April 2010, Vol 3, No 2 by Green Hill Healthcare Communications, LLC

APRIL 2010

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CANCER CENTER PROFILE

VOL 3, NO 2

HEALTHCARE REFORM BILL

Healthcare Reform 2010: The Good, the Bad, Desert Regional and the Ugly for Oncology Dawn Holcombe, MBA, FACMPE, ACHE Comprehensive By President, DGH Consulting, and Executive Director, Connecticut Oncology Association, South Windsor, Connecticut Cancer Center Provides Variety he Patient Protection and Afford- The Good: More coverage for those able Care Act, known to most of who need it of Services The bill is reported to provide or subsius as the Healthcare Reform Bill, change the face of healthcare for dize healthcare coverage for 32 million Under One Roof will many generations to come. As the dust currently uninsured people, or one tenth

By Karen Rosenberg

The Comprehensive Cancer Center houses a medical oncology infusion center, physician offices and exam rooms, radiation oncology treatment area, “stat” laboratory, pharmacy, outpatient surgery facilities, a comprehensive breast center, a patient resource center, psychosocial and nutritional support services, a research department, and financial counseling services.

pened in 1989, the Comprehensive Cancer Center (CCC) at Desert Regional Medical Center was the first multidisciplinary outpatient cancer program in the Palm Springs, California, area. The CCC represents the collaboration of the multispecialty regional medical center with Aptium Oncology, a national provider of oncology manageContinued on page 17

RY TA EN M I L MP CO

CE Credit

settles from the process of this bill becoming the law of the land, we start to explore what its provisions may mean for patients with cancer and for those who care for them. We do know that insurance reform of some kind was passed, but the actual details and ramifications will not be clearly understood or visible for some time to come.

of the nation’s population. Children with preexisting conditions, including cancer, will no longer be able to be excluded from the coverage of their families’ policies, starting in September 2010. Such protection for adults will not start until January 1, 2014. Current policies with such terms will have to rescind those restrictions by the effective dates.

By January 1, 2014, workers are expected to have insurance options regardless of their employer offerings. Workers may purchase insurance on their own Continued on page 14

CODING AND BILLING

PHYSICIAN EXECUTIVE MBA

Infusion Nursing Resources: One Approach to Doing More with Less

Business Management Programs Help Clinicians Improve Healthcare Delivery

By David Delaney, MD Chief Medical Officer, MedAptus, Inc

s any infusion nurse will attest to, coding and billing for infusion services is highly challenging. Not only are multiple and concurrent therapies delivered in a single clinic visit— chemotherapy, nonchemotherapy, and hydration—but the regulations that govern reimbursement for these services also tend to change frequently, creating another level of complexity. It wasn’t that long ago when only a small number of codes were used in the infusion billing

process. This made it practical for the coding process to happen at the point-of-care, relying on nurses for entry given their direct knowledge of what services were provided. However, over time, new codes were created, others were renumbered, and a coding hierarchy was introduced, resulting in the need for nurses to spend more and more time on this task as well as related training. While some clinics, in response to increased infusion complexity,

Multidisciplinary management of an elderly patient with locally advanced esophageal cancer associated with lymphoma

Novel regimen attenuates weight loss associated with cachexia Based on a presentation by Suresh Sanchetee, MD

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Young women and breast cancer A volunteer’s view of the Young Survival Coalition

ealthcare is more than medicine and patient care. Physicians, nurses, and hospital administrators are realizing that healthcare is also a business. As a result, healthcare professionals are looking for ways to improve quality of care while lowering costs. Colleges and universities are answering the call with business management courses geared toward medical professionals. “Healthcare has traditionally set itself apart from other industries. It’s extremely important to take best practices from across all industries and disciplines and learn everything we can to deliver the highest quality of care more efficiently,” says Judy Smith, MD, FACS, medical director of the Roswell Park Cancer Institute in Buffalo, New York. The cost of cancer care and how to best treat the disease are concerns for clinical professionals

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Inside Conference News

By Eileen Koutnik-Fotopoulos

The Patient’s Voice

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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: 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. 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. Contraindications: None known. Warnings: Pregnancy Category D. Dexrazoxane was toxic to pregnant rats at doses of 2 mg/kg (1/80 the human dose on a mg/ m2 basis) and embryotoxic and teratogenic at 8 mg/kg when given daily during the period of organogenesis. Teratogenic effects in the rat included imperforate anus, microphthalmia, and anophthalmia. In offspring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. In rabbits, doses of 5 mg/kg daily during the period of organogenesis caused maternal toxicity and doses of 20 mg/kg were embryotoxic and teratogenic. Terato-

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genic effects in the rabbit included several skeletal malformations such as short tail, rib and thoracic malformations, and soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, as well as agenesis of the gallbladder and of the intermediate lobe of the lung. 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. Precautions: Totect is a cytotoxic drug. When administered to patients receiving anthracycline-containing cytotoxic therapy, additive cytotoxicity may occur. Treatment with Totect is associated with leukopenia, neutropenia, and thrombocytopenia. Reversible elevations of liver enzymes may occur. Blood counts and liver enzymes should be monitored. Greater exposure to dexrazoxane may occur in patients with compromised renal function. The Totect dose should be reduced by 50% in patients with creatinine clearance values <40 mL/min. Dimethyl sulfoxide (DMSO) should not be used in patients who are receiving dexrazoxane to treat anthracycline-induced extravasation. Women who have the potential to become pregnant should be advised that Totect might cause fetal harm. There are no known drug interactions. No carcinogenicity studies have been done with Totect in animals. The carcinogenic potential of dexrazoxane has not been investigated. 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. Dexrazoxane is mu-

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tagenic 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. The effect of dexrazoxane on labor and delivery in humans has not been studied. It is not known whether dexrazoxane or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from dexrazoxane, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The safety and effectiveness of Totect in pediatric patients have not been established. No differences in safety or efficacy were observed between older and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older patients has been observed. 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. Adverse reactions: Adverse reactions of nausea/ vomiting, diarrhea, stomatitis, bone marrow suppression (neutropenia, thrombocytopenia), altered liver function (increased AST/ALT), and infusion site burning have been observed. These adverse reactions have been reversible.

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Editorial Board EDITOR-IN-CHIEF

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

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

John F. Aforismo, BSc Pharm, RPh, FASCP RJ Health Systems International Wethersfield, CT Oncology Pharmacy

Elizabeth Bilotti, RN, MSN, APNc John Theuer Cancer Center Hackensack University Medical Center Hackensack, NJ Oncology Nursing

Arun Kumar, MD

University of Chicago Chicago, IL Surgical Oncology

VA Medical Center Huntington, WV Medical Oncology

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

Shaji K. Kumar, MD

Greg Pilat, MBA Advocate Health Care Oak Brook, IL Oncology Administration

Ritu Salani, MD

Mayo Clinic Rochester, MN Hematology-Oncology

Ohio State University Medical Center Columbus, OH Medical Oncology

Mehra Golshan, MD

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

Andrew Salner, MD

Dana-Farber Cancer Institute Boston, MA Surgical Oncology

Advocate Health Care Oak Brook, IL Radiological Technology

Hartford Radiation Oncologists Association Hartford, CT Radiation Oncology

Patrick A. Grusenmeyer, ScD, FACHE

Patrick Medina, PharmD, BCOP

Timothy G. Tyler, PharmD, FCSHP

Oklahoma University College of Pharmacy Tulsa, OK Oncology Pharmacy

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

Cleveland Clinic Taussig Cancer Institute Mayfield Heights, OH Oncology Nursing

Christiana Care Health System Newark, DE Oncology Administration

Nicole A. Bradshaw, MS, CIC

Marilyn L. Haas, PhD, CNS, ANP-BC

Patricia Molinelli, RN, MSN, AOCNS

Gary C. Yee, PharmD, FCCP, BCOP

Mountain States Tumor Institute Nampa, ID Oncology Administration

Mountain Radiation Oncology Asheville, NC Oncology Nursing

Somerset Medical Center Somerville, NJ Oncology Nursing

University of Nebraska Medical Center Omaha, NE Oncology Pharmacy

Anna M. Butturini, MD

Dawn Holcombe, MBA, FACMPE, ACHE

Judy A. Olson, RT(R), RDMS

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

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

Scott E. Eggener, MD

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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

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

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FROM THE EDITOR

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

GH Green Hill Healthcare Communications

y now you are well aware that the President signed the Patient Protection and Affordable Care Act, and like you I am left wondering what this will mean for oncology, especially as practiced in the community setting. In this issue, Dawn Holcombe highlights some potential positives as well as some potential negaMark J. Krasna, MD tives. Our May special issue ST. JOSEPH CANCER will focus more closely on how INSTITUTE legislative reform and the escaEditor-in-Chief lating cost of cancer care may affect our practice. Then, as the months go by and the specifics of the healthcare bill’s ramifications become apparent, we will keep you up to date on changes that affect you. But much more is happening in cancer care than reform legislation. The Society of Surgical Oncology’s Annual Cancer Symposium and the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium brought us new information to discuss with our colleagues during

our prospective cancer conferences. Once again, these prospective conferences are the crux of multidisciplinary care, as evidenced in this month’s tumor board—one that highlights the important role comorbid conditions play in treatment planning. This issue also marks the launch of our collaboration with the Association of Cancer Executives. It is our hope that you will not forget that these individuals are vital members of our teams. Their business expertise can help us to not just survive but to thrive in the current economic and political climate. We begin with a look at charge capture by infusion nurses and, in some centers, by specialized coders. Proper charge capture is essential to successful reimbursement, and it becomes more difficult with each passing year. Another fundamental element of reimbursement is collecting copayment from patients. Although, as clinicians we are focused on our patients’ care, we must also be vigilant to the many legal and financial obstacles to providing that care. Having the resources for myriad support services can enhance any cancer program. As always, we hope you continue to benefit from reading the Journal of Multidisciplinary Cancer Care. We look forward to your feedback.

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CONTENTS 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. ISSN # 1949-0321. Journal of Multidisciplinary Cancer Care® 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.

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FEATURE ARTICLES 6 Conference News: ASCO GI Novel regimen attenuates weight loss associated with cachexia Everolimus shows promise in metastatic gastric cancer 9 Conference News: Society of Surgical Oncology Patients undergoing esophagectomy fare best in high-volume regions Surveillance after ovarian cancer treatment is spotty 10 Continuing Education Multidisciplinary management of an elderly patient with locally advanced esophageal cancer associated with lymphoma 16 Psychosocial Issues New CancerCare CEO looks ahead 26 The Patient’s Voice Young women and breast cancer 28 Reimbursement Smart money. Part 1: Making patients partners in healthcare decisions DEPARTMENTS 18 Oncology Drug Codes Medications used for the treatment of lymphomas 24 International News 28 Recent FDA Approvals 29 News Notes

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Conference News ASCO GI The following articles are based on presentations at the American Society of Clinical Oncology’s 2010 Gastrointestinal Cancers Symposium held in Orlando, Florida, January 22-24, 2010.

Novel Regimen Attenuates Weight Loss Associated with Cachexia By Caroline Helwick

or the treatment of cachexia in gastrointestinal (GI) cancer, investigators from India reported that a regimen of thalidomide plus the antipsychotic olanzapine and megestrol acetate effectively attenuated weight loss. “In India, 90% of patients with gastrointestinal cancers come to us with advanced disease, and we can only offer them palliative care. We have found a regimen that will stabilize weight loss for less than $2 per day,” Suresh Sanchetee, MD, of Rajasthan Cancer Cure Hospital, Jodhpur, India, told the Journal of Multidisciplinary Cancer Care. The double-blind randomized study included 50 patients with GI cancer who had lost at least 10% of their body weight and who received thalidomide 100 mg daily plus olanzapine 5 mg once daily and megestrol 80 mg once daily, or thalidomide alone, for 24 weeks. The primary outcomes were change in weight and nutritional status. The cur-

rent analysis was based on evaluation of weight and lean body mass at 8 weeks. Sanchetee explained the rationale for the regimen. “The proinflammatory cytokine TNF-α [tumor necrosis factoralpha] has an important role in cancer

patients,” he said. “All of these are factors in cachexia.” The patients’ mean premorbid weight was approximately 68 kg. Upon entry to the study, patients had lost approximately 17% of their weight. At 4 weeks,

“While patients receiving thalidomide only continued to lose weight, those receiving the three-drug regimen stabilized.” ——Suresh Sanchetee, MD

cachexia. Thalidomide is an inhibitor of this synthesis. Olanzapine is effective in chemotherapy-induced nausea and vomiting. And megestrol has been used to attenuate weight loss in cancer

70% of the patients were available for analysis, and 43% were available at 8 weeks. At 4 weeks, patients on the threedrug regimen had gained an average of

0.37 kg and added 1.0 cm3 in arm muscle mass, compared with a loss of 2.21 kg and 4.46 cm3 in arm mass for the thalidomide-only group. This amounted to absolute differences of -2.59 kg in weight (P = .005) and -5.6 cm3 (P = .002) in muscle between the groups. At 8 weeks, patients in the experimental group had lost 0.06 kg in weight and 0.5 cm3 in arm mass compared with a loss of 3.62 kg and 8.4 cm3 for those in the thalidomide-only group. The absolute differences between the groups were -3.57 (P = .034) and -7.9 cm3 (P = .014), respectively, he reported. Improvement in physical functioning correlated positively with weight gain (P = .001), he added, while noting that quality of life was improved with the regimen as well. “Basically, while patients receiving thalidomide only continued to lose weight,” he observed, “those receiving the three-drug regimen stabilized.” l

Everolimus Shows Promise in Metastatic Gastric Cancer By Jill Stein

verolimus monotherapy is usually well tolerated with promising activity in patients with previously treated metastatic gastric cancer, Japanese investigators announced. Everolimus, an orally bioavailable inhibitor of mammalian target of rapamycin, has shown anticancer activity in preclinical cellular and animal models and in patients with advanced gastric cancer. “Given the poor long-term outcomes associated with surgical and traditional chemotherapeutic management of advanced gastric cancer, it is important to examine the use of new targeted agents in this population,” Hiroya Takiuchi, MD, with Osaka Medical College, pointed out. Takiuchi reported findings in 53 patients with metastatic gastric adenocarcinoma who received daily everolimus after failing up to two prior chemotherapy regimens. “Gastric cancer is the fourth most

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common cancer worldwide and the second most common cause of cancer mortality, with an estimated 700,000 deaths annually,” Takiuchi observed. “While surgical resection for gastric cancer is curative, patients commonly present with unresectable disease,” he added. “What’s more, the relapse rate following curative-intent resection is high [roughly 60%].”

the patient developed progressive disease or unacceptable toxicity or chose to quit the study prematurely for any other reason, with a dose reduction allowed for tolerability. The primary study end point was disease control rate (DCR), which referred to the percentage of patients with a complete response, partial response, or stable disease as the best overall response.

