cancer Center’s David King Community Clinical Scientist Award. Minniti has been a leader in clinical research at his singlespecialty group practice in Mickleton, New Jersey, where he joined his father, Carl Minniti Sr, in 1992. “It was a great honor to get this award,” Minniti told the Journal of Multidisciplinary Cancer Care. “It’s a recognition for work that’s done in the community.” The award recognizes physicians who have demonstrated leadership in the development, participation, and evaluation of clinical studies and/or are active in the development of new screening, risk assessment, treatment, or supportive care programs for cancer patients. The community setting allows patients to access care close to their homes and support networks, during a time when such support is of great importance. “We’re the frontlines in terms of patients being treated,” says Minniti. “If we can offer an upfront clinical trial, we’re putting them in a better position.” The entire oncology community has an important role to play in delivering care and driving clinical trials, so collaboration with larger academic centers and hospitals is the touchstone of the Minnitis’ practice. Thanks to his rela-

october 2010 I VoL 3, No 7

tionships with Fox Chase Cancer Center and South Jersey Hospital, Minniti has access to an array of larger cooperative group trials. He says that it was his fellowship at Fox Chase that steered him toward research. “We were tuned into the research pathway,” he said. “Some of the fellows

ticipate are motivated by being able to play a part in the fight against cancer, something that will benefit their friends and family members in the future; others hope that a new treatment will be superior to the status quo. Minniti says that the medical community must also do a better job getting the word out, so

“We’re the frontlines in terms of patients being treated. If we can offer an upfront clinical trial, we’re putting them in a better position.” —Carl J. Minniti Jr, MD

pursued basic science research, and others, like myself, pursued clinical re search. It was a natural progression to continue to do research in my private practice.” The recent healthcare reform law promises significant changes for community oncology, including a new requirement that insurance companies reimburse costs related to clinical trials, a move that should benefit clinical research by lowering financial barriers to participation. But Minniti still worries about low patient accrual. Many patients who par-

that more patients come to the door knowledgeable about clinical trials. But Minniti says that the Internet is already helping inform patients; and if patients are gathering more information at home, it could, Minniti hopes, lead to a greater interest in trials. “A very small percent of patients are placed on clinical trials,” he says. “And I think if we can get the message out to patients more effectively, that is a good way to go. It can be very effective. The message needs to get to the patients, so that when a patient gets to a physician they’re already thinking about it,

instead of the physician having to initiate the discussion.” Community oncologists face a number of obstacles in setting up trials aside from patient accrual, specifically in data management. Minniti says that setting up a rigorous clinical research program can be complicated. But he says that over the long term, trials are an important contribution to the practice and the field as a whole. “There’s a significant time commitment required on the part of the physician,” he said. “And a good data management program is essential.” But community oncology faces a number of challenges, particularly with regard to reimbursement. Minniti acknowledges the increased pressure on doctors to move from private practice into a hospital setting. But for the meantime, he plans on staying put— the King Award has inspired him to redouble his efforts. Minniti is a past president of the American Cancer Society Southern New Jersey Region, and chief in the division of oncology and immediate past president of medical staff at Underwood Memorial Hospital. He has also been the recipient of the American Cancer Society South Jersey Region’s Silver Chalice Award for Cancer Control and the Leukemia & Lymphoma Society New Jersey Chapter’s Service to Mankind Award. l

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Cancer Center Profile Reducing Disparities in Cancer Care... continued from cover Making it a reality MSTI has “plans to beef up programs that are partly already in place but need greater funding, whether that is getting early screening with mammography at a greater intensity or getting more education within the communities,” said Paul G. Montgomery, MD, FACP, a medical oncologist. “There has been some education, there needs to be more. There has been some mobile mammography units going to rural areas, there needs to be more.” Funding from the NCCCP contract should help MSTI provide these additional services and “allow us to make an impact.” The action plans start by analyzing data on their patients. These data show where MSTI needs to focus, including geographic areas and ethnic populations. Then, areas with disparities are targeted for what is needed. Montgomery gave this example: Geographic areas where patients disproportionately present in the later stages of cancers can be targeted for patient education, hopefully leading to improved early diagnosis and screening. To help get information and services out to people, MSTI plans to expand its services beyond the Boise clinic, where most of the specialized clinics are currently housed. With the high-risk breast cancer clinic, for example, all patients must travel to Boise. But, the plan is to expand into the Twin Falls area, which is about 130 miles away, and at a future date, perhaps into the Fruitland area, according to Jill Winschell, RN, a breast cancer nurse navigator.

“These rural navigators will be situated in those areas and begin to develop community resources and community outreach to occur directly in their communities.” —Jill Winschell, RN Nurse Navigator Navigation services will expand beyond the new clinic. MSTI is currently looking to fill several positions for new navigators, starting with a navigator for the Twin Falls area and one for the Fruitland area in the western end of the Treasure Valley, which is home to a large Hispanic and rural population. A third breast care navigator will be hired for additional western Idaho locations.

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“These rural navigators will be situated in those areas and begin to develop community resources and community outreach to occur directly in their communities,” said Winschell. A second mobile mammography coach also is in the works. The current coach is booked every day, except when it is down for service, according to Winschell. “In fact, they have traveled up to Grangeville, which is 220 miles north. And we will be traveling into Oregon, which will be new for us.” Disparities meet supportive care Psychosocial and survivorship resources are expected to expand into all five sites as well, which will help MSTI embrace another of the NCCCP pillars—“Enhance cancer survivorship and palliative care services.” In addition, “we have the opportunity to provide supportive oncology clinics to meet the advanced disease population,” said Alicia Rosales, LMSW, an oncology social worker. A supportive care oncology clinic was opened in May in the Boise location. “It is not in replacement of the patients’ visits to their primary oncologist, but something that is linked in parallel,” said Dan Zuckerman, MD, medical director for the supportive care and survivorship clinics. With this clinic, patients who require help from multiple supportive disciplines now have a place to go. The clinic offers dietitians, social workers, and physical therapists. There are plans to increase psychiatric services by hiring someone with a specific interest in psycho-oncology. Although dedicated psychosocial oncology personnel can be difficult to staff in rural areas, Zuckerman is hoping to use funding from the NCCCP for this purpose. This funding may also allow a supportive oncology clinic to open in each of the five sites. Rosales envisions a half- day clinic of survivorship and a half-day clinic of advanced disease patients, staffed by a multidisciplinary team. The clinics would offer a dietitian, a social worker, a psychiatrist, a pharmacist, a nurse practitioner, and referrals to financial counselors and physical therapists. The rural location of its patients affects survivorship services as well. With patients in remote areas, survivorship services means “making sure that patients have the information, the resources, and the tools they need to empower themselves to lead healthy lives. We have to take into account that all of them may not have the opportunity to participate in exercise classes. We have to give them the information about how they can do it on their own in their own geographic setting,” said Rosales.

St. Luke’s Mobile Mammography Service brings mammography to the rural areas of southwestern Idaho.

Patient education is a similar challenge. In the Hispanic community, many believe that cancer cannot be

“Many of our patients cannot come into our main center in Boise, so our goal and our responsibility is to provide care in their own communities.” —Dan Zuckerman, MD Medical Director, Supportive Care and Survivorship Clinics cured. “It is even harder when these groups of workers are spread over a large area, to be able to reach out and have them understand that cancer can be cured. A great deal of time and effort will be needed to communicate that early diagnosis is important,” said Montgomery. “We are hoping that we can do more community outreach and interaction with the people in those communities to deal with a lot of those disparities and get the rural and Hispanic population into the healthcare system in a timely manner,” echoed Winschell. MSTI employs both Hispanic and Spanish-speaking oncologists and nurses to help with these efforts. Clinical trials and biospecimen research NCCCP sites are also tasked to “increase participation in clinical tri-

als,” and “participate in biospecimen research initiatives to support personalized medicine.” Using funding from the contract, MSTI will be able to start a phase 1 clinical trial program within the next 2 years, “which will be a huge thing because there is no place in Idaho or in our surrounding area that offers phase 1 trials,” said Zuckerman. At current, MSTI accrues only to phase 3 trials, usually from one of the cooperative groups—Southwest Oncology Group, Radiation Therapy Oncology Group, National Surgical Adjuvant Breast and Bowel Project, Eastern Cooperative Oncology Group, and Cancer and Leukemia Group B—as well as to a limited number of industry-sponsored and investigator-initiated phase 2 trials. Biospecimen processing is already under way. In conjunction with Boise Veterans Affairs Medical Center and Boise State University, MSTI has broken ground on the building where biospecimens will be stored. “I think one of the things nationally is the NCI is trying to standardize how biospecimens are stored and to enable researchers from anywhere in the country to access these biospecimens,” said Zuckerman. Meeting the challenge “The challenge is not only to deliver best standards of care, but also to implement that across our multiple sites. Many of our patients cannot come into our main center in Boise, so our goal and our responsibility is to provide care in their own communities,” explained Zuckerman. Along with fellow NCCCP site Billings Clinic Cancer Center in Billings, Montana, MSTI hopes to meet the NCI’s challenge of providing the best evidence-based care to all Americans. l

october 2010 I VoL 3, No 7

Models of Care

Split Scheduling for Chemotherapy Increases Efficiency, Reduces Costs By Karen Rosenberg

ith community to be sitting in the chair. cancer centers facFor example, say a patient ing rising costs has an 8:00 AM appointment but first the nurse has and declining revenues, to get a blood count, the finding more efficient ways results of the blood count to run a practice is critical. have to be interpreted, and In this interview, Cathy the nurse has to get a docMaxwell, RN, OCN, director’s order before the infutor of clinical operations at sion can begin. So if you Advanced Medical Specialties in Miami, Florida, Cathy Maxwell, RN, OCN have that patient scheduled in the chemo chair at 8:00 discusses how community cancer centers can make the most effi- AM, your schedule is already set up cient use of chemotherapy nurses by incorrectly. One of the best ways to use efficient scheduling and how this not your nurses’ time efficiently is what we only increases nurse and patient satis- call a “split schedule.” This means that the patient comes in the day before the faction but also reduces costs. infusion for their blood count, for their What efficiencies can be gained office visit with the doctor, and for with proper scheduling in an infusion assessment of their readiness for the treatment; then he or she gets treatcenter? Because chemotherapy nurses are usu- ment the next day. Many people think their patients ally among the higher paid employees, it is important to use them efficiently. You won’t accept split scheduling, but we do don’t want to have them doing tasks and this in the three sites that I’m responsiduties that do not require a registered ble for and it is very successful. In this nurse (RN), and you want to schedule day and age when you have to control them in a way that you’re not wasting your inventory of drugs, this is the best them as resources. That all translates way to predict what you’re going to into dollars. There are different ways to need for the next day, which is especialstaff an infusion suite to make optimal ly important when you’re talking about expensive drugs. We used to carry use of nurses’ time. The scheduling of the treatments is $800,000 to $1 million worth of drugs crucial because you want to make sure in our mixing room every day for three that your schedule reflects what is actu- locations. We are now at $400,000 with ally going to happen as much as you the split schedule, and our goal is to get possibly can predict. I’ve found that in even lower than that. many cases, the schedule is already set How would you achieve that? up to fail before the first patient walks My goal by the end of the year is to in the door because it doesn’t reflect what time the patient is actually going get the doctors’ orders 48 hours ahead of

