Oncology Practice Management by The Lynx Group

ONCOLOGY PRACTICE

MANAGEMENT

™

FOR ONCOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS™

www.OncPracticeManagement.com

Practice Consolidation and Growth Improve Outcomes By Meg Barbor, MPH

How to Prepare for MACRA: ASCO’s Tips for Oncologists By Chase Doyle

Robin T. Zon, MD,

FACP, FASCO he Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) permanently eliminates the sustainable growth rate formula and provides annual payment adjustments through 2019. Although this law may ultimately stabilize Medicare physician reimbursement, oncologists are currently working to prepare for this long-term transition.

Continued on page 15

Liquid Biopsies Show High Correlation with Tissue Biopsy for Genetic Mutations Brad A. Prechtl, MBA

he growth of Florida Cancer Specialists (FCS) has brought together hundreds of physicians, with the ultimate goal of enhancing patient care, said Brad A. Prechtl, MBA, Chief Executive Officer at the 2016 Community Oncology Alliance conference. Continued on page 10

By Wayne Kuznar

Philip C. Mack, PhD

ith the exception of resistance mutations, somatic alterations in circulating tumor (ct) DNA (ie, a liquid biopsy) are consistent with alterations found in tissue biopsies of patients with advanced solid tumors, said Philip C. Mack, PhD, Director of Molecular Pharmacology, University of California Davis Comprehensive Cancer Center, Sacramento, at the 2016 American Society of Clinical Oncology (ASCO) annual meeting. Continued on page 31

From the publishers of

O r C fo i n s U G d e s e d .. 4 0 DR Co s U ..... . 10 n t o n ... rr e ati ia.. DIC Cu ic m ed e M euk L

EDITORIAL ADVISORY BOARD EDITOR-IN-CHIEF Dawn Holcombe, MBA, FACMPE, ACHE President DGH Consulting South Windsor, CT

Carla Balch CEO Altos Solutions, a Division of Flatiron Health, Inc New York, NY

Bonnie J. Miller, RN, BSN, OCN, FAAMA Administrative Director Women’s Cancer Center Fox Chase Cancer Center Philadelphia, PA

Peggy Barton, RN Practice Administrator Toledo Clinic Cancer Centers Toledo, OH

Karna W. Morrow, CPC, RCC, CCS-P, PCS Senior Consultant CSI Coding Strategies, Inc Powder Springs, GA

Risë Marie Cleland President Oplinc, Inc Portland, OR

Ricky Newton, CPA Treasurer and Director of Financial Services and Operations Community Oncology Alliance Director Cancer Specialists of Tidewater, Ltd Virginia Beach, VA

Teri U. Guidi, MBA, FAAMA President and CEO Oncology Management Consulting Group Pipersville, PA

Robert D. Orzechowski, MBA, SPHR, SHRM-SCP Chief Operating Officer Lancaster Cancer Center Lancaster, PA

Vicki Kennedy, LCSW Vice President Program Development & Delivery Cancer Support Community Washington, DC

Nancy G. Payne, CMPE Executive Director Space Coast Cancer Center Titusville, FL

Patricia Krueger, RPh Practice Administrator Oncology & Hematology Specialists, PA Denville, NJ

Michael J. Reff, RPh, MBA President National Community Oncology Dispensing Association

Mariana S-B Lamb, MS Executive Director Medical Oncology Association of Southern California Upland, CA

Sheryl A. Riley, RN, OCN, CMCN Director of Clinical Services SAI Systems Shelton, CT

ENGAGE

HEALTHCARE COMMUNICATIONS, LLC

Senior Vice President/Group Publisher Russell Hennessy rhennessy@the-lynx-group.com Publisher Cristopher Pires cpires@the-lynx-group.com Associate Publisher Zach Ceretelle zceretelle@the-lynx-group.com Senior Editorial Director Dalia Buffery dbuffery@the-lynx-group.com Senior Associate Editor Lilly Ostrovsky Associate Editor Lara J. Lorton Editorial Assistant Cara Guglielmon Production Manager Wayne Williams

ONCOLOGY PRACTICE

MANAGEMENT

FOR ONCOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS™

TABLE OF CONTENTS FROM THE EDITOR Summer Homework for Oncology: Successes and Failures in Oral Drugs Management.....................................................................8 By Dawn Holcombe, MBA, FACMPE, ACHE

President/CEO Brian Tyburski Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Senior Vice President/Group Publisher John W. Hennessy jhennessy2@the-lynx-group.com Senior Vice President, Sales & Marketing Philip Pawelko ppawelko@the-lynx-group.com Vice President, Finance Andrea Kelly Senior Financial Assistant Audrey LaBolle Director, Human Resources Jennine Leale Medical Director Julie Strain Director, Strategy & Program Development John Welz Editorial Director Susan Berry Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Design Managers Chris Alpino Lora LaRocca Director, Digital Marketing Samantha Weissman Digital Content Manager Anthony Trevean Digital Editor John Parkinson Digital Media Specialist Charles Easton IV Jr Digital Content Manager Walford Guillaume Junior Digital Developer Christina Bethencourt Sales Operations Manager Margaret Hoffmann Executive Administrative Assistant/Office Manager Dana Rivera Administrative Assistant Colette Puhalski IT Manager Kashif Javaid Office Coordinator Robert Sorensen

FEATURES Reimbursement

How to Prepare for MACRA: ASCO’s Tips for Oncologists..................1 ASCO Meeting Highlights

Liquid Biopsies Show High Correlation with Tissue Biopsy for Genetic Mutations....................................................................................1 COA Conference Highlights

Practice Consolidation and Growth Improve Outcomes..................1 Support Services Provide Some Relief from Financial Distress of Cancer Treatment, but More Is Needed........................................12 Survivorship Care

Integrating Survivorship Care in Oncology: A Conversation with Patricia Ganz, MD………………..……...........................................16 NCCN Guidelines Update

Updated NCCN Multiple Myeloma Guideline Expands Patient Eligibility and Therapeutic Options..........................................22 Continued on page 6

ASSOCIATION & CONGRESS DIVISION President Abigail Adair Account Group Supervisor Karie Gubbins Account Supervisors Alex Charles Deanna Martinez Senior Account Executives Jeremy Shannon Meg Spencer Business Development Advisor Saher Almaita

