May 2010, Vol 3, No 3 by Green Hill Healthcare Communications, LLC

MAY 2010

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VOL 3, NO 3

Reform and Cost 2010 Special Issue: Healthcare Cost and Reform HEALTHCARE REFORM LAW

Healthcare Law Means Big Changes—and Some More of the Same—for Oncology By Daniel Denvir

he new healthcare reform law promises big changes for all of medicine, oncology included. Patients newly covered by private insurance means better reimbursement and new initiatives to drive value may transform the way oncology care is delivered and paid for in the long run. Yet, the Patient Protection and Affordable Care Act does not address many of the most pressing issues for oncology. “There was no significant change that impacts reimbursement for oncolo-

gists,” said Matt Brow, vice president of corporate communications, government relations, and public policy at US Oncology. “If you were concerned about a reduction in reimbursement, that was averted; if you looked for improvement, that didn’t happen either.” President Barack Obama signed healthcare reform into law on March 23 and the Senate passed reconciliation legislation 2 days later. The law will extend coverage to an estimated 30 million to 34 million patients currently

without insurance, including 16 million who will come onto the Medicaid rolls, the eligibility for which is raised to 133% of the federal poverty line. The flood of new privately insured patients is good news for reimbursements, paid in part by public subsidies available for individuals and families making up to 400% of the poverty level. “The private aspect is actually going to be bigger,” according to Brow, who discussed the legislation at the Association of Community Cancer Centers

annual national meeting, just days before the House vote. “Instead of increasing a poorly paying business line for you, this bill will increase a well-payContinued on page 10

TRENDS OF REFORM ROUNDTABLE

CODING AND BILLING

The Transformation of Healthcare in Private Practice Oncology

Oncology Drug Coding and Reimbursement

A Roundtable Discussion with Mark J. Krasna, MD Medical Director, St. Joseph Cancer Institute; Editor-in-Chief, Journal of Multidisciplinary Cancer Care Ronald Barkley, MS, JD US Oncology; Cofounder, Cancer Center Business Summit

By Karen Rosenberg

Michael L. Blau, JD Partner and Chair, Health Care Venture Practice, Foley & Lardner LLP; Cofounder, Cancer Center Business Summit Jessica Turgon Senior Manager, ECG Management Consultants, Inc

ith federal healthcare reform enacted and the cost of care escalating, community oncologists are challenged not only to remain up-todate on clinical research but also to

find new ways to cover their patients’ expenses and their own operating costs. In this discussion, editor-in-chief Mark Krasna, a surgical oncologist, asks the experts what community practices can expect in

2010. Although this is a politically charged area, our panel focuses on the practical aspects of delivering the highest quality of care. Mark Krasna (MK): Besides Continued on page 6

Inside Clinical Pathways Pathways as a Model for Cancer Management By Kathy Lokay

page 20

Electronic Health Record Oncology EHR: Taking the Road Less Traveled By Timothy G. Tyler, PharmD, FCSHP

page 12

An Interview with John F. Aforismo, BSc Pharm, RPh, FASCP

Conference News Diagnostic Imaging: Use and Reimbursement Based on a presentation by Jason Launders, MSc

page 14

he essential element of full reimbursement is proper coding. Without the proper codes, payers will not compensate oncology practices for the drugs and services they provide during the course of patient care. It is important to remember that coding is about more than just the drugs used; coding involves all the aspects of treating a patient—diagnosis codes, drug codes, procedure codes, and even administrative codes. In an interview with the Journal of Multidisciplinary Cancer Care, John F. Aforismo, BSc Pharm, RPh, FASCP, chairman and founder of RJ Health Systems International, discusses on- and off-label use, the role of various staff members, and the upcoming switch to International Classification of Diseases, 10th Revision, Clinical Modification (ICD10-CM) codes. His knowledge of the payers’ point of view will help practices make the most of their billing. Continued on page 11

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Editorial Board EDITOR-IN-CHIEF

Minsig Choi, MD

Mark J. Krasna,

G. V. Montgomery VA Medical Center Jackson, MS Medical Oncology

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

Managed Care and Pharmaceutical Management Burt Zweigenhaft, BS BioPharma Partners LLC New York, NY

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

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

Scott E. Eggener, MD

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

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

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 Haas, PhD, CNS, ANP-BC

Patricia Molinelli, RN, MSN, AOCNS

Gary C. Yee, PharmD, FCCP, BCOP

Mountain States Tumor Institute Nampa, ID Oncology Administration

CarePartners 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

Genetic Counseling Cristi Radford, MS, CGC

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

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DGH Consulting South Windsor, CT Oncology Administration

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

Sarasota Memorial Hospital Sarasota, FL

MAY 2010 I VOL 3, NO 3

INTRODUCTION

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

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he cost of healthcare is on everyone’s mind these days. Hardly a day goes by that some aspect of the healthcare reform law doesn’t make the news. And the Internet provides stakeholders from all points of view the opportunity to voice them. With this issue, we have tried to filter through the noise and furnish those inDawn Holcombe volved with oncology the inforMBA, FACMPE, mation that is relevant to us. ACHE Of chief concern is the quality of the care we provide our patients; however, this requires working within the legislative and legal environment of our nation and our states. With the Patient Protection and Affordable Care Act, 30 million to 34 million people are expected to be newly covered by insurance—16 million of which will be enrolled in Medicaid. This is good news for those who will now have access to our services, and we must find a way to continue to provide cancer care to them. This situation is urgent; more than 30 community cancer clinics have closed because of financial concerns in the past year and a half. A major reason cited is a decline in reimbursement from Medicare, a program whose sustain-

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.

MAY 2010 I VOL 3, NO 3

able growth rate is due to decrease our payments yet again. Our profession must be on the forefront of new ideas that bring all stakeholders—patient, provider, payer (including the Centers for Medicare & Medicaid Services)—into alignment to develop approaches to care that provide quality and value. In fact, our private payers, in working with forward-thinking oncology practices, have already developed some options. Bundled payments and guideline-based pathways are already in effect at several practices and may provide the answer for some. Other practices may benefit from an as yet untried approach. I urge all oncology practices to work with their payers to develop pricing arrangements that work for all and to encourage payers to understand that oncology care (and payment issues) involves far more than just the drugs. Of course, this is often easier said than done. Appropriate reimbursement necessitates a complex set of administrative tasks. From paper encounter forms to point-of-service charge capture to fully integrated electronic health record systems; from specialized coding staff to coding software; these, too, have various approaches to success. My hope is that this special issue of Journal of Multidisciplinary Cancer Care shows you the importance of all your team members in the crucial areas of healthcare reform and cost. Together we can ensure that our profession remains financially solvent enough to provide our patients with the best care.

MAY 2010

VOL 3, NO 3

FEATURE ARTICLES 12 Electronic Health Record Oncology EHR: taking the road less traveled 14 Conference News: ACCC ACCC panel says get ready for CER Diagnostic imaging: use and reimbursement Standardized treatment regimens: improving care, lowering cost, clarifying communication 16 Reimbursement The reimbursement challenge for 2010 20 Clinical Pathways Pathways as a model for cancer care management 22 Multidisciplinary Models Multidisciplinary cancer programs—the emerging standard 24 Specialty Pharmacy The NCCN Task Force on Specialty Pharmacy issues preliminary report DEPARTMENTS 5 From the Editor Healthcare reform’s impact on community practice oncology 8 Recent FDA Approvals 18 Oncology Drug Codes Medications used for the treatment of melanomas (skin cancer) 20 FDA Updates

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

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

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

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From the Editor

Healthcare Reform’s Impact on Community Practice Oncology

he Patient Protectpay biosimilars at the averion and Affordable age sales price (ASP) of the Care Act has now biosimilar plus 6% of the passed both houses of ASP of the reference/innoCongress. Although it is vator biologic, with the thought that this will be an goal to remove the incenearth-shaking and complete tive for using the higher overhaul of our healthcare cost drugs. system, in fact, the impleFor a long time, clinical mentation won’t happen trials have been in need of a until 2014; and many of the federal mandate to overdetails may get shot down Mark J. Krasna, MD come the 20-plus states in as the plan moves forward. ST. JOSEPH CANCER the union that do not proKey among the reforms, INSTITUTE vide coverage. The new over 1200 pages of ver- Editor-in-Chief legislation requires insurbiage, are the following, ance company coverage of related to cancer care, which are of par- routine care costs associated with a ticular interest to our readers. patient’s participation in a clinical Although participation is voluntary, trial—an essential element to no longer accountable care organizations (ACOs) penalizing patients on trial by an archaic are allowed to manage and coordinate interstate loophole. This stipulation may care across settings. The concept is to result in increased trial participation. improve value and control costs by New fees on medical device manufacaligning provider incentives toward turers will mean, for example, higher costs integration, quality, and efficiency. for such equipment as linear accelerators. Coordinating patient care across setPayment Advisory Boards will make tings and using lower-cost, equally effec- recommendations to Congress. Their tive regimens will be rewarded. This in goals will be to reduce Medicare spenditself is a good concept and one that has ing by $28 billion. been tried by some private insurers, In the accompanying roundtable diswith promising results. cussion on reform, legal, compliance, The Centers for Medicare & Medi- and strategic experts have given their caid Services’ (CMS) Innovation best guesses about the impact this Center, a newly created entity, has a $10 reform will have on cancer care. Their billion budget to test innovative pay- bottom line is very telling: The ment models within the Medicare sys- Transformation of Healthcare in Private tem. The center must consider 13 par- Practice Oncology. Common aspects ticular models. One of these models is between the legislated reforms and the

The concept is to improve value and control costs by aligning provider incentives toward integration, quality, and efficiency. Coordinating patient care across settings and using lower-cost, equally effective regimens will be rewarded.

claims for the multitude of drugs, treatments, and imaging procedures; paying a budgeted rate for a particular episode of care based on diagnosis, staging, and anticipated cost. If a group institutes protocols and does not have any medically unnecessary services, this will bring about the most efficient care for oncology patients, which is always the right thing. The employment of oncologists is a much localized phenomenon. In specific markets, there is interest in figuring out arrangements around infusion, especially in regard to underinsured or uninsured patients. Finally, the healthcare reform law has expanded coverage to many of the uninsured. The new plan creates a health benefit exchange where low-income, uninsured patients will get relatively lowcost policies, because the insurance companies will design these plans as low-cost policies and because they will be competing for the business of this pool of patients. These lower cost insurance products will be designed to reduce the cost and payments for oncology care. The expansion of coverage in a reformed

system will probably garner less payment on a per unit service that is available to providers and facilities where underinsured patients are seen. This likely will exacerbate the debt problem for providers that care for the uninsured. Hospitals with a charitable taxexempt mission will accept as many of these cases as possible, but they will also try to find ways to connect patients to as many sources of payment as they can, whether it be the drug company patient-assistance funds, Medicaid, or state uncompensated care pools. As a rule, most physicians really care about doing what’s right for their patients. We have all seen, and our journal has highlighted, multidisciplinary conferences that have occurred in the community. Medical, radiation, and surgical oncologists together with imaging and pathology are doing what’s right for the patient, not what’s going to pay best for any particular doctor. So, the message remains the same: We must find ways to provide the best care for each patient; we must continually transform healthcare. l

Fifteen Health IT Pilot Communities Selected The Department of Health and Human Services has awarded $220 million across 15 Beacon Community programs throughout the country that will serve as pilot communities for eventual wide-scale use of health information technology (IT). The grants will not only help achieve meaningful and measurable improvements in healthcare quality, safety, and efficiency in the selected communities, but also help lay the groundwork for an emerging health IT industry.