Although no complete or partial responses were documented, 45% of patients had a decrease in tumor size from baseline by independent radiologic review. Various combination chemotherapy regimens are used for treating advanced gastric cancer, with a median overall survival typically less than 1 year, he said. In the present phase 2 trial, oral everolimus, 10 mg/day, was administered in continuous 28-day cycles until

Trial participants had a median age of 63 years, and most were men. The study population was evenly split between second-line and third-line patients. Most patients had been pretreated with 5-fluorouracil alone or with cisplatin, and about half had

undergone a prior gastrectomy. The study showed a DCR of 56%, a rate that occurred in both secondand third-line patients. Although no complete or partial responses were documented, 45% of patients had a decrease in tumor size from baseline by independent radiologic review. The median overall survival was 10.1 months, with a median follow-up time of 9.6 months. Adverse events were typically grade 1 or 2 in severity. Grade 3 adverse events occurred in 20 patients, and grade 4 adverse events that were considered to be possibly due to everolimus treatment occurred in only four patients. Takiuchi said that, based on these favorable results, a phase 3 trial is currently under way that is comparing everolimus plus best supportive care with placebo plus best supportive care in patients with advanced gastric cancer whose disease has progressed after prior systemic chemotherapy. l

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Evolution in

1 OF A SERIES PART

Oncology Practice Management

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Sea Change in Oncology Medications Creates Demand For OncoMed

s oncologists and hematologists face a multitude of simultaneous paradigm shifts related to their ability to deliver new biotechnology cancer-fighting medications, more providers are turning to New York–based OncoMed, The Oncology Pharmacy, a leading pharmaceutical services company that specializes solely in oncology pharmaceuticals. In response to this surge in demand, OncoMed recently opened its newest facility in New England to provide highlevel oncology pharmacy services in that region, and the company has announced plans to open four additional new facilities this year in Boca Raton, Florida; Buffalo, New Burt Zweigenhaft York; Chicago, Illinois; and CEO Phoenix, Arizona. The company, founded in 2004, is licensed to provide oral, injected, and infused patient-specific oncology prescriptions in all 50 states to patients covered by Medicare, Medicaid, and private health plans. “We have established ourselves as a trusted member of the cancer care community for delivering ‘just in time treatment day’ oncology pharmaceuticals and care management services,” said CEO Burt Zweigenhaft. “We’ve done this by studying the marketplace, listening to physician practices, and providing market-proven solutions to the challenges that our 600 current oncology practice providers face in the cancer care environment today.” “We are recognized for our rigorous clinical standards in preparing and delivering complex pharmaceutical regimens,” Zweigenhaft said. “The evolving role of the oncology pharmacist is to be a cohort of the doctor’s office. This is done by assisting with critical clinical thinking during the regimen selection process. We also maximize the clinical yield of these expensive drugs through eliminating drug waste by compounding the patient-specific orders and then delivering them in treatment day doses.” The OncoMed service model deploys specially trained oncology pharmacy technicians and expert oncology pharmacists to reduce administrative pressures on physician practices related to the complex and timeconsuming tasks of investigating a patient’s insurance benefits, confirming therapy reimbursement, and navigating managed care prior authorization processes. Additionally, the company has a staff of specially trained Insurance Reimbursement Advocates who help patients gain access to the numerous patient financial assistance programs as the traditional $20 to $50 copayments now typically rise into the thousands of dollars, as is the case with Medicare Parts B and D. Industry experts expect dramatically increasing copays to be the trend, as noted recently during speeches and panels conducted at the National Comprehensive Cancer Network (NCCN) and the Hematology Oncology Pharmacy Association conferences.

Having an oncology pharmacist review and process each order ensures that all prescription regimens are routinely evaluated against the rapidly emerging standards in care, such as the NCCN Guidelines. This enables OncoMed’s pharmacists to alert physician practices to contraindicated drugs or treatment complications in advance of therapy. Events like this do happen, and one such event occurred recently when OncoMed pharmacists received a prescription for Avastin and Erbitux to treat the same patient with previously untreated metastatic colorectal cancer. In this instance, the oncology pharmacist called the physician and alerted him to the very recent study that found the combination of Avastin and Erbitux, when administered alongside chemotherapy, worsens colorectal cancer outcomes among patients with previously untreated, metastatic colorectal cancer and results in shorter progression-free survival and worse quality of life. The physician was grateful for the clinical information and then changed the treatment order. “It’s a field that’s constantly evolving, with research driving changes in oncology day by day,” added Kevin Askari, RPh, President and Chief Clinical Pharmacist of OncoMed. “Our goal is to act as a Kevin Askari, RPh President and Chief virtual oncology pharmacy Clinical Pharmacist within the practice, and also be used as a pharmacological resource and experienced knowledge center in the oncologist’s office.” Among the challenges they are facing today, oncology providers point to: • Reduced margins on drug reimbursement; • Additional administrative burdens to verify complex patient benefit programs; • Evolving new studies and standards in care, with more drug combinations and protocols from which to choose; • More patients who see dramatic increases in copays, a financial responsibility that many can’t handle; • More prior authorization requirements for approved treatments; and • An explosion in inventory “carry costs” and the risks of bad debt with low drug margins. OncoMed gives providers a new option for dealing with these problems and the economic challenges of managing and dispensing oncology medicine. “Working with OncoMed has been a win-win situation for our practice,” said Jeff Gaspar, Practice Administrator for North Shore Hematology/Oncology, a six-physician practice on Long Island, New York. “We can get medication on the same day that it is prescribed, which is very important because of the rapidly changing disease status seen in oncology patients.” Gaspar went on to say that, “the oncology pharmacy model is superior in knowledge, execution, and services delivered when compared with the mail-order specialty pharmacies or drug replacement programs that some managed

Pharmacists filling orders at the OncoMed facility.

care plans now require our practice to use.” “Having to treat patients with chemotherapy regimens that range from weekly to every 21 days in a disease that is continuously morphing, while dealing with the multiple side effects and reimbursement challenges, is a lot for us to manage in the current economic environment,” Gaspar said. “So when we outsource the drugs and end up with an inexperienced provider on the other side of the phone or fax machine who does not understand the therapy or treatment cycle time sensitivity, as we have experienced from the specialty mailorder pharmacies, it places a huge burden on my staff and puts our practice in a very difficult position.” OncoMed’s pharmacy model enables physician practices to budget internal resources more appropriately, thereby reducing staff time spent investigating benefits with insurance carriers as well as the procurement sourcing tasks of accessing limited distribution drugs from manufacturers and wholesalers as well as FDAimposed special processes. The result for practices is reduced capital expenses and risks associated with copayment collection and bad debt. OncoMed also facilitates the prior authorization process with insurance carriers. At the heart of the prescription intake process and supervising all dispensing activities are OncoMed’s oncology pharmacists. All compounding and mixing is conducted in a USP <797>–compliant clean room environment. Each dose and measure goes through a six-point quality check process done by oncology pharmacists or pharmacy technicians to ensure safety and accuracy. OncoMed goes an extra step to ensure that all of its pharmaceuticals are purchased under a publicly disclosed “Drug Pedigree Program” that specifically allows only direct documented purchases from the prime manufacturers to ensure 100% drug efficacy and inventory safety. “I can’t stress the human factor enough,” said Askari, the Chief Clinical Pharmacist. “Our facilities are topnotch, but we know they are only as good as the people who work within them. That is why we have formalized an ongoing oncology pharmacy training program for everyone regardless of their role in our organization and we have a Professional Practices Review and Oversight Committee that reviews our performance quarterly.” Continued on page 9

EVOLUTION IN ONCOLOGY PRACTICE MANAGEMENT™ Continued from page 8

The arsenal of oncology pharmaceuticals and biotechnology targeted drugs has grown dramatically in recent years. As recently as the 1970s, there were no biologics and few drug choices, and cancer frontline treatments were mainly surgery and radiation. Many of the first chemotherapy drugs, novel at the time, are obsolete today as stand-alone drugs (some remain effective in combination with the new targeted biotechnology drugs used in protocols). “Given the expanding complexity of therapies and protocols, I saw there was a need for an oncology pharmacy,” said Askari. “I wanted to be involved in an evolving, dynamic field. Every day, even now, you get bombarded with new information. The treatment that was the best thing yesterday may not work today.” Amid this complexity, Askari said his emphasis remains on safety and quality. As an example, he said, “we hire only pharmacists who meet our own rigorous oncology pharmacy experience standards, who are then shadowed under close supervision for 6 months before they work on the dispensing front.” Historically, oncology providers have purchased and dispensed oncology medicines under a “buy and bill” system where they buy the drugs from the manufactur-

er/wholesaler, keep them in their office, and prepare the drugs and dispense them to patients when needed. Medicare and other managed care payers have changed the drug reimbursement methodologies and moved to market-based reimbursement schedules, reducing the amount they reimburse the physician

Not all physician practices have the necessary scale, professional resources, and capitalization required to provide these drugs and services profitably and that is exactly the market niche that OncoMed is positioned to service. “Physicians should be focused on caring for their patients and their complex disease,” said Zweigenhaft. “They should not have to “The oncology pharmacy model is superior in worry about running a pharmacy and the knowledge, execution, and services delivered when tasks of acquiring and maintaining an compared to the mail order specialty pharmacies inventory of medications, the drug authoror drug replacement programs that some managed ization burdens, collection of copayments and drug reim-bursement, and the risk of care plans now require our practice to use.” —Jeff Gaspar bad debt.” Zweigenhaft added that, “we see new challenges appearing as more state Practice Administrator pharmacy boards seek to control enforceNorth ShoreHematology/Oncology ment of the drug preparation sites using USP <797> and PCAB [Pharmaceutical practices. Today, most payers have moved to discount- Compounding Accreditation Board] certifications.” ing the AWP (Average Wholesale Price) to AWP The validation of the OncoMed Oncology minus 15% to 18% and/or some have replaced the Pharmacy model is evidenced by the hundreds of AWP standard with the Medicare standard of ASP physicians who have chosen the company as their pre(Average Sales Price) plus 6%. ferred partner to navigate the sea change in oncology This reimbursement compression, as well as the pharmaceuticals. Perhaps the greatest value, however, more administratively complex process for acquiring is the support the oncology pharmacy model can prothe medications, has made the downside economics of vide for the patients, who face the supreme challenge “buy and bill” more apparent to physician practices. of defeating their cancer. u

For more information or to request a presentation, call OncoMed at 1-877-662-6633 or go to www.oncomed.net

Conference News Society of Surgical Oncology The following articles are based on presentations at the Society of Surgical Oncology’s 63rd Annual Cancer Symposium held in St. Louis, Missouri, March 3-7, 2010.

Patients Undergoing Esophagectomy Fare Best in High-volume Regions By Jill Stein

atients with esophageal cancer who are slated to undergo an esophageal resection should be referred to a high-volume region where at least 12 such operations are performed each year, researchers reported. Data from the University of Florida College of Medicine in Gainesville demonstrated that postoperative mortality was lower and the hospital stay was shorter in high-volume regions. Senior author Kfir Ben-David, MD, assistant professor, and his colleagues said that their study, which used information from a large database that covered the time period from 1997 through 2006, is the largest population-based study to date for esophagectomies performed in Florida hospitals. “It is estimated that there were 16,470 new esophageal cancer patients in the United States in 2009, with

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14,530 deaths the same year,” the researchers wrote in their poster presentation. “In addition, esophageal adenocarcinoma continues to have a rapidly increasing incidence. “The increasing incidence of esophageal cancer in the United States and elsewhere, along with the curability of early-stage disease, means unequivocally that esophagectomy should be done in centers with low morbidity and mortality,” they added. “However, esophagectomy has been associated with considerable morbidity and mortality, and volume is an important determinant of the quality of care.” Thus, although referral of patients with esophageal cancer to surgical centers with appropriate volume improves quality of care, decisions regarding regionalization of care should be based on data showing that regionalization

will improve outcomes in a given region, they noted. For this reason, the investigators sought to determine variations in outcome across the state of Florida for a single high-risk cancer operation, esophagectomy. Three regions in Florida were designated as high-volume regions. Overall, 991 esophagectomies were performed during the 10-year study period, and the incidence of esophagectomy was significantly higher in 2002 through 2006 compared with 1997 through 2001. Results showed that the risk-adjusted postoperative mortality was significantly lower (odds ratio, 0.54) in high-volume regions (5.1% for high-volume vs 10.4% for low-volume regions). However, the difference in risk-adjusted postoperative mortality was not due to a difference in anastomotic leak rates,

which occurred in 8.2% of patients in both high- and low-volume regions. The mean length of hospitalization was 16.3 days in high-volume regions compared with 18.0 days in low-volume regions (P = .06). Although there was no significant difference in leak complications between high- and low-volume regions, expertise and resources available for managing life-threatening complications may be responsible for the observed differences in outcome, BenDavid and his coworkers said. Overall, the findings suggest that regionalization of esophagectomy to high-volume locations in Florida can potentially reduce procedure-related mortality, length of hospital stay, and total charges, they added. l Conference News continued on page 16

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CONTINUING EDUCATION EDITORIAL BOARD

PROGRAM MCC2 • RELEASE DATE: APRIL 15, 2010 • EXPIRATION DATE: APRIL 15, 2011

Maher Saegh, MD Attending Physician in Internal Medicine Mercy Jordan Creek 1055 Jordan Creek Parkway West Des Moines, IA 50266

ESTIMATED TIME TO COMPLETE: 1.0 HOUR

Adjunct Assistant Professor of Geriatrics Des Moines University 3200 Grand Avenue Des Moines, IA 50312 Stephen Curry, MD Staff Radiologist G.V. Montgomery Veterans Affairs Medical Center 1500 E. Woodrow Wilson Drive Jackson, MS 39216 Namita Pareek, MD Fellow, Division of Gastroenterology University of Mississippi School of Medicine 2500 North State Street Jackson, MS 39216 Clay Calcote, MD Staff Pathologist G.V. Montgomery Veterans Affairs Medical Center 1500 E. Woodrow Wilson Drive Jackson, MS 39216 Giorgio Aru, MD Chief of Thoracic Surgery G.V. Montgomery Veterans Affairs Medical Center 1500 E. Woodrow Wilson Drive Jackson, MS 39216 Professor, Department of Surgery University of Mississippi School of Medicine 2500 North State Street Jackson, MS 39216 Minsig Choi, MD Staff Oncologist G.V. Montgomery Veterans Affairs Medical Center 1500 E. Woodrow Wilson Drive Jackson, MS 39216 Assistant Professor of Medicine University of Mississippi School of Medicine 2500 North State Street Jackson, MS 39216

Multidisciplinary Management of an Elderly Patient with Locally Advanced Esophageal Cancer Associated with Lymphoma By Maher Saegh, MD1; Stephen Curry, MD2; Namita Pareek, MD3; Clay Calcote, MD2; Giorgio Aru, MD2,3; Minsig Choi, MD2,3 1Mercy Jordan Creek, West Des Moines, Iowa; Des Moines University, Iowa; 2G.V. Montgomery Veterans Affairs Medical Center, Jackson, Mississippi; 3University of Mississippi School of Medicine, Jackson, Mississippi STATEMENT OF NEED

LEARNING OBJECTIVES

This program will enhance comprehension of the thought processes involved in applying personalized medicine by elucidating the one team’s prospective discussion in their treatment decisions for an elderly patient with low-grade lymphoma and esophageal carcinoma.

After completing this activity, the reader should be better able to: • Describe the roles of various methods of diagnosis and staging for suspected esophageal malignancies

TARGET AUDIENCE

• Compare the options of neoadjuvant chemotherapy, chemoradiation therapy, and esophagectomy

Medical, surgical, and radiation oncologists, and other interested healthcare professionals, especially those caring for cancer patients.

• Discuss the association between surgical mortality and treatment decision-making

Esophageal cancer is a relatively uncommon disease in the United States. In 2009, it is estimated that 16,470 new cases were diagnosed and 14,530 patients died of this disease.1 Although mortality associated with this cancer has remained high over the past three decades, multidisciplinary treatment has incrementally improved the clinical outcome. Emerging evidence shows that high-volume centers have decreased surgical morbidity, resulting in better overall survival.2 We present an interesting case of an elderly patient with low-grade lymphoma and esophageal carcinoma and discuss its multidisciplinary management.

Case Presentation Chief complaint: Progressive dysphagia for 4 months and weight loss. History of present illness: A 71-year-old white man presented to the primary care clinic with difficulty in swallowing that had progressed from solid foods to liquids over the past 4 months. This was associated with foulsmelling eructation and epigastric discomfort. He had lost 10 lb during this period. He denied changes in bowel movements as well as urinary or neurologic symptoms. Review of his systems was otherwise unremarkable.

The patient was referred to a gastroenterologist and an upper endoscopy performed. This revealed a 3-cm ulcerated nonbleeding lesion in the esophagus at about 24 cm to 27 cm from the incisors; a biopsy was performed. The initial biopsy did not show any signs of malignancy. A computed tomography (CT) thorax scan and a second esophagogastroduodenoscopy were performed. The findings revealed an ulcerated lesion 26 cm to 30 cm from the incisor. Biopsies from this area showed undifferentiated largecell malignancy. Staging workup included

bronchoscopy and positron emission tomography (PET). Medical and surgical history: Low-grade non-Hodgkin’s lymphoma 3 years ago, on observation; well-controlled hypertension and dyslipidemia, on medication; chronic sinusitis. Family history: Father had prostate cancer in his seventies. Mother had rectal cancer. Sister had lung cancer with brain metastases. Daughter has leukemia.