Nurses and patients interact in the chemotherapy infusion suite at Advanced Medical Specialties.

october 2010 I VoL 3, No 7

Tips for Scheduling Chemotherapy Infusions • Develop and follow guidelines for scheduling • Consider time needed for intravenous access and premedication • Allow extra time for new patients • Schedule in 15-minute slots (ie, 2-hour treatment = 8 slots) • Stagger the infusion schedules (ie, recliner 1 at 8:15; recliner 2 at 8:30; …) • Assign four to five recliners per nurse, and arrange them close together in pods • Make necessary adjustments to the nurses’ assignments the day before treatment to adjust to the census • Have enough chairs and enough time to handle patients • Limit the number of exceptions to the scheduling guidelines

time, because we would be able to tighten up our inventory even more. In most places around the country, you have until about 6:00 PM to place your orders for delivery by 10:00 AM the next morning. If you have that ability, you don’t have to house expensive drugs; you can order them as you need them. If you have same-day scheduling, you don’t know for sure whether the patient is going to get their chemotherapy until after the office visit. Meanwhile, the patient has an appointment in the chemotherapy infusion suite and the nurses are waiting for the patient. If there is a delay in receiving the patient or the treatment is canceled, it wastes resources and costs the practice money. When the doctor orders a change in treatment, in our practice we need 5 business days to run it through our financial department to make sure the patient’s out-of-pocket costs haven’t changed, that it’s not an off-label regimen, and that we don’t need prior approval from the insurance company. What changes have you seen in your practice as a result of the implementation of split scheduling? With the split schedule, patients’ treatment begins as soon as they arrive at the infusion suite so you can stay on schedule and staff the suite for what you truly need, not what you think you might need. This way, you can use your nurses more efficiently, not waste resources, and free up chair space. Another thing that we noticed when we started split scheduling was that overtime was practically eliminated. In centers where the nurses are paid hourly salaries, eliminating overtime can result in huge savings. Keeping on schedule increases both

nurse satisfaction and patient satisfaction. Studies of patient satisfaction showed that patients most dislike waiting. So even though with split scheduling patients have to come in for two visits, their actual time in the office is less. They’re not wasting time waiting. They go in, see the doctor, and go home. Then when they come back for their treatment, they get in on time, know how long it’s going to take, and go home. They’re much happier because of that. We had an independent group do a patient satisfaction survey a few months after we started split scheduling in a new satellite office. This satellite office was opened in an effort to decompress our original office of 15 doctors. We split the schedule at that time because all of the chemotherapy was prepared at the remote site and we needed to be certain the patients were going to get their prescribed doses and drugs. We interviewed those patients who had experienced both same-day scheduling and split scheduling. We found that patient satisfaction was higher for the split schedule than the old schedule, and patients believed the wait time was better at the new office. That made it easier when we decided to start split scheduling in a larger practice. We basically told the patients that we had no choice, because with split scheduling we found we could lower inventory, cut costs, and reduce overtime. Did you meet with any resistance from patients when you introduced split scheduling? We distributed a letter in our waiting room about 2 months before starting that explained the reasons for the change, but we still had a lot of angry

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Models of Care

patients and family members at first. I had to do a lot of damage control. I called every patient or caregiver who requested to speak to someone and explained to them that we were doing this to stay in business. When we were honest with them and explained why we did it, they were extremely understanding and cooperated. Anyone thinking of starting split scheduling has to realize it’s going to be rough at first, but after you get through that period, it’s a piece of cake. In addition, within the next month, we saw

the change in inventory and change in overtime, so you get instant financial gratification from making that change. What are some other ways practices can increase efficiency? To run efficiently, you have to schedule your nursing staff so that you have the bulk of your nurses there at the busier times. I recommend having flexible nursing schedules with staggered starting times and a per diem pool of nurses to help you cover vacations and other time off.

Cancer treatments today are much more complicated than they used to be, and it takes more interactions from the nurse to take care of the patient. A nurse who works 10 hours probably shouldn’t take care of more than 10 or 11 patients who are getting chemotherapy. In our practice, we separate patients who are coming in for shots and blood counts and other non–infusion-related services from those who are getting infusions. They’re seen in the rapid treatment area where a nurse looks at their blood count and a medical

assistant gives the injections. That way the nurses who are in the infusion suite are doing infusions. In most cases, you don’t need an RN to give an injection. But you do need an RN (in some states an LPN) to give chemotherapy. Our challenge every day is to keep everybody safe and happy. As things change in our field, we have to be flexible, we have to change. We have to stay efficient, save money, but at the same time we have a huge service to deliver. l Models of care continues on page 25

CLINICAL PATHWAYS

Clinical Pathways Programs: Confusing Choices for Payers and Physicians. Part 2: Promising Options By Dawn Holcombe, MBA, FACMPE, ACHE President, DGH Consulting, South Windsor, Connecticut

linical pathways is a hot topic of discussion by both payers and physicians. There are growing demands for consistency in care decisions Dawn Holcombe, MBA, FACMPE, ACHE and reduction in variation in treatment options, where appropriate. These, however, are coupled with recognition that the complexity of cancer itself and the individuality of patients and cancer tumors in their response to different treatments means it will be difficult to determine one best treatment for a given cancer diagnosis. Increasingly, either payers or physicians are exploring the options offered by evidence-based clinical decision making that lead to clinical pathways programs. However, there is great variation among the current programs in use, and wide variation in satisfaction on both sides with current models. Confusion about the choices and ideal construct for clinical pathways programs abound among both payers and physicians. This article will explore some of the self-styled “pathways” programs that are currently in discussion/use between payers and providers. A number of individual pilots and initial programs have developed among payers and providers across the country. Some of these are based on one or more care choices in one or more cancer disease states. Some are based on individ-

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ual treatment choices made by physicians in one practice, and others were developed through an extensive committee process. Most have an ongoing review structure. The following are representative examples of programs seeking to address the need for oncology treatment decision-making pathways.

Innovent Oncology This subsidiary of US Oncology, a forprofit network of oncology and radiology practices and services, offers Level 1 Pathways and other services. Its Level 1 Pathways cover about 17 cancers and are based on “evidence-based treatment guidelines.” Physicians may access the

pathways—which are individual to state and stage of disease—either through the US Oncology–owned iKnowMed electronic health record system or through a web-based portal. Reporting is available for compliance and tracking of noncompliance by physician and by state and stage of disease. Continued on page 20

Five Distinguishing Characteristics of Clinical Pathways Programs

hese key characteristics can help indicate whether a program is right for you.

Clinical source and maintenance There should be a clear and transparent process for clinical pathways development and a timeline for ongoing clinical review of any pathways or guidelines. Pathway definition A true clinical pathway is increasingly clarified as the identification of one preferred treatment for a given state and stage of disease, which has been selected via a rigorous clinical review of the appropriate clinical guideline alternatives and based first upon clinical efficacy, then toxicity profile, and, lastly, assuming comparability across the first two criteria, cost of treatment. If it is a true pathways program, expect it to list one preferred treatment tailored to individual states

and stages of disease. Anything else is still a guideline or preferred menu of treatments, but not a pathway. However, true clinical pathways are never expected to be applicable for 100% of patients with that given state and stage of disease, and will allow for trackable variation off-pathway, which can occur for approximately 20% of patients under a pathway model.

way where appropriate, but track the reasons and causes for such variation as part of the clinical monitoring feedback loop. Reporting for such programs will offer a deep granularity of analysis. Reporting will be by state and stage of disease for all patients, not just a select few. In addition, reporting will not be merely compliance/noncompliance rates.

Point of clinical decision making True clinical pathways application occurs at the point of medical decision making, so a pathways program should instigate onset of medical decision making (known as “front-end” programs), not track care at the back end through claims reporting (also called “back-end” programs).

Documented ease of physician use Physicians should select clinical pathways platforms that are complaint with their practice operations and technology. Platforms should provide statistics showing consistency of use and quality of data collection by physicians via the program’s technical platform (often a web portal). l

Tracking and monitoring A true clinical pathways program will allow for physicians to select treatment options that are off-path-

For a complete discussion on this topic, see part 1 of this article in the August issue.

october 2010 I VoL 3, No 7

Clinical Pathways Clinical Pathways Programs... continued from page 19 One contract has been announced with Aetna, which initially is with one large US Oncology group in Texas, with plans to expand throughout up to 20 other states. Primary use of Level 1 Pathways has been within US Oncology practices, with little uptake in non– US Oncology practices. International Oncology Network This oncology drug distribution subsidiary of AmerisourceBergen offers inventory and regimen analysis software to its customers. The International Oncology Network software can track treatment rendered against regimen menus entered by the customer. The software focuses on a few disease states with fewer than 10 preferred regimens for each state. Physicians who wish to track and report their treatments as a basis for payer negotiations may do so, individually or in groups. There are no publicly known payer contracts using this solution at this time. National Comprehensive Cancer Network This consortium of 21 nonprofit hospitals and cancer centers across the United States has established an exclusive partnership with Proventys to develop the Proventys CDS Oncology system, which is a web-based platform that will integrate and automate the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines so that physicians may tailor clinical decision making in real time. Physicians will be able to move through an automated decision-making process, factoring through disease staging and restaging, diagnostic tests, and choices for chemotherapy and supportive care treatment and monitoring. The Proventys CDS Oncology system will be available to oncologists in the community and hospitals in the fourth quarter of 2010, both directly and through payer-sponsored quality initiatives. Of the 110 NCCN cancerfocused guidelines, the program will initially focus on breast, colon, and non–