Association Director Patrice Melluso Meeting & Event Planner Linda Mezzacappa Senior Account Executive George Fuller Project Manager Rachael Baranoski Senior Project Coordinator Gretchen Dann Project Administrator Sara Mohamed

™

ONCOLOGY PRACTICE

MANAGEMENT

FOR ONCOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS™

TABLE OF CONTENTS FEATURES (Continued) ASCO Meeting Highlights

Aggressive End-Of-Life Care Still Offered to Younger, Non-Medicare Patients with Cancer...................................................32 Atezolizumab Could Be Start of “Seismic Shift” in Metastatic Bladder Cancer Therapy.......................................................................34 Alectinib May Be New First-Line Treatment for Patients with NSCLC and ALK Mutation......................................................................36 Three-Drug Regimen with Daratumumab a New Standard of Care for Relapsed or Refractory Multiple Myeloma.....................38

DEPARTMENTS Clinical Trials Tracker

Select Ongoing Trials Currently Enrolling Patients with Leukemia..................................................................................................19 Cancer Drug Coding

Medications Used for the Treatment of Leukemia and Their Associated ICD-10 Codes......................................................................40 By Kristin A. Esposito, CPhT

™

Oncology Practice Management™, ISSN 2164-4403 (print), is published 12 times a year by Engage Healthcare Communications, LLC, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. Copyright © 2016 by Engage Healthcare Communications, LLC. All rights reserved. Oncology Practice Management™ is a trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America. The ideas and opinions expressed in Oncology Practice Management™ do not necessarily reflect those of the Editorial Board, the Editors, or the Publisher. Publication of an advertisement or other product mentioned in Oncology Practice Management™ should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the Editors nor the Publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication. EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DIRECTOR, Oncology Practice Management, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. E-mail: editorial@oncpracticemanagement.com Telephone: 732-992-1892. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Engage Healthcare Communications, LLC, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. POSTMASTER: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Oncology Practice Management™, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. Fax: 732992-1881. YEARLY SUBSCRIPTION RATES: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

MISSION STATEMENT

Oncology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the high-quality care that patients with cancer deserve, providers must master the ever-changing business of oncology. Oncology Practice Management™ offers process solutions for members of the cancer care team—medical, surgical, and radiation oncologists, as well as executives, administrators, and coders/billers—to assist them in reimbursement, staffing, electronic health records, REMS, and compliance with state and federal regulations.

FROM THE EDITOR

Summer Homework for Oncology: Successes and Failures in Oral Drugs Management By Dawn Holcombe, MBA, FACMPE, ACHE, President, DGH Consulting, South Windsor, CT

ho can best manage patients with cancer who are receiving oral regimens? The prescribing physician? The prescribing physician with an in-house dispensing system? A specialty pharmacy, or a pharmacy benefits manager that is contracted by a health plan or a self-funded employer? This debate is not new and it resurfaces periodically in the form of a discussion on “brown bagging,” where drugs are delivered by a specialty pharmacy to patients for self-administration or are transported to their physician’s office for administration; or a discussion of “white bagging,” where a physician submits an order directly to a specialty pharmacy, and the drug is shipped to the physician for administration. Thoughtful reviews of the process of brown bagging have often led to general concerns regarding this alternative. The risks for patient nonadherence because of split doses, inconsistent adherence, overshipping, mistakes in drug handling related to temperature and stability are significant. White bagging is sometimes considered an alternative to the oncologist buying the drugs and only submitting a bill to the insurer once the treatment has been administered to the patient (known as the buy-andbill model). In the managed care environment, however, the term “white bagging” is not often used; rather the process is described as a transition of specialty medications from the medical benefit to the pharmacy benefit. The goal of such transitions is to

In addition to the many legal and policy battles gearing up during the summer against this absurdly late (13 years late) interpretation of the MMA, individual practices can contribute a valuable perspective.

implement more effective management tools, such as formularies, utilization management, rebates and discounts for specific drugs, external guidance on the medical appropriateness of a treatment, and the utilization of preferred or exclusive networks under the pharmacy benefit, all of which are expected to yield double-digit savings over the buyand-bill medical benefit model. In recent years, Blue Cross Blue Shield of Massachusetts has repeatedly tried to transition oral and of-

fice-administered drugs to the pharmacy benefit, but the oncology community mobilized each time to show how much more costly such a move would be, particularly for drugs that have been shipped and paid for but have not been used, because of changes to a patient’s health status, and the unwillingness of the medical community to assume the risk for an untimely and a possibly mishandled drug. CVS/Caremark has recently decided to narrow the delivery networks for Medicare Advantage Part D drugs to include specialty pharmacies only, not recognizing physician practices as delivery networks. CVS/Caremark justifies this decision based, in part, on its interpretation of the language that the Centers for Medicare & Medicaid Services (CMS) used to define the Medicare Part D program. The program was created when Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) in 2003, which allowed covering outpatient prescription drugs under the Medicare Part D benefit. It took CVS/Caremark 13 years to read the MMA and conclude that CMS intended specialty pharmacies to be the only pharmacy networks allowed to distribute Part D drugs, not regarding the word “pharmacy” in “pharmacy networks” to represent an entity that is allowed to dispense pharmacy drugs under its scope of practice, which could include a pharmacy, a physician office, or a cancer center. This is not a universal interpretation of the MMA, and CVS/

FROM THE EDITOR

Caremark is the only medical entity to have reached this conclusion and call for a change in practice as of January 2017. Several legal, ethical, operational, financial, and commonsense objections to this limited policy change that is separating the patient from the treating physician in a complex disease such as cancer. At a minimum, this appears to be a clear positioning by CVS/Caremark to grab the market share in the attractive oncology market, and to edge physicians (who can dispense oral drugs and can best manage their patientsâ&#x20AC;&#x2122; complicated treatment) out of the way, at least for their patients. Patients are clinically and financially affected by such separations. This is an intrusive force (and staff) that confuses patients with directions and possible calls and outreach, and Medicare Advantage beneficiaries also have to pay different (often significantly higher) copayments and coinsurance under the pharmacy benefit, without support from a supplemental insurance

for which they are eligible under traditional Medicare. The power of an Excel spreadsheet and a collective voice may be able to turn this tide. In addition to