CONTINUING MEDICAL EDUCATION ACCREDITATION AND DESIGNATION OF CREDIT STATEMENT

This activity is provided free of charge to participants.

Veritas Institute for Medical Education, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Veritas Institute for Medical Education, Inc. designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

FINANCIAL DISCLOSURES

METHOD OF PARTICIPATION

1. Read the article in its entirety 2. Log on to www.jomcc.com 3. Click on “CME Credits” 4. Click on “Click here to complete the posttest and obtain a CME certificate online” 5. Register to participate 6. Enter program number MCC2 7. Complete and submit the CME posttest and CME Activity Evaluation and Request for Credit Form online 8. Print your Certificate of Credit

Veritas Institute for Medical Education, Inc. is required to disclose to the activity audience the relevant financial relationships of the planners and faculty involved in the development of CME/CE content. An individual has a relevant financial relationship if he or she has a financial relationship in any amount occurring in the last 12 months with a commercial interest whose products or services are discussed in the CME/CE activity content over which the individual has control. In addition, all faculty are expected to openly disclose any unlabeled/unapproved/investigational uses of drugs or devices discussed in this activity. Disclosures are as follows: • Maher Saegh, MD, has nothing to disclose. • Clay Calcote, MD, has nothing to disclose. • Stephen Curry, MD, has nothing to disclose. • Giorgio Aru, MD, has nothing to disclose. • Namita Pareek, MD, has nothing to disclose. • Minsig Choi, MD, has nothing to disclose. The staffs of Veritas Institute for Medical Education, Inc. and Green Hill Healthcare Communications, LLC have nothing to disclose. DISCLAIMER

The opinions expressed in this activity are those of the presenters and do not necessarily reflect the opinions or recommendation of Veritas Institute for Medical Education, Inc. Copyright © 2010 Veritas Institute for Medical Education, Inc. All rights reserved.

PLANNING COMMITTEE

april 2010 I VOl 3, NO 2

Gloria Mui

Julie Ann Tagliareni

Anne L. Finger

Dawn Lagrosa

Karen Rosenberg

Medical Director Veritas Institute for Medical Education, Inc. 611 Route 46 West Hasbrouck Heights, NJ 07604

CME Director Veritas Institute for Medical Education, Inc. 611 Route 46 West Hasbrouck Heights, NJ 07604

President Veritas Institute for Medical Education, Inc. 611 Route 46 West Hasbrouck Heights, NJ 07604

Managing Editor Green Hill Healthcare Communications, LLC 241 Forsgate Drive Monroe Twp, NJ 08831

Editorial Director Green Hill Healthcare Communications, LLC 241 Forsgate Drive Monroe Twp, NJ 08831

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www.JOMCC.com Social history: More than 30 pack-year smoking history. Rare use of alcohol. Medications: Metoprolol 25 mg daily, hydrochlorothiazide 12.5 mg daily, lisinopril 20 mg daily, aspirin 81 mg daily, lidocaine viscus 2% two teaspoonfuls before meals, methocarbamol 500 mg twice a day, omeprazole 20 mg twice a day, tramadol 50 mg every 8 hours as needed, simvastatin 20 mg at bed time. Allergies: None. Laboratory values: Normal complete blood count and basic metabolic panel with a creatinine of 1.3 mg/dL, calcium 8.9 mg/dL, and albumin of 3.4 g/dL. Physical examination: Vital signs: Temperature 97.4°F; respiratory rate 19 breaths per minute; pulse 59 beats per minute; blood

Gastroenterologist’s perspective The gastroenterologist’s role in the management of esophageal malignancies continues to evolve. Esophagogastroduodenoscopy (EGD) is indicated for tissue diagnosis, detection of the length of the involved segment, and determination of residual luminal size. Endoscopic ultra- Namita Pareek, MD sonography (EUS) provides local tumor staging. EUS with fine-needle aspiration (FNA) can also be used to assess enlarged nodes. Endoscopically placed esophageal stents are used for relief of dysphagia. The prognosis of esophageal cancer is well correlated with the TNM stage of the tumor. Stage determination is paramount to delivery of optimal therapy and to avoid unnecessary intervention. Computed tomography (CT) without positron emission tomography (PET) scan is generally used first for systemic staging. For locoregional tumor and nodal staging, EUS with or without FNA is superior to CT and PET.3,4 Lymphatic involvement is extremely rare if a tumor is limited to stage T1a (lamina propria); in these cases, endoscopic mucosal resection can be curative. However, a finding of nodal involvement for T2 (invasion into muscularis propria) and T3 (invasion to adventitia) can be as frequent as 60% of cases.5 In these patients, the addition of neoadjuvant chemotherapy or chemoradiation can improve clinical outcome.6-8 EUS is integral to the evaluation of esophageal malignancies. However, for this patient, it was not needed. Based on his CT and PET scans, he was determined not to be a candidate for initial surgical intervention, and neoadjuvant

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pressure 104/66 mm Hg. General: Awake alert; oriented x 3; not in acute distress. Head, ears, eyes, nose, throat: Pink conjunctiva; anicteric; no tonsillopharyngeal congestion. Neck: Multiple soft, palpable lymph nodes in the cervical and supraclavicular area ~1 cm to 2 cm in size. Axillary: Bilateral lymphadenopathy, 2 cm to 3 cm in size, soft and rubbery. Cardiovascular: Regular rate and rhythm; normal S1 and S2; no murmur or gallops. Lungs: Symmetrical chest expansion; clear to auscultation bilaterally. Abdomen: Soft, nontender; nondistended; normal active bowel sounds. Extremities: Without edema. Imaging studies: Chest CT scan: Multiple enlarged lymph nodes in

treatment was recommended. Radiologist’s perspective The CT scan confirmed circumferential esophageal wall thickening at the distal third of the esophagus. Based on the image, the patient exhibited signs highly suspicious for m a l i g n a n c y. The scan also demonstrated multiple enlarged lymph Stephen Curry, MD nodes in the mediastinum and both axillae. This patient presented a diagnostic dilemma, because both CT and fluorodeoxyglucose (FDG) PET evaluations for nodal metastases were confounded by the presence of preexisting pathologic lymph nodes from the previously diagnosed low-grade lymphoma. Moreover, these nodes had increased in size since the previous study. The axillary and mediastinal adenopathy suggested preexisting lymphoma rather than esophageal carcinoma, although coexisting extension of the esophageal malignancy could not be excluded. PET has a limited role in the evaluation of primary tumors in esophageal cancer. PET has a sensitivity of 80% for detecting primary tumors, but this percentage falls precipitously for more superficial lesions.9 The standardized uptake value (SUV) has shown some correlation with depth of tumor invasion.10 PET, however, is useful in detecting distant metastasis. Often, local nodal metastases are obscured by the intense FDG avidity of the primary lesion. For locoregional disease, CT or EUS is clearly superior to PET. PET, nonetheless, is quite effective in systemic staging. PET can detect unsuspected metastatic disease in 14% to 20% of patients and change their man-

the left cervical, left axillary (largest 4.8 cm), mediastinum lymph node including a 2.2-cm precarinal area, enlarged spleen and liver, and 2-cm subcrural lymph node. A 3-cm thickening of the esophageal wall located at the carina. PET scan: Extensive fluorodeoxyglucose (FDG) uptake in cervical, supraclavicular, axillary, mediastinal, paraaortic, para iliac, inguinal lymph nodes with the standardized uptake value (SUV) range up to 11.4 (left axillary), a mass in the midesophagus below the level of carina (esophageal lesion) with intense FDG uptake with SUV of 11.8. There was no bone or visceral uptake to suggest metastasis. Bronchoscopy: No endobronchial lesions seen. Transbronchial needle aspiration of lymph nodes at 4R and 7 was performed, no evidence of metastasis noted. Performance status: 1.

agement.11-13 The unique presentation in this patient, however, made CT the primary imaging modality. Pathologist’s perspective An endoscopic biopsy of the esophageal lesion was available for review. The tissue had also been reviewed by two gastrointestinal pathologists from the original laboratory prior to receipt at our facility. The slide clearly demonClay Calcote, MD strated a highgrade malignant neoplasm with some areas appearing to exhibit a spindle-cell (fusiform) morphology. Immunophenotypic evaluation by paraffin immunoperoxidase failed to show expression of any antigens that would allow more definitive classification of the neoplasm. Specifically, studies for epithelial, melanocytic, and lymphocytic markers were all negative. Differential diagnosis per one gastrointestinal pathologist was sarcomatoid carcinoma versus sarcoma. The original pathology classification as well as our working classification was “undifferentiated malignant neoplasm.” Comparison of this malignancy to the patient’s diffuse follicular lymphoma showed the two neoplasms to be morphologically distinct from one another, hence excluding gastrointestinal lymphoma. The resected specimen after neoadjuvant chemotherapy consisted of a 13cm segment of the esophagus with the attached portion of stomach. No gross lesion was identified. Nearly the entire segment of esophagus was submitted for histologic evaluation, and no residual cancer was identified. The specimen yielded nine lymph nodes, all free of neoplasm. It is rare to see a complete

pathologic response to neoadjuvant chemotherapy alone; most clinical studies report a 2% to 4% incidence.14 Prognosis in these patients with complete pathologic response is generally better than that of those with residual disease.15,16 Thoracic surgeon’s perspective Esophageal cancer is a lethal disease associated with 4% to 10% of surgical mortality.17 Therefore, critical assessment is paramount to determining the need for surgical resection in a multidisciplinary format. Giorgio Aru, MD Recent advances in imaging, such as PET, have helped exclude patients with occult metastatic disease from unnecessary surgical intervention. All esophageal cancer patients need multidisciplinary group assessment for the role of neoadjuvant treatments, because most symptomatic esophageal cancer patients have locally advanced disease with high risk of local or even distant metastasis. At our institute, Ivor-Lewis esophagectomy (ILE) is preferred. This technique is preferred because it combines laparotomy and right thoracotomy with direct visualization of the thoracic esophagus, allowing the surgeon to perform the full lymphadenectomy that is essential in cancer surgery. The other commonly used approach in the United States is transhiatal esophagectomy (THE), which involves a laparotomy and a cervical incision and avoids a thoracotomy. Minimally invasive esophagectomy (MIE) has been proposed as an alternative to ILE or THE, but the experience with it is limited. Our Continued on page 12

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CONTINUING EDUCATION Continued from page 11

term results showed that 5year survival improved from 17% for those in the surgery group to 23% for those in the chemotherapy and surgery group (hazard ratio [HR], 0.84; P = .03).20 However, a similar trial by US intergroup 113 showed no difference in overall survival for preoperative chemotherapy.6 Recently, the MAGIC trial compared surgery alone versus surgery with perioperative chemotherapy with epiruFigure 1. Single axial CT image through the region of sus- bicin/cisplatin/5-fluoro picion reveals asymmetric esophageal wall thickening. uracil (ECF) in gastroesophageal cancers. Results patient tolerated surgery well, with no showed improved clinical outcome in complications. the chemotherapy group. At the median of 4 years of follow-up, the progresOncologist’s perspective sion-free survival was significantly betThe patient’s case was reviewed at ter in the chemotherapy arm versus the multidisciplinary gastrointestinal surgery alone arm (HR, 0.66) as was the tumor board, which included thoracic overall survival (HR, 0.75). It translatsurgeons, general surgeons, gastroen- ed to a 13% improvement in 5-year surterologists, pathologists, radiologists, vival, from 23% to 36%.7 This patient was seen by both medical and medical and radiation oncologists. Initial discussion focused on staging, and radiation oncologists to discuss the because that would determine his treat- options of neoadjuvant chemoradiation ment paradigm. The patient’s CT and versus chemotherapy. Due to his age and PET scans suggested the possibility of medical comorbidity, he was not an widespread metastatic disease (Figures 1 ideal candidate for combined chemoraand 2). How- dition therapy using a cisplatin-based ever, the pat- regimen. Although chemoradiation tern for lymph with weekly carboplatin/paclitaxel was node enlarge- an alternative, the ability to give a full ment that in- dose of chemotherapy seemed more cluded the paraaortic, inguinal, and axillary area suggested the evolution of his preexisting Minsig Choi, MD lymphoma. In addition, the high SUV in the lymph nodes suggested the possibility of a high-grade rather than low-grade lymphoma.18,19 Because patients with lowgrade lymphoma can transform to a high grade, a biopsy of the cervical lymph node was felt to be appropriate. The biopsy revealed low-grade follicular lymphoma; hence we focused on the management of esophageal cancer— the life-threatening condition in this patient. Esophagectomy remains the standard of care for patients with locally advanced esophageal cancer with a 5year survival rate of 15% to 24%.17 Neoadjuvant treatments that include chemotherapy and radiation therapy Figure 2. Pretreatment FDG PET scan have been incorporated to improve the shows widespread increased nodal clinical outcome. The United Kingdom activity in the cervical, supraclavicular, Medical Research Council esophageal axillary, mediastinal, paraaortic, para cancer trial randomized 802 patients iliac, and inguinal lymph nodes. The with esophageal cancer to two cycles of increased activity posterior to the cisplatin/5-fluorouracil followed by sur- mediastinum, below the level of carina (esophageal lesion), had an SUV of 11.8. gery versus surgery alone. The long-

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appealing in this patient because neoadjuvant chemotherapy would treat both the esophageal cancer and the lymphoma. Emerging data show that operative mortality in patients treated neoadjuvantly with chemotherapy alone is lower than in patients treated with chemoradiation therapy.14 This patient received epirubicin/ oxaliplatin/capecitabine (EOX), based on data from the Randomized ECF for Advanced and Locally Advanced Esophagogastric Cancer (REAL) data series.21 The REAL study demonstrated that oxaliplatin/capecitabine is as effective as cisplatin/5-flourouracil but with less toxicity. This patient was restaged with CT and PET, which revealed resolution of his previous lymphadenopathy as well as decrease in the SUV in the primary tumor (Figure 3). He underwent ILE, tolerating both procedures, and currently is recuperating from surgery. Pathologic examination revealed complete response from chemotherapy, with all lymph nodes negative for malignancy. Conclusion Clinical outcomes for patients with esophageal cancer have gradually improved over the past three decades. Merging surgery, radiation therapy, and chemotherapy for individuals with esophageal cancer in a multidisciplinary setting is the key to success. The optimal approaches in treatment for esophageal cancer should be individualized. In this case, the patient was given neoadjuvant chemotherapy alone so that both his lymphoma and esophageal cancer could be treated simultaneously.

Figure 3. Posttreatment FDG PET (after three cycles of chemotherapy) shows resolution of FDG activity in the lymph nodes and decreased SUV activity in the primary lesion (esophagus).