The selected communities will use health IT resources within their community as a foundation for bringing doctors, hospitals, community health programs, federal programs, and patients together to design new ways of improving quality and efficiency to benefit patients and taxpayers. Each Beacon Community has elected specific and measurable improvement goals in each of three vital areas for health systems improvement: quality, costefficiency, and population health. l

The 15 Beacon Communities specific to oncology: Align nationally recognized, evidence-based guidelines of cancer care with Medicare payment incentives in the areas of treatment planning and follow-up care planning for Medicare beneficiaries with cancer. This, too, makes sense intuitively and has been advocated by the American Society of Clinical Oncology’s Quality Oncology Practice Initiative, the American College of Surgeon’s Commission on Cancer, and the National Quality Forum for several years. Pay-forperformance measures have, in fact, been implemented by several private insurers as well. Generic incentives will allow CMS to

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private-payer plans include value purchasing, cost containment, a new value proposition dealing with medically unnecessary services, bundled pricing and episodes of care, and/or shared costsavings with providers. These changes are already occurring in the private sector, setting wheels in motion to pay providers less than or at least differently from the manner in which they are reimbursed today. We are now in the position to experiment with more longitudinal care pricing with bundles of care. This pricing would make it easier to manage and probably reduce costs from a standpoint of personnel and systems to handle

• HealthInsight, Salt Lake City, Utah • Mayo Clinic Rochester, Minnesota • University of Hawaii at Hilo • Geisinger Clinic, Danville, Pennsylvania • Rhode Island Quality Institute, Providence • Community Services Council of Tulsa, Oklahoma • Delta Health Alliance, Stoneville, Mississippi • Eastern Maine Healthcare Systems, Brewer • Indiana Health Information Exchange, Indianapolis • Inland Northwest Health Services, Spokane, Washington • Louisiana Public Health Institute, New Orleans • Rocky Mountain Health Maintenance Organization, Grand Junction, Colorado • Southern Piedmont Community Care Plan, Concord, North Carolina • The Regents of the University of California, San Diego • Western New York Clinical Information Exchange, Buffalo

MAY 2010 I VOL 3, NO 3

Trends of Reform Roundtable Transformation of Healthcare... Continued from cover those changes legislated at going to get to treat this the national level through episode of care. Unless the Patient Protection and something changes, unless Affordable Care Act, are there is a different diagnothere trends of healthcare sis, that’s all the money you reform already taking hold will get. in the private sector? I suppose what I am sayMichael Blau (MB): ing is “no good deed goes There are some common unpunished.” Let’s use as an aspects between the legislaexample a group that is tive level and the private- Mark J. Krasna, MD optimally efficient, one that payer sector. The concepts has already instituted protoof value purchasing, cost containment, cols and has guarded against redundant a new value proposition dealing with or unnecessary services. It provides the medically unnecessary services, bundled most efficient care for oncology and its pricing and episodes of care, and/or clinicians always do the right thing. So shared cost-savings with providers are for a set episode-of-care payment, any all trends that are occurring in the pri- variability in cost, for example, if the vate sector regardless of whether they drug prices go up (new drugs come on are legislated or mandated as part of the market, existing drugs get repriced), healthcare reform. Currently, there are if labor costs go up, if overhead costs go demonstration projects, and pilot proj- up, during any of the care period, the ects in these areas by private payers. practice is responsible for those costs. Ronald Barkley (RB): For providers, Assuming that the payer gave the practhe questions are: Where do they fit in tice the correct amount to begin with, a consolidating industry, and what do the only way the group can make up the they need to do to be prepared? The differential is by reducing the costs, that wheels are already in motion, and as is, by rationalizing the amount of care or Michael said, private sector healthcare the amount of drug or the amount of plans have already commenced the dia- input into the treatment. logue with providers to explore methJessica Turgon (JT): Oncology as a ods of payment that are different from service line within a community is simthe manner in which providers are ilar to some of the cardiac care models. reimbursed today. I believe we have If we look at the changes in the cardiac enough data to manage and predict true service line and draw parallels to oncolcosts. Even with a condition with great ogy, the changes cardiologists have variability like cancer, we have enough been facing regarding bundled reimof a database to be able to understand bursement for their ancillary services our costs and to be in the position to have led to an increasing trend in the experiment with more longitudinal care marketplace for cardiologists to be pricing with bundles of care. This pric- employed by hospitals or to work with ing would make it easier to manage and hospitals in a more integrated fashion probably reduce costs from a standpoint than ever before. No one was employof the redundancy of personnel and sys- ing cardiologists 3 or 4 years ago. Now, tems we need to have in place to handle everyone is employing cardiologists. So claims for the multitude of drugs, treat- it’s interesting to draw a parallel to canments, and imaging procedures. For cer and think through what a bundled providers, being able to know in case rate would do to an oncology servadvance that they will receive—for ice line if it’s targeted toward outpatient example, $50,000 for a defined cancer services. How much of the testing paysite and stage—would be a good place ments would be included in that type of to start. bundled rate? How will community Currently, I’m only aware of one oncologists be affected? major payer, UnitedHealthcare, that is Time will tell whether that trend offering a bundle-of-care approach, takes place. Does the community oncolmeaning, as I understand the program, ogist go away and oncology care ends up it is paying a budgeted rate for a partic- more integrated with the local commuular episode of care based on diagnosis, nity hospital? As the cost-containment staging, and anticipated cost. Costs are trend continues, what types of ancillary based on historic information by group, services, testing, or drugs will be bunso effectively UnitedHealthcare pays dled or sought to be contained within a the amount of money it thinks a payment methodology? provider would receive for treating this MK: Do you see more oncology pracepisode of care in a standard way pur- tices? Or do you see more oncologists in suant to the expected protocol using the an employed model? That could be a anticipated drugs. The company, how- good thing from the impact on the cost. ever, pays the money upfront and JT: It could be. Certain attributes expects the provider to stay within this within each market make the employbudget. This is the spend that you’re ment of oncologists a very localized

MAY 2010 I VOL 3, NO 3

phenomena, whereas the cardiology trend is more national. In different markets, there is some interest in figuring out arrangements around infusion, especially in regard to underinsured or uninsured patients. We are seeing a pushback about having two standards of care. Hospital infusion units are experiencing more volume compared with infusion therapy in the physician setting, because underinsured and uninsured patients are going into the hospital setting. Oncologists are standing up and saying that they really have to have one standard of care. How they take care of their patients in our community should be the same standard of care whether these patients go to the practice setting or the hospital setting. MK: When you look at the overall landscape of healthcare and you look at the greatest challenge being stressed at the national level, that of the uninsured—whether that number is 10 million or 40 million—how do you foresee that the new state-based American Health Benefit Exchanges will affect the delivery of care? MB: Let me go back and reframe this question a little differently. In healthcare reform today, we have expanded

and because they will be competing for the business of this pool of patients. This will be through a bid process sponsored by the exchange. This will drive down the premium price to some extent, also because these exchanges will be transparent and because people will have options about what coverage they purchase. There will still be great pressure to find ways to reduce the premium. And there’s only one way for insurers to really reduce premiums when all is said and done, and that is to reduce payment for healthcare services—through higher deductibles, cost or utilization controls, or lower payments to providers. These less expensive product designs take us back to where we started the conversation. What’s going on in the private-payer market will only be accelerated by the healthcare law. These lower cost insurance products will be designed to reduce the cost and payments for all sorts of care, including oncology care. We will probably see value-based purchasing, capped rates, episodes of care, and stricter medical necessity guidelines and clinical protocols for oncology. That may be one consequence of the expansion of coverage.

We will probably see value-based purchasing, capped rates, episodes of care, and stricter medical necessity guidelines and clinical protocols for oncology. ——Michael L. Blau, JD

coverage to many of the uninsured. That said, the question becomes: How are they going to access care? The answer, I think, may be in ways that make the problem of the underinsured more acute for the following reasons. Think about how the uninsured are going to access insurance under the healthcare reform system. The plan (effective January 1, 2014) creates a health benefit exchange where lowincome, uninsured patients (133% to 400% of the poverty level) can purchase an essential health benefits package that provides a comprehensive set of services, covers at least 60% of the actuarial value of the covered benefits, limits annual cost-sharing to the current law health savings account limits ($5950/individual and $11,900/family in 2010), and is not more extensive than the typical employer plan. These will be relatively low-cost policies, because the insurance companies will design them as low-cost policies

Another consequence goes directly to what you were asking: How do we deal with the underinsured and their cost of care? With expansion of coverage in a reformed system, there will probably be less payment on a per unit service available to providers and facilities where underinsured patients are seen. This will exacerbate the underinsured problem for providers. I don’t see a clear resolution to this problem, other than I think all providers are, in effect, being asked to step up and provide a higher level of community service and accept a higher level of bad debt than they have historically shouldered. MK: I’m going to jump in on that one. I work in a faith-based organization, and for years, my approach has been to have our organization remove the charity care that’s reported each year and instead look at that care as a budget line item, meaning budget for how much charity care you need by putting systems in place to identify it, even

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Trends of Reform Roundtable

within a faith-based organization. As a simple example, in our moderate-sized community cancer center, I budgeted for at least $1 million of charity cancer care purely on the hospital side, what we would call Part A. In addition, as you mentioned, is the issue of relying on the goodwill of the hospital staff to do more pro bono work. Even if the center comes up with ways of covering the Part A charges with charity, foundations, or gifts, the organization has no method of covering the Part B charges, except to go to the doctors and say it would like them to assume more bad debt. Eight of the 16 NCI Community Cancer Centers Program (NCCCP) sites are faith-based organizations. They are doing a great job at screening for cancers, but when they then find the cancer, it’s hard to pay for that patient’s care. It is good that we’re getting patients screened and finding cancers earlier, but the question becomes: Who’s going to pay for the treatment of those cancers after you find them? Unless anyone has any comments regarding those two general questions, we will move on to what’s happening in the private sector and how those providers and payers are dealing with these issues. RB: Just a couple of comments on cost, and then I’ll talk about episodes of care. Mike discussed the idea that for the uninsured insurance cooperatives, insurance pools will need to deal with premium reductions and affordable premiums and arrive at reduced cost. In these discussions, it is useful to clarify what we mean by “cost.” From an insurance perspective, the definition of cost is what the insurance company has to pay; it does not mean the true cost. Translated, that means whatever the mechanics of addressing the population without insurance, it comes back to the reality that there is only so far you can reduce true costs regardless of the insurance viewpoint of cost. Now I’ll comment on the underinsured, which will lead us to the discussion on episodic payment. A good example of a situation providers deal with on a daily basis is that of a cancer patient with Medicare who does not have a supplemental policy to Medicare. In medical oncology alone, a regimen may run $80,000 to $100,000, and for a patient with 80% coverage from Medicare, the 20% out-of-pocket not covered by a Medicare supplemental policy simply may not be affordable. That would be maybe $20,000 to $40,000 out-of-pocket because they didn’t have a Medicare supplemental policy. That creates a real dilemma for physicians working in private practice

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regarding what to do with these patients. I am seeing an unfortunate trend. Some practices are making it a policy that they cannot afford to treat Medicare patients who do not have a Medicare supplement and sending these patients for treatment elsewhere. MK: How are hospitals and physicians dealing with the patients who are underserved but need cancer care?

to as many sources of payment as they can, whether it be the drug company patient assistance funds, Medicaid, or state uncompensated care pools. MK: How are guidelines and quality measures going to affect the cost of care? Other than episodes of care, by instituting guidelines or quality measures, are we going to be able to cut cost of care and will it have a significant impact?

Guideline-based pathways, in my experience, don’t automatically reduce costs. They open the dialogue for reducing variability and starting to understand the costs of taking different actions. ——Ronald Barkley, MS, JD RB: For providers, when someone presents with no insurance or underinsurance, what is needed, in addition to standard front-office practices, is an investment in additional personnel to act as patient liaisons and financial counselors. These employees counsel patients who come to a private medical office, a hospital, or an organization such as a physician organization that is affiliated with the hospital to attempt to price and budget what the cost of their care will be and then to reach out and patch together subsidies, for instance, free drugs from pharmaceutical companies, to assist the patients in being able to afford their care. This is a costly and complicated process that adds to the providers’ costs-of-care burden. MK: What are the specific options, structures, or processes that are available to provide for underinsured or uninsured patients? For example, at a hospital or a physician practice, what are the options to come up with roughly $100,000 to do a colectomy with adjuvant chemotherapy for a full course of treatment for a patient who was in a screening program and was found to have colon cancer but can’t afford to get his colon cancer removed? MB: Let me go back and answer a slightly different question. If the burden of providing that care without payment at all or without adequate payment too often falls to a community oncologist, that provider will not be able to take on multiple charity cases without going out of business. We have to recognize that the typical community oncologist is not going to take many uninsured or underinsured patients. Hospitals with a charitable tax-exempt mission will accept as many of these cases as possible, but they will also try to find ways to connect patients

RB: Guideline-based pathways are an opportunity to reduce variability in treatment and variability in costs for care. They are better positioned to have budget predictability, so that you can start to understand what is possible under a different payment model, bundled rates or otherwise. After providers agree to certain pathways and eliminate or have an internal review process for outliers from the pathways, they have the opportunity to understand where the costs are really coming from and start to talk about efficacy of different drugs and procedures. Guideline-based pathways, in my experience, don’t automatically reduce costs. They open the dialogue for reducing variability and starting to understand the costs of taking different actions. MB: I think that is correct, but we have to look at it with at least two different lenses. Looking through the lens of providers, clinical protocols generally are being adopted for quality-consistency purposes, not for cost-containment purposes, and, to the extent that they do result in efficiencies, providers are looking at pathways as a way to get bonus payments. They are saying, “We are doing the right thing, we are adopting a clinical protocol, we are getting rid of the variability, we have a better mousetrap and payers should reward us for that by giving us another 5% or whatever for adopting the protocol, following it, documenting it, and showing that we are meeting quality standards.” It’s not clear in that equation whether there is cost savings for the system. It’s just another way of getting paid. From the payers’ perspective, it’s a very different ball game. Payers are saying that to the extent the industry can forge either a national consensus or a consensus among the payer’s oncology

advisory board about what is the costeffective approach to care, it should be imposed on oncology providers to wring out cost savings. For example, in a specific case, the payer’s stance may be that once there is determination and documentation of cancer staging, intention of care, and diagnosis of a site-specific cancer, only a prespecified (less expensive) drug regimen or radiation therapy regimen will be covered and paid. We are now beginning to see carveout companies starting to manage the oncology spend and cost on behalf of payers. And those companies are developing relatively sophisticated clinical protocol algorithms and decision-support tools that can be used to either support the oncologist’s decision-making or to influence how the physician decides to proceed in treating a patient. The purpose of the carve-out company is to drive down cost, effectively to take responsibility for the management of those costs and earn a margin by taking some financial risk on its ability to use its protocols to drive down costs. By this means, the carve-out company ultimately benefits from containing cost. That may become an increasing part of the payer paradigm. MK: I’m purposely challenging you with this question. There are three areas where the federal government claims the greatest loss and challenge for transforming the healthcare system: unnecessary medical care, physician self-referral, and the potential increase in healthcare costs due to the lack of adequate tort reform. I throw that last one out with a little caution, because I know two of our speakers are also lawyers. But I would like each of you to talk about those three aspects. For example, the medical oncologist orders an x-ray film, and then the radiation oncologist needs a computed tomography or a positronemission tomography scan. He may be saying that because the scans are needed, he may be saying that because he owns the company that does the scanning, or he may be saying that because he wants to cover himself legally. What do you really think is going on? I’ll ask each of you to comment on that aspect of the added costs that have happened in cancer care. RB: I’ll speak to this from personal experience in managing and working closely with a number of physicians who are in the trenches treating patients. I think it’s pretty uncommon for a physician at the point of care to be doing anything outside the communityaccepted standard of care. I think the idea of waste on unnecessary medical care and on extra proceContinued on page 8