small-cell lung cancers, and Hodgkin lymphoma. P4 Healthcare This online healthcare community offers services to payers, pharma, and physicians. Services include consulting on rational physician reimbursement, specialty pharmacy services, free-standing retail infusion clinics, data sales on physician drug use, denial management software, and compliance with the P4 Pathways program. The P4 Pathways program refers to preferred treatment menus for selected cancer disease states. Compliance by physicians is tracked through claims data from a software program embedded in the oncologist’s practice management system, in addition to external data supplied via paper for clinical data not found in claims records. Physicians are reported as compliant or not compliant with fewer than 10 preidentified treatment choices for each disease state. Reporting is limited regarding treatment by state and stage of disease, and there is no tracking of which (or why) treatments administered outside of the identified preferred menu are chosen. P4 Healthcare has one contract with CareFirst BlueCross BlueShield of Maryland that tracks physician compliance with the menus. Another contract exists between the physician-led Oncology Physician Resource (OPR) and BlueCross BlueShield of Michigan, which uses P4 technology as the platform for tracking compliance with preferred menus created by the OPR physicians. Capital BlueCross of Pennsylvania announced a P4-based program, but little is known about implementation or compliance. BlueCross BlueShield of Tennessee announced a program with P4 Pathways, but met with significant physician resistance before it could be implemented. Highmark BlueCross of Pennsylvania recently announced an intention to offer P4 Pathways programs to physicians not using Via Oncology pathways; however, the programs have not yet

been implemented. (Healthcare Holding Solutions is under a pending sale agreement to Cardinal Health.) Via Oncology This subsidiary of the University of Pittsburgh Medical Center (UPMC) provides cancer value management services. Via Oncology develops oncology networks, which in turn provide a model of utilization and disease management through clinical algorithms and decision-support software applied by physicians at the point of care. Via Oncology Pathways started as UPMC clinical pathways and now encompass more than 17 disease sites with more than 500 decision/treatment branches individual to state and stage of disease. Physicians access the pathways through a web portal at the point of medical decision making. Reports track clinical decision making by state and stage of disease, as well as variation choices and reasons for variation for continual medical review. Via Oncology Pathways encompass medical oncology treatment, supportive care, diagnostics, and radiation oncology. More than half of the physicians now using the program are external to the UPMC network. Highmark BlueCross of Pennsylvania has contracted with UPMC to use Via Oncology Pathways for 3 years. (A recent UPMC/Highmark site of service disagreement led to an announcement that Highmark would also allow P4 Pathways programs to be considered by non-UPMC physicians, but the Via Oncology contract stills stands and is not affected by the hospital–payer disagreement.) Horizon BlueCross BlueShield of New Jersey has announced contracts with two large community physician practices to implement a program with Via Oncology Pathways. Other practices in states ranging from Maine to California are using their own implementation of Via Oncology Pathways in their private payer negotiations.

A promising future Payers and physicians are exploring a number of solutions, and consideration of a pathways program is a very hot topic. It is clear that there is great variation among the definitions and execution plans of clinical pathways in oncology, but demand for discussions on the topic will not slow. It will be interesting to see how quickly both payers and physicians embrace the technology and the concept to effect quality cancer programs. UnitedHealthcare is exploring evidence-based case rates and diseasemanagement payments for certain cancer sites among a handful of oncology practices. However, one large community oncology practice participating in that program noted that they would not have been in a position to negotiate a reasonable case rate and internal management process for this pilot if they had not already had an electronic health record system as well as been using the Via Oncology Pathways program for 1 year. The additional awareness of their ability to manage their cancer patients both as individuals and as a population gave them the operational and fiscal knowledge necessary to move forward with exploring the UnitedHealthcare program. As the discussion of oncology clinical pathways programs matures and the demand for information and integrated physician medical decision making at the point of treatment decision increases, the oncology pathways environment will probably look much different even over the next few years. The programs in place now will serve as an interesting, but ever-changing platform for the evolution of oncology clinical pathways for the future. l Disclosure Although the author consults in a variety of roles for physicians, payers, and some of the providers discussed, all information shared on the programs has been derived from publicly available sources and does not reflect confidential or proprietary information.

HEALTHCARE REFORM

CER Will Help Guide Health Policy By Caroline Helwick

CHICAGO—The cost of caring for cancer rose from $27 billion in 1990 to $90 billion in 2008, yet unwarranted variation in care and costs persists across centers, providers, and patients. There is little evidence on comparative effectiveness of the different management options and on the value provid-

october 2010 I VoL 3, No 7

ed by different healthcare services, but this is expected to change, said Elena B. Elkin, PhD, assistant attending outcomes research scientist at Memorial Sloan-Kettering Cancer Center, at the 2010 annual meeting of the American Society of Clinical Oncology. More than $1 billion in the stimulus

package is earmarked for comparative effectiveness research (CER), and these findings will be used to inform clinical guidelines, provider reimbursement, and coverage decisions and cost-sharing. Healthcare reform and the mandated expansion of insurance coverage provide “demand and opportunity” for

investigating the impact of insurance on cost and value of care. But in the interpretation of CER, she cautioned that “correlation does not equal causation,” and said that although there are “promises” inherent in the move toward CER there are “pitfalls” as well. l

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Presents the Third Annual Curriculum for

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Supportive Care

Revisiting the Use of IV Iron in Patients with Cancer By Michael Auerbach, MD Auerbach Hematology Oncology Associates, Baltimore, Maryland

he role of intravewas not until 1980, when nous (IV) iron as an Hamstra and colleagues addition to erythropublished their prospective poiesis-stimulating agents experience with 471 iron(ESAs) to optimize therapy deficient patients who in patients with anemia received IV iron dextran from cancer or chemothera(Imferon), that the first py-induced anemia has large series appeared.12 In this study, three patients been examined in nine were considered to have prospective, randomized trihad “anaphylactoid” reacals,1-9 all of which demon- Michael Auerbach, MD strated improvement in tions, with symptoms and ESA response, time to maximal signs including respiratory arrest, response, reduction in ESA dose to hypotension, purpura, cyanosis, dyspreach maximal response, and improve- nea, syncope, wheezing, and hives. ment in quality-of-life parameters There were no deaths. The authors con(when mea-sured). The observed bene- cluded that IV iron should be reserved fit was independent of baseline iron for conditions in which oral iron could parameters, and although responses not be used.12 IV iron remained on the were greater in iron-depleted patients, pharmacopeia, but its use was limited. In 1989, recombinant human erythsignificant benefit was seen in patients who were iron replete at study entry. ropoietin (EPO) became available for One study, which was powered to show the treatment of dialysis-associated anea difference in red blood cell transfu- mia. Shortly thereafter, numerous studsions, found a 36% reduction in the ies showed the benefit of IV iron in number of patients transfused.5 In all optimizing responses to EPO-treated these studies, which represent data on patients, and the addition of IV iron to more than 1200 patients, no significant the treatment paradigm in dialysis-assotoxicity was noted. ciated anemia became standard pracDespite these data, there remains tice. At the end of 1991, low-molecularresistance to the addition of IV iron to weight (LMW) iron dextran (INFeD, the standard treatment paradigm for can- Schein, now Watson Pharma) was cer and chemotherapy-induced anemia. released for clinical use and rapidly This resistance is, in large part, due to replaced HMW iron dextran, which misinformation and misinterpretation was removed from markets in 1992, as about the clinical nature of serious the IV iron formulation used in dialysis adverse events (AEs) associated with the centers. In 1996, the initial review of administration of IV iron. This brief safety was published. The authors conoverview aims to change this perception. cluded that AEs with LMW iron dextran were rare, and only a history of History allergies predicted otherwise infrequent In the early 20th century, Goetsch AEs.13 At the same time, another and colleagues introduced colloidal fer- HMW iron dextran (Dexferrum, ric hydroxide for IV infusion as therapy American Regent) was approved as an for patients with hypochromic ane- alternative to INFeD. No comparison mias.10 Toxic reactions to this prepara- safety data were, or subsequently are, tion were frequent and severe and set available. the stage for the admonition that IV In 2002, ferric gluconate (Ferrlecit, iron be reserved for only extreme clini- Schein, now Watson Pharma) and cal circumstances. In the 1940s, iron shortly thereafter iron sucrose (Venofer, saccharides—and shortly thereafter American Regent) were introduced as iron dextran—were introduced for clin- alternatives to iron dextran in patients ical use and were associated with an on dialysis. In two retrospective studies, acceleration of IV iron use for those sit- Michael and colleagues as well as uations in which oral iron was not Coyne and colleagues concluded that adequate. In 1964, Marchasin and serious AEs were much more common Wallerstein showed the felicitousness of with iron dextran than with ferric glutotal dose infusions of up to 3000 mg of conate,14,15 which rapidly replaced iron a high-molecular-weight (HMW) iron dextran for dialysis-associated anemia. dextran in 45 iron-deficient patients In 2004, however, Chertow and col(Imferon, Fisons PLC; no longer avail- leagues published a retrospective review able). All patients responded, and no of 30 million doses of IV iron, reporting serious toxicity was observed.11 Yet, it that serious AEs were much more likely

october 2010 I VoL 3, No 7

to occur with the HMW formulation and concluding that when this product is avoided, the other preparations (LMW iron dextran, iron sucrose, ferric gluconate) are safe with an incidence of serious AEs of <1:200,000.16 Five studies, albeit all retrospective, corroborated these findings.17-21 However, a sixth retrospective analysis reported no difference.22 Nonetheless, use of iron dextran in nephrology patients, for all intents and purposes, remains negligible.

The NCCN recommends that if iron is indicated, it should be given intravenously. The guidelines specifically proscribe HMW iron dextran by brand and state that the preferred product is LMW iron dextran.