It is time to track these anecdotes and to make them a part of an ongoing record. I will provide a standardized Excel template for tracking these stories, which can be requested via my e-mail at dawnho@aol.com.

the many legal and policy battles gearing up during the summer against this absurdly late (13 years

late) interpretation of the MMA, individual practices can contribute a valuable perspective. Every month I hear stories of how patients are adversely affected and even harmed by a payer or a pharmacy benefit manager and by the mandated delivery of cancer drugs. It is time to track these anecdotes and to make them a part of an ongoing record. I will provide a standardized Excel template for tracking these stories, which can be requested via my e-mail at dawnho@aol.com. Please populate these Excel spreadsheets with your own stories, good and bad. You may mask the patientâ&#x20AC;&#x2122;s personal information for privacy, but as you amass stories, please share these Excel sheets with me for compilation into an article to be shared in the managed care market and in oncology. This may help to stem the rising tide of similar initiatives by other specialty pharmacy vendors. We need to speak up for our patients. Reinterpreting the MMA in this manner 13 years after the fact makes no sense. n

COA CONFERENCE HIGHLIGHTS

Practice Consolidation and Growth Improve... Continued from page 1

“Growth has been an incredible success story for FCS, and ultimately the patients are the ones who benefit in our practice,” he said at the 2016 Community Oncology Alliance conference. “We’ll see 60,000 new patients in this year alone, and we will have over 1 million follow-up visits. We’re trying to bring practices together to keep community oncology alive and well.” Mr Prechtl discussed how practice survival and the growth of FCS have led to new revenue and improved cancer care. Florida Cancer Specialists: Largest US Private Practice FCS is the largest privately owned oncology/hematology practice in the United States, currently with 195 physicians and 147 nurse practitioners and physician assistants in 93 offices in Florida. The focus at FCS is to keep practices in Florida open and flourishing, which has allowed the organization to continue growing. “Our tagline is, ‘World class medicine and hometown care,’ and what we’re trying to do is keep patients close to home. Nearly 70% of our patient base is Medicare and Medicaid, and a lot of patients have difficulty traveling long distances, so our strategy is a number of full-service, smaller locations, so that patients do not have to travel as far,” said Mr Prechtl. “I think one of the most significant advantages that we have brought the patients as we have consolidated is the amount of ancillary services we have been able to bring into the organization,” Mr Prechtl said. FCS now boasts a central laboratory with capabilities for extensive in-house testing and outpatient he-

matopathology services. “We have 4 board-certified hematopathologists, and it is one of the areas that is a key differentiator for us when we bring in

“Our tagline is, ‘World class medicine and hometown care,’ and what we’re trying to do is keep patients close to home….So our strategy is a number of full-service, smaller locations, so that patients do not have to travel as far.” —Brad A. Prechtl, MBA

groups. The turnaround time and quality of the interpretation is incredible,” he said. The FCS has added testing, such as histology, fluorescence in situ hybridization testing, and the Prosigna Breast Cancer Prognostic Gene Signature Assay. The organization has

12 fixed positron emission tomography/computed tomography scanners and 3 mobile units, with 7 sites offering radiation therapy, which were gained through the acquisition of practices. Rx to Go: The Adventures of In-House Pharmacy FCS also has an in-house pharmacy, called Rx to Go, which started in 2007 and has seen significant growth since the influx of new oral drugs into the market in 2012. According to Mr Prechtl, a typical community oncology practice would have 81% of its reimbursement based on chemotherapy. “In terms of the ‘Medicare Experiment,’ this could have a devastating impact on a practice and could cause many to be underwater from a reimbursement versus compensation standpoint. Ultimately, that will drive patients to the hospitals, and it’s already been proved that hospitals are more expensive than outpatient facilities for comparable services. So our strategy is to diversify services within FCS to offset this,” Mr Prechtl said. Approximately 63 cents of every dollar at FCS is chemotherapy-related. “This means we’re that much less at risk if there’s a change just on chemotherapy alone,” Mr Prechtl said. He attributes this security to the growth of Rx to Go. “Rx to Go has had the most profound impact in reducing our chemotherapy as a percentage of collections. In 2009, only 3% of our collection base was related to Rx to Go, and now it’s at 16% and growing,” said Mr Prechtl. He emphasized the importance of offering oral oncolytics within a practice. “It’s not only a way to diContinued on page 12

COA CONFERENCE HIGHLIGHTS

Support Services Provide Some Relief from Financial Distress of Cancer Treatment, but More Is Needed By Meg Barbor, MPH

t the 2016 Community Oncology Alliance conference, Patricia J. Goldsmith, Chief Executive Officer of CancerCare, and Alan J. Balch, PhD, Chief Executive Officer of the Patient Advocate Foundation (PAF), discussed

the services their organizations provide for patients, highlighting the cost barriers for patients with cancer. CancerCare: Patients Cutting Costs by Skipping Treatment In 2015, CancerCare provided

180,000 patients with cancer various services, including financial assistance, counseling, and education. “In 2015, CancerCare provided nearly $13 million in financial assistance to more than 21,000 people to help with treatment-related costs

Practice Consolidation and Growth Improve... Continued from page 10

versify, but it offers a great benefit to patients,” Mr Prechtl said. Benefits of Merging Practices Mr Prechtl also stressed the importance of fully integrated technology. “When we converted practices and merged them into FCS, we ensured that we kept one technology platform,” he said. FCS utilizes 1 electronic medical record system, 1 practice management system, 1 picture archiving and communication system, and 1 laboratory information system, allowing the organization to deliver seamless quality care across their various markets in Florida. “One of the areas we’re most proud of is our clinical research program,” Mr Prechtl added. FCS has 93 active clinical trials and participated in 23 of the clinical trials that led to the approval of many of the new cancer drugs in 2015. Other benefits of merging practices include improved revenue cycle processes and performance and less hassle for physicians, because they

get the benefit of autonomy without the added responsibility of managing a practice.