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Trends of Reform Roundtable Transformation of Healthcare... Continued from page 7 dures being ordered because the physician is referring to services he owns is overplayed. The tort system may certainly be on the minds of physicians as they start to define standards of care, but I think the amount of money that is to be pulled out of the system from these items that you’ve identified is overstated. JT: If we look at what the Office of Inspector General (OIG) is looking at, it has been reported for every dollar that the OIG spends in investigating Medicare and Medicaid fraud, the agency generally experiences a $17 return. MB: The other statistic is that there are currently five times more Federal Bureau of Investigation agents on OIG investigations than there are on drug investigations. JT: This highly complex system has lots of moving parts, and there are different ways of addressing these issues. A little off the topic, the IT aspect of healthcare reform has been very interesting. The focus of IT reform is meaningful use and e-prescribing. A lot of effort and dollars have been exerted in implementing this small piece of stimulus. It will be interesting to see if that improves efficiencies in the long term or if physicians are just buying devices to show that they meet a standard and to receive additional compensation from the government. MK: Those are both good points. The IT reform comes with a carrot and a stick, meaning physicians will be rewarded in the next 2 years if they implement it, but by 2013 if they haven’t implemented, they are going to start getting docked. MB: I would say that the impact of tort reform is hard to quantify. Undoubtedly, defensive medicine is practiced to a certain extent by many physicians who are afraid of being second-guessed in a litigation context. I have seen some empirical quantification that shows that it accounts for an increase in overall costs of healthcare. My own sense is that its impact, while significant, is smaller than the impact from issues like fraud and abuse, administrative costs, end-of-life care, and care of the chronically ill.

But tort reform is a hot-button political issue. Physicians want to do the right thing from a quality perspective. They also don’t want to leave themselves exposed, so they will always have some perverse incentive to practice defensive medicine and do a little bit more than is strictly medically necessary—which certainly adds some cost to the system. MK: The American Board of

garding physician self-referral, I also think that what Mark has said is correct. But we also know that there are bad apples and that some people will act in their self-interest more than others. That’s why we have fraud and abuse laws. That’s why we have the OIG. That’s why we have an entire framework of enforcement and prosecution for those who abuse the system. This is why I started by saying you can’t build

The focus of IT reform is meaningful use and e-prescribing. A lot of effort and dollars have been exerted in implementing this small piece of stimulus. It will be interesting to see if that improves efficiencies in the long term. ——Jessica Turgon Radiology Foundation sponsored a multidisciplinary national summit meeting to address the issue of overutilization (“Medical Imaging: Addressing Overutilization in the Era of Healthcare Reform,” August 6-7, 2009, Bethesda, Maryland). What was interesting from that report was the alleged 30% excess imaging that is being performed. The meeting participants determined that the majority of waste testing in radiology, if it existed, was due to defensive medicine, that the incidence of selfreferral has almost completely disappeared, and that waste from repeating tests unnecessarily makes up a very low percentage of use. The foundation decided that about 30% of the questionable use of testing was directly attributed to physicians being concerned that they would not be covered legally if they did not do the testing. MB: I don’t disagree, but I think it is hard to determine the metaphysical aspect. You don’t know the physicians’ motives. The data don’t give the reasons or motives for the additional utilization. But I do understand that it was categorized precisely as Mark stated. There’s no doubt that there is a cost impact from defensive medicine. Re-

policy around the outliers. There are always going to be abusers in the system, but if you create the entire system as if everyone is an abuser, that system will compromise the ability to provide quality care as well as stifle innovation and have a lot of other unintended consequences along the way. Retests that add cost to the system are a problem. Another problem, to a certain extent, is the medical necessity of utilization in situations where the patients’ desires are not clear. For example, some research has been done on the extent and efficacy of informed consent of patients near the end of life and whether patients fully understand their options, as well as the risks and benefits and the costs and benefits of various treatment options. Patients need to be sufficiently informed to understand and decide whether the marginal course of treatment is really worth it. I think that is perhaps the biggest area of potential waste. The last issue I’ll mention is the turf battles around, for instance, prostate cancer. Should the urologist be treating the patient with brachytherapy? Should the radiation therapist be treating the patient with radiation therapy? Should the medical oncologist be treating the

patient with chemotherapy? What is the best approach? Economic interests may affect each practitioner’s decision. In addition, different professional skills, beliefs, and convictions in each clinician’s specialty may influence those judgments. There are also different cost points associated with those different approaches to care. All of that is legitimate to debate, but I think that it’s part of the variability in healthcare that leads to increased costs. MK: That was a perfect segue into my summary comment; the name of the journal is the Journal of Multidisciplinary Cancer Care. I am passionate about multidisciplinary care, and what you’ve just said is the underpinning of that concept. The true concept of multidisciplinary cancer care, is not just having a group practice that’s a multispecialty group, but is all the specialists coming to the table prospectively before any patient gets any treatment and having all the specialists in the room look at the patient and the patient’s information and make the decision that’s the right and the best treatment for this patient purely on the basis of what’s right for the patient. Although, as you pointed out, there are cost constraints and certain drivers for each physician, as a rule, most physicians really care about doing what’s right for the patient. We have all seen and our journal has highlighted multidisciplinary conferences that have occurred in the community. Even in private practices you can bring medical, radiation, and surgical oncologists together with imaging and pathology and do what’s right for the patient, not what’s going to pay best for any particular doctor. The main reason this works in private practice is because, ultimately, the message you’re giving the patient is: We’re going to do what’s right for you, no matter what. We don’t care about how the cost will impact us. We’re going to do it because it’s the right thing to do for you. And when patients hear that, ultimately, you’re going to get more patients referred to your group, because everyone knows that the group is doing the right thing. l

Recent FDA Approvals Erlotinib for Initial Maintenance for NSCLC The US Food and Drug Administration (FDA) has granted approval for a new indication that expands the use of erlotinib (Tarceva, OSI Pharmaceuticals) to include first-line maintenance therapy for locally advanced or metastatic non–small-cell lung cancer (NSCLC).

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Approval was based on the results of the phase 3 SATURN trial, a placebo-controlled, randomized, double-blind study with 889 advanced NSCLC patients. Overall survival in patients treated with erlotinib improved 23% compared with those in the placebo group (HR, 0.81; P = .0088). Patients in the erlotinib group also had a 41% improved progres-

sion-free survival compared with those in the placebo group (HR, 0.7129; P <.0001). The drug was previously approved for secondline therapy for locally advanced or metastatic NSCLC and for locally advanced, unresectable, or metastatic pancreatic cancer (in combination with gemcitabine). l

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Healthcare Reform Law Healthcare Law Means Big Changes... Continued from cover ing business line for you.” The law also raises Medicaid reimbursement rates to the levels paid out under Medicare, although that provision will expire in 2 years if Congress takes no action. A few exceptions aside, come 2014 individuals will be required to be insured. Smaller employers and millions of other Americans will buy insurance through new state-level exchanges. Exchanges are intended to push down premium costs, which could put a downward pressure on reimbursements. Regardless, the number of patients on Medicare is expected to balloon because of aging trends, and these privately insured patients should offset some of these costs. “Private insurers will almost certainly continue to pay significantly better than Medicare 10 years from now,” said Brow. More patients, same providers The law expands access to affordable healthcare to cancer patients who are currently uninsured. “The discoveries made possible through our investment in biomedical research don’t do a lot for cancer patients who don’t have access to healthcare,” according to Jeff Allen, PhD, executive director of Friends of Cancer Research in an e-mail to the Journal of Multidisciplinary Cancer Care. “The bill takes major steps to ensure that millions of Americans that previously did not have access will.” Unfortunately, it is not clear if the system is ready to handle an influx of patients. According to Brow, the system needs more oncologists and more efficiencies created through the increased deployment of nurse practitioners. The law should reduce underinsurance, as well. It eliminates lifetime caps, extending a financial lifeline to patients with catastrophic illness. And insurers will be barred from denying coverage because of a patient’s preexisting condition starting in 2014; in the meantime, these patients will be able to join statelevel high-risk pools. A number of provisions will affect Medicare patients. For one, the law gradually closes the so-called Medicare doughnut hole by 2020. But reductions in payment to Medicare Advantage could push many seniors back onto standard Medicare. The law also incentivizes the purchase of generics of expensive biologic drugs. A new biosimilar payment schedule reimburses biosimilars at average sale price (ASP) plus 6% of the price of the reference biologic instead of the ASP plus 6% of the biosimilar that is currently paid. Thus, a $2000 biosimilar with a $4000 reference biologic will be reimbursed at $2240, an increase of $120.

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But the law may not hasten generics’ arrival on the market, as it grants 12year patent exclusivity to developers of biologics, 7 years more than is afforded to producers of conventional drugs. Big changes for radiation oncology Radiation oncology may undergo the most dramatic changes, including a 2.3% excise tax on the sale of medical devices and an increase in the assumed utilization rate from 50% to 75%. According to Jason Launders, MSc, an expert on diagnostic imaging at the ECRI Institute, the increase in the utilization rate will have the greatest impact. Lower reimbursements for less-

improvement and cost control. The law creates an Independent Payment Advisory Board charged with keeping Medicare spending from growing beyond a set rate and a new CMS Innovation Center charged with researching and implementing new reimbursement models. “Certainly there is anxiety about the board. Principally this is because you’re taking away Congress’ power to make some of the resource decisions that Congress has historically made,” said Brow. “On the Innovation Center, I’m optimistic.” Following an initial investment in the 2009 stimulus bill, the healthcare law

“Instead of increasing a poorly paying business line for you, this bill will increase a well-paying business line for you.” ——Matt Brow, US Oncology

used equipment could put some technology out of the reach of smaller providers, quickening the migration of imaging to bigger centers that can reap the benefits of economies of scale. “Smaller facilities will have very limited options and will not be profitable under these rules since the required patients will not be there,” Launders wrote in an e-mail to the Journal of Multidisciplinary Cancer Care. “Hos pitals, which need diagnostic imaging, will take wider ownership. Outpatient imaging centers will still exist, but will have far less independence.” According to Brow, the data do not support setting the utilization rate at 75%, and increased hospital visits for imaging services could have the perverse effect of raising costs, because hospital care is so expensive. Another provision requires physicians to disclose any financial stake in imaging. This should have little impact, because in-house scanning will remain the most convenient option for patients. A first step on cost control The past year of debate over healthcare centered on expanding access and tamping down on exploding costs. Critics of the legislation charged that using government subsidies to increase access would lead to rationing and diminished care. The new law positions the Centers for Medicare & Medicaid Services (CMS) to take the lead in researching and implementing innovative models that combine quality

makes further payment on comparative effectiveness research, including the establishment of a Patient-Centered Outcomes Research Institute to coordinate hundreds of millions of dollars in new research funding. With increasing pressure on reimbursement, emerging pay-for-performance models could be a good solution for providers. “The fact that most of the discussion and the debate right now about delivery systems is around finding out how to pay for value is actually a positive development,” said Brow. In a boon for research, the law also mandates that payers reimburse costs associated with clinical trials, lowering financial barriers to patient participation and speeding up the process. Perhaps the biggest change for oncologists is the creation of a CMS program that allows for accountable care organizations (ACOs) to share in savings if they can reduce costs and demonstrate improved outcomes and a commitment to evidence-based medicine. ACOs, organizations that oversee the entire continuum of care for a patient, could help control costs in a way that leaves oncologist income intact. “In oncology, half the patient population is Medicare beneficiaries, and it’s essentially a break-even operation; no contribution to practice or physician income,” said Brow. “To find a way to be paid for providing better quality care, more valuable care, and more costeffective care, is important.” Hospitals and larger centers will prob-

ably take the lead in establishing ACOs, and it is as yet unclear if independent providers will follow, because they do not know if the investments in administration required will be offset by the shared cost-savings. Much of this depends on the formula that CMS chooses and whether private payers insist on separate reimbursement models—a potential administrative headache. “I think we are going to see oncologists joining ACOs,” according to Michael Blau, JD, partner and chair, Health Care Venture Practice, Foley & Lardner LLP. “The question is: How many will be doing it willingly, and how many unwillingly? If you’re an employee of a hospital or health system, and they’re going into an ACO...then you’re going to go along for the ride. If you’re an independent private practice community oncologist, you have a number of decisions to make.” Community cancer centers that take a comprehensive approach to patient care could be well positioned to take advantage of the program. “A community cancer center that has multidisciplinary care and is providing or coordinating home health and hospice,” said Blau, “has a lot of the foundational elements in place that begin to look like an oncology-specific ACO.” But it is possible that once providers demonstrate that they can deliver quality care at lower costs, CMS could raise the benchmarks, making lower reimbursements “the new normal.” The law also creates a Medicaid pilot to test episode-based, bundled payments. Cost-control efforts, many of which are targeting overhospitalization, could hurt the bottom line at hospitals, a fear that was underlined by a recent report from the Office of the Actuary at CMS. The decreased number of uninsured patients should offset some of the reductions in federal payments for charity care. But hospitals will be required to submit a “community needs assessment” every 3 years, and could lose their nonprofit status if they fall short. “Some of the ways physicians and other ACOs might reduce costs will directly reduce downstream revenue to hospitals,” said Brow. “If you’re avoiding hospitalizations, avoiding emergency room visits…that results in fewer intensive care unit visits, these are likely over time to reduce spending at hospitals.” The new report from the CMS actuary will likely increase pressure to control costs. And a number of problems for oncology remain on the table. A reform of the Medicare sustainable growth rate did not make it into the final bill, and advanced care and endof-life planning fell victim to partisan politics. l