Barriers to IV iron use Despite the safety and efficacy demonstrated in the nine prospective oncology studies, the clinical community’s larger perception of danger associated with the use of IV iron persists. Although AE rates may be driven higher by HMW iron dextran, all iron supplementation products suffer the stigma.23 This incorrect perception is further driven by the near lack of prospective comparison studies. Only two small prospective studies and one meta-analysis compared the efficacy and safety of LMW iron dextran with iron sucrose; no difference was seen.24-26 Another reason contributing to the sparse use of IV iron in oncology may be the lack of consensus on how best to administer the different products and the benefit or lack thereof of premedication. Premedication, which has been shown to be responsible for more side effects than IV iron itself27 and of no other clinical benefit, continues to be widely used before IV iron administration. After a test dose, acute myalgias (chest and back tightness) occur infrequently without tachycardia, hypotension, strider, or periorbital edema.28 This reaction abates within minutes and

rarely recurs with rechallenge. It is not rare for physicians and nurses unfamiliar with the innocuous nature of the reaction to intervene with antihistamines and pressors, which cause significant vasoactive reactions that are subsequently attributed to the IV iron. Lastly, inconvenience may contribute to the lack of widespread use of IV iron. In the United States (but not in Europe), payers do not allow the administration of ESAs and IV iron on the same day. This unsubstantiated regulation is fueled by the lack of ICD-9-CM codes for iron-restricted erythropoiesis or functional iron deficiency. For absolute iron deficiency, ESAs are contraindicated until iron is replete. For those common situations in chemotherapy-induced anemia when iron parameters suggest iron repletion, however, functional iron deficiency is often present, and addition of IV but not oral iron to the treatment paradigm, routinely improves responses to ESAs. If the only ICD-9-CM code for iron deficiency, 280.9, is placed on the billing form, the ESA will not be reimbursed; if omitted, however, the IV iron will not be covered. This conundrum remains. Recent developments The recent update to the National Comprehensive Cancer Network (NCCN) guidelines provides new optimism.29 The NCCN recommends that if iron is indicated, it should be given intravenously. The guidelines specifically proscribe HMW iron dextran by brand and state that the preferred product is LMW iron dextran (ie, INFeD). Principals at the US Food and Drug Administration (FDA), however, re cently published a review of the AE reporting on iron dextrans using the FDA AE reporting system, death certificates, and emergency department visits. They concluded that reactions with all of the products are possible and, using the current system, it is not possible to determine the relative rates of serious AEs with the absence of head-to-head trials.30 Furthermore, three new IV iron products promise to allow complete replacement of iron intravenously in 15 minutes or less. Of these, ferumoxytol (Feraheme, AMAG Pharmaceuticals) is approved in the United States as a 510-mg bolus injection administered over 17 seconds for patients with iron deficiency and chronic renal diseases. Data with higher doses are anticipated

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Supportive Care

in the near future as are safety and efficacy data in other conditions associated with iron deficiency. The other two products, iron carboxymaltose (Ferinject, Vifor Pharma) and iron isomaltoside (MonoFer, Pharmacosmos), are approved in Europe. Iron carboxymaltose can be administered as a 1-g infusion over 15 minutes, and iron isomaltoside as a 15-minute infusion in doses up to 20 mg/kg. The safety and efficacy of IV iron have been demonstrated with transferrin saturation up to 50% and serum ferritin levels up to 1000 ng/mL. Although all IV irons are associated with serious AEs, current reporting mechanisms tell us nothing about relative frequency of AEs. Based on the preponderance of published literature, it appears prudent to use HMW iron dextran with caution. These data suggest it may be time to revisit the treatment paradigm to include the routine use of IV iron within these parameters. l References 1. Auerbach M, Ballard H, Trout JR, et al. Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related

anemia: a multicenter, open-label, randomized trial. J Clin Oncol. 2004;22:1301-1307. 2. Henry DH, Dahl NV, Auerbach M, et al. Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Oncologist. 2007;12:231-242. 3. Hedenus M, Birgegård G, Näsman P, et al. Addition of intravenous iron to epoetin beta increases hemoglobin response and decreases epoetin dose requirement in anemic patients with lymphoproliferative malignancies: a randomized multicenter study. Leukemia. 2007;21:627632. 4. Pedrazzoli P, Farris A, Del Prete S, et al. Randomized trial of intravenous iron supplementation in patients with chemotherapy-related anemia without iron deficiency treated with darbepoetin alpha. J Clin Oncol. 2008;26:1619-1625. 5. Bastit L, Vandebroek A, Altintas S, et al. Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alpha administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. J Clin Oncol. 2008;26:1611-1618. 6. Auerbach M, Silberstein PT, Webb RT, et al. Darbepoetin alfa 300 or 500 mmg once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. Am J Hematol. June 4. 2010. Epub ahead of print. 7. Kim YT, Kim SW, Yoon BS, et al. Effect of intravenously administered iron sucrose on the prevention of anemia in the cervical cancer patients treated with concurrent chemoradiotherapy. Gynecol Oncol. 2007;105: 199-204. 8. Beguin Y, Maertens J, De Prijck B, et al. Darbepoetin-alfa and I.V. iron administration after autologous hematopoietic stem cell transplantation: a prospective randomized multicenter trial. Blood (ASH Annual Meeting Abstracts). 2008;112:54. 9. Dangsuwan P, Manchana T. Blood transfusion reduction with intravenous iron in gynecologic cancer

patients receiving chemotherapy. Gynecol Oncol. 2010; 116:522-525. 10. Goetsch AT, Moore CV, Minnich V. Observations on the effect of massive doses of iron given intravenously to patients with hypochromic anemia. Blood. 1946;1:129-142. 11. Marchasin S, Wallerstein RO. The treatment of iron-deficiency anemia with intravenous iron dextran. Blood. 1964;23:354-358. 12. Hamstra RD, Block MH, Schocket AL. Intravenous iron dextran in clinical medicine. JAMA. 1980;243:17261731. 13. Fishbane S, Ungureanu VD, Maesaka JK, et al. The safety of intravenous iron dextran in hemodialysis patients. Am J Kidney Dis. 1996;28:529-534. 14. Michael B, Coyne DW, Fishbane S, et al; for the Ferrlecit Publication Committee. Sodium ferric gluconate complex in hemodialysis patients: adverse reactions compared to placebo and iron dextran. Kidney Int. 2002;61:1830-1839. 15. Coyne DW, Adkinson NF, Nissenson AR, et al; for the Ferrlecit Investigators. Sodium ferric gluconate complex in hemodialysis patients. II. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients. Kidney Int. 2003;63:217-224. 16. Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmén J. On the relative safety of parenteral iron formulations. Nephrol Dial Transplant. 2004;19:1571-1575. 17. Mamula P, Piccoli DA, Peck SN, et al. Total dose intravenous infusion of iron dextran for iron-deficiency anemia in children with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2002;34:286-290. 18. Fletes R, Lazarus JM, Gage J, Chertow GM. Suspected iron dextran-related adverse drug events in hemodialysis patients. Am J Kidney Dis. 2001;37:743749. 19. McCarthy JT, Regnier CE, Loebertmann CL, Bergstralh EJ. Adverse events in chronic hemodialysis patients receiving intravenous iron dextran––a comparison of two products. Am J Nephrol. 2000;20:455-462. 20. Auerbach M. Finding a safe and effective intra-

venous iron treatment for restless legs syndrome. Sleep Med. 2010;11:429-430. 21. Ondo WG. Intravenous iron dextran for severe refractory restless legs syndrome. Sleep Med. 2010; 11:494-496. 22. Walters BA, Van Wyck DB. Benchmarking iron dextran sensitivity: reactions requiring resuscitative medication in incident and prevalent patients. Nephrol Dial Transplant. 2005;20:1438-1442. 23. Auerbach M, Glaspy J. What is the right balance between iron and erythropoiesis stimulating agents in chemotherapy induced anemia? European Journal of Clinical & Medical Oncology. 2009;1:17-20. 24. Sav T, Tokgoz B, Sipahioglu MH, et al. Is there a difference between the allergic potencies of the iron sucrose and low molecular weight iron dextran? Ren Fail. 2007;29:423-426. 25. Moniem KA, Bhandari S. Tolerability and efficacy of parenteral iron therapy in hemodialysis patients, a comparison of preparations. Transfus Alternat Transfus Med. 2007;9:37-42. 26. Critchley J, Dundar Y. Adverse events associated with intravenous iron infusion (low-molecular-weight iron dextran and iron sucrose): a systematic review. Transfus Alternat Transfus Med. 2007;9:8-36. 27. Barton JC, Barton EH, Bertoli LF, et al. Intravenous iron dextran therapy in patients with iron deficiency and normal renal function who failed to respond to or did not tolerate oral iron supplementation. Am J Med. 2000;109:27-32. 28. Auerbach M, Ballard H, Glaspy J. Clinical update: intravenous iron for anaemia. Lancet. 2007;369(9572): 1502-1504. 29. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Cancer- and Chemotherapy-induced Anemia. V.2.2011. www.nccn.org/pro fessionals/physician_gls/PDF/anemia.pdf. Accessed September 13, 2010. 30. Wysowski DK, Swartz L, Borders-Hemphill BV, et al. Use of parenteral iron products and serious anaphylactic-type reactions. Am J Hematol. 2010;85:650-654.

Simple Intervention Boosts Sperm Cryopreservation in Male Cancer Patients By Jill Stein

SAN FRANCISCO—An hour-long lecture by a fertility specialist during oncology grand rounds dramatically improves the rate of pretreatment sperm cryopreservation in young men with cancer, according to data presented by researchers at the American Urological Association 2010 Annual Scientific Meeting. The researchers, from the University of Wisconsin in Madison, found that a single lecture by an urologist specializing in male infertility increased sperm cryopreservation in male cancer patients fourfold. “Even though our study was observational, our results highlight the importance of educating our colleagues in the oncology world about this resource,” Daniel H. Williams IV, MD, assistant professor of urology and director of male reproductive medicine and microsurgery, said in an interview. His team compared sperm cryopreservation rates before and after the lecture, which focused on the risks of treatmentinduced male infertility, advances in assisted reproductive technology, and the local availability of sperm cryopreservation.