“It is a win-win for physicians who join us. They give up the hassle of managing a practice day in and day out, and they get access to our secondto-none ancillary services that they would not be able to provide otherwise.” —Brad A. Prechtl, MBA

“It is a win-win for physicians who join us. They give up the hassle of managing a practice day in and day out, and they get access to our sec-

ond-to-none ancillary services that they wouldn’t be able to provide otherwise,” Mr Prechtl said. He stressed the importance of transparency, which “creates an organization where there is trust and confidence that everyone is being treated equally, and everyone has access to the same information.” FCS purchased more than $1 billion worth of drugs in 2015. “Our goal is to not be in a position where we’re underwater from a cost versus reimbursement standpoint, where we’d have to send patients to a hospital to receive their care,” Mr Prechtl stated. However, FCS keeps a inventory of no more than 3 days for a drug. “We have acquired 37 practices in our history, and we’re extremely proud of the fact that we’ve never had one group unwind, nor have we had a physician leave other than for relocation, retirement, or disability. But we’re far from perfect, and we learn from the feedback of every group we bring in,” Mr Prechtl concluded. n

COA CONFERENCE HIGHLIGHTS

such as transportation, home care, childcare, and copayment assistance,” said Ms Goldsmith. CancerCare’s website (cancercare. org) provides up-to-date information about cancer and received 2.2 million visits in 2015 alone. In addition, a feature called “Ask CancerCare” allows individuals to receive answers to their questions from licensed social workers. “When I joined CancerCare and I saw how many individuals we interact with and serve, I felt that we had an obligation to understand cancer patients, their caregivers, their journey, and the challenges they face,” Ms Goldsmith said. In a recent study by CancerCare, 3000 patients with cancer were surveyed to assess the most common barriers they faced during their treatment. Among younger respondents (aged <65 years), 10% to 25% reported being dissatisfied with their insurance coverage for cancer treatment, including access to new treatments or to genetic testing; the cost of medications, copays and deductibles; access to complementary therapies; and access to an insurance case manager. “So this clearly is showing a lot of challenges with respect to current insurance design and its adequacy for patients with cancer,” Ms Goldsmith said. “Employment status during treatment is important for many obvious reasons,” she said. Of the respondents aged 25 to 64 years, 25% stopped working during treatment, and 13% switched from full-time to part-time employment. Approximately 33% of all respondents continued to work full-time. “Many people who are being treated for cancer are insured and need to work in order to maintain benefits,” Ms Goldsmith said. “Twenty-five percent stopped working during cancer treatment. That is a very, very large number.” For patients aged 25 to 64 years

who receive treatment, the average monthly out-of-pocket costs totaled $1112 compared with $584 for older patients (aged ≥65 years) who are

“Many people who are being treated for cancer are insured and need to work in order to maintain benefits.... Clearly, financial distress is contributing to all of the other levels of distress that a patient faces.” —Patricia J. Goldsmith

covered by Medicare. Approximately 20% to 33% of patients reported that it was difficult to determine out-of-pocket costs before incurring the expense. “Out-of-pocket hospital fees were considered the most difficult to determine, and physician fees the easiest,” said Ms Goldsmith. “But I use that term ‘easy’ in a very relative sense.” “Clearly, financial distress is contributing to all of the other levels of distress that a patient faces,” she said. “And expenses related to cancer treatment had an impact on numerous aspects of patients’ finances.” Of

respondents aged <54 years: • 33% cut back on essentials (eg, groceries, transportation) and/or borrowed from family or friends • 25% applied for assistance from support organizations • 2 1% missed utility bills • 17% missed rent or mortgage payments. Of younger patients (aged <54 years), 5% declared bankruptcy. “You can see that the need is acute, and people are not just cutting back on things like vacation or luxury items. We are talking about things that people need each and every day but are unable to afford,” she said. Many patients took steps to reduce costs, such as: • 3 9% skipped physician appointments • 38% postponed or did not fill prescriptions • 34% skipped doses of prescribed drugs • 30% ordered medication from non-US sources • 3 1% cut pills in half. “These are staggering data. Certainly the needs and challenges are more acute in the under 64 agegroup, but even in the 55 and older age-group, 8% responded ‘always’ or ‘sometimes’ with respect to cutting their pills in half. These financial challenges are completely compromising the best care for individuals in so many different ways,” she emphasized. Patient Advocate Foundation: Case Management and Copay Assistance Dr Balch discussed PAF’s case management and copay assistance for patients with cancer. “At PAF, our mission is to help patients with access and affordability issues. Most of the patients we serve are cancer patients, but we served over 500 different disease areas last year,” Dr Balch said. In 2015, the foundation provided Continued next page

COA CONFERENCE HIGHLIGHTS

Support Services Provide Some Relief from Financial Distress of Cancer... Continued from page 13

direct assistance to more than 80,000 patients, and obtained more than $40 million in debt relief on behalf of patients and their providers. The majority of the patients served by PAF in 2015 were relatively young (aged <56 years) and ethnically “fairly diverse.” More than 33% of the patients were commercially insured, with an average household income of ≤$23,000. The PAF FoundationACCESS Careline is dedicated to garnering access to targeted therapies. “The Careline provides personalized case management services to patients who face challenges related to accessing care consistent with the genetic characteristics of their disease,” said Dr Balch. Overall, 426 patients to date have been helped through this program, and “when we are able to complete the case work, there is about a 60% success rate for gaining access to treatment through some means. But about 10% of patients die before we are able to get them assistance, which speaks to the amount of time it takes to work through these barriers in front of them,” Dr Balch said. PAF conducted a financial toxicity survey between March 2015 and April 2015. Of the 685 patients who were assisted through case management and who completed the survey, 90% had a financial hardship because of the cost of their medical care, and 83% characterized this hardship as extremely or somewhat severe. “The financial toxicity and acuity

is far more intense in this population for obvious reasons,” said Dr Balch. Overall, 26% of patients had to stop or postpone treatment, and an-