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Coding and Billing Oncology Drug Coding... Continued from cover Why is it important to code properly? John Aforismo (JA): It is important for two reasons. One, the most obvious reason, is to ensure that the practice is reimbursed appropriately for goods and services that it provided to the patient. The other reason is because the payers who reimburse the oncology practice use coding information for developing patient-management programs. Payers perform data analysis with the information, so they need accurate and proper coding right down to the ICD-9-CM and administrative code level to make data analysis easier. What are some of the common mistakes oncology practices make when coding? JA: They may use the incorrect Healthcare Common Procedure Coding System (HCPCS) code for the drug used or any ancillary drugs in question. They may input the wrong code, either one that aligns to a different drug, or just the wrong code. Or they may input a nonclassified code where there is a code already established. That could hinder or slow the reimbursement to the practice. A practice may also use the incorrect ICD-9-CM code to identify the type of chemotherapy or the site of cancer. Payers are now looking at these codes more closely. In the past, if a practice used the improper HCPCS code for the drug or the amount of units provided, that just stopped the claim. But now if the ICD-9-CM code is not appropriate, if there isn’t one assigned, or if the administrative code used in conjunction with the HCPCS code is not appropriate, the claim will be flagged for a medical review. Payers are even looking at the dosage units, those that appear in Column 24G of the Centers for Medicare & Medicaid Services (CMS) 1500 claim form. There are databases that provide the minimum and maximum dosing on a specific product, and, if the dosage input on the claim submitted does not fall within that range, a medical review will be triggered. How can practices ensure proper coding? At the Hematology/Oncology Pharmacy Association annual meeting, one of the speakers said that in some practices, pharmacists in the billing department make sure that drugs are coded properly. JA: Having a pharmacist in the billing department helps ensure use of the proper National Drug Code (NDC) number and HCPCS code. I’m a pharmacist as well, so I’m not slighting pharmacy at all, but pharmacists probably do not have the right background to look

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at the ICD-9-CM or administrative codes that also go on a claim form. A nonclinical nurse can help with these aspects. Another method is to use a

Recently, CMS eliminated consultation codes. Have there been other changes in coding that will affect oncology practice?

Basically, by requiring all this information, the payers are going to be doing some things they never did before—that is, managing patients. ——John F. Aforismo, BSc Pharm, RPh, FASCP

software product that provides some of this information. A few of these are available. How can one learn about coding? Is it through on-the-job training or are there courses/special training available? JA: It is my understanding that there are coding classes that a nurse, or a pharmacist, or someone who’s in charge of billing can take to learn the proper codes for each drug and procedure. BC Advantage in Las Vegas, Nevada, and MedLearn in St. Paul, Minnesota, offer classes. These are companies that hold seminars, either live or via the web, on appropriate coding in oncology as well as other areas of medicine. How does off-label use of cancer drugs affect coding? How are those drugs coded? JA: Probably 99% of the payers could not tell you that you are using an oncology product off-label. There are very few databases that will look at that NDC number and say “oh yes, it is US Food and Drug Administration– approved or it is compendia-approved or compendia-listed.” More important, payers review claims as they arrive. They have started to build fail-safes, which means that when a claim comes in, they will review it retrospectively and inform the provider that an oncolytic was used for an unapproved or an off-label use. Then, the payer will ask for two peer-reviewed studies to back up that use. Another way that payers strive to ensure that uses are appropriate is what we call “prior authorization” on drugs. Even in oncology, there will be payers that will not pay for specific drugs until the provider advises them why he or she wants to use the drug for a patient. Then the payer will say “here are my criteria to use this drug.” The physician’s office will have to supply that data ahead of time. Once it’s approved, the patient can receive that drug for the approved period of time.

JA: I think the main issue that will affect oncology practices in the future is that payers will be asking for appropriate ICD-9-CM codes and appropriate

administrative codes that go with a particular drug. They are going to use these data as a method of understanding what the patient was receiving and to build guidelines to treat the patient. Basically, by requiring all this information, the payers are going to be doing some things they never did before—that is, managing patients. I don’t know of any other recent changes in coding. But, more important, CMS and others are requiring administrative codes. In the future, they also will be requiring various laboratory codes to get a claim reimbursed. ICD-10-CM is coming soon. Will there be major changes? How can practices prepare for that? JA: The ICD-10-CM codes are a Continued on page 17

Defining the Codes ICD-9-CM and ICD-10-CM The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM), is used in assigning codes to diagnoses associated with inpatient, outpatient, and physician office utilization in the United States. ICD-9-CM is based on the International Classification of Diseases (ICD) developed by the World Health Organization but provides for additional morbidity detail and is annually updated. ICD-9-CM consists of a classification system for surgical, diagnostic, and therapeutic procedures (in an alphabetic index and a tabular list). The National Center for Health Statistics and the Centers for Medicare & Medicaid Services are the US governmental agencies responsible for overseeing all changes and modifications to the ICD-9-CM. The ICD is revised periodically to incorporate changes in the medical field. The Tenth Revision (ICD-10) differs from the Ninth Revision (ICD-9) in several ways although the overall content is similar. First, ICD10 is printed in a three-volume set. Volume 3 will be used in assigning codes associated with inpatient procedures. Second, ICD-10 has alphanumeric categories rather than numeric categories. Third, some chapters have been rearranged, some titles have changed, and conditions have been regrouped. Fourth, ICD-10 has almost twice as many categories as ICD-9. Fifth, some fairly minor changes have been made in the coding rules for mortality. ICD-10-CM, the clinical modification manual

based on the 10 revision, will be implemented October 1, 2013. Healthcare Common Procedure Coding System The level 2 Healthcare Common Procedure Coding System (HCPCS) codes are established by the Center for Medicare & Medicaid Services’ Alpha-Numeric Editorial Panel. These codes primarily represent items and supplies, as well as nonphysician services that are not covered by the American Medical Association’s Current Procedural Terminology (CPT) codes. Medicare, Medicaid, and private health insurers use HCPCS procedure and modifier codes for claims processing. Level 2 alphanumeric procedure and modifier codes comprise the A to V range. CPT Administrative Codes The American Medical Association’s Current Procedural Terminology (CPT) is a systematic listing of codes for procedures and services performed by US physicians. This physician-related procedure identification system serves as the basis for healthcare billing in the United States. These codes assign a five-digit number to each service or procedure provided by a physician. CPT codes are maintained by the CPT Editorial Panel, which meets three times a year to discuss issues associated with new and emerging technologies as well as difficulties encountered with procedures and services and their relation to CPT codes. The codes are updated annually. l

MAY 2010 I VOL 3, NO 3

Electronic Health Record

Oncology EHR: Taking the Road Less Traveled By Timothy G. Tyler, PharmD, FCSHP Director, Pharmacy Services, Comprehensive Cancer Center, Desert Regional Medical Center, Palm Springs, California

n late 2009, researchers Cancer Center is a 50,000from the University square foot outpatient canCollege London reportcer center on the campus of ed that between 50% and Desert Regional Medical 80% of electronic health Center, a 400-bed regional record (EHR) systems are medical center managed by unsuccessful outside of a Tenet Healthcare in Palm controlled testing environSprings, California. It offers ment. They observed that radiation, medical, and surthe bigger the EHR project, gical oncology as well as a the more likely it was to Timothy G. Tyler, PharmD, comprehensive breast cenfail. There have been colos- FCSHP ter. It is fully staffed by a sal EHR failures in general multidisciplinary team of medicine, with costs approaching bil- physicians, nurses, pharmacists, lab lions of dollars. In the complex world of technologists, dosimetrists, physicists, oncology, implementation has resulted dietitians, and social workers. The 20in actual reversal of implemented sys- year-old center caters to a geriatric tems in more than 10% of projects.1 “snowbird” population. Also in 2009, the American Society In the late 1990s, I worked with a of Clinical Oncology (ASCO) and the team to explore the use of an EHR sysOncology Nursing Society released tem at the cancer center. The team national guidelines for the safe adminis- included corporate staff, our hospital tration of chemotherapy in the outpa- partner, physicians, nurses, and laboratient setting in the hopes that their tory, pharmacy, and information techeffort to standardize care “can reduce nology (IT) professionals. The pilot the risk of errors, increase efficiency, launched three systems; within 6 and provide a framework for best prac- months, we were evaluating our third tice.”2 In their discussion of the stan- and final option, which remained in a dards, the groups noted that “increased pilot trial for 9 years. use of electronic medical record systems Months into the pilot, we realized the may lead to improvement in the safety technology was not ready for prime and quality of outpatient chemotherapy time, at least not for the medical oncoladministration.”2 ogy needs of the cancer center. The proThe signing into law of the American gramming was either too rigid or did not Recovery and Reinvestment Act of meet the complex needs of ambulatory 2009 established programs to provide medical oncology. That said, the medincentive payments to eligible profes- ical staff involved in the pilot did enjoy sionals and hospitals participating in the utility and convenience of the elecMedicare and Medicaid that adopt and tronic laboratory, notes, and order sets make “meaningful use” of certified EHR that I developed. This meant we could technology.3 not really sunset the project. The only With EHR now a national mandate, option was to move forward. even holdouts are keenly looking at the The application did not fully meet $19 billion in stimulus incentives from clinic needs, however, leaving the the current administration to convert to already busy pharmacy team working to the electronic side of the fence. The act fill in the gaps. To make matters worse, is the major driver for adopting EHR, the company that created the EHR which until now has been regarded by product was acquired, and the new many as too complex and expensive to company no longer supported the softimplement. ware. It was time to develop a more sustainable solution. One cancer center’s experience In April 2006, Aptium Oncology I would like to share my long and revisited the EHR project and chartered arduous EHR journey spanning more a new team to assess its viability. I than a decade and a half in the hope of remained on the team. Taking 1 week passing on valuable insight to readers. off from clinic duty, I traveled to our Although the journey has been fraught corporate office and sat with 12 others with challenges, detours, and false starts, from across our enterprise. We evaluatit has been consistently interesting. ed five vendors in our quest for a system As the director of pharmacy services that would meet the needs of our eight for an ambulatory cancer program for 17 cancer centers across the United States. years, I offer a unique perspective. My We prepared a needs document with a employer, Aptium Oncology, Inc, is a third-party consultant—a must in evalleader in outpatient ambulatory cancer uating vendors fairly. care, providing consulting and manageWe chose to move forward with ment solutions. The Comprehensive Eclipsys, which ironically was the com-

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pany that had acquired the legacy system in use at Desert Regional. Although our capital investment at this point was not that significant, the outlay for manpower to date was considerable. In the end, we chose to deploy our internal experts to design, build, and implement the new EHR system. We soon realized that the most desirable feature of an oncology EHR—customization—would require significant cost, effort, and time. We started with a generic EHR designed for acute-care hospitals or nononcology physician office practices. To us, it seemed the vendors did not understand the outpatient oncology worldview. We had our work cut out for us. On the road less traveled, this could be a road block for many travelers. We did not realize that even in a company of our size and with our expertise, this would be a challenge. “It took us about 8 months to understand the architecture and nomenclature well enough just to be able to begin the process of a customized build,” says Suzanne Bledsoe, vice president of information technology and the project lead for the Eclipsys oncology EHR project at Desert Regional. “Then it took a team of about 10 dedicated clinicians about 18 months to generate, perfect, and test the build that we use today.” Mark Leavitt, chair of the Certification Commission for Healthcare Information Technology, speaking at the annual conference of the American Health Information Management Association this past October, corroborated Bledsoe’s perspective. “Physician practices and hospitals that have yet to select or implement an EHR system should get a move on. Those who wait until next year will face a high risk of failing to achieve meaningful use of health IT in time for the 2011-2012 federal incentives. You’re dreaming if you think you can achieve it in less than a year. Achieving meaningful use of an EHR system will take at least 18 months, if not 2 years.”4 To date, we have had the full-time use of a pharmacist, dietitian, nurse specialist, and nurse manager in addition to our existing IT support team, consultants, and vendor support. Our roles have expanded to include interfacing with software engineers. Fortunately, the internal experts have a combined 30 years of experience and fully understand process flows in a cancer center. Still, we invested considerable capital in this project and it is hard to see how a solo practice or hospital provider could even initiate a project of this scale and resources.