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The dramatic increase in sperm cryopreservation seen 1 month after the lecture was maintained at follow-up several months later. Because of therapeutic advances, pediatric and adult cancer survivors are living “well into” their reproductive years, Williams pointed out. However, most cancer treatment regimens have adverse effects on testicular function

Oncology has recommended that oncologists routinely discuss the potential for infertility as well as fertility preservation options with patients before cancer therapy and also refer interested patients to reproductive specialists. In addition, the guidelines recommend that semen cryopreservation be adopted as standard practice. Unfortunately, epidemiologic studies

“Cancer treatments now focus not only on survival but on quality of life, and fertility and fertility potential is a large component of quality of life after cancer treatment.” —Daniel H. Williams IV, MD

and male reproductive potential. Unfortunately, posttreatment fecundity is difficult to predict. Sperm cryopreservation provides an opportunity to preserve a man’s fertility before cancer treatment, he said. In fact, the American Society of Clinical

indicate that most young male cancer patients are not advised to bank sperm before their cancer treatment. Surveys have consistently identified a lack of information as the main reason for the low sperm cryopreservation rate. About 40 healthcare personnel at-

tended the lecture. Attendees were mostly pediatric and adult oncologists but also included oncology nurses and other staff. In the 24-month period before the lecture, only one cancer patient per month banked sperm. After the lecture, the rate significantly increased to 3.7 cancer patients per month over the subsequent 7 months after the lecture (P <.0001). Most of the change was due to a nearly sixfold increase in the number of nontesticular cancer patients, from 0.42 to 2.42 per month (P <.0001). “With improvements in cancer therapies, young men of reproductive age who develop cancers—lymphomas, leukemias, and testicular malignancies, among others—are surviving longer,” Williams said. “As a result, cancer treatments now focus not only on survival but on quality of life, and fertility and fertility potential is a large component of quality of life after cancer treatment.” Continued efforts should be made to educate healthcare professionals about sperm cryopreservation with an emphasis on improving the comprehensive cancer care and posttreatment quality of life in these patients, he added. l

october 2010 I VoL 3, No 7

Genetics

Identifying Newly Diagnosed Individuals with Breast Cancer at Risk for Hereditary Breast Cancer By Cristi Radford, MS, CGC Sarasota Memorial Health Care System, Sarasota, Florida

ultiple professional sion: one before definitive and societal guidesurgery and one after lumplines emphasize the ectomy and before radiaimportance of genetic countion therapy. In addition, seling and testing for indineither referral was interviduals at risk for hereditnal. To increase the number ary breast cancer.1,2 For a of women offered genetic woman newly diagnosed counseling and testing with breast cancer, informabefore definitive surgery, tion gained from genetic SMHCS implemented a counseling and testing can Cristi Radford, MS, CGC quality-improvement inidirectly impact her surgical tiative. Identification fomanagement and treatment plan. cused on women at risk for HBOC. The Of the syndromes known to have an genetic counselor met with breast elevated risk of breast cancer, hereditary health (BH) clinicians, four oncology breast and ovarian cancer (HBOC) is certified nurses, to determine the prethe most common. HBOC is associated ferred medium for a risk assessment tool. with mutations in the BRCA1 and A flow sheet, modeled on Medicare criBRCA2 genes. Women with a BRCA teria for BRCA1/2 testing, was designed mutation have up to a 65% chance of to capture women with personal and developing a new primary breast can- family histories suggestive of HBOC. cer3 and often choose mastectomy with BH clinicians used the tool during contralateral risk-reducing mastectomy intakes for all individuals presenting for over breast-conservation surgery.4,5 Ac- biopsy, and information was recorded. cording to the American Society of For individuals returning to the BH Breast Surgeons, in ideal circumstances, center with positive results, a BH clinipatients who are at significant risk for cian introduced genetics. Fact sheets for harboring a BRCA mutation may interested clients were faxed to the undergo testing before definitive sur- genetic counselor for an appointment. gery.6 However, for a woman and her Between January 1, 2009, and Dehealthcare team to use genetic informa- cember 31, 2009, 99.6% (229/230) of tion, a woman has to be identified as at newly diagnosed individuals seen at the risk and undergo appropriate services in BH center were screened for features of a timely manner. One method for iden- HBOC. Approximately, one fourth tifying women at risk for BRCA muta- (53/229) were identified as being at risk tions is an inexpensive, one-page flow for BRCA mutations. This is consistent chart. with data obtained at major academic A chart review of patients seen medical centers.7 BH clinicians were between May 1, 2007, and December involved in positive biopsy disclosure 31, 2008, at Sarasota Memorial Health for 23 (43.4%) at-risk individuals. Of Care System’s (SMHCS) Genetic Ed- the 19 (82.6%) individuals referred for ucation Program revealed that only two genetic counseling, the genetic counindividuals were referred for genetic selor spoke with and offered services to counseling at the time of surgical deci- 15 individuals: seven proceeded with

genetic counseling before definitive surgery, one after treatment was complete, three were uninsured and could not afford the cost, and four were not interested. Regarding the at-risk individuals who did not receive positive results from BH clinicians, as of July 1, 2010, 23% (7/30) had been referred for genetic counseling. However, none were referred before definitive surgery. A chart review is planned to determine if any at-risk individuals underwent inoffice genetic testing.

biopsy results from BH clinicians. In addition, as of July 1, 2010, only 17 of 53 at-risk individuals had undergone a genetic counseling consult at SMHCS. Identifying individuals at risk for hereditary breast cancer requires a multidisciplinary team approach. The mechanism used depends on the needs and resources of the institution. To ensure all at-risk individuals are offered genetic services, hospitals need to evaluate their current method of identification and consider collaboration with local genetic professionals and/or companies providing phone genetic counseling. l

By creating a flow chart and providing minimal training to BH clinicians, SMHCS was able to increase the number of women speaking to a genetic counselor before definitive surgery from one to 15.

References

By creating a flow chart and providing minimal training to BH clinicians, SMHCS was able to increase the number of women speaking to a genetic counselor before definitive surgery from one to 15. Although this is a greater than 1000% increase, it is less than ideal. The National Comprehensive Cancer Network guidelines clearly state “a genetic counselor or medical geneticist should be involved early in counseling patients who potentially meet criteria for an inherited syndrome.”8 The process failed to account for the 30 at-risk individuals who would not receive positive

1. Lu K, Kauff N, Powell B, et al; for American College of Obstetricians and Gynecologists; ACOG Committee on Practice Bulletins—Gynecology; ACOG Committee on Genetics; and Society of Gynecologic Oncologists. ACOG practice bulletin No. 103: hereditary breast and ovarian cancer syndrome. Obstet Gynecol. 2009;113: 957-966. 2. Khatcheressian JL, Wolff AC, Smith TJ, et al; for the American Society of Clinical Oncology. American Society of Clinical Oncology 2006 update of the breast cancer follow-up and management guidelines in the adjuvant setting. J Clin Oncol. 2006;24:5091-5097. 3. Antoniou A, Pharoah PDP, Narod S, et al. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2 mutations detected in case series unselected for family history: a combined analysis of 22 studies. Am J Hum Genet. 2003;72:1117-1130. 4. Stolier AJ, Fuhrman GM, Mauterer L, et al. Initial experience with surgical treatment planning in the newly diagnosed breast cancer patient at high risk for BRCA-1 or BRCA-2 mutation. Breast J. 2004;10:475-480. 5. Schwartz MD, Lerman C, Brogan B, et al. Impact of BRCA1/BRCA2 counseling and testing on newly diagnosed breast cancer patients. J Clin Oncol. 2004;22: 1823-1829. 6. American Society of Breast Surgeons Official Statement. BRCA genetic testing for patients with and without breast cancer. June 12, 2006. www.breastsur geons.org/statements/PDF_Statements/BRCA_Testing. pdf. Accessed July 1, 2010. 7. Shannon KM, Lubratovich ML, Finkelstein DM, et al. Model-based predictions of BRCA1/2 mutation status in breast carcinoma patients treated at an academic medical center. Cancer. 2002;94:305-313. 8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Genetic/Familial High-Risk Assessment: Breast and Ovarian. V.1.2010. www.nccn.org/ professionals/physician_gls/PDF/genetics_screening.pdf. Accessed July 1, 2010.

MODELS OF CARE

Breast Centers... continued from page 11 costs $50,000 to $75,000, is a cost-effective solution for older women with less dense breasts. However, image quality and cancer detection rates are inferior to digital mammography for select patients. Analog mammography also requires film to be processed and stored,” he said. FFDM, which costs $350,000 to $450,000, provides enhanced image quality for younger women with more dense breasts. A drawback is that it is an expensive digital imaging solution,

october 2010 I VoL 3, No 7

compared with film or computed radiography mammography. Katz encourages breast centers to evaluate and weigh the benefits of these technologies in the patients they treat. Up-and-coming technology systems that breast centers might consider in the future include positron-emission mammography (PEM) and breast-specific gamma imaging (BSGI). PEM is more costly, compared with BSGI ($600,000-$700,000 vs $250,000$300,000, respectively). Both technolo-

gies have higher specificity and fewer false positives, compared with breast MRI. BSGI is also favored by breast surgeons. Few breast centers are currently using PEM or BSGI, and few large-scale clinical studies have evaluated the efficacy of these technologies, explained Katz. The future of cancer centers The feedback from healthcare providers and patients receiving treatment at breast centers has been “uniformly

positive,” said Katz. The strides made with breast centers are laying the foundation for other tumor site–specific centers, such as lung, colorectal, and prostate cancer. “Breast centers are the furthest along in setting the standards and moving ahead with tumor-specific sites. They are leading the charge for setting the stage for these types of tumor-site strategies,” said Katz. “It is very exciting to see these centers accomplish their mission and improve patient outcomes.” l

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Genetics

Genetic Profiling Changing Clinical Practice in Some Areas of Oncology By John Schieszer

CHICAGO—Gene-expression profiling, combined with a novel chemoradiation regimen, may predict pathologic complete response in patients with esophageal cancer, according to new data presented at the 46th annual meeting of the American Society of Clinical Oncology. New studies presented at this meeting highlighted several new “genetic fingerprinting” techniques that may improve and guide chemotherapy in specific cancer populations. Researchers looked at pathologic complete response rate and toxicity in a phase 2 trial involving 36 patients with stage II to IVa esophageal cancer, 29 (81%) of whom had undergone surgery in the course of their treatment. The treatment consisted of three 85-mg/m2 doses of oxaliplatin over the course of a month, a 625-mg/m2 twice-daily dose of oral capecitabine, and radiation therapy, followed by surgery 4 to 6 weeks later. Two cycles of oxaliplatin and capecitabine were given postoperatively. Gene-expression profiling (using microarrays by Agilent Technology) was conducted on primary tumor tissue. The researchers have found that eight of the 29 patients who had their esophagus removed following the oxaliplatin regimen had no cancer in the surgical specimen (a 28% pathologic complete response rate). “Another clear result is that this regimen is very welltolerated by patients without significant

side effects,” said study investigator Nikhil Khushalani, MD, assistant professor of medicine at Roswell Park Cancer Institute, Buffalo, New York. “There appear to be several gene pathways that are enriched when studying different subgroups, the pathologic complete response group versus the nonpathologic complete response group.” The study continues to accrue patients, and Khushalani expects to have mature survival data by fall 2010. “I believe this is an efficacious regimen, and it’s definitely well-tolerated,” he said. “We hope that the exploratory gene-expression profiling results will translate into clinically meaningful hypotheses that can be validated in a large, preferably multicenter study.” Genetic profiling to identify trastuzumab resistance in breast cancer patients Other researchers at Roswell Park Cancer Institute are hoping to determine whether genetic profiling may effectively identify which breast cancer patients are most likely to respond to the drug trastuzumab. Trastuzumab interferes with a protein, known as the human epidermal growth factor receptor type 2 (HER2), which is linked to breast cancer. However, a high number of breast cancer patients (approximately 50%) don’t respond to the drug and experience

recurrence. Currently, there is great interest in research that might elicit factors that drive responses. Over the past 2 years, researchers looked at 41 breast carcinoma cases in which amplified HER2 levels were seen