“Financial hardship distress was found to be at about 90% in the case management population…but in the copay population, where they are getting some form of help, that distress goes down to 70%.” —Alan J. Balch, PhD

other 26% did not follow medical advice as prescribed (eg, spread out medications, delayed follow-up visits). “Where patients are making the

most trade-offs is in their everyday cost of living,” Dr Balch said. Overall, 62% of patients cut or reduced noncritical household expenses, 40% paid utility bills late, and 37% were unable to afford groceries. “About 33% of respondents had about $15,000 per year of outof-pocket costs, but an average income of $23,000 or less. Do the math,” he added. After implementing its Co-Pay Relief program, PAF surveyed approximately 500 patients who received financial assistance through the program. “The survey covered 11 different disease categories, but I can tell you the cancer data are almost the same,” said Dr Balch. Responding to the question, “Without charitable assistance, what would happen to you?” • 29% of patients said they would stop treatment entirely • 49% would struggle to afford housing, food, and transportation • 2 1% would change treatments. “Financial hardship distress was found to be at about 90% in the case management population, where patients are asking for help but are not necessarily receiving it yet, but in the copay population, where they are getting some form of help, that distress goes down to 70%,” Dr Balch said. “Copay support is helping patients better adhere to medication and their medical treatment, and is helping somewhat with their costof-living issues, but it is not enough,” Dr Balch concluded. n

REIMBURSEMENT

How to Prepare for MACRA... At the 2016 American Society of Clinical Oncology (ASCO) annual meeting, Robin T. Zon, MD, FACP, FASCO, Vice President and Partner, Michiana Hematology Oncology, PC, Mishawaka, IN, and Chair of ASCO’s Task Force for Clinical Pathways discussed the implications of MACRA for oncologists and provided tips for oncology practices. “Moving forward, it’s important to think about how to reward physicians and providers while considering the professional services agreements with hospitals and commercial payer contracts,” Dr Zon said. Preparing for 2019 To prepare for the 2019 MACRA Composite Score, she recommends the following activities. 1. Participate in 2016 quality reporting. To avoid 2018 penalties, providers must successfully report to the Physician Quality Reporting System (PQRS), the Medicare Electronic Health Record (EHR) Incentive Program (formerly “Meaningful Use”), and the Value Modifier. Until 2019, any applicable Value Modifier payment adjustment is separate from payment adjustments made under PQRS or the EHR Incentive Program, Dr Zon said. 2. Review your Quality and Resource Use Reports (QRUR). This report, which is filed under the group’s tax identification number (TIN), will indicate performance on quality and cost. An annual QRUR will be available in the fall, after the reporting period. Currently, providers are able to obtain their respective report for 2014 and a 6-month report from 2015. “One person from your TIN must register to obtain your QRUR, which is available through the CMS [Centers for Medicare & Medicaid Services] website. This will

“One person from your TIN must register to obtain your QRUR, which is available through the CMS website. This will let you know the changes that you need to make in order to not be in the penalty phase of the composite score of MACRA.” —Robin T. Zon, MD, FACP, FASCO

let you know the changes that you need to make in order to not be in the penalty phase of the composite score of MACRA,” she said. 3. Focus on performance. It is important for providers to review quality measure benchmarks and understand what is required for above-average performance. In addition, practice strategies and clinical workflows should be implemented to help meet the chosen quality measures for PQRS and the quality and cost measures used under the Value Modifier program. As for cost measures, for exam-

Continued from page 1

ple, providers should establish processes to monitor hospitalizations and to measure length of stay, while noting that it may be useful to consider medical home–type services to reduce hospitalizations. 4. Ensure data accuracy. Because performance is compared with similar groups across the country, the accuracy of data is vital to ensure adequate characterization. This entails confirming the National Provider Identifier for each physician. “Make sure the specialty, the address, and the group affiliation are correct, and then review your own information in Physician Compare. There are usually a bunch of errors in it, so it’s very important to download and review.” 5. ICD-10 coding. “As we move to a risk-adjusted world, coding to the highest level of specificity, coding all comorbidities, and coding all pertinent conditions become increasingly important,” said Dr Zon. “You also have to document this. Make sure your electronic medical record, or whatever you’re using to communicate to other physicians, is accurate and up-to-date.” Pay for Value, Not Volume Groups and providers currently paid by volume will have to change, because future compensation will be based on value. MACRA represents “an opportunity for us as providers,” Dr Zon said. “We need to advocate for our patients to make sure that at the end of the day, not only are they receiving high-quality and valued care as a healthcare system would define it, but valuable care as they would see it.” Finally, if available, physicians should make use of a patient portal and e-prescribing capabilities while meeting medication reconciliation requirements, she concluded. n

SURVIVORSHIP CARE

Integrating Survivorship Care in Oncology: A Conversation with Patricia Ganz, MD

Dr Ganz is Professor of Health Policy and Management, Fielding School of Public Health, Professor of Medicine, David Geffen School of Medicine, University of California, Los Angeles; Director, Center for Cancer Prevention & Control Research, Jonsson Comprehensive Cancer Center, Los Angeles

atricia Ganz, MD, is a Professor of Health Policy and Management, Fielding School of Public Health, Professor of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), and Director, Center for Cancer Prevention & Control Research, Jonsson Comprehensive Cancer Center, Los Angeles. At the 2016 Cancer Survivorship Symposium, Dr Ganz spoke with Oncology Practice Management about the importance of cancer rehabilitation, the politics of surveillance, and the greatest unmet needs facing survivors.

send patients to me, because they knew I had expertise. They would send me their difficult patients, and some patients gravitated toward me because they were not happy with the kind of care they were receiving.

Given that this is the inaugural survivorship conference, can you discuss the evolution of survivorship? Dr Ganz: Like anything in medicine, it takes a long time to change things. If you look at the Institute of Medicine reports from 10 to 12 years ago, critical numbers of survivors have made a difference, but the transformation of the healthcare system has been very challenging. Even though this issue is going back 30 years, it is still a work in progress.

What was your role in this evolution? How did your program at UCLA come about? Dr Ganz: I have been a researcher for a long time, which has been my primary activity, but I always saw patients who were referred to me. Whether I was studying the management of menopausal symptoms in women, chemo brain, or sexuality, physicians in the community would

survivorship care is very difficult. An institution may pay for high-ticket items, such as a new machine or a new sequencer, but getting personnel can be a challenge. After 10 years, UCLA is now paying a salary to nurse practitioners.