There is a continuous need to emphasize the importance of the multidisciplinary approach in complex cancer cases, such as esophageal cancer, to bring about the best clinical outcomes. l References 1. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2009. CA Cancer J Clin. 2009;59:225-249. 2. Bilimoria KY, Bentrem DJ, Talamonti MS, et al. Risk-based selective referral for cancer surgery: a potential strategy to improve perioperative outcomes. Ann Surg. 2009 Nov 5. Epub ahead of print. 3. van Vliet EP, Heijenbrok-Kal MH, Hunink MG, et al. Staging investigations for esophageal cancer: a meta-analysis. Br J Cancer. 2008;98:547-557. 4. Vasquez-Sequeiros E, Wiersema MJ, Clain JE, et al. Impact of lymph node staging on therapy of esophageal carcinoma. Gastroenterology. 2003;125: 1626-1635. 5. Matsubara T, Ueda M, Kaisaki S, et al. Localization of initial lymph node metastasis from carcinoma of the thoracic esophagus. Cancer. 2000;89:1869-1873. 6. Kelsen DP, Ginsberg R, Pajak TF, et al. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998;339:1979-1984. 7. Cunningham D, Allum WH, Stenning SP, et al; for the MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006;355:11-20. 8. Safranek PM, Sujendran V, Baron R, et al. Oxford experience with neoadjuvant chemotherapy and surgical resection for esophageal adenocarcinomas and squamous cell tumors. Dis Esophagus. 2008;21: 201-206. 9. Himeno S, Yasuda S, Shimada H, et al. Evaluation of esophageal cancer by positron emission tomography. Jpn J Clin Oncol. 2002;32:340-346. 10. Kato H, Kuwano H, Nakajima M, et al. Comparison between positron emission tomography and computed tomography in the use of the assessment of esophageal carcinoma. Cancer. 2002;94:921-928. 11. Flamen P, Lerut A, Van Cutsem E, et al. Utility of positron emission tomography for the staging of patients with potentially operable esophageal carcinoma. J Clin Oncol. 2000;18:3202-3210. 12. Kato H, Miyazaki T, Nakajima M, et al. The incremental effect of positron emission tomography on diagnostic accuracy in the initial staging of esophageal carcinoma. Cancer. 2005;103:148-156. 13. van Westreenen HL, Westerterp M, Bossuyt PM, et al. Systematic review of the staging performance of 18F-fluorodeoxyglucose positron emission tomography in esophageal cancer. J Clin Oncol. 2004;22: 3805-3812. 14. Luu TD, Gaur P, Force FD, et al. Neoadjuvant chemoradiation versus chemotherapy for patients undergoing esophagectomy for esophageal cancer. Ann Thorac Surg. 2008;85:1217-1224. 15. Rohatgi PR, Swisher SG, Correa AM, et al. Failure patterns correlate with the proportion of residual carcinoma after preoperative chemoradiotherapy for carcinoma of the esophagus. Cancer. 2005;104: 1349-1355. 16. Ancona E, Ruol A, Santi S, et al. Only pathologic complete response to neoadjuvant chemotherapy improves significantly the long term survival of patients with resectable esophageal squamous cell carcinoma: final report of a randomized, controlled trial of preoperative chemotherapy versus surgery alone. Cancer. 2001;91:2165-2174. 17. Enzinger P, Mayer R. Esophageal cancer. N Engl J Med. 2003;349:2241-2252. 18. Noy A, Shröder H, Gönen M, et al. The majority of transformed lymphomas have high standardized uptake values (SUVs) on positron emission tomography (PET) scanning similar to diffuse large B-cell lymphoma (DLBCL). Ann Oncol. 2009;20:508-512. 19. Ngeow JY, Quek RH, Ng DC, et al. High SUV uptake on FDG-PET/CT predicts for an aggressive B-cell lymphoma in a prospective study of primary FDG-PET/CT staging in lymphoma. Ann Oncol. 2009;20:1543-1547. 20. Medical Research Council Oesophageal Cancer Working Party. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002; 359:1727-1733. 21. Cunningham D, Starling N, Rao S, et al; for the Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358:36-46.

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Coding and Billing Infusion Nursing Resources... Continued from cover have elected to move the process to the back office using specialized coders who rely on clinical notes to extract charge data, most groups still rely on nurses, given their first-person encounter knowledge. These nurses in turn typically rely on paper to document charges —paper that creates a host of potential issues. Paper “superbills” might seem to make sense in other outpatient areas where coding is more straightforward, as in the selection of a single procedure code, but they simply do not represent the infusion coding hierarchy in a way that is intuitive. The result can be David Delaney, MD confusion around “primary” relationships between chemotherapy services, therapeutic or other services, and hydration, not to mention several distinct procedure codes for initial, sequential, additional, and concurrent services. Encounters that are miscoded can lead to compliance issues, which are of growing concern given today’s environment of recovery audit contractors who have an awareness that infusion coding is complex and thus likely to yield mispayment situations.

Tools have grown from simple coding mechanisms to intelligent advisors that provide immediate and real-time feedback to users, driving appropriate coding and reducing downstream denials. And since nursing resources in busy clinics are typically quite tight, the utilization of encounter forms requires initial training and retraining as codes change, and also leads to missing charges, depending on how shift changes are handled. For clinics that allow shift changes during a patient’s appointment, services can be omitted if one nurse believes the other has already completed documentation. The worst case scenario is one where forms become misplaced altogether, leading to a loss of vital revenue. Beyond compliance and financial concerns stemming from paper processes, there is the reality of nurses whose

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training is in delivering care and compassion having to manage these administrative responsibilities while trying to balance clinical duties surrounding patient care. These challenges, while frustrating, are not new to healthcare. These challenges are essentially what

led to the development of automated charge capture software applications for physicians, which leveraged the introduction of handheld computers in the 1990s. Charge capture technology has evolved significantly over the past sev-

eral years—tools have grown from simple coding mechanisms to intelligent advisors that provide immediate and real-time feedback to users, driving appropriate coding and reducing downstream denials. Adoption in academic Continued on page 17

with new enhanced online services There is A place you can go for user-friendly online tools and reimbursement forms… …where your coverage questions can be Answered …where online Access to forms is simple …where you can talk to A reimbursement specialist directly

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For insurance verification…prior authorization…patient assistance program information…and billing and claims processing support. Amgen Assist™ and Amgen Inc. do not guarantee success in obtaining reimbursement. Third party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or resolved by our Amgen Assist™ staff. ©Amgen. All rights reserved. MC48319 11/09

Making Access easier.

april 2010 I VOl 3, NO 2

Healthcare Reform Bill Healthcare Reform 2010... Continued from cover from new program offerings swell by more than 10 milor seek insurance from their lion in the next 5 years. In employer. Employers with many states, physician pracfewer than 50 workers will tices and hospitals are alnot be required to offer insurready scrambling to provide ance. services to Medicaid paEmployers with 50 to 200 tients in the face of signifiworkers may still choose cantly inadequate reimwhether or not to offer bursement rates. In Coninsurance, but at a cost. necticut, for instance, local Employers with 50 workers Dawn Holcombe, MBA, screening clinics for colon or more that do not offer FACMPE, ACHE cancer had to close in early health insurance as a benefit 2009 not because of a lack of but who have at least one full-time people who needed screening, but employee receiving a subsidy from the because of a lack of resources for government to purchase health insur- colonoscopy services; facilities could ance on his or her own, will be subject only afford to accept a limited number of to hefty fines—as much as $2000 for patients with no reimbursement options. each full-time worker. Employers with For oncology, the pressures posed by 200 or more employees will be mandat- the healthcare reform bill are significant. ed to automatically enroll workers in Many physicians already care for as many their health insurance plan (but they Medicaid patients as they can afford in may choose to opt out on their own). their offices, but have to refer increasing numbers of Medicaid patients to hospital The Bad: Benefits will be services (which are now becoming more substantial, but at what cost? vocal about their funding and resource The legislation includes guaranteed limitations for Medicaid services). insurance coverage for persons particiRecent state-based reforms in Conpating in clinical trials; however, the necticut and Massachusetts have demdetails and impact of such coverage on onstrated that increasing coverage does premiums and benefit copays and coin- not equate to increased access. A new surance are not yet clear. One of the state-funded universal healthcare option biggest challenges is that coverage is in Connecticut failed when the option mandated, but the cost of such coverage was unable to attract sufficient physito employers and individual patients is cians and hospitals to enroll as providers, not yet addressed. despite high numbers of enrolled potenInsurers are mandated to cover preex- tial patients. Expansion of the Medicaid isting conditions, but at some recognized program in Massachusetts has had a procost. The delay for covering adults with found impact on local providers. preexisting conditions is intended to According to Philip Betbeze, reporting allow insurers to increase their rolls of for HealthLeaders Media, “Boston insured patients. Medical Center, a hospital that was breaking even before [Massachusetts Coverage does not equal access. The dis- state health] reform, is now losing $12 cussion about the national healthcare million a month.”1 The healthcare reform bill provides reform bill has focused largely on the

We have already seen that reimbursement reductions and public insurance plans that pay below the cost of care result in reduced access to care providers in oncology. increase in insurance options for individuals, but has not addressed how and by whom this new care will be provided. We have already seen that reimbursement reductions and public insurance plans that pay below the cost of care result in reduced access to care providers in oncology. We can probably expect that this situation will not be remedied, but exacerbated, under the national healthcare reform. In the process of adding this coverage for millions, expectations are that the ranks of those served by Medicaid may

april 2010 I VOl 3, NO 2

subsidies for some of the expansion of Medicaid programs in states, but these subsidies begin to decrease starting in 2017, leaving states to fund the balances. Many states, including Virginia, Texas, and Mississippi, are already making public statements of concern about their ability to absorb the additional costs. The Ugly: Medicare reimbursements are already a challenge for oncology A recent study released by Avalere Health on the costs of cancer care and presented at the Community Oncology

Alliance annual conference was summarized by that organization: “Medicare covers only 56% of the actual costs of administering chemotherapy and providing related infusion room services to seniors with cancer. The remaining costs— for essential services provided such as treatment planning, care coordination, and follow-up care planning—are not reimbursed by Medicare, causing many oncology practices to struggle to continue to provide under the Medicare program.”2 A significant portion of the funding of the costs of the healthcare reform program is expected to be covered by savings (reductions), both from current Medicare payments and also from savings to be generated by reductions in the Medicare Advantage program. To the extent that

important to watch how those financial reductions translate into coverage changes for patients with cancer. Healthcare reform—but probably not healthcare improvement for cancer care. Many aspects of the health insurance reform bill will make positive changes for Americans, but the implications for patients with cancer and those who care for them are fairly grim. When insurance expansion occurs in the sectors that already have proved to underreimburse complex cancer care, there will be an inevitable and direct effect on the resources available for cancer care. Neither physician practices nor hospitals, at this point, are anticipating any improvements in reimbursement under the healthcare reform bill and are defi-

Neither physician practices nor hospitals, at this point, are anticipating any improvements in reimbursement under the healthcare reform bill and are definitely anticipating significant increases in volumes of patients covered under insurance plans they may not be able to continue to accept. “savings” mean direct reductions in payments to oncology practices for services incurred in treating Medicare patients (whether through Medicare directly or Medicare Advantage programs), practices and hospital centers may make difficult choices about their ability to continue to participate in the Medicare programs. Much is made of planned increases and support of primary care in the healthcare reform language, but most of those increases will come at the cost of reductions to specialists, like those who care for patients with cancer (new reductions, on top of existing 2010 Medicare cuts and reductions). Medicare Advantage—or disadvantage? Medicare Advantage programs offer additional benefits outside of the basic Medicare options for patients, but those benefits also come with greater restrictions. Oncologists are seeing increasing numbers of patients who have converted to Medicare Advantage programs, only to find significantly higher copayments or formulary restrictions on the drugs needed to treat their cancer. Some oncologists in Florida have actually coined the phrase “grief counselors” to identify the additional challenges their financial counselors are finding when helping patients to navigate the consequences of insurance changes to Medicare Advantage plans. As healthcare reform reduces payments to Medicare Advantage insurers, it will be

nitely anticipating significant increases in volumes of patients covered under insurance plans they may not be able to continue to accept. If large numbers of physicians and hospitals are not able to provide services to these newly insured patients, how is that true health reform? More details about the implementation and application of the healthcare reform bill are yet to be unveiled. This will definitely be an uphill struggle, no matter what your position is on the bill. For better or worse, nothing will ever be the same again. l References 1. Betbeze P. Hospital bailout? It could happen. March 26, 2010. HealthLeaders Media. www.healthleaders media.com/content/LED-248619/Hospital-BailoutIt-Could-Happen. Accessed March 31, 2010. 2. Community Oncology Alliance. Study: Medicare covers only half the cost of administering chemotherapy to seniors with cancer. February 4, 2010. PRNewswire. www.prnewswire.com/news releases/study-medicare-covers-only-half-the-costof-administering-chemotherapy-to-seniors-withcancer-83564552.html. Accessed March 31, 2010.

Continuing Coverage of the Healthcare Reform Bill Special Issue: May 2010 Healthcare Reform and Private Practice A Roundtable Discussion Legal Issues in Cancer Care

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Psychosocial Issues

New CancerCare CEO Looks Ahead An interview with Helen H. Miller, LCSW By Karen Rosenberg

elen H. Miller, LCSW, recently assumed the position of chief executive officer of CancerCare, succeeding Diane Blum, who held the position for 20 years. Ms Miller received her master’s degree from Columbia University School of Social Work and has directed cancer prevention and wellness programs at major cancer centers. The Journal of Multidisciplinary Cancer Care spoke with Ms Miller about the role of CancerCare in helping patients and their significant others cope with the practical and emotional challenges associated with a diagnosis of cancer.

What services does CancerCare provide and how do its services complement the services provided by hospitals and clinics? CancerCare is a 65-year-old nonprofit agency that provides free counseling, education, support groups, and financial assistance for patients and others affected by cancer. Last year, we provided services to more than 100,000 individuals. These services complement those provided by hospitals or cancer centers. When I worked in a hospital setting, I often referred patients to CancerCare for additional help with psychosocial issues. We are located in New York City, but people who don’t live in the metropolitan area can get our services through websites and over the telephone. For instance, we offer Connect Education

Workshops, in which oncology experts provide free 1-hour workshops on various cancer-related topics over the phone or as podcasts. We offer health education credit for healthcare professionals who participate in these workshops. Our services are available to anyone affected by cancer: patients, family members, caregivers. We even had an employer come to us for counseling to

stage they are at in the course of the disease. Are they recently diagnosed or have they been through treatment for an ongoing period? Are they in the end stage of life or are we dealing with bereavement for a family? For many types of cancer, such as breast cancer, there is a genetic component, and one issue is what can be done from a preventive standpoint if there is a family

“One reason nurses have always made so many of the referrals here is that they know that we understand that you can’t talk to a patient without taking into account the doctor’s role and the nurse’s role.” ——Helen H. Miller, LCSW learn how to deal with the business, personal, and professional issues presented by an employee with cancer. We also provide free educational materials and resources for healthcare professionals, and we have social workers with expertise in specific types of cancer who are available for consultation. Do you find that people with different types of cancer have different psychosocial issues and different needs? They absolutely do. Being even more specific, people’s needs reflect what

Society of Surgical Oncology

history of the disease. It’s very important to have trained social work professionals who are familiar with the different types of cancer because of the complexity of the medical system and the rapid advances in treatment. How can nurses and social workers work together to best meet a patient’s psychosocial needs? My emphasis in training since day 1 has been the team approach. I firmly believe that the nurse or nurse practitioner is the core person from the med-

ical standpoint because she is the one who often spends more time with the patient than the physician. I think one reason nurses have always made so many of the referrals here is that they know that we understand that you can’t talk to a patient without taking into account the doctor’s role and the nurse’s role. What are your personal goals as CEO? Diane [Blum] did a great job, and CancerCare is already well respected as a resource people affected by cancer can turn to for help. I hope to continue to expand that resource and make it more of a household word. It’s important for everyone in the cancer community to know about us and for us to continue to work with nurses and expand and continue to communicate as to how we can help, especially during these difficult financial times. I am looking at outcomes in terms of what we are doing, how we are doing, and the results of what we are doing. It is especially important to continue to deliver high-quality, efficient care in these changing times. Where can we be better or how can we reach more people? How do we continue to do what we have done and not overburden our staff when there are economic challenges? Diane is a hard act to follow, but I feel very fortunate that she had the commitment to the organization to try to make the transition a smooth one. l

Continued from page 9

Surveillance After Ovarian Cancer Treatment Is Spotty

esearchers are reporting a wide variation in posttreatment surveillance among gynecologists who care for patients with ovarian cancer. Garo Harmandayan, DO, with St. Louis University School of Medicine, presented the results of a questionnaire completed by 283 members of the Society for Gynecologic Oncologists. The study was undertaken to identify the current surveillance patterns of credentialed experts. “While the surveillance of patients after initial curative-intent treatment of ovarian cancer has important medical implications, the particular modalities used in surveillance by clinicians and how frequently they are recommended are unknown at present,” Harmandayan pointed out. “Routine postoperative surveillance

april 2010 I VOl 3, NO 2

testing is practiced by gynecologists and recommended by many organizations; however, there is a lack of objective evidence to support any particular surveillance strategy in ovarian cancer patients,” he said. For their study, the investigators developed a survey based on four “idealized” scenarios depicting generally healthy women with ovarian cancer of various Federation of Gynecology and Obstetrics stages. Survey participants were asked to indicate the number of office visits, pelvic examinations, Pap smears, complete blood counts, metabolic panels, serum CA125 levels, chest films, abdominal pelvic computed tomography (CT) scans, chest CT scans, abdominal-pelvic magnetic resonance imaging scans, and transvaginal ultra-

sound examinations they would recommend each year for 10 years after initial curative-intent treatment. These 11 modalities include all modalities cited in the relevant medical literature. All gynecologic oncologists surveyed said that they performed ovarian cancer surgery and also participated in longterm follow-up. Results showed that the most frequently performed tests for each year for all four scenarios were office visit, pelvic examination, and serum CA125 level. Imaging studies were rarely recommended. The intensity of surveillance practice varied widely. For example, the number of pelvic examinations recommended in the first postoperative year for women with stage I ovarian cancer ranged from one to 12. Also, respondents tended to recom-

mend less testing with increasing postoperative years for all recommended tests. For example, the mean number of times an office visit was recommended for stage IV patients was 4.4 times during the first year, which fell to 1.1 times by the tenth year. A marked variation in the intensity of a particular strategy is generally construed as evidence of overuse, underuse, and/or misuse of scarce resources, Harmandayan observed. For this reason, further research to evaluate causes of the observed variation is warranted. Finally, he said that the study is the first to examine the actual practice of routine surveillance testing for women after primary treatment for ovarian cancer. l —JS

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Cancer Center Profile Cancer Center Profile... Continued from cover ment and consulting services. The CCC now employs 120 healthcare professionals and provides a full range of services, including screening, diagnosis, treatment, and follow-up care under one roof. The 60,000-square-foot center houses a medical oncology infusion center, physician offices and examination rooms, a radiation oncology treatment area, outpatient surgery facilities, a laboratory, a pharmacy, a research department, a comprehensive breast center, and a patient resource center. The center employs a multidisciplinary team of physicians with expertise in all the major types of cancer and offers a variety of treatment options, including chemotherapy, radiation therapy, gene therapy, and surgery. Patients have access to on-site psychosocial, nutritional support, and

workers help arrange housing for patients and their families; translators are also available to assist foreign visitors.