“The group that was treated with trastuzumab and developed recurrence had a genetic makeup different from those who were not treated and developed recurrence.” —Thaer Khoury, MD

and for which fresh frozen tissue was available. Of these patients, 12 were treated with trastuzumab, and three (25%) experienced recurrence. Among the 11 patients not treated with the drug, six (55%) had recurrence. Gene microarrays were used to identify differentially expressed genes for trastuzumab (responsive vs resistant). The investigators found that the dif-

ferentially expressed genes for recurrence or nonrecurrence were distinct between the group treated with trastuzumab and the group that was not treated with the drug. The researchers predict that differential expression of key genes identified in this study may offer insights into trastuzumab resistance among breast cancer patients. It is hoped that this type of technology fingerprinting can lead to new potential biomarkers for diagnosis, prognosis, and treatment. “The group that was treated with trastuzumab and developed recurrence had a genetic makeup different from those who were not treated and developed recurrence,” said study investigator Thaer Khoury, MD, who is an assistant professor of pathology and laboratory medicine at Roswell Park Cancer Institute. “The idea from the beginning was to know why these patients who are treated with trastuzumab develop recurrence and why the others did not. There is definitely something going on, and we’re starting to understand these mechanisms.” Khoury, who presented the study findings at the meeting, said they should be of particular interest to clinicians working in this area of cancer. The message about treatment and how it should be guided is now changing, as molecular markers are complementing clinical markers. l

MODELS OF CARE

Undiagnosed Cancer Clinic Helps Patients Deal with the Unknown

team of oncology clinicians in New York has now started what they call “The Undiagnosed Cancer Clinic.” The clinic was launched mroe than 1 year ago, and it has become an important new resource for primary care providers and their patients in cases where cancer is suspected but a clear diagnosis is not indicated by symptom presentation and/or diagnostic tests. In many respects, the clinic it is something that is long overdue and may start a new trend in oncology. The Undiagnosed Cancer Clinic has been set up by a team of oncology experts at Roswell Park Cancer Institute, Buffalo,

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New York, to help improve the efficiency of diagnosis and care of cancer for people living in and around western New York. However, because of its success, other clinics like this may sprout up around the United States. “It’s about efficiency and decreased wait times for these patients and their families, and the ability to drill down to what the issue is,” said Martin Mahoney, MD, PhD, who helps run the clinic. In many of the patients presenting at this clinic, cancer is suspected or an abnormality has been found on a radiogram or computed tomography scan that is consistent with cancer, but fur-

ther testing and a biopsy is needed to confirm what type of cancer it is. The clinic’s multidisciplinary team of spe-

This clinic is designed to …get these patients diagnosed and set on a treatment plan as quickly as possible.

cialists can obtain a biopsy using the most appropriate method, make a diag-

nosis, and refer the patient for care with one of the disease-site experts at Roswell Park Cancer Institute. Mahoney pointed out often valuable time can be lost as care providers try to determine what to do next, and which type of biopsy may be the least invasive and yield rapid results. In some cases, he said, patients are referred from specialist to specialist in the effort to make a definitive diagnosis. The Undiagnosesed Cancer Clinic is designed to combat that problem and get these patients diagnosed and started on a treatment plan as quickly as possible. l —JS

october 2010 I VoL 3, No 7

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

Medications Used for the Treatment of Breast Cancer Breast cancer forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare. The following sections will assist healthcare professionals and payers by providing appropriate coding, billing, and reimbursement information associated with the management of breast cancer. The following sections include: • Associated ICD-9-CM codes used for the classification of breast cancer • Drugs that have been FDA-approved in the treatment of breast cancer • Drugs that are compendia listed for off-label use for breast 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 • Current Code Price (AWP-based pricing) • Most recent ASP plus 6% (Medicare allowable), if applicable • Possible CPT® Administration Codes for each medication

generic (Brand) name

HCPCS code: code description

anastrozole (Arimidex)

J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0170: anastrozole, oral, 1 mg

anastrozole (Arimidex) bacillus Calmette-Guerin (Tice BCG, TheraCys) bevacizumab (Avastin) capecitabine (Xeloda) capecitabine (Xeloda) carboplatin (Paraplatin) cisplatin (Platinol AQ) cisplatin (Platinol AQ) cyclophosphamide (Cytoxan) cyclophosphamide (Cytoxan)

Associated ICD-9-CM Codes Used for Breast Cancer 174 Malignant neoplasm of female breast Includes: breast (female) connective tissue soft parts Paget’s disease of: breast nipple Use additional code to identify estrogen receptor status (V86.0, V86.1) Excludes: skin of breast (172.5, 173.5) 174.0 Nipple and areola 174.1 Central portion 174.2 Upper-inner quadrant 174.3 Lower-inner quadrant 174.4 Upper-outer quadrant 174.5 Lower-outer quadrant 174.6 Axillary tail 174.8 Other specified sites of female breast Ectopic sites

This information was supplied by:

FDAapproved for breast cancer

175 Malignant neoplasm of male breast Use additional code to identify estrogen receptor status (V86.0, V86.1) Excludes: skin of breast (172.5, 173.5) 175.0 Nipple and areola 175.9 Other and unspecified sites of male breast Ectopic breast tissue, male

PO BOX 290616, Wethersfield, CT 06109 T: (860) 563-1223 • F: (860) 563-1650 www.RJHealthSystems.com

Compendia listed off-label use for breast cancera

Current code price (AWP-based pricing), effective 10/1/10 NDC level pricing $13.48

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10

CPT ® administration codes

$169.10

NDC level pricing S0170: not payable by Medicare $114.93

96413, 96415

$68.50

$58.44

96413, 96415

$8.52

$6.85

N/A

$28.41

$22.58

N/A

$48.55

$3.70

96409, 96413, 96415

$4.33

$1.50

96409, 96413, 96415

$21.66

$7.49

96409, 96413, 96415

$2.09

$0.83

$10.57

$5.96

J9031: bCG (intravesical) per installation J9035: injection, bevacizumab, 10 mg J8520: capecitabine, oral, 150 mg J8521: capecitabine, oral, 500 mg J9045: injection, carboplatin, 50 mg J9060: cisplatin, powder or solution, per 10 mg J9062: cisplatin, 50 mg J8530: cyclophosphamide, oral, 25 mg J9070: cyclophosphamide, 100 mg (all 100-mg NDCs inactive: 500-mg NDCs used to calculate code price)

174.9

Inner breast Lower breast Malignant neoplasm of contiguous or overlapping sites of breast whose point of origin cannot be determined Midline of breast Outer breast Upper breast Breast (female), unspecified

N/A

N/A 96409, 96413, 96415

Continued on page 28

october 2010 I VoL 3, No 7

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Chronic Lymphocytic Leukemia The Essentials of Patient Care LOG ON TODAY TO PARTICIPATE www.coexm.com/ace02.asp Release Date: April 29, 2010 Expiration Date: April 28, 2011

TARGET AUDIENCE This activity is intended for hematologists, oncologists and others who are involved with the care of patients with Chronic Lymphocytic Leukemia (CLL).

STATEMENT OF NEED CLL is the most common type of leukemia in the United States, with over 15,000 new cases per year, characterized by the accumulation of monoclonal B cells in the bone marrow, peripheral blood, and lymphoid tissue. Primarily a disease of the elderly, the median survival for CLL varies substantially: many patients survive more than 10 years after diagnosis, but a subset of symptomatic patients have shorter life expectancies—in the range of 1.5 to 6 years. The clinical/research body of knowledge in CLL is rapidly changing and represents a challenge for the whole treatment team.

FACULTY Neil E. Kay, MD Professor Department of Medicine Mayo Clinic Rochester, Minnesota

Michael Keating, MD Course Chair Professor of Medicine Deputy Department Chairman Department of Leukemia M.D. Anderson Cancer Center Houston, Texas

EDUCATIONAL OBJECTIVES On completion of this activity, participants should be able to: • List the essential steps in diagnosis and treatment planning of the CLL patient • Select CLL treatment regimens based on patient characteristics • Define data supporting the benefit/risk ratio of upfront, relapsed, and refractory CLL setting • Define strategies to manage fludarabine-resistant CLL • Describe emerging therapies in CLL

This activity is supported by an educational grant from Genentech BioOncology and Biogen Idec.

This activity has been approved for 1.5 AMA PRA Category 1 Credits™. For further information and to participate, please go to: www.coexm.com/ace02.asp

In collaboration with

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 26

generic (Brand) name cyclophosphamide (Cytoxan)

cyclophosphamide (Cytoxan) cyclophosphamide (Cytoxan) cyclophosphamide (Cytoxan) daunorubicin citrate liposome (DaunoXome) docetaxel (Taxotere) doxorubicin (Adriamycin) doxourubicin HCl liposome (Doxil) epirubicin (Ellence) estradiol (Estrace) etoposide (Vepesid) exemestane (Aromasin) exemestane (Aromasin)

HCPCS code: code description J9080: cyclophosphamide, 200 mg (all 100-mg NDCs inactive: 500-mg NDCs used to calculate code price) J9090: cyclophosphamide, 500 mg J9091: cyclophosphamide, 1 gram J9092: cyclophosphamide, 2 gram J9151: injection, daunorubicin citrate, liposomal formulation, 10 mg J9171: injection, docetaxel, 1 mg J9000: injection, doxorubicin hydrochloride, 10 mg J9001: injection, doxorubicin hydrochloride, all lipid formulations, 10 mg J9178: injection, epirubicin HCl, 2 mg J8499b: prescription drug, oral, non-chemotherapeutic, not otherwise specified J8560: etoposide, oral, 50 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0156: exemestane, 25 mg

fluorouracil (Adrucil) fluoxymesterone (Androxy)

J9190: injection fluorouracil, 500 mg J8499b: prescription drug, oral, non-chemotherapeutic, not otherwise specified fulvestrant J9395: injection, fulvestrant, (Faslodex) 25 mg gemcitabine J9201: injection, (Gemzar) gemcitabine hydrochloride, 200 mg goserelin acetate J9202: goserelin acetate (Zoladex 3.6 mg ONLY) implant, per 3.6 mg hydroxyurea J8999b: prescription drug, (Hydrea) oral, chemotherapeutic, not otherwise specified hydroxyurea S0176: hydroxyurea, oral, (Hydrea) 500 mg ifosfamide (Ifex)