Even in a place where I am an expert and an authority, getting an institution to pay for survivorship care is very difficult. So, I had a large number of cancer survivors in my practice while doing research. We were funded by the LIVEÂ STRONG Foundation approximately 10 years ago, which gave me the opportunity to do a more formal, but very minimalist, program. My practice is still very much boutique and consultative. Even in a place where I am an expert and an authority, getting an institution to pay for

Is it because it is difficult to quantify the value of survivorship care? Dr Ganz: No, I do not think so. Because when anybody is close to someone with a life-threatening condition, they want survivorship care for their family. I think there is a lack of awareness. But if you cannot heal the mind, you cannot heal the body; the physical rehabilitation and the functional decline that occur with a lot of cancer treatments are very substantial. We do not put a value on that in the sense that we look at whether the tumor shrinks, but we do not see if the patient can walk out of the hospital.

Can you elaborate about the notion of cancer rehabilitation? Dr Ganz: Cancer rehabilitation basically includes a needs assessment, which is what a treatment summary and survivorship care plan do, and it goes through the needs of the patient. You can then do referrals and interventions for whatever those needs are. In the 1970s, there were cancer rehabÂ ilitation programs across the country that were in-house and in institutions. At that time, we did very disfiguring surgical procedures, and those patients needed a lot of Continued on page 18

SURVIVORSHIP CARE

Integrating Survivorship Care in Oncology: A Conversation with... Continued from page 16

physical rehabilitation. As we began to do less surgery and more multimodal therapies (ie, breast-sparing and limb-sparing), people began to question the need for rehabilitation and staying in the hospital. Women used to stay at the hospital for a week to 10 days after having a mastectomy. When I started doing my research on breast cancer in the early 1980s, the number of days dropped to between 3 and 5; now, outpatient mastectomies are performed. So, the opportunity to engage with patients and to do hospital-based rehabilitation disappeared. Also, Medicare changed its reimbursement so that cancer was no longer a reimbursable condition. People are now realizing that we need rehabilitation, and there is a movement in the physical medicine community to put cancer survivorship on there. We need to do these things from the time of diagnosis, because if you let people debilitate and decline with their treatment in-

Key Points  Getting reimbursement

for survivorship care can be difficult  Cancer rehabilitation and survivorship care should begin at diagnosis  Tailor the treatment to the patient’s personal risk factors and intervene early  We need to move survivors back to primary care to ensure they get full care, not just prevention of cancer recurrence

stead of maintain their health, then you are going to have a worse time. You cannot suddenly start rehabilitation 6 months later.

What are some of the greatest unmet needs facing survivors? Dr Ganz: One is the idea of planning the treatment so you minimize morbidity. Upfront, you are thinking about the comorbidities that the person has. You want to tailor the patient’s treatment to his or her personal risk factors and then find a way to intervene early. You need to personalize medicine for the patient, as well as the tumor. You need to identify who is going to be at high risk for fatigue, psychosocial distress, and depression. Assess upfront, and then monitor and intervene early, if possible, for any side effects; and make sure that you do not abandon patients after their treatment ends.

The issue of oversurveill ance in survivors has struck a nerve in patients and providers alike. Why is adopting a less-is-more philosophy of care so controversial? Dr Ganz: Because people do not understand the evidence. We have a culture that believes that more is better, even if there is no benefit, but more may be harmful. Being poked with an intravenous line, having tests done, and the patient being anxious because he or she does not know what the tests are going to show are costs that the patient bears, and there may be zero benefit, not to mention the time away from doing things that are more pleasurable. If there is reassurance, it may be

false reassurance. Just because your scan is negative, it does not mean you are cured. Very often patients will say, “I was doing all of these tests. Why didn’t you detect my cancer?” In the meantime, they have cumulatively received large amounts of radiation.

We have a culture that believes that more is better, even if there is no benefit, but more may be harmful....Just because your scan is negative, it does not mean you are cured.

We need to move the patient back to primary care, because oncologists check for recurrence, but they may not have given the patient a flu vaccine, counseled the patient about weight gain or tobacco use, or made sure the patient was getting other screening that is important. If a primary care physician is sharing care with a patient, then the patient does not see cancer as his or her only illness, but also realizes the need for other preventive services.

Are you trying to expand your program at UCLA? Dr Ganz: I would like to see the program institutionalized to integrate it into oncology care. UCLA has really good primary care physicians. My goal is to have that be integrated into team care. n

CLINICAL TRIALS TRACKER

Select Ongoing Trials Currently Enrolling Patients with Leukemia The following clinical trials represent a selection of key studies currently recruiting patients with leukemia for inclusion in investigations of new therapies and new treatment regimens. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.

Duvelisib or Ofatumumab Monotherapy for CLL or SLL This nonrandomized, openlabel, parallel-assignment phase 3 extension clinical trial examines the efficacy of duvelisib monotherapy or ofatumumab monotherapy in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who experienced disease progression after treatment with duvelisib or ofatumumab in Study IPI-145-07. Men and women aged ≥18 years with a diagnosis of active CLL or SLL who meet ≥1 of the International Workshop on Chronic Lymphocytic Leukemia 2008 criteria for requiring treatment, have an ECOG performance status of 0 to 2, and have measurable nodal disease by computed tomography may be eligible for enrollment if other criteria are met. Eligible patients will receive the alternative treatment (duvelisib or ofatumu mab) from what they received in Study IPI-145-07. The primary outcome measure is overall response rate (ORR). The secondary outcome measures include treatment-emergent adverse events, duration of response, and progres-

sion-free survival (PFS). This study plans to enroll 150 patients at multiple locations across the United States and abroad. For more information, contact Christina Gardell at 617-453-1283 or christina.gardell@ infi.com. The NLM Identifier is NCT02049515.

Nilotinib with/without Pegylated Interferon for the First-Line Treatment of Chronic-Phase CML This phase 3, randomized, open-label, parallel-assignment clinical trial compares the efficacy of nilotinib alone versus with pegylated interferon (IFN) alfa-2a. Patients aged 18 to 65 years with chronic-phase chronic myeloid leukemia (CML) and an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive nilotinib alone or with pegylated IFN alfa-2a. The primary outcome measure is molecular response. Some of the secondary outcome measures include major molecular response, safety, quality of life, event-free survival (EFS), PFS, and overall survival (OS). This study expects to enroll 200 patients in France. For more information, contact Madeleine Etienne, CRA, at madeleine.etienne@ chu-lyon.fr. The NLM Identifier is NCT02201459.