Pharmacist plays many roles Through its affiliation with Aptium Oncology– managed cancer centers throughout the country, the CCC offers patients Multidisciplinary staff of Desert Regional Comprehensive Cancer Center. the opportunity to participate in phase 1 to 4 clinical trials. I’m also involved in building the proto- a transplant from Indiana, it has been Oncology pharmacist Craig Elg, cols for all the new research trials. Once very welcoming.” Rupp previously PharmD, BCOP, coordinates clinical we sign on to do something, those order worked on the oncology floor of a local trials in addition to his other responsi- sets are put into the EMR so that the hospital in Indiana and in private oncology practices in Indiana and bilities. “At any given time, we have 40 physicians have easy access to them.” to 50 clinical trials open and running,” In addition to their more traditional California. In her previous jobs, she says the he says. “One of my responsibilities is to responsibilities for counseling patients make sure that the pharmacy portion of and providing support to medical staff nurses had to take on other responsibilon a variety of supportive care issues, ities, such as mixing chemotherapy, in such as fatigue and pain management, addition to their nursing duties. “We Elg and his fellow pharmacists at the wore all hats. We were the nurse; we “I can rely on all the different professions—the center have the ability through special mixed and administered chemotherapy California law to prescribe controlled in our office; we ran the lab; we were pharmacists, the dietitians, social workers, and substances to help manage patients the social worker; the dietitian, everyothers—to add their knowledge and expertise to thing.” At the CCC, she says, “I can with cancer pain. taking care of the patient as a whole.” Desert Regional CCC provides an rely on all the different professions— ——Kristin Rupp, RN, BSN, OCN environment in which employees are the pharmacists, the dietitians, social encouraged to do new things and take workers, and others—to add their on new responsibilities, Elg has found. knowledge and expertise to taking care “You get a lot of support from Admin- of the patient as a whole. This allows financial counseling services. In addi- those trials is running smoothly and istration and the medical staff. It is a me to focus on my nursing role.” tion, the CCC provides genetic testing correctly. I go to the site initiation visits very collaborative practice here and There are also advantages for for women at high risk for breast or and meet with the monitors to make definitely an enjoyable place to work.” patients. “We have everything here ovarian cancer, a hospice program, a sure that the protocol is being followed under one roof,” making it possible for pain management program, support properly, the drugs are being stored in Nurse appreciates range of patients to see different specialists in the correct manner, destruction policies specialties groups, and volunteer services. one visit, she notes. “The level of Oncology nurse Kristin Rupp, RN, expertise that I am surrounded by every Because of its excellent reputation, are being followed, and all the paperpatients come from far away to be treat- work is done. Since we implemented BSN, OCN, agrees, saying, “We feel as day makes care of the patient top ed at Desert Regional CCC, and social our electronic medical record (EMR), if we are a family here. Coming here as notch.” l

Infusion Nursing Resources... Continued from page 13 settings in particular has grown tremendously given the solution’s positive impact on revenue cycles (now more important than ever). Recently, charge capture automation for the outpatient infusion setting has been introduced. Using the tool, nurses simply click on the line items that represent services rendered; calculations as per the coding hierarchy are performed, and the appropriate charge data master codes generated. If a potential coding violation is identified during this process, such as an intravenous (IV) infusion of less than 16 minutes not reported as an IV push, or the erroneous selection of hydration as the primary service, the user is alerted, proactively, to correct the oversight. The utilization of charge capture

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technology also shortens the entirety of the infusion billing process. Beyond the elimination of paper handoffs between staff members, both clinical and administrative, the usage of a com-

same day of service. Nurse users at these sites additionally report high satisfaction with the application and characterize it as both easy to learn and easy to use.

Charge capture automation is an option that has shown success in alleviating nurse administrative burden, while simultaneously driving both compliance and financial benefit. puterized system allows immediate transmission of clean charges from the point-of-care to the billing system. In fact, at two large cancer centers using infusion charge capture software, 99% of charges are sent for billing on the

The demand for oncology services is showing no signs of slowing, even as early detection and survival rates improve. Clinics that want to be proactive in their approach to managing increasing demand in the face of an

existing nursing shortage must explore all options for expanding the capacity of nurses. Infusion coding and billing is a complex area that many nurses are directly responsible for, yet, these vital resources are appropriately much more interested in spending that time providing patient care. Charge capture automation is an option that has shown success in alleviating nurse administrative burden, while simultaneously driving both compliance and financial benefit. The net result? A win for nurses, a win for the organization, and a win for patients. l This article was originally published in The ACE Report, May/June 2009. Reprinted with permission from the Association of Cancer Executives.

april 2010 I VOl 3, NO 2

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

Medications Used for the Treatment of Lymphomas The following sections include: • Associated ICD-9-CM codes used for the classification of lymphomas • Drugs that have been FDA-approved in the treatment of lymphomas. Please note: if a check mark appears in the FDA column it will NOT appear in the Compendia section even if a drug is included in the NCCN (National Comprehensive Cancer Network) Drugs & Biologics Compendium • Drugs included in the NCCN Drugs & Biologics Compendium for off-label use in lymphomas. NCCN is recognized by the Centers for Medicare & Medicaid Services (CMS) as a referencing source • Corresponding HCPCS/CPT codes and code descriptions • Current Code Price (AWP-based pricing) • Most recent ASP plus 6% (Medicare allowable) • Possible CPT Administration Codes for each medication

generic (Brand) name

HCPCS code: code description

alemtuzumab (Campath) asparaginase (Elspar) bendamustine (Treanda) betamethasone (Celestone Soluspan)

J9010: injection, alemtuzumab, 10 mg J9020: injection, asparaginase, 10,000 units J9033: injection, bendamustine HCl, 1 mg J0702: injection, betamethasone acetate, 3 mg and betamethasone sodium phosphate, 3 mg

april 2010 I VOl 3, NO 2

Associated ICD-9-CM Codes Used for Lymphomas The following fifth-digit subclassification is for use with categories 200-202: 0 unspecified site, extranodal and solid organ sites 1 lymph nodes of head, face, and neck 2 intrathoracic lymph nodes 3 intra-abdominal lymph nodes 4 lymph nodes of axilla and upper limb 5 lymph nodes of inguinal region and lower limb 6 intrapelvic lymph nodes 7 spleen 8 lymph nodes of multiple sites 200 Lymphosarcoma and reticulosarcoma and other specified malignant tumors of lymphatic tissue 200.0 Reticulosarcoma 200.1 Lymphosarcoma 200.2 Burkitt’s tumor or lymphoma 200.3 Marginal zone lymphoma 200.4 Mantle cell lymphoma 200.5 Primary central nervous system lymphoma 200.6 Anaplastic large cell lymphoma 200.7 Large cell lymphoma 200.8 Other named variants Lymphoma (malignant): lymphoplasmacytoid type mixed lymphocytic-histiocytic (diffuse) Lymphosarcoma, mixed cell type (diffuse) Reticulolymphosarcoma (diffuse) 202 Other malignant neoplasms of lymphoid and histiocytic tissue 202.0 Nodular lymphoma 202.1 Mycosis fungoides 202.2 Sézary’s disease 202.3 Malignant histiocytosis 202.4 Leukemic reticuloendotheliosis 202.5 Letterer-Siwe disease 202.6 Malignant mast cell tumors 202.7 Peripheral T-cell lymphoma 202.8 Other lymphomas Lymphoma (malignant): not otherwise specified diffuse Excludes: benign lymphoma (229.0) 202.9 Other and unspecified malignant neoplasms of lymphoid and histiocytic tissue Follicular dendritic cell sarcoma Interdigitating dendritic cell sarcoma Langerhans cell sarcoma Malignant neoplasm of bone marrow not otherwise specified

FDAapproved for lymphomas

NCCN Drugs & Biologics Compendium off-label use for lymphomas

Current code price (AWP-based pricing), effective 4/1/10

Medicare allowable (ASP + 6%), effective 4/1/10-6/30/10

CPT administration codes

✓

$680.73

$578.01

96413, 96415

✓

$70.42

$60.94

96401, 96413

✓

$21.60

$18.47

96413

✓

$6.85

$6.55

11900, 11901, 20600, 20605, 20610, 96372

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

FDAapproved for lymphomas

generic (Brand) name

HCPCS code: code description

bexarotene (Targretin)

J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified J9040: injection, bleomycin sulfate, 15 units J9041: injection, bortezomib, 0.1 mg J9045: injection, carboplatin, 50 mg J9050: injection, carmustine, 100 mg J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified J9060: cisplatin, powder or solution, per 10 mg J9062: cisplatin, 50 mg J9065: injection, cladribine, per 1 mg J8530: cyclophosphamide, oral, 25 mg

✓

bleomycin (Blenoxane) bortezomib (Velcade) carboplatin (Paraplatin) carmustine (BiCNU) chlorambucil (Leukeran)

Current code price (AWP-based pricing), effective 4/1/10

Medicare allowable (ASP + 6%), effective 4/1/10-6/30/10

CPT administration codes

✓

NDC level pricing $45.30

NDC level pricing $26.08

96401, 96409

✓

$45.43

$38.24

96409

$48.55

$5.31

✓

$205.69

$176.41

✓

NDC level pricing $4.33

NDC level pricing $1.98

96409, 96413, 96415

✓

$21.66

$9.91

96409, 96413, 96415

✓

$58.20

$28.22

✓

$2.09

$0.84

J9070: cyclophosphamide, 100 mg

✓

$7.55

$4.35

96409, 96413, 96419

J9080: cyclophosphamide, 200 mg

✓

$15.10

$8.69

96409, 96413, 96415

J9090: cyclophosphamide, 500 mg

✓

$37.76

$21.73

96409, 96413, 96415

J9091: cyclophosphamide, 1.0 gram

✓

$68.00

$43.46

96409, 96413, 96415

J9092: cyclophosphamide, 2.0 grams

✓

$122.39

$86.92

96409, 96413, 96415

$2.31

$1.51

$22.21

$7.37

96409, 96413, 96415, 96450 96409, 96413

$25.20

$19.46

96409, 96413

✓

$1,756.80

$1,494.82

96409, 96413, 96415

✓

$0.15

$0.09

✓

$0.09

$0.38

11900, 11901, 20600, 20605, 20610, 96372, 96374 N/A

✓

$13.20

$3.04

96409

cisplatin (Platinol-AQ) cisplatin (Platinol-AQ) cladribine (Leustatin) cyclophosphamide, oral (Cytoxan) cyclophosphamide, injection (Cytoxan) cyclophosphamide, injection (Cytoxan) cyclophosphamide, injection (Cytoxan) cyclophosphamide, injection (Cytoxan) cyclophosphamide, injection (Cytoxan) cytarabine (Cytosar-U) dacarbazine (DTIC-Dome) daunorubicin (Cerubidine) denileukin diftitox (Ontak) dexamethasone (Decadron)

J9100: injection, cytarabine, 100 mg J9140: dacarbazine, 200 mg J9150: injection, daunorubicin, 10 mg J9160: injection, denileukin diftitox, 300 micrograms J1100: injection, dexamethasone sodium phosphate, 1 mg

dexamethasone (Decadron) doxorubicin HCl (Adriamycin)

J8540: dexamethasone, oral, 0.25 mg J9000: injection, doxorubicin hydrochloride, 10 mg

www.jOmcc.com

NCCN Drugs & Biologics Compendium off-label use for lymphomas

✓

N/A

96409, 96413, 96415 96413, 96415 N/A

96413, 96415 N/A

april 2010 I VOl 3, NO 2

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

generic (Brand) name

HCPCS code: code description

FDAapproved for lymphomas

doxorubicin liposome J9001: injection, doxorubicin (Doxil) hydrochloride, all lipid formulations, 10 mg etoposide J9181: injection, (Etopophos, Toposar) etoposide, 10 mg etoposide J8560: etoposide, (Vepesid) oral, 50 mg fludarabine J9185: injection, fludarabine phosphate phosphate, 50 mg (Fludara) gemcitabine J9201: injection, gemcitabine (Gemzar) hydrochloride, 200 mg hydrocortisone J1720: injection, hydrocortisone (Solu-Cortef) sodium succinate, up to 100 mg ibritumomab A9542: indium In-111 tiuxetan ibritumomab tiuxetan, diagnostic, (Zevalin) per study dose, up to 5 millicuries ibritumomab A9543: yttrium Y-90 ibritumomab tiuxetan tiuxetan, therapeutic, per (Zevalin) treatment dose, up to 40 millicuries ifosfamide J9208: injection, (Ifex) ifosfamide, 1 gram interferon J9214: injection, interferon, alfa-2b alfa-2b, recombinant, (Intron-A) 1 million units interferon gamma 1-b J9216: injection, interferon, (Actimmune) gamma 1-b, 3 million units isotretinoin J8499a: prescription drug, (Accutane) oral, non-chemotherapeutic, not otherwise specified lenalidomide J8999a: prescription drug, (Revlimid) oral, chemotherapeutic, not otherwise specified lomustine J8999a: prescription drug, (CeeNU) oral, chemotherapeutic, not otherwise specified lomustine S0178: lomustine, (CeeNu) oral, 10 mg mechlorethamine (Mustargen) melphalan (Alkeran) melphalan (Alkeran) mesna (Mesnex) mesna (Mesnex) methotrexate

J9230: injection, mechlorethamine hydrochloride (nitrogen mustard), 10 mg J8600: melphalan, oral, 2 mg J9245: injection, melphalan hydrochloride, 50 mg J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified J9209: injection, mesna, 200 mg J8610: methotrexate, oral, 2.5 mg

NCCN Drugs & Biologics Compendium off-label use for lymphomas

Current code price (AWP-based pricing), effective 4/1/10

Medicare allowable (ASP + 6%), effective 4/1/10-6/30/10

CPT administration codes

✓

$578.88

$472.01

96413

✓

$0.53

$0.49

✓

$47.64

$28.26

N/A

✓

$309.70

$205.81

96413

✓

$173.83

$145.10

96413

✓

$2.46

$3.14

✓

$4,200.00

N/A

96365, 96366, 96372, 96374 96374

✓

$37,800.00

N/A

79403

96413, 96415

$56.40

$30.76

96413, 96415

$21.90

$15.84

96372, 96401

✓

$517.89

$430.93

✓

NDC level pricing NDC level pricing NDC level pricing $10.59

✓

$178.71

✓

NDC level pricing NDC level pricing NDC level pricing S0178: not payable by Medicare $154.50

N/A

96409

N/A

✓

$5.68

$4.83

✓

$1,922.50

$1,500.32

✓

NDC level pricing $10.44

NDC level pricing $4.26

96409

$3.61

$0.16

N/A

✓

96372

96409, 96413 N/A

Continued on page 22

april 2010 I VOl 3, NO 2

www.jOmcc.com

NHL Mantle Cell Trial Now Recruiting Investigators and Enrolling Study Participants Celgene CC-5013-MCL-001

A Phase 2 Study for Patients With Relapsed/Refractory Mantle Cell Non-Hodgkin’s Lymphoma Primary Investigator André Goy, MD Primary Objective To determine the tumor response and duration of response of lenalidomide monotherapy in subjects with mantle cell lymphoma (MCL) who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib Key Eligibility Criteria* • Individuals with MCL previously treated with all of the following (alone or in combination): – Bortezomib† – An anthracycline or mitoxantrone – Rituximab – Cyclophosphamide • Individuals must have documented relapse after bortezomib treatment or be refractory to bortezomib • Excluding individuals who are candidates for high-dose chemotherapy/allogeneic stem cell transplant *Additional criteria apply. †Note: When the agent bortezomib is mentioned this also includes ANY BORTEZOMIB-CONTAINING REGIMEN.