Wes Scruggs, chief information officer and executive vice president of Aptium Oncology, agrees. “We have gone full force to configure the best possible oncology EHR for our clinicians. Few organizations are in a position to make this kind of investment, and with the stimulus incentive clock beginning very soon, it would be nearly impossible to pull this off from scratch.” Already, Scruggs and the IT project lead are fielding queries from an increasingly EHR-conscious world. A 2009 EHR satisfaction survey conducted by Oncology Metrics reported that among 18 EHR vendors, not one has captured market dominance or fielded oncology-specific content, so no prepackaged oncology application is currently available. The report further noted that 65% of those without a current system agree that an oncology-specific EHR would be their top choice when they do adopt.5 “The EHR at the Comprehensive Cancer Center at Desert Regional went live in October 2009, and we have not looked back. Getting off at the speed we are going now is out of the question,” states Marika Loveless, RN, EHR project director. “We have worked relentlessly to develop a finely tuned system that meets both our clinicians’ and patients’ needs, and our system reflects that.” A means to an end It has been a great journey and the road still stretches out before me and my fellow EHR travelers. No doubt implementing an oncology EHR is a daunting prospect, but the rewards are significant in terms of efficiency, cost savings, and improved workflow. But, ultimately, an EHR is nothing more than a means to an end. Let us not forget the reason we travel this road—to connect with and treat those who come to us asking for help. l References 1. Greenhalgh T, Potts HWW, Wong G, et al. Tensions and paradoxes in electronic patient record research: a systematic literature review using the meta-narrative method. Milbank Q. 2009;87:729-788. 2. Jacobson JO, Polovich M, McNiff KK, et al. American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards. J Clin OncoI. 2009;27:5469-5475. 3. Centers for Medicare & Medicaid Services. Health information technology. www.cms.hhs.gov/Recovery/ 11_HealthIT.asp. Accessed March 16, 2010. 4. Leavitt M. CCHIT’s new era: certification under ARRA. Presented at: American Health Information Management Association Annual Conference; October 5, 2009; Grapevine, TX. 5. Towle EL. Stimulating EHRs…(or not). Presented at: 2009 Cancer Center Business Summit; October 8, 2009; Dallas, TX.

The Comprehensive Cancer Center recently submitted an abstract on oncology EHR implementation for the upcoming ASCO meeting.

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Presents the Third Annual Curriculum for

CONSIDERATIONS IN MULTIPLE MYELOMA A Newsletter Series for Cancer Care Professionals Center of Excellence Media, along with Editor-in-Chief Sagar Lonial, MD, of Emory University, are pleased to offer your multidisciplinary cancer team this series of newsletters focusing on the challenges of treating patients with multiple myeloma.

SAGAR LONIAL, MD Associate Professor of Hematology and Oncology Emory University School of Medicine

# Earn Continuing Education Credits # 8-part newsletter series

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Target Audience These activities were developed for physicians, nurses, and pharmacists.

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These activities are supported by an educational grant from Millennium Pharmaceuticals, Inc.

Conference News ACCC The following articles are based on presentations at the Association of Community Cancer Centers (ACCC) 36th Annual National Meeting held March 17-20, 2010, in Baltimore, Maryland.

ACCC Panel Says Get Ready for CER By Daniel Denvir

omparative effectiveness research (CER) is at the forefront of new cost-control efforts, according to a panel of experts. CER aims to evaluate both the clinical and cost-effectiveness of treatments through head-to-head trials, including preventive measures. And although CER promises important new clinical insights, no one doubts that rising healthcare costs are forcing payers and providers alike to think about driving value. “Although you keep hearing this isn’t about money, I don’t think anyone believes that for one second,” said Al B. Benson, III, MD, FACP, incoming president of the Association of Community Cancer Centers. “It’s all about money. It’s going to affect our pocketbooks in many ways. We’re all going to see reimbursement based on supplying data.” Exploding healthcare costs and the new healthcare law have focused increased attention on CER. The American Recovery and Reinvestment Act of 2009 dedicated $1.1 billion to CER, and the Patient Protection and Affordable Care Act creates the Patient-Centered Outcomes Research Institute to coordinate federal CER support, seeded with hundreds of millions of dollars in new funding. “The purpose for setting it up...was to create an independent entity that would be separate from government pressure and have a sustained funding source,” Jeff Allen, executive director of

Friends of Cancer Research, Allen said the paltry told the Journal of Multiinformation provided by the disciplinary Cancer Care. current model is a more sigAdvocates say the funds nificant concern and CER are just a start. In the New should enhance the identiEngland Journal of Medicine, fications of subset variaJerry Avorn, MD, wrote tions. Consumer advocates, that, “at 1/20 of 1% of our such as the Consumers $2 trillion annual health Union, have backed CER. care expenditure, the CER In March 2010, Michael funding amounts to a frac- Al B. Benson, III, MD, Hochman, MD, and Danny tion of what any corpora- FACP McCormick, MD, MPH, tion would spend to find published an analysis of out whether it was getting its money’s medication studies (JAMA. 2010;303: worth from its purchases” (2009;360: 951-958). They found that most drugs 1927-1929). were not compared with currently availGiven the intensely partisan envi- able therapies, and that many studies ronment in Washington, CER has simply measured drugs against a placebecome a political football of sorts: bo. The authors suggested that the study Republicans have charged that CER design in commercially funded studies is will lead to rationed care; and pharma- more likely to show positive results than ceutical companies and device makers those of uncommercially funded reeager to get their products to market are search. They also found that nonprofit nervous about lost profits. foundations or the government funded In an attempt to placate critics, the most comparative effectiveness studies, stimulus act included a provision that so it seems likely that public funding ostensibly limits the role CER could play will drive CER in the future. in reimbursement, but the clause is more “We talk in oncology organizations a politics than substance. Allen said that great deal about drug reimbursement,” the Centers for Medicare & Medicaid said Benson. “That pales when you look Services will likely treat CER data the at imaging. And we in oncology order a same way it treats any research in evalu- lot of tests. We make a lot of money for ating cost and clinical effectiveness. our radiology department. And unfortuOthers worry that CER will under- nately, when you look at the literature, mine patient-centered medicine, and there’s very little guidance with how to some advocates worry it could gloss over use imaging.” differences among subpopulations. In June 2009, the Institute of

Medicine released 100 top priorities for CER, including six for the fields of oncology and hematology. They include comparing the effectiveness of genetic and biomarker testing for preventing and treating cancer and the use of diagnostic imaging. Allen said it seems likely that CER will first be applied to these “low-hanging fruit.” One of the biggest challenges beyond politics will be the collection of data. “We do have to generate evidence,” said H. Kim Lyerly, MD, director of the Duke Comprehensive Cancer Center, Durham, North Carolina. “One of the challenges, though, is cost.” Because hospitals already collect much of this data, electronic health records would not be necessary—but they would be a big help in making data collection more affordable. “What we would hope is that this would be one component of practicing evidence-based medicine,” said Benson. There is no shortage of methodological questions to work out, including how to ensure that outliers are identified. And after CER data are generated, these will have to percolate down into the day-to-day of clinical practice. “Getting new research findings into the hands of doctors and patients is easier said than done,” said Allen. “Some estimate that it takes upward of a decade to implement a new research finding into routine clinical practice.” l

Diagnostic Imaging: Use and Reimbursement

lthough major technologic advances continue, steep prices for equipment and heightened concern over radiation overdoses pose challenges for the field of diagnostic imaging, according to Jason Launders, MSc. Launders, who is a senior project officer and medical physicist with the Health Devices Group, ECRI Institute, Plymouth Meeting, Pennsylvania, has focused his research on computed tomography (CT) scans. “As we move more and more into chronic disease management, diagnostic imaging is really becoming part of the whole continuum of care.” This includes screening, initial diagnosis, initial treat-

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ment strategy, therapy guidance, and subsequent treatment strategy. But the rise of digital imaging over the past decades has led to cost increases. “It needs to be rethought, how we’re paying for imaging. Currently, imaging takes up a very large slice of the pie and, as we all know, [cost increases are] unsustainable,” said Launders. In addition, a slow US Food and Drug Administration (FDA) approval process has made it difficult for providers to secure reimbursement for some imaging. The FDA’s tardiness in reclassifying full-field digital mammography (FFDM) from a class III to class II device is of concern. But first, the FDA must issue a guidance to manufacturers. “And we’re

still waiting for the guidance, which the FDA has to provide before that can happen,” said Launders. “So clearly the development, the evolution, of FFDM has been held back by that. The number of truly new devices over the past 10 years is very small.” For existing technology, market saturation may bring prices down. Launders noted that “60% of all mammography units in this country are now digital. The digital mammography vendors are saying that basically the market has disappeared. Very few devices are being sold. Maybe that will start pushing the prices down below the half million mark, which is where they’re at now.” Launders said that although there are

now higher reimbursements for FFDM, patients must be seen more quickly, in 5- or 10-minute time slots, for the practice to remain profitable. And although digital mammography is only of proven benefit to a subset of women, it will nonetheless displace the less costly film. “You can’t provide digital mammography and screen-field mammography in a workload. You can’t say beforehand, ‘you don’t meet the criteria for digital; therefore, we’re going to use film.’ I think the days of film are going to be over. The high price of digital mammography has to come down; otherwise screening mammography could be under threat. It’s just going to become too expensive.”

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Conference News

Another major innovation is the wireless digital radiography detector, which can be retrofitted onto any x-ray machine and kept in use when new equipment is purchased. “You may well find that you don’t need as many x-ray rooms when you move forward with the detector, because the workflow will be so much better,” said Launders. There have been a number of advances in CT scanning, including dual-energy technology, which streamlines the identification of distinct anatomy. But CT has also been the site of growing concern over radiation exposure, and payers are pushing back on reimbursement because of cost. “Slices really aren’t the question,” said Launders. “The real question today is: How low can you get that dose?” Lawsuits filed against Cedars-Sinai Medical Center and GE allege dangerous radiation overdoses of patients undergoing CT scans. “A class action lawsuit really changes everyone’s perspective,” said Launders. “This is huge, almost like a turning point in diagnostic radiology, because I don’t think there

has been a major legal case before on too high a dose.” GE, Siemens, Toshiba, and Philips are all marketing equipment that lowers dosage by 50%—but at $500,000, the equipment is expensive. “This is an area of some concern, because most patients are going to be denied the low-dose technology.”

ever, every year,” he said. “The problem is there’s no reimbursement specific to it.” Clinical trials are ongoing, but prices are still too high. “I think tomosynthesis will be the future of mammography, because it will leave normal mammography in the shadows.” Computer-aided detection (CAD) is making rapid advancements, despite

The high cost of CT means the equipment increasingly will be available only at larger providers. According to Launders, the high cost of CT means the equipment increasingly will be available only at larger providers. “I can see that most of the big CT [complex CT imaging] is only going to be available in major centers in years to come because of the cost of the technology—we’re now talking $2.5 million for a top-of-the-price-range CT scanner.” Tomosynthesis is another lower-dose alternative, which is especially adept at seeing through overlying anatomy. “We’re talking about a DVD worth of data per patient to be stored almost for-

spotty reimbursements. “I think CAD will become invisible in the workplace. I think it will become part of the workload, it will be built into the workstations…it will be such a time saver for any radiologist.” Launders noted other advances in technology. Regarding magnetic resonance (MR) imaging, Launders said that 3T scanners will increasingly displace 1.5T ones, but that reimbursement is still a problem. Positron-emission tomography (PET) continues to progress. The National

Oncology PET Registry (NOPR) has been successful, despite initial doubts. “The results have been rather quick in coming. And they’ve certainly bolstered the evidence that PET can be used.” In particular, time-of-flight dramatically shortens the time necessary for a PET scan, lowering its price. However, this reconstruction technology itself remains very expensive. “I think despite the high cost of the equipment, in a few years—or very soon—PET will be so useful in so many cases, especially in oncology, that when you can afford to add a PET scanner, you will add time-of-flight.” He said that hybrid imaging “is on the rise,” including PET/CT and single photon emission computed tomography/CT. MR/PET imaging has generated much interest, but is still in very early stages of development. Technological innovation is moving ahead, but as Launders emphasized both reimbursement and dosing will likely be coming down. l —DD

Standardized Treatment Regimens: Improving Care, Lowering Cost, Clarifying Communication

ublic and private payers are moving to control exploding healthcare costs, and increased cost control is inevitable, so it is in providers’ interest to get a seat at the table, according to Kimberly Bergstrom, PharmD, chief clinical officer for McKesson Specialty Care Solutions. “It is an important topic, because this is one of those things, if we don’t get a handle on it, it’s going to happen to us,” she said. “People and groups and organizations are going to start dictating how we provide cancer care, and we can’t let that happen.” According to Bergstrom, the Regimen Profiler (Onmark, a McKesson Specialty Care Solutions company)—a web-based resource—allows providers to standardize treatment regimens across their practice and to evaluate costs. Providers can use these data to communicate the value they are providing to payers and move reimbursement away from the increasingly embattled fee-for-service model, which can incentivize excessive and expensive care. “[Payers] have a huge interest in reducing your drug margin to save them money,” said Bergstrom. “They want to move [providers] away from their dependence on the drug margin and

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move to more service-based fees. They want to separate the oncology income from drug sales.” But many payers, said Bergstrom, are currently reducing costs on their own terms, and cutting into providers’ bottom lines. “This really provides us with a great dilemma,” she said. “Decreased revenue, increased administrative burden, and costs to all of you to be able to work with payers. Payers are managing specialized care aggressively. And they’re