Acalabrutinib versus Ibrutinib in Previously Treated High-Risk CLL This randomized, single-blind, parallel-assignment, phase 3 clinical trial is designed to evaluate PFS with acalabrutinib versus with ibrutinib in patients with previously treated CLL. Patients aged ≥18 years with measur-

able nodal disease as assessed by computed tomography and with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive acalabrutinib or ibrutinib. The primary outcome measure is PFS. The secondary outcome measures include the incidence of treatment-emergent grade ≥3 infections, Richter’s transformation, and of atrial fibrillation, and OS. This study plans to enroll 500 patients in Arizona and California. For more information, contact Acerta Pharma at 888-292-9613. The NLM Identifier is NCT02477696.

AG-221 versus Conventional Care Regimens in Older Patients with Late-Stage AML plus IDH2 Mutation This phase 3, multicenter, randomized, parallel-assignment, openlabel clinical trial compares the efficacy and safety of AG-221 with conventional care regimens in patients with acute myeloid leukemia (AML) that is refractory to or that has relapsed after second- or thirdline AML therapy and is positive for an isocitrate dehydrogenase (IDH2) mutation. Men and women aged ≥60 years with primary or secondary progression of myelodysplastic syndromes, myeloproliferative neoplasms, or therapy-related AML according to World Health Organization (WHO) classification, who received second- or third-line AML therapy may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive AG-221 plus best supportive care or a conventional care regimen. The primary outcome measure is OS. The secondary outcome meaContinued next page

CLINICAL TRIALS TRACKER

Select Ongoing Trials Currently Enrolling Patients with... Continued from page 19

sures include ORR, EFS, duration of response, time to response, treatment-related mortality at 30 and 60 days, 1-year survival, overall remission rate, complete remission rate, hematologic improvement rate, rate of hematopoietic stem-cell transplantation, time to treatment failure, adverse events, and EuroQol C30 and EuroQoL Group EQ-5D-5L questionnaire measures. This study expects to enroll 280 patients at multiple locations across the United States and abroad. For more information, contact Associate Director Clinical Trial Disclosure at 888-2601599 or clinicaltrialdisclosure@cel gene.com. The NLM Identifier is NCT02577406.

Ibrutinib plus Rituximab versus Fludarabine Phosphate, Cyclophosphamide, and Rituximab for CLL or SLL This phase 3, randomized, open-label, parallel-assignment clinical trial will compare the efficacy of ibrutinib and rituximab versus that of fludarabine phosphate, cyclophosphamide, and rituximab in patients with untreated CLL or SLL. Men and women aged 18 to 70 years with a diagnosis of CLL or SLL who did not receive previous chemotherapy, Bruton’s tyrosine kinase inhibitor therapy, or monoclonal antibody therapy for CLL or SLL, and who have an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ibrutinib plus rituximab or a combination of rituximab, fludarabine phosphate, and cyclophosphamide. The primary outcome measures are change in quality of life as determined by the Functional Assessment of Can-

cer Therapy-Leukemia (FACT-Leu) Trial Outcome Index (TOI) and PFS. The secondary outcome measures include adherence to prescriptions, the change in FACT-Leu TOI score from baseline to 3 months, the change in FACT-Leu TOI score from baseline to 6 months, the impact of CLL on quality of life, incidence toxicity, and OS. This study plans to enroll 519 patients at multiple locations across the United States. For more information, contact Tait Shanafelt, MD, at shanafelt.tait@mayo.edu. The NLM Identifier is NCT02048813.

Ublituximab plus TGR-1202 versus Obinutuzumab plus Chlorambucil for CLL This randomized, open-label, parallel-assignment phase 3 clinical trial evaluates the combination of ublituximab and TGR-1202 versus obinutuzumab plus chlorambucil, as well as compared with ublituximab or TGR-1202 alone, in patients with CLL. Men and women aged ≥18 years with treatment-naïve or previously treated CLL requiring treatment, and with an ECOG performance status of 0 to 2, may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ublituximab plus TGR-1202, obinutuzumab plus chlorambucil, ublituximab alone, or TGR-1202 alone. The primary outcome measure is PFS, and the secondary outcome measure is ORR. This study plans to enroll 450 patients at multiple locations across the United States. For more information, contact the TG Therapeutics Clinical Support Team at 212-554-4484 or clinicalsupport@ tgtxinc.com. The NLM Identifier is NCT02612311.

Ublituximab plus Ibrutinib versus Ibrutinib Alone for High-Risk CLL The purpose of this phase 3, randomized, open-label, parallel-assignment clinical trial is to evaluate the addition of ublituximab to ibrutinib compared with ibrutinib alone in patients with previously treated CLL and high-risk cytogenetic features. Patients aged ≥18 years with previously treated CLL requiring treatment who have ≥1 high-risk cyto genetic features and an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ublituximab plus ibrutinib or ibrutinib alone. The primary outcome measures are ORR and PFS. This study plans to enroll 330 patients at multiple locations across the United States. For more information, contact the TG Therapeutics Clinical Support Team at 212-554-4484 or clinicalsupport@ tgtxinc.com. The NLM Identifier is NCT02301156.

Intensive Chemotherapy with or without Dasatinib for AML This phase 3, randomized, open-label, parallel-assignment, multicenter clinical trial is evaluating standard induction therapy and consolidation therapy with or without dasatinib in adults with newly diagnosed core binding factor AML. Women and men aged ≥18 years with core binding factor AML and no previous chemotherapy for leukemia except hydroxyurea for ≤5 days during the diagnostic screening phase may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive standard induction therapy with daunorubicin and

CLINICAL TRIALS TRACKER

cytarabine, as well as consolidation therapy (high-dose cytarabine) with or without dasatinib. The primary outcome measure is EFS. The secondary outcome measures include the cumulative incidence of relapse, the cumulative incidence of death, OS, relapse-free survival, toxicity, and the pharmacodynamics inhibition of KIT. This study plans to enroll 277 patients at multiple locations in Germany and in Austria. For more information, contact Hartmut Doehner, MD, at hartmut.doehner@uniklinik-ulm.de, or Peter Paschka, MD, at peter.pas chka@uniklinik-ulm.de. The NLM Identifier is NCT02013648.