J9208: injection, ifosfamide, 1 gram

october 2010 I VoL 3, No 7

Current code price (AWP-based pricing), effective 10/1/10 $21.15

$52.87

$29.79

96409, 96413, 96415

$95.21

$59.59

96409, 96413, 96415

$171.35

$119.18

96409, 96413, 96415

$68.00

$57.66

96413

$24.29

$18.01

96413

$13.20

$3.04

96409

$613.03

$486.80

96413

$5.38

$1.80

NDC level pricing $57.33

NDC level pricing $28.48

N/A

$3.37

NDC level pricing S0156: not payable by Medicare $1.74

N/A

NDC level pricing $13.50

NDC level pricing $97.29

NDC level pricing $83.02

96402

$177.83

$148.35

96413

$451.19

$194.29

96372, 96402

FDAapproved for breast cancer

Compendia listed off-label use for breast cancera

3 3

NDC level pricing $1.28

$56.40

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10 $11.92

NDC level pricing S0176: not payable by Medicare $34.15

CPT 速 administration codes 96409, 96413, 96415

96409, 96413

N/A

96409 N/A

N/A

96413, 96415

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

generic (Brand) name

HCPCS code: code description

irinotecan (Camptosar) ixabepilone (Ixempra) lapatinib ditosylate (Tykerb)

J9206: injection, irinotecan, 20 mg J9207: injection, ixabepilone, 1 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J0640: injection, leucovorin calcium, per 50 mg J9217: leuprolide acetate (for depot suspension), 7.5 mg J9218: leuprolide acetate, per 1 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0178: lomustine, oral, 10 mg

letrozole (Femara) leucovorin calcium (Wellcovorin) leuprolide (Eligard, Lupron Depot) leuprolide (Lupron) lomustine (CeeNu) lomustine (CeeNu)

CPT 速 administration codes

$31.48

$6.12

96413, 96415

$73.76

$63.74

96413, 96415

NDC level pricing NDC level pricing $3.60

NDC level pricing NDC level pricing $1.05

$493.20

$208.22

96402

$27.52

$4.79

96402

$9.67

NDC level pricing S0178: not payable by Medicare $8.12

N/A

NDC level pricing $10.59

FDAapproved for breast cancer

medroxyprogesterone J1051: injection, (Depo-Provera) medroxyprogesterone acetate, 50 mg megestrol J8999b: prescription drug, (Megace) oral, chemotherapeutic, not otherwise specified megestrol S0179: megestrol acetate, (Megace) oral 20 mg melphalan (Alkeran) melphalan (Alkeran) methotrexate sodium methotrexate sodium methotrexate sodium mitomycin (Mutamycin) mitomycin (Mutamycin) mitomycin (Mutamycin) mitoxantrone (Novantrone) oxaliplatin (Eloxatin)

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10

J8600: melphalan, oral, 2 mg J9245: injection, melphalan hydrochloride, 50 mg J8610: methotrexate, oral, 2.5 mg J9250: methotrexate sodium, 5 mg J9260: methotrexate sodium, 50 mg J9280: mitomycin, 5 mg J9290: mitomycin, 20mg J9291: mitomycin, 40 mg J9293: injection, mitoxantrone hydrochloride, per 5 mg J9263: injection, oxaliplatin, 0.5 mg

Compendia listed off-label use for breast cancera

Current code price (AWP-based pricing), effective 10/1/10

NDC level pricing $0.66

NDC level pricing S0179: not payable by Medicare $4.80

N/A

96372, 96374, 96409

N/A

96402

N/A

$5.68

$1,922.50

$1,401.83

$3.61

$0.12

$0.29

$0.19

$2.86

$1.89

$67.20

$20.77

96372, 96374, 96401, 96409, 96450 96372, 96374, 96401, 96409, 96450 96409

$218.40

$83.07

96409

$300.00

$166.15

96409

$106.50

$40.83

96409, 96413

$8.25

$4.71

96413, 96415

N/A 96409, 96413 N/A

Continued on page 30 www.jomcc.com

october 2010 I VoL 3, No 7

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 29

generic (Brand) name paclitaxel (Taxol) paclitaxel protein-bound particles (Abraxane) pemetrexed (Alimta) prednisone tamoxifen (Nolvadex) tamoxifen (Nolvadex) testolactone (Teslac) thiotepa (Thiotepa) toremifene citrate (Fareston) trastuzumab (Herceptin) triptorelin (Trelstar Depot, Trelstar LA) topotecan (Hycamtin) topotecan (Hycamtin) vinBLAStine vinCRIStine (Vincasar) vinCRIStine (Vincasar) vinCRIStine (Vincasar) vinorelbine (Navelbine)

HCPCS code: code description J9265: injection, paclitaxel, 30 mg J9264: injection, paclitaxel protein-bound particles, 1 mg J9305: injection, pemetrexed, 10 mg J7506: prednisone, oral, per 5 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0187: tamoxifen citrate, oral, 10 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J9340: injection, thiotepa, 15 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J9355: injection, trastuzumab, 10 mg J3315: injection, triptorelin pamoate, 3.75 mg J8705: topotecan, oral, 0.25 mg J9350: injection topotecan, 4 mg J9360: injection, vinblastine sulfate, 1 mg J9370 : vincristine sulfate, 1 mg J9375: vincristine sulfate, 2 mg J9380: vincristine sulfate, 5 mg J9390: injection, vinorelbine tartrate, per 10 mg

Current code price (AWP-based pricing), effective 10/1/10 $15.54

$11.20

$9.38

96413

$61.65

$51.44

96409

$0.04

N/A

NDC level pricing $1.89

N/A

NDC level pricing $138.00

NDC level pricing S0187: not payable by Medicare NDC level pricing $114.09

NDC level pricing $78.26

NDC level pricing $68.28

96413, 96415

$870.00

$181.93

96372, 96402

$89.73

$77.10

N/A

$1,306.10

$1,090.84

96413

$3.18

$1.64

96409

$5.83

$3.98

96409

$11.66

$7.96

96409

$29.15

$19.90

96409

$42.60

$11.05

96409

FDAapproved for breast cancer

Compendia listed off-label use for breast cancera

3 3

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10 $7.45

CPT ® administration codes 96413, 96415

N/A

51720, 96409 N/A

Compendia references available upon request. When billing a non-classified medication using a CMS 1500 claim form you must include both the HCPCS code (ie, J8999 for Nolvadex) in Column 24D and the drug name, strength, and National Drug Code (NDC) in Box 19 in order to ensure appropriate reimbursement.

References HCPCS Level II Expert 2010 • Current Procedural Terminology (CPT®) 2010 (CPT © copyright 2010 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Volumes 1 and 2, 2010 • The Drug Reimbursement Coding and Pricing Guide by RJ Health Systems International, LLC, Volume 7, Number 4, 4th Quarter 2010 • FDA-approved indication (from the product’s prescribing information) • National Cancer Institute® • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Wethersfield, Connecticut • CMS (Centers for Medicare & Medicaid Services), Medicare Allowable 4th Quarter 2010 (effective dates 10/1/10-12/31/10). Prices listed herein are effective as of October 1, 2010.

october 2010 I VoL 3, No 7

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CONTINUING EDUCATION CREDITS Current activities at www.COEXM.com include:

Hematologic Cancers

New “Tip Sheets” Help NHL Patients Communicate with the Oncology Team By Caroline Helwick

research-based educational program aimed at enhancing communication between nonHodgkin lymphoma patients and their healthcare providers has just been launched and is available for healthcare providers. Framing Life With Lymphoma was developed by the Cancer Support Community, which unites The Wellness Community and Gilda’s Club Worldwide, and was supported by a grant from Cephalon. “Non-Hodgkin lymphoma is the seventh most common cancer, yet the majority of people who are diagnosed have very little information on the disease and how it may impact their

lives,” said David Henry, MD, clinical professor of medicine at Pennsylvania Hospital and the physician advisor for Framing Life With Lymphoma. The program contains simple tip sheets outlining ways to approach each conversation the patient is likely to encounter from diagnosis through treatment. The information was created through input from an expert steering committee and a national survey of 150 hematologists/oncologists and 133 patients with indolent lymphoma. The survey found that 96% of physicians and 86% of patients felt their communication could be made more efficient with informational aids. The survey also revealed that about two in

five patients do not ask all their intended questions during visits, usually because they don’t remember. “This survey shows that it is critical that patients have resources to help them understand their condition and treatment options. This helps them communicate more effectively with their physicians,” Henry said. “In addition to providing information, physicians need to work with their patients to create a team-based approach to treatment,” he added. “Working as a team creates an environment where informed patients are more comfortable addressing their concerns and questions, and this can have a positive impact on their overall

treatment experience.” Kim Thiboldeaux, president and CEO of the Cancer Support Community, also applauded the program. “We hope Framing Life With Lymphoma will become an important resource for the lymphoma community,” she said. “A clear majority of patients and physicians reported that discussion materials would improve their conversations. That is what this program aims to do.” The patient tip sheets for newly diagnosed patients and those undergoing treatment, along with the survey results and other program information, can be downloaded at www.Framing LifeWithLymphoma.org. l

INTERNATIONAL NEWS

Reports from the European Society of Cardiology Congress and the Joint Annual Meeting of the International Continence Society and International Urogynecological Association By Jill Stein

Western Lifestyle Responsible for UK Breast Cancer Surge LONDON—A Western lifestyle characterized by an excess of food and alcohol and a lack of exercise may explain increasing breast cancer rates in the United Kingdom, new data suggest. Findings from the World Cancer Research Fund (WCRF) show that the breast cancer rate in the United Kingdom is more than four times higher than in eastern Africa, which has the lowest breast cancer rate worldwide. The organization recently reported that 87.9 women per 100,000 in the United Kingdom were diagnosed with breast cancer in 2008 versus only 19.3 women per 100,000 women in eastern Africa, which includes Kenya and Tanzania. Cancer experts have suggested that the growing gap in breast cancer rates between rich and poor countries may be partly a function of better surveillance and diagnosis in wealthier countries. They also emphasize, however, that lifestyle is an important contributor. In fact, it is estimated that 40% of breast cancer cases in the United Kingdom, or more than 18,000 cases per year, could be avoided if women adopted a healthier lifestyle involving a better diet, more exercise, and less alcohol. Women in eastern Africa consume less alcohol than UK women and are less likely to be obese. They are also more

october 2010 I VoL 3, No 7

likely to breastfeed, and breastfeeding has been associated with a lower rate of breast cancer. Rachel Thompson, MD, with the WCRF, said that breast cancer is not the only cancer for which lifestyle may be a contributor. In fact, roughly a third of the most common cancers in the United Kingdom could be prevented by lifestyle changes, she noted.