Profiler as pathway Nick Leasure, MD, of Berks Hematology Oncology Associates in Reading, Pennsylvania, spoke after Bergstrom and discussed using the profiler at his practice. The seven-physician practice began using the new system 1 year ago. He said that although clinical effectiveness is still his top priority, the profiler can help break a tie between two clinically equivalent treatments. Most important, these data allow the practice to demon-

Control and standardization of effective treatment regimens should go hand in hand. using two key tools that they know best: they’re reducing your fee schedules and they’re requiring prior authorization.” But reduced costs don’t have to mean reduced care. According to Bergstrom, cost control and standardization of effective treatment regimens should go hand in hand. “They are creating payment policies that actually reward clinical performance,” she said. “A lot of that has to do with the focus on standardized treatment guidelines and rewards for achieving certain clinical measures.”

strate value to payers. Soon, the practice will meet with a payer, with the hope of smoothing the coming transition away from fee-for-service. The profiler is just one tool Berks used as part of a larger effort to standardize regimens. “The concern whenever you speak about regimen standardization is the loss of physician autonomy,” said Leasure. “We decide to use a certain number of regimens; now we’re being told how to prescribe and what to prescribe. I think that although that’s a concern, just the opposite is the

case...in our practice.” Although physicians have found the standardization process helpful, Leasure said that if physicians are not part of the decision-making from square one, there could be resistance to change. Bergstrom agrees. “If you can really get your physicians together and talk about how to focus your approach to care for certain diagnoses, and really narrow the choices of regimens, you will improve quality across the cancer care team,” she said. “Because all of a sudden, instead of every physician doing a slightly different version of cyclophosphamide/doxorubicin/vincristine/prednisone [CHOP] or leucovorin/fluorouracil/oxaliplatin [FOLFOX]…everyone’s going to be singing from the same songbook. The nurses aren’t confused. Everyone is standardized. Your billers know what to bill: it’s the same thing over and over again.” Bergstrom and Leasure said that regimen standardization is a boon for quality and reimbursement alike. “Payers need consistency of care,” said Bergstrom. “If they can predict what the costs of cancer care are, they will be able to set their premiums better.” l —DD

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Reimbursement

The Reimbursement Challenge for 2010 By Caroline Helwick

NEW ORLEANS—As reproposed RVU cut of 6% for imbursement for services oncology will affect the botcontinues to decline, oncoltom line, he said. Reimogy practices must be proacbursement will be cut by 1% tive and develop a strategy in 2010, and a 6% cut will to minimize losses, said be phased in over the next Steven L. D’Amato, RPh, 4 years. BCOP, clinical pharmacy A change in the sustainspecialist with the Maine able growth rate has again Center for Cancer Medbeen delayed, but if impleicine, Scarborough, Maine. Steven L. D’Amato, mented “it will mean a huge D’Amato was an invited RPh, BCOP financial loss for private pracspeaker at the annual meettices,” D’Amato predicted. ing of the Hematology/Oncology Phar- By current predictions, the reduction in macy Association. payment for chemotherapy administra“The landscape for oncology reim- tion should be approximately 25%. bursement presents challenges for clini“On the hospital side, however, there cians and payers. Reimbursement for are increases,” he noted. The Hospital services is declining in both the hospital Outpatient Prospective Payment Sysand private sectors as administrative tem will experience a reimbursement burdens are increasing. Efficiencies are increase, with an inflation adjustment necessary to maximize reimbursement of 2.1% (0.1% for systems not particiand minimize losses,” D’Amato said. pating in quality reporting). “These days we need to maximize Regarding drug payments, CMS will efficiencies to make sure we get every no longer exempt 5-hydroxytryptadollar coming to us,” he told conference mine-3 (5-HT3) antiemetic products from standard packaging methodology. attendees. Drugs costing less than $65 per day are 2010 billing and coding changes not reimbursed separately, whereas “Billing and coding changes occur those costing more than $65 will confrom year to year. If you don’t keep up, tinue to be paid separately. Separately this can affect your bottom line,” billed drugs are reimbursed at the averD’Amato said. age sales price plus 4%. Consultation code changes took effect January 1, 2010. The Centers for Physician Quality Reporting Initiative The voluntary Physician Quality Medicare & Medicaid Services (CMS) eliminated the use of all consultation Reporting Initiative (PQRI) will give codes for various places of service incentive payments to eligible profesexcept for telehealth consultation G- sionals who satisfactorily report data on codes. In place of the consultation quality measures for covered professioncodes, CMS increased the relative value al services furnished to Medicare Part B units (RVUs) for new and established fee-for-service beneficiaries. In 2010, an office visits, increased the work RVUs oncology staging measure was added. “With electronic medical records, for initial hospital and initial nursing facility visits, and incorporated the this is fairly easy to carry out,” he said. increased use of these visits into the “Our group does four or five measures, practice expense and malpractice calcu- submits them to CMS electronically, and we hope to receive payment.” lations, he said. “Private payers, however, may still Payment for 2009 participation is pay for established consultation codes. scheduled for the fall of 2010. This presents a challenge for billing office staff. You must keep track,” he Contracts with payers: get involved Practices should have a pharmacist said. “We ask our physicians to code as they always have, and our billing office team member involved in the financial edits the codes depending on the payer side of oncology. Participation by oncolallowances.” His group is in the process ogy pharmacists in this aspect of care of determining the financial repercus- is becoming increasingly important, D’Amato told attendees. Institutions sions of these code changes. should have contracting teams to idenOther changes in reimbursement tify issues pertinent to new contracts or Changes in RVUs, which are used for contracts coming up for renewal. calculating physician reimbursement for Pharmacists should participate in these work performed, are being gradually discussions as they bring many skills to implemented. For 2010, CMS will im- the negotiating table. plement work, practice, and malpractice Private payers are looking to control RVU reductions that will redistribute costs and spending through the use of payments under the fee schedule. The specialty pharmacies (see article on

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Table. Financial Opportunities within Managed Care Organizations Know the current reimbursement landscape Compare contracts Develop cost-effective formularies Develop or incorporate clinical pathways that consider cost-effectiveness Participate in contracting and with carve-out companies that can benefit both payer and provider Implement effective precertification processes that reduce or eliminate risk page 24), preauthorizations, and other mechanisms. Such maneuvers result in reduced reimbursements and increased administrative burdens on oncology practices. In addition, payer requirements may slow patients’ access to care because treatments cannot begin until authorizations are received and because of the additional administrative burden of managing denials, D’Amato said. E-prescribing incentive program Participation in the PQRI is not a prerequisite for participating in CMS’ Electronic Prescribing Incentive Program in 2010. “The program requirements have been simplified, with a minimum of just 25 encounters for patients you have e-prescribed and for whom you utilized the G8443 code,” he said. CMS has expanded the reporting mechanism to be claims-based, registrybased, and electronic health records– based.

In 2008, new cancer cases numbered 1.437 million. Caring for these patients totaled $93 billion in direct costs and $228 billion overall, after secondary costs and comorbidities were considered. MCOs also are concerned about the cost of novel and new agents, especially oral oncolytics, and the evolving paradigm of cancer as a chronic disease. Other challenges for MCOs are the changing reimbursement model and new mandates to measure quality and performance. “When you contract with MCOs, be creative,” D’Amato told oncology pharmacists. “For example, for antiemetics you could agree to use a less expensive agent but ask to be paid more to offset what you would make instead, if using the more expensive agent. There are many opportunities to enhance reimbursement and reduce costs within MCOs” (Table). Unfortunately, the future will be rife

Private payers are looking to control costs and spending through the use of specialty pharmacies, preauthorizations, and other mechanisms. Such maneuvers result in reduced reimbursements and increased administrative burdens on oncology practices. “With the 2% PQRI incentive and the 2% e-prescribing incentive, providers have the opportunity for a 4% increase in Medicare reimbursement,” he noted. By 2010, CMS will begin penalizing professionals who are not e-prescribers, reducing payments by 1%, then by 1.5% in 2013, and by 2% in 2014. Managed care organizations Managed care organizations (MCOs) and programs are intended to reduce unnecessary healthcare costs through a variety of mechanisms. Medical oncology has become a new priority for MCOs, based on the rise in cancer incidence and cost of care.

with other worries, D’Amato predicted. There will be issues related to random audits from payers, for which clinics receive no payment; recovery audit contractor reviews, which aim to identify potential overpayments and underpayments made to providers and are required in all states; coding compliance by physicians; the rise in underinsured and uninsured patients who need assistance in accessing care; the demand for risk evaluation and mitigation strategies; budget and staffing shortages; and competition by specialty pharmacies. “As a profession,” D’Amato concluded, “oncology pharmacists have a lot to deal with in addition to their primary responsibility, which is patient care.” l

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Coding and Billing Oncology Drug Coding... Continued from page 11 more definitive method of coding. CMS offers a crosswalk from ICD-9-CM codes to the various ICD-10-CM codes. The best way that a practice can prepare is to keep track of what CMS is doing. Also, I believe there is a database on the CMS website. Practices that focus on a specific cancer or cancers should start studying those code conversions from ICD-9-CM to ICD-10-CM. 2013 (the year the new codes go into affect) isn’t that far away. Oncology practices should be familiarizing themselves with the oncology codes. How did they break down, for example, breast cancer? As I remember, there may be five or six ICD-9-CM codes for breast cancer now, but with the ICD-10-CM codes, I think there are almost 20. That makes it a more finite coding system. All this is being done basically to track patients. It sounds like it requires a specialized staff member to keep up-to-date on all the latest coding changes. JA: I couldn’t agree more. Oncology practices need to have a department with someone who learns not only the proper coding for a CMS 1500 claim form but also the rules and requirements of the various payers that the oncology practice has contracted with. There are nuances within them all. Are there any other recent developments that will affect payment by private payers? JA: Today, each oncology practice needs to work with its payers very closely when it comes to contract negotiations and explain how it provides patient care. Don’t always be overly concerned about the cost of the drugs the practice is dispensing and using in the office. Add to the drug costs all the other costs incurred for the services the practice renders to patients. Those costs, sometimes, are neglected. If a practice advises a payer how it takes care of patients, I think the cost structure would be more in line with the complete service provided. Practices tend to concentrate on the drug because it is a tangible item for which the practice needs to get appropriate reimbursement. This is true and fair, but the practice also needs to get appropriate reimbursement on the services rendered to the patients. Even if it’s just an intramuscular injection or having intravenous therapy, a nurse has to spend time with the patient. All these services need to be broken down and explained to the payer, because an understanding of these steps could affect how the practice gets reimbursed by the payer. The more the payer knows, the better it is for a practice to

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expand its payment rates. Will there be any aspect of the healthcare reform act that will affect coding in the oncology office? JA: I think there are aspects of the bill that are going to affect coding in

every doctor’s office. The pressure is going to be on for them to see more patients and do more with less staff, but more important, I think coding for oncology care will be more closely scrutinized as more and more patients are seen in oncology offices. So practices

will need to be very well versed on the rules. And a point I can’t stress enough is that oncology practices should have, must have, staff who can properly bill according to the rules set down by the various contracts that the office has with its various payers. l

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

www.amgenassist.com 1-800-272-9376

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.

MAY 2010 I VOL 3, NO 3

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

Medications Used for the Treatment of Melanoma (Skin Cancer) The following sections include: • Associated ICD-9-CM codes used for the classification of melanoma • Drugs that have been FDA-approved in the treatment of melanoma. Please note: if a check mark appears in the FDA column it will NOT appear in the off-label use column • 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

aldesleukin (Proleukin) bacillus Calmette-Guerin (Tice BCG) carboplatin (Paraplatin) cisplatin (Platinol AQ) cisplatin (Platinol AQ)

J9015: injection, aldesleukin, per single-use vial J9031: bCG (intravesical), per installation J9045: injection, carboplatin, 50 mg J9060: cisplatin, powder or solution, per 10 mg J9062: cisplatin, 50 mg

MAY 2010 I VOL 3, NO 3

Associated ICD-9-CM Codes Used for Melanoma 172 Malignant melanoma of skin Includes: melanocarcinoma melanoma (skin) not otherwise specified >melanoma in situ of skin< Excludes: skin of genital organs (184.0-184.9, 187.1-187.9) sites other than skin-code to malignant neoplasm of the site 172.0 Lip Excludes: vermilion border of lip (140.0-140.1, 140.9) 172.1 Eyelid, including canthus 172.2 Ear and external auditory canal Auricle (ear) Auricular canal, external External [acoustic] meatus Pinna 172.3 Other and unspecified parts of the face Cheek (external) Chin Eyebrow Forehead Nose, external Temple 172.4 Scalp and neck 172.5 Trunk, except scrotum Axilla Perianal skin Breast Perineum Buttock Umbilicus Groin Excludes: anal canal (154.2) anus not otherwise specified (154.3) scrotum (187.7) 172.6 Upper limb, including shoulder Arm Forearm Finger Hand 172.7 Lower limb, including hip Ankle Leg Foot Popliteal area Heel Thigh Knee Toe 172.8 Other specified sites of skin Malignant melanoma of contiguous or overlapping sites of skin whose point of origin cannot be determined 172.9 Melanoma of skin, site unspecified