Study Design

Pretreatment Phase (4 Weeks)

N=133

• MCL diagnosis conﬁrmed by local pathological review

Treatment Phasea (until disease progression)

• Lenalidomide starting dose 25 mg po once dailyb

Lenalidomide will be dosed po once daily on days 1-21 of each 28-day cycle. Subjects with creatinine clearance ≥30 mL/min but <60 mL/min will receive a lower starting dose of lenalidomide 10 mg po once daily. Dose may be escalated to 15 mg po once daily if no dose-limiting toxicities occur during the ﬁrst 2 cycles.

Investigational use of lenalidomide. For more information contact Deborah Ingenito, Celgene Study Manager dingenito@celgene.com (908) 673-9581 www.clinicaltrials.gov (NCT00737529)

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 20

FDAapproved for lymphomas

NCCN Drugs & Biologics Compendium off-label use for lymphomas

Current code price (AWP-based pricing), effective 4/1/10

Medicare allowable (ASP + 6%), effective 4/1/10-6/30/10

CPT administration codes

generic (Brand) name

HCPCS code: code description

methotrexate sodium

J9250: methotrexate sodium, 5 mg

✓

$0.29

$0.21

96372, 96374, 96401, 96409, 96450

methotrexate sodium methoxsalen (Oxsoralen, 8-MOP, Oxsoralen Ultra) methylprednisolone (Depo-Medrol)

✓

$2.86

$2.10

✓

NDC level pricing $5.70

NDC level pricing $3.40

96372, 96374, 96401, 96409, 96450 N/A

✓

$10.20

$6.64

11900, 11901, 20600, 20605, 20610, 96372

✓

$2.36

$2.28

96365, 96366, 96372, 96374

✓

$4.15

$3.06

96365, 96366, 96372, 96374

methylprednisolone (Medrol) mitoxantrone (Novantrone) nelarabine (Arranon) ofatumumab (Arzerra) ofatumumab (Arzerra):

J9260: methotrexate sodium, 50 mg J8499a: prescription drug, oral, non-chemotherapeutic, not otherwise specified J1030: injection, methylprednisolone acetate, 40 mg J1040: injection, methylprednisolone acetate, 80 mg J2920: injection, methylprednisolone sodium succinate, up to 40 mg J2930: injection, methylprednisolone sodium succinate, up to 125 mg J7509: methylprednisolone, oral, per 4 mg J9293: injection, mitoxantrone hydrochloride, per 5 mg J9261: injection, nelarabine, 50 mg C9260: injection, ofatumumab, 10 mg J9999a: not otherwise specified, antineoplastic drugs

✓

$0.61

$0.08

$109.60

$45.27

96409, 96413

$123.19

$105.91

96413, 96415

✓

$52.80

N/A

96413, 96415

✓

J9263: injection, oxaliplatin, 0.5 mg J9268: injection, pentostatin, per 10 mg C9259: injection, pralatrexate, 1 mg J9999a: not otherwise classified, antineoplastic drugs

✓

NDC level pricing $6.83

96413, 96415

oxaliplatin (Eloxatin) pentostatin (Nipent) pralatrexate (Folotyn) pralatrexate (Folotyn)

NDC level pricing $8.25

✓

$2,182.80

$1,246.38

96409, 96413

prednisolone (Millipred, Orapred, Veripred) prednisone

J7510: prednisolone, oral, per 5 mg

methylprednisolone (Depo-Medrol) methylprednisolone (Solu-Medrol) methylprednisolone (Solu-Medrol)

✓

NDC level pricing $0.02

96409

✓

NDC level pricing $0.66

✓

$0.05

$0.04

N/A

✓

NDC level pricing $55.68

rituximab (Rituxan)

J9310: injection, rituximab, 100 mg

✓

$664.32

NDC level pricing S0182: not payable by Medicare $578.40

N/A

procarbazine (Matulane)

J7506: prednisone, oral, per 5 mg J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified S0182: procarbazine HCl, oral, 50 mg

april 2010 I VOl 3, NO 2

✓

96413, 96415

96409

$187.50

N/A

procarbazine (Matulane)

✓

11900, 11901, 20600, 20605, 20610, 96372

N/A

96413, 96415

www.jOmcc.com

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

generic (Brand) name

HCPCS code: code description

romidepsin (Istodax)

C9399a: unclassified drugs or biologicals (This code should only be used for new drugs and biologicals that are approved by the FDA on or after January 1, 2004) J9999a: not otherwise classified, antineoplastic drugs

romidepsin (Istodax) temozolomide, injection (Temodar) temozolomide, oral (Temodar) temsirolimus (Torisel) thalidomide (Thalomid) thiotepa (Thioplex) tositumomab (Bexxar) tretinoin (Vesanoid) vinBLAStine vinCRIStine (Vincasar PFS) vinCRIStine (Vincasar PFS) vinCRIStine (Vincasar PFS) vorinostat (Zolinza)

FDAapproved for lymphomas

J9328: injection, temozolomide, 1 mg (For billing prior to 1/1/10, use J9999 or C9253) J8700: temozolomide, oral, 5 mg J9330: injection, temsirolimus, 1 mg J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified J9340: injection, thiotepa, 15 mg A9545: iodine I-131 tositumomab, therapeutic, per treatment dose J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified J9360: injection, vinblastine sulfate, 1 mg J9370: vincristine sulfate, 1 mg J9375: vincristine sulfate, 2 mg J9380: vincristine sulfate, 5 mg J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified

NCCN Drugs & Biologics Compendium off-label use for lymphomas

Current code price (AWP-based pricing), effective 4/1/10 NDC level pricing

Medicare allowable (ASP + 6%), effective 4/1/10-6/30/10

CPT administration codes

NDC level pricing

96413, 96415

NDC level pricing $4.90

96413, 96415

✓

NDC level pricing $5.66

✓

$10.65

$8.83

N/A

✓

$58.72

$49.83

96413

✓

NDC level pricing $113.53

N/A

✓

NDC level pricing $138.00

✓

$34,873.19

✓

N/A

96413, 96415

51720, 96409 79403

NDC level pricing $1.02

N/A

✓

NDC level pricing $3.18

✓

$8.12

$4.31

96409

✓

$16.24

$8.62

96409

✓

$40.60

$21.54

96409

✓

NDC level pricing

N/A

✓

96409

When billing a nonclassified medication using a CMS 1500 claim form you must include both the HCPCS code (ie, J9999 for Folotyn) 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 • CPT 2010 • ICD-9-CM for Professionals Volumes 1 & 2; 2010 • The Drug Reimbursement Coding and Pricing Guide, Vol 7, No 2; RJ Health Systems International LLC; 2nd Quarter 2010 • FDA-approved indication (from products’ prescribing information) • NCCN Drugs & Biologics Compendium; 2010. National Comprehensive Cancer Network, Inc. Available at: www.nccn.org. Accessed February 15, 2010. To view the most recent and complete version of the NCCN compendium, go online to www.nccn.org • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Wethersfield, Connecticut • CMS-Medicare allowable 2nd Quarter 2010 (effective dates 4/1/10-6/30/10). Prices listed herein are effective as of April 1, 2010. ASP indicates average sales price; AWP, average wholesale price; CMS, Centers for Medicare & Medicaid Services; CPT, Current Procedural Terminology; FDA, US Food and Drug Administration; HCPCS, Healthcare Common Procedure Coding System; NCCN, National Comprehensive Cancer Network.

This information was supplied by:

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

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april 2010 I VOl 3, NO 2

International News

Reports from International Meetings and Researchers By Jill Stein

Zoledronic Acid Cuts Fracture Risk in Men with Advanced Prostate Cancer BARCELONA—Men with prostate cancer and malignant bone metastases who are treated with intravenous (IV) zoledronic acid are significantly less likely to sustain bone fractures than men not receiving an IV bisphospho-

nate, researchers announced at the 25th Anniversary European Association of Urology Congress. Henry Henk, PhD, with i3 Innovus in Eden Prairie, Minnesota, and colleagues presented data in 4976 men with prostate cancer and bone metastases. “Prostate cancer patients with malignant bone metastases frequently experi-

ence skeletal-related events including pathologic fracture, spinal cord compression, and hypercalcemia of malignancy, which are associated with significant morbidity and mortality,” Henk said. Patients enrolled in the trial between January 1, 2001, and December 31, 2006, and remained in the study until they died or the study ended (December 31, 2007).

Men treated with zoledronic acid developed fewer fractures (vertebral fractures, nonvertebral hip fractures, and nonvertebral non-hip fractures) than men who did not receive a bisphosphonate. Overall, there were 5.9 fractures per 100 person-years in patients treated with zoledronic acid compared with 8.5 Continued on page 26

Business Management Programs... Continued from cover treating cancer patients. “The high cost of cancer care in general is an issue. Our patients and providers have high expectations, and we have to learn how to manage the business of cancer better,” explains Smith. She notes that how cancer is treated by providers has changed. “It’s not just managing acute cancer but also longterm care.” Furthermore, the demand for cancer care is increasing because “of the aging population and the high number of cancer survivors,” adds Smith. In effort to improve Roswell Park’s operations and optimize patient care, Smith is one of 68 students enrolled in Harvard Business School’s Managing Healthcare Delivery executive education program. Launched in October 2009, the $22,000 nondegree program consists of three 1-week sessions over 9 months. “More and more clinicians, particularly clinical leaders, are recognizing that a significant portion of their job is not only to deliver excellent care, but also to manage and allocate resources appropriately,” says Cara M. Sterling, director of the healthcare initiative at Harvard Business School. “Clinicians tend to be fact-based learners who appreciate the body of knowledge related to managing people, applying information technologies, and understanding and designing management metrics, to name just a few, that business schools have to offer. The majority, however, don’t have 2 years to invest in an MBA program. This program was developed specifically for healthcare delivery professionals who want an immersive management education experience, but want to do it in the context of their current job,” explains Sterling on the rationale for developing the Harvard program. During the 9-month program, sessions cover developing effective operational models, teams, and delivery strategies; managing performance of daily operations and processes; and fostering an environment of learning and leadership. Between the modules, participants work on projects that are relevant to their organization and relate to

april 2010 I VOl 3, NO 2

the curriculum. In the first session, students complete a series of exercises that are meant to encourage self-reflection and help identify areas of organizational opportunity. Participants also complete online tutorials in finance and accounting. In the second session, participants write a business plan for a new service line or rewrite the plan for an existing one. Faculty keep in touch with the students by sending periodic “healthcare in the news” articles, recommended readings, and surveys about specific management issues, according to Sterling. “Managing healthcare delivery has become increasingly complex,” says Harvard Business School professor Richard Bohmer, MBChB, MPH, faculty chair of the Managing Healthcare Delivery program. “Individuals who attend this program are looking for the right balance between clinical management and science.”

by Health Sector Management, will start in August 2010, with the first class of 25 students graduating in May 2011. The cost of the program is around $48,000. The program will allow students to develop business knowledge in tandem with advanced health information technology (IT) skills. Curriculum requirements include seven management courses and five informatics courses, including a new practicum experience to be completed in a real-world setting at Duke. Duke has a long history in business management and healthcare management programs. This new graduate program is the “intersection of those two,” according to Randy Sears, assistant director of Master of Management in Clinical Informatics. The Master of Management in Clinical Informatics “is an outgrowth of an industry conference Duke held in

The program will allow students to develop business knowledge in tandem with advanced health information technology skills. “If you want to run an organization more effectively, you have to design an organization that runs well,” explains Bohmer. He points out that individuals in a nonmanagerial role, such as in a practice with oncologists, also can benefit from the Harvard program. In an oncology practice, for example, staff needs to have an appreciation for baseline managerial principles to bring people together to work effectively and to get the highest quality outcomes for the practice and patients. Managing Healthcare Delivery is not the only program available for the medical community. Duke University’s Fuqua School of Business is recruiting students for enrollment in a 1-year Master of Management in Clinical Informatics degree program in partnership with the Duke Center for Health Informatics. The program, administered

April with thought leaders,” explains Sears. In March, Duke hosted an inaugural Informatics Conference. The meeting brought together healthcare industry professionals to discuss business practices and the application of technology to healthcare. “IT alone is not a panacea to improve the patient experience or to impact the cost of healthcare. IT needs to be married to process improvement and organization innovation to change paradigms. Bringing this all together is our focus at Fuqua,” comments Kevin A. Schulman, MD, director of Duke’s Health Sector Management program. At the University of St. Thomas in St. Paul, Minnesota, students complete nine programs over 24 months to receive a certificate in Advanced Health Care Management. The university, in partnership with the Minnesota

Medical Group Management Association, developed this educational program to help organizations prepare for the future of healthcare. The cost is $375 per program. Program topics meet seven core competencies determined by the University of St. Thomas and the Minnesota Medical Group Management Association. Core competencies include leadership, finance, operations, marketing, IT, human resources, and care delivery and policy. Participants will be educated on new ideas, strategies, and tools to improve their organization; learn theory and participate in experiential instruction that will provide the tools to integrate knowledge learned into organizations’ operations; gain education and exposure to ideas and concepts beyond what healthcare professionals experience in their daily role; and network with other healthcare professionals. Vanderbilt University’s Owen Graduate School of Management graduated its first Master of Management in Health Care class in September. The 1year, part-time, 30-credit-hour degree program targets physicians, nurses, and other clinical professionals. The program cost for the 2008-2009 academic year was $43,000, according to the university’s website. The program is organized into three main components: core general business classes, healthcare-focused business classes, and a 1-year team strategy project. Specific courses include managerial economics, services marketing, managerial accounting, finance, operations, and healthcare leadership. In a press release, Larry Van Horn, director of the Health Care MBA program, says, “The cost, quality, and access problems facing the US healthcare system are monumental. The clinician who understands the science of medicine and the science of business is in a position to create more value for our healthcare system. This program is designed to empower clinicians to make business decisions and effectively lead healthcare delivery organizations.” l

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Before the research is published…