No Evidence that Statins Cause Cancer STOCKHOLM—Statins do not increase the risk of cancer, according to the results of a large meta-analysis released at the European Society of Cardiology Congress 2010. Researchers from the University of Oxford, United Kingdom, and the University of Sydney, Australia, said in a news release that their results will “reassure the millions of people worldwide who are taking statins to lower cholesterol levels and clarify earlier research that had raised concerns of a causal link.” The data are from the Cholesterol Treatment Trialists’ Collaboration, which reviewed data from 170,000 patients enrolled in 26 trials. Overall, 10,000 patients developed cancer and more than 3500 died of cancer. “Statin therapy had no adverse effect on cancer at any site or in any group of individuals, irrespective of their cholesterol levels,” said principal investigator

Statin therapy had no adverse effect on cancer at any site or in any group of individuals, irrespective of their cholesterol levels. Jonathan Emberson, MD, of the University of Oxford. “There was also no association of cancer with statin dose or duration.” The study was funded by the UK Medical Research Council, the British Heart Foundation, and the National Health and Medical Research Council (Australia).

Overactive Bladder without Hematuria May Be Cancer Symptom TORONTO—Overactive bladder (OAB) symptoms without hematuria may be a presenting symptom of bladder cancer, researchers reported at the joint annual meeting of the International Continence Society and International Urogynecological Association. Most patients with bladder cancer present with hematuria. Jeffrey Weiss, MD, of State University of New York Downstate College of Medicine in Brooklyn, and colleagues searched a database for the years 1998 through 2008 to identify patients without hematuria who underwent cystoscopy as part of an evalua-

tion for refractory OAB. Overall, 1420 patients underwent cystoscopy, and eight were found to have bladder cancer. The mean duration of OAB symptoms was 3.3 years. In all cases, the initial biopsy in patients with bladder cancer demonstrated low-grade Ta transitional carcinoma that, in most cases, resembled a typical papillary transitional cell tumor on cystoscopy. At a mean follow-up of 5.2 years, four (50%) patients had experienced one or two recurrences and two had disease progression—in one case to carcinoma in situ and in the other case to high-grade T3 disease. The study also found that bladder cancer was 10 times more common in women with OAB than men with OAB despite the fact that it is two to three times more common in men than in women in the general population. Because OAB symptoms without hematuria may be an initial symptom of bladder cancer, patients with OAB symptoms even without hematuria should be advised to undergo cystoscopy to rule out underlying bladder cancer, the authors said. l

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New NewTools ToolsArriving ArrivingtotoMeasure Measureand and NCCN NCCNRoundtable: Roundtable:Clinical Clinicaland and Manage Economic ManageChemotherapy ChemotherapyCare Care EconomicIssues IssuesImpacting Impacting Business, Cancer Business,clinical clinicalconcerns concernsnow nowconnected connectedinin CancerCare CareDelivery Delivery value-focused value-focusedapproach approach ByBy Daniel Denvir Daniel Denvir

payers

Baltimore, MD—A long-held business Baltimore, MD—A long-held business truism is is that “if“if you can’t measure it, it, truism that you can’t measure you it.”it.” The application youcan’t can’tmanage manage The application ofofthis thisbelief beliefto tothetheoncology oncologysetting setting was demonstrated at a session of the was demonstrated at a session of the Association AssociationofofCommunity CommunityCancer Cancer Cen ters’ 36th Annual National Cen ters’(ACCC) (ACCC) 36th Annual National Meeting. Kimberly Bergstrom, PharmD, Meeting. Kimberly Bergstrom, PharmD, chief clinical officer for McKesson chief clinical officer for McKesson Specialty Care Solutions, told attendees Specialty Care Solutions, told attendees ofof thethe growing importance of of developing growing importance developing and andusing usingstandardized standardizedchemotherapy chemotherapy treatment regimens, and of of thethe tools that treatment regimens, and tools that

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“Collision “Collisioncourse” course”ininsight sight cancan benchmark performance andand foster benchmark performance foster compliance with treatment guidelines. Dr DrGoodman Audrey Andrews Goodman compliance with treatment guidelines. By By Audrey Andrews Public and private payers areare movalluded to atolevel Public and private payers movalluded a level ingingto tocontrol exploding healthcare thatthat of frustration control exploding healthcare Hollywood, Hollywood,FL—Clinical FL—Clinicalpractice practice of frustration never been costs, told attendees, issued by by thethe National costs,DrDrBergstrom Bergstrom told attendees, guidelines guidelines issued National hashas never been and control in in cancer andbecause becauseincreased increasedcost cost control Comprehensive ComprehensiveCancer CancerNetwork Network higher higher cancer was areare followed by by conscien“Too many wasinevitable, inevitable,it itis isin inproviders’ providers’ (NCCN) (NCCN) followed conscien- care. care. “Too many interest to to getget a seat at at thethe table. tious oncologists in in their everyday areare stillstill interest a seat table. tious oncologists their everyday patients patients “It“It is is anan important topic, because areare developed young. WeWe important topic, because practice, practice,butbutthey they developed dying dying young. this is one of of those things, if we don’t on on clinical efficacy andand without innovations andand a cure,” he said. this is one those things, if we don’t based based clinical efficacy without need need innovations a cure,” he said. getget a handle on it, it’s going to happen regard to costs. At a roundtable held But the inadequacy of current treatof current treata handle on it, it’s going to happen regard to costs. At a roundtable held But the inadequacy to to us,” sheshe said. “People and groups NCCN’s 15th Annual for for cancer is no the the main us,” said. “People and groups during duringthethe NCCN’s 15th Annual ments ments cancer is longer no longer main Equally challenging, he sugand organizations areare going to to start and organizations going start Conference, Conference, moderator moderator Clifford Clifford problem. problem. Equally challenging, he sugdictating how we provide cancer care, Goodman, PhD, Senior Vice President gested, is finding a means to pay for dictating how we provide cancer care, Goodman, PhD, Senior Vice President gested, is finding a means to pay for and wewe can’t letlet that happen.” at The Lewin Group, predicted, “The ever-costlier carecare thatthat threatens to to and can’t that happen.” at The Lewin Group, predicted, “The thethe ever-costlier threatens appropriate use of evidence-based bankrupt the healthcare system. Continued on page 8 appropriate use of evidence-based bankrupt the healthcare system. Continued on page 8 guidelines is on a collision course As society struggles to find soluAs society struggles to find soluguidelines is on a collision course with the financial nonsustainability of tions, “the ground is shaking beneath with the financial nonsustainability of tions, “the ground is shaking beneath the healthcare system.” us,” Dr Goodman commented. the healthcare system.” us,” Dr Goodman commented.

Value-Based Value-BasedCancer CancerCare Care will willbebeatatthe theASCO ASCOAnnual Annual Meeting, June 4-8, in Chicago. Meeting, June 4-8, in Chicago.

Continued on page 19 Continued on page 19

Please visit usus atat booth 18121 Please visit booth 18121

SEER-Medicare SEER-MedicareDatabase DatabaseAnalysis Analysis Confirms Expensive Prostate Confirms Expensive Prostate Breast BreastCancer CancerSurvival SurvivalImproves, Improves, Cancers CancersGaining GainingSupremacy Supremacy Photo by © ASCO/Todd Buchanan 2009 Photo by © ASCO/Todd Buchanan 2009

Thanks ThankstotoNew NewTherapies Therapies

efficacy

cost effectiveness

But remains to to Butcost-effectiveness cost-effectivenessofofthis thismove move remains bebedetermined determined

Breast Cancer Conference (EBCC7). Breast Cancer Conference (EBCC7). This improvement, the researchers By Rosemary Frei, MSc This improvement, the researchers By Rosemary Frei, MSc Barcelona—Survival for patients with suggest, is due to increased use of The 2010 Genitourinary Cancers Barcelona—Survival for patients with suggest, is due to rise increased use of San Francisco, CA—The popularity of The 2010 Progress Genitourinary Cancers metastatic breast cancer has improved anthracyclines and the of targeted Symposium: in Multi San Francisco, CA—The metastatic breast has improved anthracyclines and the rise of targeted minimally Symposium: Progresswas in held Multidramatically in the cancer last 20 years, espe- therapies. Management invasive radical popularity prostatec- of disciplinary minimally radical prostatec- March dramatically in the last 20 years,with espe- “There therapies. disciplinary Management cially in the subgroup of patients is no doubt that trastuzu- tomy 5-7 in San Francisco. Allwas ses-held (MIRP),invasive intensity-modulated tomy (MIRP), intensity-modulated cially in the subgroup of patients with “There is no doubt that trastuzu March 5-7 in San Francisco. All HER2-positive tumors, according to mab (Herceptin), which targets the radiation therapy (IMRT), and of sions emphasized a multidisciplinarysesradiation therapy (IMRT), and of approach HER2-positive mab gene, (Herceptin), which important targets the brachytherapy sions emphasized a multidisciplinary research presentedtumors, at the 7thaccording European to HER2 is the most to care; a number of them combined with IMRT research presented at the 7th European HER2 gene, is the most important forbrachytherapy approach to cost care;and a number of them brought out the value issues prostate cancercombined started towith take IMRT off Continued on page 27 for 2002, prostate cancer started analysis to take off associated broughtwith out the cost for andgenitourivalue issues Continued on page 27 after caring a new database after 2002, a new database analysis associated with caring for genitourinary cancers. has confirmed. hasthe confirmed. nary cancers. At American Society of Clinical At the American Society of Can Clinical Oncology’s 2010 Genitourinary - and Women’s Hospital, Harvard Oncology’s 2010Paul Genitourinary Can- Medical and Women’s Hospital, Harvard School, Boston, and his cocers Symposium, L. Nguyen, cerspresented Symposium, Nguyen, Medical School, his coMD, the Paul resultsL. of his investigators foundBoston, MIRP and jumped investigators found MIRP jumped MD, analysis presentedof the team’s dataresults from of thehis from 1.5% of radical prostatectomies team’s analysis of dataand from from of 28.7% radicalinprostatectomies Surveillance, Epidemiology Endthe (RPs) in 1.5% 2002 to 2005. They Surveillance, Epidemiology and End also(RPs) in 2002 28.7% in 2005. They Results (SEER)-Medicare database. found that to IMRT soared from also found that IMRT treatments soared from Results (SEER)-Medicare Dr Nguyen, director of database. Prostate 8.7% of external radiation Dr Nguyen, director of Prostate for 8.7% of external radiation treatments prostate cancer to 81.7%. In addiBrachytherapy, Dana-Farber/Brigham Brachytherapy, Dana-Farber/Brigham for prostate cancer to 81.7%. In 24 addiContinued on page

By Colin Gittens By Colin Gittens

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Continued on page 24

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