FDAapproved for melanoma

Off-label uses for melanoma

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

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

CPT administration codes

$1,092.34

$844.43

96409

✓

$169.10

$114.37

51720

✓

$48.55

$5.31

96409, 96413, 96415

✓

$4.33

$1.98

96409, 96413, 96415

✓

$21.66

$9.91

96409, 96413, 96415

✓

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

FDAapproved for melanoma

Off-label uses for melanoma

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

dacarbazine

J9130: dacarbazine, 100 mg J9140: dacarbazine, 200 mg J3490a: unclassified drugs

✓

$11.34

$3.73

96409, 96413

✓

$22.21

$7.37

96409, 96413

J9214: injection, interferon, alfa-2b, recombinant, 1 million units J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified S0176: hydroxyurea, oral, 500 mg

✓

NDC level pricing $21.90

NDC level pricing $15.84

NDC level pricing $1.28

NDC level pricing S0176: not payable by Medicare $1,500.32

96409, 96413 96413, 96415

dacarbazine imiquimod (Aldara) interferon alfa-2b (Intron-A) hydroxyurea (Hydrea) hydroxyurea (Hydrea) melphalan (Alkeran) paclitaxel (Taxol) peginterferon alpha-2b (Peg-Intron)

J9245: injection, melphalan hydrochloride, 50 mg J9265: injection, paclitaxel, 30 mg J3590a: unclassified biologics

peginterferon alpha-2b S0146: injection, (Peg-Intron) pegylated interferon alfa-2b, 10 mcg per 0.5 mL (code price is per 10 mcg) temozolomide J8700: temozolomide, (Temodar) oral, 5 mg vinBLAStine J9360: injection, vinblastine sulfate, 1 mg

✓

N/A

96372, 96401

N/A

✓

$1,922.50

✓

$17.70

$11.46

✓

NDC level pricing $110.68

NDC level pricing S0146: not payable by Medicare

✓

$10.65

$8.83

N/A

✓

$3.18

$1.02

96409

96372

When billing a nonclassified medication using a CMS 1500 claim form you must include both the HCPCS code (ie, J3590 for Peg-Intron) in Column 24D and the drug name, strength, and National Drug Code (NDC) in Box 19 in order to ensure appropriate reimbursement. References HCPCS Level II Expert 2010 • Current Procedural Terminology (CPT) 2010 • ICD-9-CM for Professionals Volumes 1 & 2 2010 • The Drug Reimbursement Coding and Pricing Guide by RJ Health Systems International, LLC, Volume 7, Number 2, 2nd Quarter 2010 • FDA-approved indication (from product’s prescribing information) • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Wethersfield, Connecticut • CMS (Centers for Medicare and Medicaid Services)—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.

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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MAY 2010 I VOL 3, NO 3

Clinical Pathways

Pathways as a Model for Cancer Care Management By Kathy Lokay President, Via Oncology, Pittsburgh, Pennsylvania

o date, healthcare reform efforts have focused mainly on insurance reform, not actual healthcare reform. This initial focus is understandable for many good and obvious reasons, but fails to address the larger issues of healthcare quality and its unaffordable cost trend. Kathy Lokay These questions are far more difficult and complex, and solutions must be found for the country to afford the expansion of access achieved in the new reform law. Although this article does not present the entire answer, it does discuss one model of cancer care management that solves some of the seemingly intractable cost and quality issues. It is important to note that the costs of cancer and its related side effects make up a sizable amount of healthcare spending. With all associated costs factored in, it is estimated that the costs of cancer care will soon reach $300 billion. This expenditure is primarily generated by a comparatively small—but rapidly growing—number of patients: the aging baby boom population. In addition, new oncology drugs are coming to market at a pace that is three times that of the overall pharmaceutical market. Most come with exorbitant price tags but not always clear superiority to existing treatments. Finally, the dynamic between payers and oncology practices is changing. The emerging payment structures oncologists are facing make it imperative to step up and lead with solutions rather than have untenable controls forced upon them and their patients. Historically, payers tended to manage cancer costs with a very light hand due to the emotional nature of the disease. This approach is now ending in many markets. Payers can no longer afford to ignore 5% to 10% of their medical claims and are willing to be more assertive in applying cost-management tools. However, traditional tools, such as disease management and utilization management, are not likely to be successful for a number of reasons. Among the most notable are the intense nature of the oncologist–patient relationship, the ever-increasing complexity of the disease and associated treatments, and the almost weekly adjustments to a typical patient’s care plan for the management of toxicities. Other “tools,” such as outsourcing drugs to specialty pharmacy organizations, creating infusion centers, or reducing

MAY 2010 I VOL 3, NO 3

reimbursement, penalize oncology practices but have little impact on the underlying consumption of resources. In addition, efforts to use benefit design to increase coinsurance of or steer members from certain therapies put an undue burden on patients’ already difficult decision-making process. Today, a relatively small but increasing number of oncologists around the country are working on solutions. The University of Pittsburgh Medical Center (UPMC) Cancer Centers, a network of 38 sites of service

rence with these identified best practices and reports back to each physician with comparisons to network results. UPMC Cancer Centers has enjoyed the support of payers in western Pennsylvania in this effort. Thus far, this program has shown positive results by way of high adherence to the pathways, a trend toward fewer hospitalizations for patients, and containment of the rise in cost of care year over year. The web-based tool enables UPMC to extend the pathways program under a newly formed business unit, Via Oncology, to other forward-thinking oncology practices. Physicians and insurers across the

These best treatments are based on reviewing the literature—first for the most effective, second for the least toxic, and finally (all other things being equal) for the least costly care. in western Pennsylvania, is one of the leaders. In seeking to improve quality and outcomes for patients and increase efficiency of healthcare resources for payers, UPMC Cancer Centers decided that it needed a way to drive to the best evidence-based care, standardized over its network in a measurable way. The organization believed that the method should ensure the use of personalized medicine where the evidence warrants and avoid unnecessary treatments and uninformed decisions. Starting in 2005, UPMC Cancer Centers has developed and maintained algorithms, called pathways, for clinical decision-making that their 120-plus oncologists now use to determine the best treatment for any given site and stage of cancer. This effort has been painstaking and has involved the mutual cooperation of academic and clinical experts at UPMC. Through their collaborative work, they have defined a single best treatment for the vast majority of clinical scenarios in oncology care. These best treatments are based on reviewing the literature—first for the most effective, second for the least toxic, and finally (all other things being equal) for the least costly care. Concurrent with these clinical efforts, UPMC Cancer Centers developed a web-based software application, the Pathways Portal, for the delivery of best practice pathways in a clinical decision tool for physicians at the point of care in a format that is personalized to each patient. UPMC Cancer Centers regularly measures physicians’ concur-

country can work together to adopt such systems and to develop equally innovative programs to provide good, cost-effective care. However, the kind

of change required is difficult and timeconsuming and requires collaborative funding and changing the paradigm of physician–payer relationships. That is a tall order. It requires commercial payers to recognize that external controls on physician practice cannot be as effective as changes in the patient care process within oncology practices. Progress depends on commitment from both parties to move from prevailing provider payment policies to value-based reimbursement, including sharing cost-savings between payers and providers. It will require the federal government and Centers for Medicare & Medicaid Services to fund the correct types of demonstration projects, directing resources to programs capable of the development of practical and effective approaches to reducing variability through the adoption of evidence-based best practices. No easy solution exists to the quality and cost issues in healthcare. There will not be just one solution, but with collaboration between providers and those that pay for healthcare, the best solutions can be found. Pathways in cancer care are a model for a place to start. l

FDA Updates Infusion Pump Improvement Initiative The US Food and Drug Administration’s (FDA) Infusion Pump Improvement Initiative seeks to address infusion pump safety problems through comprehensive actions. Establish additional requirements for infusion pump manufacturers. The FDA has issued a total product life cycle draft guidance document for infusion pump manufacturers. Once finalized, manufacturers will be required to include additional design and engineering information as part of their premarket submissions and conduct additional testing of their devices. Facilitate device improvements. To address one of the most commonly reported problems, the FDA is using its in-house expertise to help prevent malfunctions in infusion pump software. In addition, it is actively working with manufacturers, members of the academic community, and others to address identified infusion pump problems.

Increase user awareness. The FDA will also launch a new infusion pump website, which will feature basic information about infusion pumps and commonly seen problems, as well as actions that could help prevent safety problems. Approval Process for Radiotherapy Equipment Strengthened To reduce the number of underdoses, overdoses, and misaligned exposures from therapeutic radiation, the FDA sent a letter to manufacturers explaining new safeguards to mitigate current risks, including use errors, and reduce future risks. The letter encourages manufacturers to attend a public workshop that will cover new safeguards and other special controls to improve safety, possible changes in premarket device testing to provide appropriate assurances of safety and effectiveness, particularly for software, and premarket review of all modifications to software. l

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ch la m Patients edicine, on anges for all w gists,” sa co id o ance m newly covered logy includ f corporate Matt Brow, vice ed eans b by priv . men co et new in t relati mmunicatio president of itiatives ter reimburs ate insurons, an ns, go withou Oncolo ement form th to drive d vernp t u gy an b e li . who w insurance, incl and pai way oncology value may tran d a reduct “If you were c policy at U ill u ion in concern S d for in sca re the elig come onto th ding 16 milli averted is deliv reimbu ed Patient th ab e on o e ib rs ered ; lon u P that did if you looked ement, that w t 133% of ility for whic Medicaid roll Act do rotection an g run. Yet, th s, for imp n’t hap as d Afford th h is ra es not e e federal flood o rovemen p address is en pressin ab P ed re le ei p f si th to over Care new d g issu man t, go healthca ent Barack er.” od new privately in ty line. The “There es for oncolo y of the most su s re O re for reim b reform gy. d patie was part by and th that im into la ama signed burs nts e pacts re no significan individ public subsid ements, paid is legislat Senate passe w on March imburs ual ies in io 2 ement t change extend n 2 days late d reconciliat 3 400% of s and familie available fo for onco ion s co th r TREN r. lo- li “The p e poverty lev making up to on to verage to an es The law wil DS O el. riv 34 mil l to F REF lion pat timated 30 m be bigge ate aspect is ORM il ac ie r, n tu ” annual ts curr discuss accordin ally go ROUN ently ed in n DTAB ciation the legislat g to Brow, w g before th ational mee LE ion at ti h of Com the Ass o increasin e House vo ng, just day m u n it y te A Rou g s o- fo Cancer r you, th a poorly payin . “Instead o ndtable Centers f is g bu b ill will Discus Mark J increase siness line sion w . a Medic Krasna, MD w it ell-pay h al Dire Continue COD ctor, S d on pa ING A t. Jose ge 10 Ronald ND B ph Can cer Inst IL US On Barkley, MS L IN itute; E G cology; ,J ditor-in Cofou D -Chief, nder, C Micha Journa e ancer Center l of Mu Partne l L. Blau, JD r and C ltidiscip Busine hair, He ss Sum linary C alth Car mit Jessic ancer e Ventu a Care re Prac Senior Turgon tice, Fo Manag An Inte ley & L er, ECG ardner RPh, F rview with Jo Manag LLP; C ASCP hn F. A ement ofound forism Consu ith fe e r, o, BSc C lt B an ants, In deral y Kare cer Ce Pharm c n Rose hea nter Bu reform , nberg siness enacted lthcare fi Summ nd new and th commu cost of ca it e pat w re esca nity o ay s to ients’ lating, ncologi lenged co ex v he esse er thei penses st n operatin n r 20 and date on ot only to re s are chalg proper tial element 10. A m clinical editor-in costs. In th their own of co research ain up-tois charged lthough this is ers will ding. Withou full reimburs cal onco -chief Mark K discussion, but also ar a emen n t th th ot politi e drugs rasn logi the pra ea, our pan to co and serv compensate o e proper codes t is el focu cally ctical as mmunit st, asks the ex a, a surgio f ncology p , payic at se es they the hig ient ca y pract p p ra hest qu pects of del s on re p ices ca erts what ro ctic . It ing is ab vid ivering ality of n expec Mark out mo is important to e during the es for care. t in in K re co v ra re o Clinica urse sna (M than lves mem K): B nosis co all the aspec just the dru ber that cod esides Pathwa l Pathway ts gs d Continue ys adminis es, drug cod of treating a used; codin d on pa Cancer as a Model fo s es tr p , ge at at p ie iv ro 6 nt—dia g e codes cedure r Manage Journal gco . ment Electro ! Aforism of Multidiscipl In an interv des, and even ! in o ! Record nic Health founder , BSc Pharm ary Cancer iew with th e , RPh, C o f R Confe J Oncology H es on- an FASCP, are, John F. ealth S Diagnos rence New bers, an d off-label use ystems Intern chairman an Road Les EHR: Taking page 2 ti d ational s , c d the th s Travele Im th e ro 0 a e and Rei , discuss gi le of var Classifica upcom d ! in mbursem ng: Use io ! Clinical tion of Disease g switch to us staff mem ent ! Internat M s, 10th 10-CM odification (I ional R ! ev is io C ) n, page 1 edge of codes. His kn D2 ow th view w e payers’ poin lt of ill help ©2010 p a Green m g ake th practic e 14 Hill Hea lthcare billing. e most of th es Comm eir unicat