Before

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VOL 3 , NO 2

CANC ER C ENTE PROF R ILE

Before the drug is approved…

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The Patient’s Voice

Young Women and Breast Cancer For those diagnosed before age 40, community, action, advocacy

iana Di Mare was 37 years old at the time of her diagnosis of breast cancer. Statistically, she was young to have breast cancer. But, young women do get this disease. During 2002 through 2006, almost 5% of new breast cancer cases occurred in women younger than 40 years of age.1 For these women, the concerns and issues around their disease differ from those experienced by women diagnosed later in life. This disjunction led Di Mare to the Young Survival Coalition (YSC). YSC is the only international network of breast cancer survivors and supporters dedicated to the critical concerns and issues unique to young women and breast cancer. YSC empowers young women by providing resources, support, and community. For Di Mare, “they were doing something active about young women who are diagnosed and it just felt right. It clicked for me. They were focusing on people like me and the issues that were real to me.” Like many young women diagnosed with breast cancer, she first sought support from groups made up mainly of older women. But these women, typically in their 50s, “are done having children or their children are not young. They may have teenagers or older children. They may already be in menopause or they are about to go into menopause. They are probably married or in a relationship.” Young women diagnosed with breast cancer “may be focusing on starting a job or a career or may be reaching a point in their career where they are becoming a professional. They may have very young children or no children at all. They may be dating and are not necessarily married yet.” Being at this different point in their lives leaves many young women with breast cancer “dealing with fertility issues and a lot of body-image issues that a woman in her 50s may not experience the same way as a young woman.” YSC meetings offered Di Mare a

place to talk with other women who were young at their diagnosis. “They were living these active lives, and it became apparent to me that they knew what I was talking about when I would bring up issues.” These interactions led Di Mare to become involved. She became a volunteer and then served on the executive committee for the northern New Jersey affiliate in Paramus, where she is now chair. In this role, she is the lead volunteer and works closely with the executive director. But she still makes time to work with patients and survivors. Plus, there are her fundraising efforts. She has participated in the Tour de Pink for the past 4 years, completing her first ride while she was in treatment. The Tour de Pink bike ride, sponsored by The Hershey Company, starts at Chocolate World in Hershey, Pennsylvania, and ends in New York City, with each rider raising at least $2500 for YSC. “We had 10 or 15 survivors and the rest were all supporters and people who had been affected by breast cancer in some way and wanted to support the organization. It was something so magical and meaningful that I have done it ever since.” YSC resources For young women affected by breast cancer, YSC publishes books listing organizations that provide information on such topics as infertility and reconstruction. YSC’s online bulletin board connects young women to discuss treatment options and side effects as well as related concerns—sex, hair loss, body issues. YSC’s events offer young women the opportunity to talk face to face about specific issues they may be facing or how they have dealt with concerns or situations. In addition, YSC fosters relationships with other local cancer organizations, such as Gilda’s Club and the Sisters Network. According to Di Mare, by developing joint events, the YSC “can

At a “You Are Not Alone” event for survivors and their supporters, held in Morristown this past fall, the Young Survival Coalition (YSC) tries to bring together survivors in a fun and social atmosphere. Young women agree that it is a great way to talk about survivorship—or just meet new friends. From left to right: Diana Di Mare, Dinamarie Alcuri, Sonia Cooper. Dinamarie is a volunteer and is on YSC’s National Board of Directors. Sonia is a volunteer and supporter.

offer its services to the diverse people who may need what it is offering but don’t necessarily see it. If we do something jointly with another organization, we can offer the services to meet what they are looking for.” YSC also performs outreach campaigns to educate healthcare professionals and young women. Di Mare says, “today so many doctors and medical professionals just don’t think of breast cancer as a first diagnosis when a young woman comes to them with a lump. Many young women are still being told that they are too young to get breast cancer. It’s not true.” To help raise awareness, the northern New Jersey affiliate sends New Jersey oncologists and breast surgeons targeted mailings that highlight research about breast cancer in young women. The affiliate also provides these offices with the coalition’s Newly Diagnosed Resource Kit so that they are aware of YSC and

the services it provides. In addition, YSC volunteers visit high schools and colleges that are looking for speakers during breast cancer awareness month or during health fairs. “We try to get in front of that population so that the young women can start understanding what their body is like and watching for any signs that they should perhaps get checked,” says Di Mare. “We try to be proactive in reaching the young women. It is not too late for them. They understand that they, too, can get breast cancer.” l Reference 1. Breast Cancer Facts and Figures 2009-2010. Atlanta, GA: American Cancer Society; 2009.

For more information about young women and breast cancer or the Young Survival Coalition, call (877) YSC-1011 or visit www.youngsurvival.org.

International News... Continued from page 24 per 100 person-years in the placebo group (P = .0003). The data also showed that longer treatment with the bisphosphonate was associated with a lower fracture risk. Women Should Maintain Ovarian Cancer Symptom Diary CARDIFF, UK—Women should keep a diary that records how often they have symptoms that may be associated with ovarian cancer, doctors have advised.

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The “Ovarian Cancer Symptom Diary” was developed to help women monitor the common symptoms that are sometimes linked with ovarian cancer, Bryan Beattie, MD, with Spire Cardiff Hospital, said. “The diary will provide doctors with a snapshot record of a woman’s health and may result in an earlier diagnosis of ovarian cancer,” he added. The diary should be used by women who experience the following symptoms

on most days of the month: stomach or pelvic pain, persistent abdominal bloating, difficulty eating, feeling full quickly, frequent urination, a change in bowel habits, excessive fatigue, and back pain. Most women do not know that such symptoms may signal ovarian cancer, Beattie commented. According to Beattie, women over 50 years of age should keep a symptom diary for 1 month each year.

The widespread use of screening for ovarian cancer is the optimal method of detecting ovarian cancer; however, an ovarian cancer symptom diary is useful in the absence of screening, he noted. Finally, although these symptoms will in most cases not “turn out to be” ovarian cancer, it is important that patients who experience them on most days share their concerns with their physician—either a general practitioner or gynecologist, he said. l

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Metastatic Colorectal Cancer: Sound Strategies for Selecting First-Line Therapies

LOG ON TODAY TO PARTICIPATE www.coexm.com/ace01.asp FACULTY

Release Date: November 25, 2009 Expiration Date: November 24, 2010

Neal P. Christiansen, MD Assistant Professor of Medicine Medical University of South Carolina Division of Hematology/Oncology Charleston, South Carolina

TARGET AUDIENCE This activity is intended for hematologists, oncologists, oncology nurses, oncology/specialty pharmacists, and others who are involved with the care of patients with metastatic colorectal cancer (mCRC).

STATEMENT OF NEED Colorectal cancer (CRC) is the third most commonly diagnosed malignancy and the second leading cause of cancer death in the United States. Approximately 149,000 new cases are diagnosed each year. At the time of presentation, about 20% of patients with CRC will have metastatic disease. Cure at this stage is rarely possible, although some patients whose metastases are limited (especially if to the liver or lung) may be “cured” by surgical means. For most sufferers of mCRC, however, treatment is palliative, offering prolonged survival, improvement in symptoms, and enhanced quality of life.

EDUCATIONAL OBJECTIVES On completion of this activity, participants should be able to: • Evaluate and assess current findings in the management of mCRC • Identify current first-line therapies, both chemotherapeutic and biologic agents, and practices in mCRC • Tailor a therapeutic regimen to meet the needs of the individual patient with mCRC • Employ select strategies to minimize exposure to ineffective therapies and their toxicities

INSTRUCTIONS To receive a statement of credit, you must: • Review the content of the activity • Successfully complete the post-test (70% or higher) • Complete the evaluation at the end of the activity Your statement of credit will be issued immediately upon successful completion of the post-test and submission of the evaluation

ACCREDITATION STATEMENT This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the University of California, Irvine School of Medicine (UCI) and Center of Excellence Media, LLC. The University of California, Irvine School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT The University of California, Irvine School of Medicine designates this educational activity for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. This activity is complimentary.

FACULTY INFORMATION AND DISCLOSURES Dr Christiansen has received consultancy fees from sanofi-aventis and Genentech. Off-label use of cetuximab (in patients in whom irinotecan has not failed) and bevacizumab (continuing after first-line therapy) will be discussed in this presentation. Conflict resolution: This presentation has been peer reviewed for evidence base and fair balance.

GENERAL DISCLOSURE STATEMENT It is the policy of the University of California, Irvine School of Medicine and the University of California CME Consortium to ensure balance, independence, objectivity, and scientific rigor in all CME activities. Full disclosure of conflict resolution will be made in writing via handout materials or syllabus. Bonnie Carroll, Director, CME, UC Irvine School of Medicine, has no financial or other relationship to products or devices with commercial interests related to the content of this CME/CE activity. Center of Excellence Media, LLC: The planners and managers have nothing to disclose related to the content of this activity. Erica Johansson, RN, Astute CE, LLC, has nothing to disclose related to the content of this activity. Dr. Randall F. Holcombe, University of California, Irvine School of Medicine, peer-reviewed the content for evidence base and fair balance. Dr Holcombe has no real or apparent conflicts of interest related to this activity. Conflict resolution: This presentation has been peer reviewed for evidence base and fair balance. This activity is in compliance with California Assembly Bill 1195, which requires continuing medical education components to include curriculum in the subjects of cultural and linguistic competency. For specific information regarding Bill 1195 and definitions of cultural and linguistic competency, please visit the CME web site at http://www.cme.uci.edu. This activity is supported by an educational grant from Genentech BioOncology.

In collaboration with

Reimbursement

Smart Money. Part 1: Making Patients Partners in Healthcare Decisions By Cindy C. Parman, CPC, CPC-H, RCC Principal, Coding Strategies, Inc, Powder Springs, Georgia

nce upon a time, ance reimbursement. Curthere was adequate rently, however, patients reimbursement from are responsible for a higher insurance payers, patients paid percentage of shared costs, their coinsurance promptly, and it may be more difficult preauthorization was only a to collect the amount due rumor, and life was good. after patients walk out the Times have certainly changed. door. A study conducted by The future of Medicare Watson Wyatt Worldwide reimbursement is uncertain, for The Commonwealth commercial insurers review Cindy C. Parman, CPC, Fund found that out-ofeach proposed treatment CPC-H, RCC pocket health costs for (and sometimes deny coveradults with employer coverage), technologic advances create large age rose 34% from 2004 to 2007.2 capital expenditures, and patients Patients experience an extensive range dodge their coinsurance like matadors of out-of-pocket costs that extend far beyond the limited coverage provided with red capes. In this time of economic instability, by health insurance and the associated certain reimbursement factors cannot copayments and deductibles. Although be controlled; for example, Medicare the total costs of treatment vary by clinwill pay the Physician Fee Schedule ical stage, one study estimated a 3allowance and the practice cannot month average spending of $2720. To accurately charge patients for negotiate a higher reimbursement. But, some economic issues can be addressed their coinsurance and/or deductible at by an individual practice. Following are the time of service, the billing staff must do their homework. This may involve a some tips to improve reimbursement. telephone call to the insurer to verify Collect patient coinsurance and the patient’s liability, review of insurer deductibles coverage policies, preauthorization, or According to information published real-time claims adjudication with spein American Medical News last July: “A cial software. In addition, it may be survey of 1,279 physician practices, necessary for the practice to consider medical billers and billing offices accepting payment with credit cards. In released June 15 by NaviNet Inc., a the past, many patients paid with cash health care communications network, or check, but with the increased found that 49% were unable to estimate amounts due from patients, credit cards the amount due at the time of care, may permit the practice to more easily other than a predetermined co-pay.”1 collect at the time of service. In the past, it was enough to send Both staff training and patient educapatients a bill for the balance. They tion are needed to collect copayments would pay the balance due after insur- at the time of service. Strategies for suc-

cess include reminding patients of the amount that will be due during the reminder telephone call before the visit, posting signs regarding patient payment responsibilities in the waiting room, and educating patients one-on-one regarding the nature of health insurance. After patients fully understand that health insurance is designed to cover part of the cost of healthcare, collection of the coinsurance may become easier. Advance beneficiary notices and waivers of liability Patients can have the treatment they want, even if it is not covered by their insurance. But, these patients must agree to pay for the treatment. An advance beneficiary notice (ABN) is a written notice physicians must provide to a Medicare beneficiary before furnishing services when the provider believes that Medicare will not pay for some or all of the services on the basis that they are not reasonable and necessary. The provider is responsible for completing the ABN and delivering the notice to the beneficiary (or a designated representative) before providing the potentially nonpayable service. In addition, the provider must verbally review the ABN with the beneficiary, answer any questions raised by this information, and deliver the ABN far enough in advance that the beneficiary has time to consider the treatment options and make an informed choice. Last, the patient must be provided with a copy of the signed notice. Healthcare providers cannot use ABNs in a “blanket” manner for all

Recent FDA Approvals Exalgo Extended-release Pain Management The US Food and Drug Administration (FDA) has approved Exalgo (CombinatoRx) extended-release tablets for the management of moderate-to-severe pain in opioidtolerant patients requiring continuous opioid analgesia for an extended period of time. Approval was based on a double-blind, placebo-controlled, randomized withdrawal study in opioid-tolerant patients with moderate-to-severe low back pain. Patients entered an open-label conversion and titration phase, were converted to a starting dose that was approximately 75% of their total daily morphine-equivalent dose, and were dosed once daily until adequate pain control was achieved while exhibiting tolerable side effects. There was a significant difference between the mean changes from baseline to week 12 in average weekly pain

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intensity numeric rating system scores obtained from patient diaries between the two groups. 5-Day Outpatient Dosing for Dacogen for MDS The US Food and Drug Administration (FDA) has approved a 5-day dosing regimen for Dacogen (Eisai) for injection to treat patients with myelodysplastic syndromes (MDS). The new dosing regimen is to be administered at 20mg/m2 continuous intravenous infusion over 1 hour daily for 5 days per every 4-week cycle. Approval was based on three open-label, single-arm, multicenter studies with any of the French-American-British subtypes, in which patients had an overall response rate of 16%. Median time to response was 162 days, and median duration of response was 443 days. l

Medicare patients. The provider must have reason to believe that Medicare will deny a specific patient’s service, and the ABN must indicate why the provider expects the Medicare carrier to deny the service. When a signed ABN is on file for a procedure, physicians should append Healthcare Common Procedure Coding System (HCPCS) modifier GA (waiver of liability statement on file) to any Centers for Medicare & Medicaid Services 1500 claim form line item for which the ABN applies. If the carrier then denies the service, the explanation of benefits will indicate that the patient received advance notice of noncoverage and is therefore financially responsible for the service. Some insurers other than Medicare allow the patient to sign a waiver of liability. For example, a preferred provider organization can require its participating physicians to acquire a signed written agreement of financial responsibility specific to the service to be rendered in advance of performing a service the organization has denied as not medically necessary under a member’s benefit plan. In these cases, the physician is contractually banned from charging the member for the service if the signed agreement was not obtained in advance. Proper use of ABNs and waivers of liability will ensure that the practice does not experience a revenue loss when patients want certain treatment that will not be reimbursed by their insurer. Partners in healthcare decisions Educating patients regarding their responsibilities and the limitations to their insurance coverage is a good start. With informed patients as partners in their healthcare decisions, the provider can improve cash flow. In Part 2 of this article, we will discuss actions a practice can take to ensure that correct insurance reimbursement is received, appeals are filed when necessary, and operations are streamlined to minimize expenses.l References 1. Elliott VS. Patient portion of fees often a mystery. July 20, 2009. American Medical News. www.amaassn.org/amednews/2009/07/20/bil20720.htm. Accessed March 10, 2010. 2. Dolan PL. Sliding economy leaves physicians wary about collections. August 31, 2009. American Medical News. www.ama-assn.org/amednews/2009 /08/31/bisa0831.htm. Accessed March 10, 2010.

Part 2 of this article will appear in the June issue.