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Multidisciplinary Models

Multidisciplinary Cancer Programs—The Emerging Standard By Christopher T. Collins, MHA Principal, ECG Management Consultants, Inc, Boston, Massachusetts

ven with the very best cancer, and most recently, nizational structure of the center, nated care for cancer, more so than technology, facilities, neurosciences. Although including hospital/physician relationany other service-line. location, physician academic medical centers ships. Despite the challenges, below are • As hospitals recapitalize their cancer relationships, clinical supwere historically in a class examples of some of the more contemfacilities, most designs are calling for port staff, and high quality of their own in terms of porary drivers that are forcing most cana full suite of services under one roof marks, your cancer center developing and emphasiz- cer centers to actively pursue or at least (at least for the main facility), which may still fall far short of ing multidisciplinary mod- explore a more coordinated approach to often leads to new considerations for reaching its potential in the els, all bets are off as well- cancer care. work flow and coordination of care long run if your patients’ established and successful • The renewed openness of hospitals across several disciplines (ideally in treatment planning and models can be found in a and physicians to discuss opportunithe reverse order). therapy is not provided Christopher T. Collins, MHA wide variety of nonacademties for alignment to varying degrees • A surge in joint ventures between through a multidisciplinary ic community-based cancer has led to more open dialogue relathospitals and physicians for lucrative team approach. In fact, the notion of centers. For more than 15 years, many ed to collaborative, multidiscipliradiation oncology programs has “cancer center” may be reduced to studies have resulted in convincing nary approaches to care, with cancer reinforced the need to align with bricks and mortar and branding if the evidence that the multidisciplinary often topping the list. medical oncologists and others to name does not represent a particular approach has improved the care of can• A renewed focus on quality and new secure the referral base and provide standard and coordination of care. In cer patients by reducing variations in pressures to demonstrate this to conmore coordinated care throughout 2006, a Kaiser Family Foundation/ treatment, facilitating clinical trials, sumers has forced hospitals and treatment. Harvard School of Public Health poll and improving coordination of specialty physicians to rethink their ability to • Accreditation bodies such as the Comfound that half of cancer patients and care. So why is this not yet the norm? measure, collaboratively study, and mission on Cancer require the detheir households have problems coordi- Implementing and sustaining a multiimprove cancer treatment outcomes. monstration of multidisciplinary nating care, and it includes a discourag- disciplinary approach to care can be • A new generation of more informed programs. ing statistic that one in four patients extremely challenging depending on patients and their primary care • Declaration that the cancer program received conflicting information from several factors, including the size and physicians are increasingly demandis a “Center of Excellence” is no their physicians. The centers and pro- scope of the cancer program, competiing premier services, which include longer sufficient—patients are seekgrams that adopt a multidisciplinary tive landscape of the market, and orgaimmediate access and well-coordiContinued on page 24 approach to care will ultimately prevail in this era where patients know and Strategies and Approaches to a Multidisciplinary Cancer Center Model demand more. That said, with few arguing with the benefits of the multidisciPotential Enablers to Migrating to a Multidisciplinary Model Setting/Situation plinary model, cancer centers currently • Redesign medical directorship agreements to include incentives for multidisciplinary Hospital-based cancer fall into one of three groups: (1) those program development in coordination with service-line executives center of 400-bed commuthat have a fully integrated, multidisci• Use facility planning process to bring leadership of private practices together to explore nity hospital supported by plinary model; (2) those that have immore collaborative care delivery models multiple private practices plemented a more team-based approach • Consider beginning with the development of a multidisciplinary approach for high-profile at a program level and desire to roll it programs such as breast cancer through co-location of services and implementation of a out across the service-line; and (3) navigator those that recognize the value of the • Spend the money, time, and effort necessary to ensure a seasoned senior administrator is model to the patient and institution in place for the oncology service-line, with a focus on the development of multidisciplinary and have a vision, but struggle with clinics in partnership with private practices how to get it off the ground. • Leverage empirical market-based data to demonstrate to physicians the value of improving the coordination of care to the benefit of patients and stature of the cancer center Impetus for change • Establish a legitimate cancer center board or council chaired by a cancer center director Cancer center owned by The concept of multidisciplinary prowith oversight of the development fund and central charge of developing a patient-centric, integrated academic grams is not new—it dates back to the multidisciplinary model across participating departments/divisions medical center in highly late 1950s when physicians found bene• Consolidate the clinical support staffing model of a cancer center and redesign funds flow competitive market with fits to patients if care was better coordiso all respective departments have a vested interest in the center (ie, use financials as a high degree of autonomy nated across several specialties or means to force departments to put the interests of the center first) among clinical departdepartments (originally known as • Embrace and emphasize teaching and translational research associated with cancer ments/divisions “affinity groups”). In oncology, the centers to broaden the meaning of a multidisciplinary center application of this concept was most • Allow for the cancer center director to play an active role in setting the faculty incentive publicly credited to Drs Henry Kaplan components, with strong linkages to coordination of patient care and research and Saul Rosenberg at Stanford University in the 1960s. At its very Limited cancer program at • Leverage existing outpatient treatment services such as radiation oncology and core, the model is designed to foster chemotherapy and explore affiliation with larger systems to provide access to other a small, rural community greater interdisciplinary interaction to hospital with little competi- services through a multidisciplinary model optimize care and improve outcomes. tion but competitive threats • Help facilitate the development of more collaborative relationships among the physicians Multidisciplinary centers have appeared affiliated with the cancer program through tumor board meetings and other forums that looming in many shapes and sizes over the years focus on outcomes and improving quality and service in different settings nationally, but seem • Engage physicians through the use of standard market-based reports to study outmigrato be emerging or reemerging in a more tion trends and other indicators that may underscore the need for better coordination of integrated form over the past 5 years or care among providers locally so in the service-lines of cardiovascular,

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Specialty Pharmacy

The NCCN Task Force on Specialty Pharmacy Issues Preliminary Report By Audrey Andrews

Hollywood, FL—As specialty pharmacy (SP) expands rapidly into oncology, there is a need to better define its role. This was the aim of the National Comprehensive Cancer Network (NCCN) Task Force on Specialty Pharmacy, whose chair presented the group’s preliminary report at the NCCN 15th Annual Conference. “There is a vibrant specialty pharmacy industry, and the impact in cancer care is expanding,” said Rowena N. Schwartz, PharmD, BCOP, director of oncology pharmacy, Johns Hopkins Hospital in Baltimore, Maryland. Much of the interest in SP comes from the evolving role of oral antineoplastic agents. Of the 400 new antineoplastic agents in the pipeline, 25% are planned as oral drugs, and spending on oral agents has more than doubled since 2002 (J Natl Compr Canc Netw. 2008;6 [Suppl 3]:S1-S14). Specialty pharmacists may prove to be a valuable source of information on using these new medications safely, effectively, and economically, according to Schwartz. The task force explored aspects of SP that are unique to oncology and presented recommendations for joining SP and oncology. In particular, the task force addressed the mechanisms and potential benefits of SP as a distribution channel for oncology therapeutics. It identified opportunities as well for disease state management, cost of care, clinical research, and safety. “The task force wanted to demonstrate that there are opportunities to optimize cancer care by partnering with specialty pharmacy,” she said. “We wanted to show how specialty pharmacy is cost-saving and offers value to third-party payers.” Defining specialty pharmacy The task force defined SP as a pharmacy service model designed to fill the

perceived gaps in pharmaceutical care associated with traditional community pharmacy practices. In oncology, the scope of the practice includes the oral antineoplastic agents and supportive care medications, such as erythropoiesis stimulating agents. Health maintenance and management of comorbidities is also part of SP. The current operational models include limited-distribution medications, infusion services, mail order, and distribution of medication via the community pharmacy network. SP serves as a “hub” between prescribers, the drug manufacturer, and the patient, Schwartz explained. Within this hub is a patient/provider registry, verification of insurance coverage, and monitoring of treatment adherence and side effects. SP can also be involved in outcomes assessment, which is a growing need in the current environment. Advances in patient care “Patients are increasingly expected to share more of the cost burden of the oral antineoplastics,” she observed. There are high copays, tiered coverage, and the infamous “doughnut hole” as well as hidden costs, such as changes in medication that lead to medication waste. “Specialty pharmacy offers costfriendly strategies to reduce costs to patients,” according to Schwartz. SP also enhances medication safety through product familiarity, product availability and access, individualized monitoring, data tracking, and hazardous waste disposal. Additionally, patients in clinical trials can have timely drug access, coordination of care (ie, modification of dose), and coordination of information through SP, the task force pointed out. But coordination of cancer care is perhaps the most important concern of SP. “We need to find out how specialty

pharmacy can impact positively on cancer care,” Schwartz said, “and not fragment care or confuse patients about the care they receive.” Optimal coordination of care will include not only authorization and drug distribution but also patient education, treatment monitoring, and disease management. This expanded responsibility for oncology pharmacists highlights the need for team collaboration and a change in mindset about the role of pharmacy. The specialty pharmacist’s unique training can be an asset to patients and oncologists alike, she pointed out. “One of the great things about specialty pharmacy is you are often work-

ing with pharmacists who are very knowledgeable about the products they are dealing with and therefore have a lot of information for patients and their families,” Schwartz explained. One area the task force did not tackle, however, were drug costs and economic concerns—maintaining these issues are too broad and complex for its mission. However, the group did recommend that an alternative financial model for pharmacy reimbursement be designed—one that will “get away from selling a product to providing services of value,” Schwartz explained, and that inefficiencies associated with increased cost be identified and eliminated. l

Preliminary Recommendations by the NCCN Task Force on Specialty Pharmacy • Specialty pharmacy personnel should be “trained” in oncology. • Optimal coordination of care for patients and their families should be the priority. • Communication among all members of the oncology team involved in drug therapy decision-making should be standardized, using a common language. • Strategies should be created to assure coordination of care for patients treated in multiple healthcare settings. • Health information technology systems (ie, electronic health records) should be developed and used to foster collaborative care. • Shared-data needs (ie, for integration of case management, insurance coverage, clinical information and outcomes) should be identified and national standards established. • Standards and requirements for care coordination and medication safety should be developed. • Operational processes that support frequent changes of treatment should be established (eg, allowing dispensing of smaller amounts of medication at one time). • Regulations should be implemented for dispensing and handling of oral chemotherapy. • The use of “brown bagging” (ie, purchases made at one place but administered in another) for chemotherapy, antineoplastic agents, and supportive care medications should be eliminated.

Multidisciplinary Cancer Programs... Continued from page 22 ing evidence of true patient-centric, multidisciplinary care. One Size Does Not Fit All There is no universal definition or set of protocols to follow to successfully implement a multidisciplinary approach to cancer treatment. The level of coordinated care can vary significantly from one cancer center to the next, as well as the required resources and timeline to

MAY 2010 I VOL 3, NO 3

implement. Whereas a navigator may lead patients seamlessly through their planning and treatment of breast cancer at one organization, the structure and physician relations in another market may bring challenges to implementing this service at a similar program elsewhere. Moreover, the task of getting physician buy-in and “selling” the tangible and intangible benefits of migrating to a more team-oriented approach

to senior executives can be challenging at many organizations today. Where to begin? In essence, the organization needs to find a way to bring physicians to the table, demonstrate the “why” (ie, mutual benefit of progressively migrating to a multidisciplinary approach), and work through a collaborative process of adopting a team approach one program at a time. Naturally, the ability to do so will greatly depend on a

number of factors, including the type, size, and setting of the cancer center. The table offers some general strategies and approaches to consider relative to migrating to a multidisciplinary cancer center model. l This article was originally published in The ACE Report. Reprinted with permission from the Association of Cancer Executives.

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The Essential Role of Immunotherapy in Follicular Lymphoma Management LOG ON TODAY TO PARTICIPATE www.coexm.com/ace03.asp Release Date: March 19, 2010 Expiration Date: March 18, 2011

TARGET AUDIENCE This activity is intended for hematologists, oncologists and other healthcare professionals who are involved with the care of patients with follicular lymphoma.

STATEMENT OF NEED Non-Hodgkin's lymphoma (NHL), the most common hematologic malignancy, represents a large proportion of the case load for the typical oncology practitioner. That load is likely to grow, since NHL is increasing in prevalence. The introduction of rituximab, the monoclonal antibody against CD20, changed the treatment landscape of lymphoma and it has been advanced further by immunotherapies that combine CD20-directed targeting with radiotherapy. The recent rapid advances in therapeutics and impressive research across this broad, heterogeneous group of malignancies represent an educational challenge for the clinician trying to stay current and provide the most appropriate, up-to-date therapy tailored for the individual patient. Immunotherapy plays a key role at all stages of the disease in reaching the goal of the highest quality response.

EDUCATIONAL OBJECTIVES On completion of this activity, participants should be able to: • Define the goals of therapy for follicular lymphoma (FL) • Describe strategies for patient selection for immunotherapy (including radioimmunotherapy [RIT]), in both the up-front and relapsed/refractory setting • Define different immunotherapy approaches in terms of efficacy, safety, and tolerability • Propose strategies to overcome adverse events and access issues that create barriers to the provision of optimal immunotherapy in FL

FACULTY Stephanie A. Gregory, MD Professor of Medicine Director, Section of Hematology Rush University Medical Center Chicago, Illinois

David Maloney, MD, PhD Associate Professor of Medicine Division of Oncology University of Washington Member Fred Hutchinson Cancer Research Center Seattle, Washington

With commentary by: Peter S. Conti, MD, PhD Professor Nuclear Medicine Keck School of Medicine University of Southern California Los Angeles, California

This activity is supported by an educational grant from Spectrum Pharmaceuticals.

This activity has been approved for 1.0 AMA PRA Category 1 Credits™. For further information and to participate, please go to: www.coexm.com/ace03.asp

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