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News Notes Patients’ Costs a Consideration for Oncologists A Tufts Medical Center study of oncologists indicates that providers are considering their patients’ out-ofpocket (OOP) costs in their chemotherapy prescribing; however, many do not communicate with patients about cost. In a survey of 787 oncologists, 84% responded that patient OOP cost influences treatment recommendations, but only 43% responded that they always or frequently discuss costs with patients. The survey also indicates that oncologists support government-funded comparative effectiveness research, but wish to retain control over treatment decision-making. Of the respondents, 79% favor more comparative effectiveness research, and 80% support more costeffectiveness data for coverage and payment decisions. Sixty percent of respondents think that providers should make the determination on which drug provides good value, not the government or insurance companies (Neumann PJ, et al. Health Aff (Millwood). 2010;29: 196-202). FDA Approves REMS for ESAs Darbepoetin (Aranesp, Amgen) and epoetin alfa (Epogen; Procrit, Amgen) will now operate under Risk Evaluation and Mitigation Strategies (REMS) that will require healthcare prescribers to register with Amgen and to enroll in a training program on use of the agents. The REMS also require prescribers to provide their patients with a medication guide. These REMS are required because studies have shown that erythropoiesis-stimulating agents (ESAs) can result in tumor growth and shorten survival in cancer patients who use them to combat anemia. ESAs can also increase risk of myocardial infarction, heart failure, stroke, and blood clots. For more information, contact Amgen’s APPRISE program at (866) 284-8089. Black Box Warning Added to Exjade The US Food and Drug Administration now requires a black box warning on the label for deferasirox (Exjade, Novartis). The warning includes cautions about potentially fatal renal, hepatic, and gastrointestional hemorrhage. These risks are most likely to occur in older patients, those at high risk for myelodysplastic syndromes, those with underlying renal or hepatic impairment, and those with low platelet counts. The new label recommends careful monitoring of creatinine levels, serum transaminases, and bilirubin. Annual Report to the Nation Finds Continued Declines in New Diagnoses and Deaths Rates of new diagnoses and rates of

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death from all cancers combined declined significantly in the most recent time period for men and women and for most racial and ethnic populations in the United States, according to the latest annual report issued by the National Cancer Institute, the American Cancer Society, and the North American Association of Central Can-

cer Registries. New diagnoses for all types of cancers decreased, on average, 1% per year from 1999 to 2006. Cancer deaths decreased 1.6% per year from 2001 to 2006. These decreases are attributed to the reduction of new cases and deaths for the three most common cancers in men—lung, prostate, colorectal—and for two of the three lead-

GEMZAR姞 (GEMCITABINE HCl) FOR INJECTION BRIEF SUMMARY (OVARIAN). For complete safety please consult the package insert for complete prescribing information. INDICATION AND USAGE: THERAPEUTIC INDICATION—Ovarian Cancer—Gemzar in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. CLINICAL STUDIES: Ovarian Cancer—Gemzar was studied in a randomized Phase 3 study of 356 patients with advanced ovarian cancer that had relapsed at least 6 months after first-line platinum-based therapy. Patients were randomized to receive either Gemzar 1000 mg/m2 on Days 1 and 8 of a 21-day cycle and carboplatin AUC 4 administered after Gemzar on Day 1 of each cycle or single-agent carboplatin AUC 5 administered on Day 1 of each 21-day cycle as the control arm. The primary endpoint of this study was progression free survival (PFS). The addition of Gemzar to carboplatin resulted in statistically significant improvement in PFS and overall response rate. Approximately 75% of patients in each arm received poststudy chemotherapy. Only 13 of 120 patients with documented poststudy chemotherapy regimen in the carboplatin arm received Gemzar after progression. There was not a significant difference in overall survival between arms. CONTRAINDICATION: Gemzar is contraindicated in those patients with a known hypersensitivity to the drug (see Allergic under ADVERSE REACTIONS). WARNINGS: Caution—Prolongation of the infusion time beyond 60 minutes and more frequent than weekly dosing have been shown to increase toxicity (see CLINICAL STUDIES in the full Prescribing Information). Hematology—Gemzar can suppress bone marrow function as manifested by leukopenia, thrombocytopenia, and anemia (see ADVERSE REACTIONS), and myelosuppression is usually the dose-limiting toxicity. Patients should be monitored for myelosuppression during therapy. See DOSAGE AND ADMINISTRATION in the full Prescribing Information for recommended dose adjustments. Pulmonary—Pulmonary toxicity has been reported with the use of Gemzar. In cases of severe lung toxicity, Gemzar therapy should be discontinued immediately and appropriate supportive care measures instituted (see Pulmonary under Single-Agent Use and under Post-marketing experience in ADVERSE REACTIONS in the full Prescribing Information). Renal—Hemolytic Uremic Syndrome (HUS) and/or renal failure have been reported following one or more doses of Gemzar. Renal failure leading to death or requiring dialysis, despite discontinuation of therapy, has been rarely reported. The majority of the cases of renal failure leading to death were due to HUS (see Renal under Single-Agent Use and under Post-marketing experience in ADVERSE REACTIONS in the full Prescribing Information). Hepatic—Serious hepatotoxicity, including liver failure and death, has been reported very rarely in patients receiving Gemzar alone or in combination with other potentially hepatotoxic drugs (see Hepatic under Single-Agent Use and under Post-marketing experience in ADVERSE REACTIONS in the full Prescribing Information). Pregnancy—Pregnancy Category D. Gemzar can cause fetal harm when administered to a pregnant woman. Gemcitabine is embryotoxic causing fetal malformations (cleft palate, incomplete ossification) at doses of 1.5 mg/kg/day in mice (about 1/200 the recommended human dose on a mg/m2 basis). Gemcitabine is fetotoxic causing fetal malformations (fused pulmonary artery, absence of gall bladder) at doses of 0.1 mg/kg/day in rabbits (about 1/600 the recommended human dose on a mg/m2 basis). Embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays. There are no studies of Gemzar in pregnant women. If Gemzar is used during pregnancy, or if the patient becomes pregnant while taking Gemzar, the patient should be apprised of the potential hazard to the fetus. PRECAUTIONS: General—Patients receiving therapy with Gemzar should be monitored closely by a physician experienced in the use of cancer chemotherapeutic agents. Most adverse events are reversible and do not need to result in discontinuation, although doses may need to be withheld or reduced. There was a greater tendency in women, especially older women, not to proceed to the next cycle. Laboratory Tests—Patients receiving Gemzar should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. Suspension or modification of therapy should be considered when marrow suppression is detected (see DOSAGE AND ADMINISTRATION in the full Prescribing Information). Laboratory evaluation of renal and hepatic function should be performed prior to initiation of therapy and periodically thereafter (see WARNINGS). Carcinogenesis, Mutagenesis, Impairment of Fertility—Long-term animal studies to evaluate the carcinogenic potential of Gemzar have not been conducted. Gemcitabine induced forward mutations in vitro in a mouse lymphoma (L5178Y) assay and was clastogenic in an in vivo mouse micronucleus assay. Gemcitabine was negative when tested using the Ames, in vivo sister chromatid exchange, and in vitro chromosomal aberration assays, and did not cause unscheduled DNA synthesis in vitro. Gemcitabine IP doses of 0.5 mg/kg/day (about 1/700 the human dose on a mg/m2 basis) in male mice had an effect on fertility with moderate to severe hypospermatogenesis, decreased fertility, and decreased implantations. In female mice, fertility was not affected but maternal toxicities were observed at 1.5 mg/kg/day IV (about 1/200 the human dose on a mg/m2 basis) and fetotoxicity or embryolethality was observed at 0.25 mg/kg/day IV (about 1/1300 the human dose on a mg/m2 basis). Pregnancy—Category D. See WARNINGS. Nursing Mothers—It is not known whether Gemzar or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from Gemzar in nursing infants, the mother should be warned and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother and the potential risk to the infant. Elderly Patients—Gemzar clearance is affected by age (see CLINICAL PHARMACOLOGY in the full Prescribing Information). There is no evidence, however, that unusual dose adjustments (i.e., other than those already recommended in DOSAGE AND ADMINISTRATION section in the full Prescribing Information) are necessary in patients over 65, and in general, adverse reaction rates in the single-agent safety database of 979 patients were similar in patients above and below 65. Grade 3/4 thrombocytopenia was more common in the elderly. Gender—Gemzar clearance is affected by gender (see CLINICAL PHARMACOLOGY in the full Prescribing Information). In the single-agent safety database (N=979 patients), however, there is no evidence that unusual dose adjustments (i.e., other than those already recommended in DOSAGE AND ADMINISTRATION section in the full Prescribing Information) are necessary in women. In general, in single-agent studies of Gemzar, adverse reaction rates were similar in men and women, but women, especially older women, were more likely not to proceed to a subsequent cycle and to experience Grade 3/4 neutropenia and thrombocytopenia. Pediatric Patients—The effectiveness of Gemzar in pediatric patients has not been demonstrated. Gemzar was evaluated in a Phase 1 trial in pediatric patients with refractory leukemia and determined that the maximum tolerated dose was 10 mg/m2/min for 360 minutes three times weekly followed by a one-week rest period. Gemzar was also evaluated in a Phase 2 trial in patients with relapsed acute lymphoblastic leukemia (22 patients) and acute myelogenous leukemia (10 patients) using 10 mg/m2/min for 360 minutes three times weekly followed by a one week rest period. Toxicities observed included bone marrow suppression, febrile neutropenia, elevation of serum transaminases, nausea, and rash/desquamation, which were similar to those reported in adults. No meaningful clinical activity was observed in this Phase 2 trial. Patients with Renal or Hepatic Impairment—Gemzar should be used with caution in patients with preexisting renal impairment or hepatic insufficiency as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations. Administration of Gemzar in patients with concurrent liver metastases or a preexisting medical history of hepatitis, alcoholism, or liver cirrhosis may lead to exacerbation of the underlying hepatic insufficiency. GEMZAR姞 (GEMCITABINE HCl) FOR INJECTION

PV 4067 AMP

ing cancers in women—breast, colorectal. Among racial/ethnic groups, cancer death rates were highest in black men and women and lowest in Asian/Pacific Islander men and women. Trends in death rates were similar for most cancer sites. The complete report was published online in Cancer (7 Dec 2009. Epub ahead of print). l

Drug Interactions—No specific drug interaction studies have been conducted. For information on the pharmacokinetics of Gemzar and cisplatin in combination, see Drug Interactions under CLINICAL PHARMACOLOGY. Radiation Therapy—A pattern of tissue injury typically associated with radiation toxicity has been reported in association with concurrent and non-concurrent use of Gemzar. Non-concurrent (given >7 days apart)—Analysis of the data does not indicate enhanced toxicity when Gemzar is administered more than 7 days before or after radiation, other than radiation recall. Data suggest that Gemzar can be started after the acute effects of radiation have resolved or at least one week after radiation. Concurrent (given together or ≤7 days apart)—Preclinical and clinical studies have shown that Gemzar has radiosensitizing activity. Toxicity associated with this multimodality therapy is dependent on many different factors, including dose of Gemzar, frequency of Gemzar administration, dose of radiation, radiotherapy planning technique, the target tissue, and target volume. In a single trial, where Gemzar at a dose of 1000 mg/m2 was administered concurrently for up to 6 consecutive weeks with therapeutic thoracic radiation to patients with non-small cell lung cancer, significant toxicity in the form of severe, and potentially life-threatening mucositis, especially esophagitis and pneumonitis was observed, particularly in patients receiving large volumes of radiotherapy [median treatment volumes 4795 cm3]. Subsequent studies have been reported and suggest that Gemzar administered at lower doses with concurrent radiotherapy has predictable and less severe toxicity. However, the optimum regimen for safe administration of Gemzar with therapeutic doses of radiation has not yet been determined in all tumor types. ADVERSE REACTIONS: Combination Use in Ovarian Cancer—In the Gemzar plus carboplatin versus carboplatin study, dose reductions occurred with 10.4% of Gemzar injections and 1.8% of carboplatin injections on the combination arm, versus 3.8% on the carboplatin alone arm. On the combination arm, 13.7% of Gemzar doses were omitted and 0.2% of carboplatin doses were omitted, compared to 0% of carboplatin doses on the carboplatin alone arm. There were no differences in discontinuations due to adverse events between arms (10.9% versus 9.8%, respectively). Table 1 presents the adverse events (all grades) occurring in ≥10% of patients in the ovarian cancer study. Table 1: Adverse Events From Comparative Trial of Gemzar Plus Carboplatin Versus Single-Agent Carboplatin in Ovarian Cancera CTC Grades (% incidence) Gemzar plus Carboplatin (N=175) Carboplatin (N=174) All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4 Laboratory b Hematologic Neutropenia 90 42 29 58 11 1 Anemia 86 22 6 75 9 2 Leukopenia 86 48 5 70 6 <1 Thrombocytopenia 78 30 5 57 10 1 38 15 RBC Transfusions c 9 3 Platelet Transfusions c Non-laboratory b Nausea 69 6 0 61 3 0 Alopecia 49 0 0 17 0 0 Vomiting 46 6 0 36 2 <1 Constipation 42 6 1 37 3 0 Fatigue 40 3 <1 32 5 0 Neuropathy-sensory 29 1 0 27 2 0 Diarrhea 25 3 0 14 <1 0 Stomatitis/pharyngitis 22 <1 0 13 0 0 Anorexia 16 1 0 13 0 0 a Grade based on Common Toxicity Criteria (CTC) Version 2.0 (all grades ≥10%). b Regardless of causality. c Percent of patients receiving transfusions. Transfusions are not CTC-graded events. Blood transfusions included both packed red blood cells and whole blood. In addition to blood product transfusions as listed in Table 1, myelosuppression was also managed with hematopoetic agents. These agents were administered more frequently with combination therapy than with monotherapy (granulocyte growth factors: 23.6% and 10.1%, respectively; erythropoetic agents: 7.3% and 3.9%, respectively). The following are the clinically relevant adverse events, regardless of causality, that occurred in >1% and <10% (all grades) of patients on either arm. In parentheses are the incidences of Grade 3 and 4 adverse events (Gemzar plus carboplatin versus carboplatin): AST or ALT elevation (0 versus 1.2%), dyspnea (3.4% versus 2.9%), febrile neutropenia (1.1% versus 0), hemorrhagic event (2.3% versus 1.1%), hypersensitivity reaction (2.3% versus 2.9%), motor neuropathy (1.1% versus 0.6%), and rash/desquamation (0.6% versus 0). No differences in the incidence of laboratory and non-laboratory events were observed in patients 65 years or older, as compared to patients younger than 65. Post-marketing experience—The following adverse events have been identified during post-approval use of Gemzar. These events have occurred after Gemzar single-agent use and Gemzar in combination with other cytotoxic agents. Decisions to include these events are based on the seriousness of the event, frequency of reporting, or potential causal connection to Gemzar. Cardiovascular—Congestive heart failure and myocardial infarction have been reported very rarely with the use of Gemzar. Arrhythmias, predominantly supraventricular in nature, have been reported very rarely. Vascular Disorders—Clinical signs of peripheral vasculitis and gangrene have been reported very rarely. Skin—Cellulitis and non-serious injection site reactions in the absence of extravasation have been rarely reported. Severe skin reactions, including desquamation and bullous skin eruptions, have been reported very rarely. Hepatic—Increased liver function tests including elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase, and bilirubin levels have been reported rarely. Serious hepatotoxicity including liver failure and death has been reported very rarely in patients receiving Gemzar alone or in combination with other potentially hepatotoxic drugs. Pulmonary—Parenchymal toxicity, including interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and adult respiratory distress syndrome (ARDS), has been reported rarely following one or more doses of Gemzar administered to patients with various malignancies. Some patients experienced the onset of pulmonary symptoms up to 2 weeks after the last Gemzar dose. Respiratory failure and death occurred very rarely in some patients despite discontinuation of therapy. Renal—Hemolytic-Uremic Syndrome (HUS) and/or renal failure have been reported following one or more doses of Gemzar. Renal failure leading to death or requiring dialysis, despite discontinuation of therapy, has been rarely reported. The majority of the cases of renal failure leading to death were due to HUS. Injury, Poisoning, and Procedural Complications — Radiation recall reactions have been reported (see Radiation Therapy under PRECAUTIONS). Dosage and administration: Gemzar is for intravenous use only. Please consult full prescribing information for complete dosage and administration guidelines.

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GEMZAR/carboplatin is one option for 2nd-line treatment of your patients with platinum-sensitive* advanced ovarian cancer. Myelosuppression is usually the dose-limiting toxicity with GEMZAR therapy.

G MZ GE ZAR AR iin n co om mb bin nat a io ion wi w th t car ab bo op pllattin n is in indi ndi d ccaate ed fo for or th t e tr t eaatm t en e t of o pattie ient nsw nt wiith th adv d an a ced ce ed o ovvar aria i n ca canc n er e tha h t has haas rre elaapsed psed ps d aatt le easst 6 mo m ntth hss aft fter er er comp co m le mp eti t on o of p pllat a in inum u --b um baasse ed d the eraapyy. My M ye ellossu up p ppr p essssiion pr on is u usssua ua allly th he do ose se-l -llim mittin ng to oxi x ciitty y wit ith h GEMZ GEMZ GE M AR AR th he era rapy py py. y.

Overall response rate (%)†

Median progression-free survival (months) GEMZAR plus Carboplatin

95% Cl (8.0-9.7) (N=178)

Carboplatin 95% Cl (5.2-7.1) (N=178)

(p=0.0038)

GEMZAR plus Carboplatin (N=178)

8.6

Carboplatin (N=178)

5.8 6

(p=0.0016)

10%

47.2%

30.9% 20%

30%

40%

50%

* Pl Plat lat a in num m-sen -ssen nssiitive tivee ti †

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