Clofarabine versus Daunorubicin Hydrochloride and Cytarabine for Newly Diagnosed ALL This randomized, open-label, parallel-group assignment phase 3 clinical trial will compare the efficacy of clofarabine with that of daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in patients with newly diagnosed AML. Men and women aged ≥60 years with newly diagnosed AML according to the WHO classification and with an ECOG performance status of 0 to 3 may be eligible for enrollment if other criteria are met. Eligible patients will receive daunorubicin hydrochloride and cytarabine or clofarabine followed by decitabine or observation. The primary outcome measure is OS. The secondary outcome measures include mortality rate, induction complete response rates, disease-free survival up to 5 years, OS up to 5 years, epidemiologic factors measured according to the Acute Leukemia Epidemiology and Survival in ECOG questionnaire, change in FACT-Leu TOI score from baseline to 30 days after the start of induction therapy, and change in the Functional Assessment of Chronic Illness Therapy-Fa-

tigue score from baseline to 30 days after starting induction therapy. This study plans to enroll 747 patients at multiple locations across the United States and abroad. For more information, contact James Foran, MD, at Foran.James@mayo.edu. The NLM Identifier is NCT02085408.

Vincristine Sulfate Liposome in Treatment- Naïve Adults with ALL The purpose of this phase 3, randomized, double-blind, parallel-assignment clinical trial is to determine whether vincristine sulfate liposome can reduce peripheral neuropathy more than vincristine sulfate, and be as effective as vincristine sulfate in adults with treatment-naïve acute lymphoblastic leukemia (ALL). Men and women aged 18 to 65 years with de novo treatment-naïve ALL diagnosed by bone marrow morphology and with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive vincristine sulfate liposome or vincristine sulfate. The primary outcome measures are ORR and the incidence of general peripheral neuropathy. This study plans to enroll 480 patients in China. For more information, contact Ying chang Mi, MD, at 86-10-22-23909999. The NLM Identifier is NCT02072785.

Chemotherapy with/ without Bortezomib in Newly Diagnosed T-Cell ALL or Stage II-IV T-Lymphoblastic Lymphoma The purpose of this randomized, open-label, parallel-assignment phase 3 clinical trial is to compare the efficacy of combination chemotherapy when given with or without bortezomib in patients with newly diagnosed T-cell ALL or stage II to stage IV T-cell lymphoblastic lymphoma. Patients aged 2 to 30 years with newly diagnosed T-lymphoblastic leukemia

or T-lymphoblastic lymphoma stage II to stage IV may be eligible for enrollment if other criteria are met. Eligible patients will receive combination chemotherapy without bortezomib or combination chemotherapy with bortezomib. The primary outcome measure is EFS up to 10 years. The secondary outcome measures include cumulative incidence rates, EFS, and incidence of toxicity. This study expects to enroll 1400 patients at multiple locations across the United States and abroad. For more information, contact David T. Teachey, MD, at 215-590-3025. The NLM Identifier is NCT02112916.

Blinatumomab versus Standard Chemotherapy in Pediatric Patients with First-Relapse B-Precursor ALL This phase 3, randomized, open-label, parallel-assignment clinical trial will evaluate EFS after treatment with blinatumomab when compared with standard-of-care chemotherapy for patients with high-risk first-relapse B-precursor ALL. The effect of blinatumomab on OS and on the reduction of minimal residual disease compared with standard-of-care chemotherapy will also be investigated. Patients aged ≤17 years with Philadelphia chromosome–negative highrisk first-relapse B-precursor ALL may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive blinatumomab or conventional consolidation chemotherapy. The primary outcome measure is EFS. The secondary outcome measures include OS, minimal residual disease response, adverse events, survival, relapse incidence, and the incidence of antiblinatumomab antibody formation. This study expects to enroll 320 patients at multiple locations abroad. For more information, contact Amgen Call Center at 866-572-6436. The NLM Identifier is NCT02393859. n

NCCN GUIDELINES UPDATE

Updated NCCN Multiple Myeloma Guideline Expands Patient Eligibility and Therapeutic Options By Wayne Kuznar

he population of patients with multiple myeloma who are eligible for therapy has been expanded to include asymptomatic patients with certain features, according to the most recent National Comprehensive Cancer Network (NCCN) guideline (version 3.2016). In addition, among the 7 new drug approvals in 2015 with indications for multiple myeloma, new options for the treatment of patients with relapsed and/or refractory multiple myeloma comprise the first HDAC (histone deacetylase) inhibitor pan obinostat (Farydak), oral proteasome inhibitor ixazomib (Ninlaro), and the first 2 monoclonal antibodies— daratumumab (Darzalex) and elotuzumab (Empliciti). Kenneth C. Anderson, MD, Program Director, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston, MA, presented the key updates at the 2016 NCCN annual conference. Eligibility Criteria Dr Anderson opened his presentation with a review of important changes to the diagnostic criteria for the treatment of patients with multiple myeloma, which expands the active multiple myeloma category and the number of patients eligible for treatment. Historically, eligibility for multiple myeloma treatment demanded abnormalities in the CRAB (calcium, renal function, anemia, and bone disease) features. “However, that is no longer true,” said Dr Anderson. The new definition of active multiple myeloma in asymptomatic pa-

tients, which qualifies such patients for treatment, includes: • Bone marrow plasmacytosis ≥60% • Abnormal free light chain ratio ≥100 (involved kappa) or <0.01 (involved lambda) • Focal bone marrow lesions detected by functional imaging.

“For the first time, we have a triplet consisting entirely of oral medications included as initial treatment” for multiple myeloma. —Kenneth C. Anderson, MD

For the first time, the NCCN guideline recommends using the revised International Staging System that incorporates cytogenetics for risk stratification.

An All-Oral Triplet Frontline Treatment The recommended treatment options for the frontline treatment of transplant-eligible candidates now include bortezomib (Velcade) plus lenalidomide (Revlimid) and dexamethasone (category 1), and ixazomib in combination with lenalidomide plus dexamethasone (category 2A). “For the first time, we have a triplet consisting entirely of oral medications included as initial treatment” for multiple myeloma, Dr Anderson said. An all-oral regimen of ixazomib plus lenalidomide and dexamethasone yielded a 100% response rate in patients with newly diagnosed multiple myeloma, and ixazomib monotherapy enhanced these responses during maintenance treatment. Dr Anderson noted that triplet therapy with bortezomib plus lenalidomide and dexamethasone improved complete response rates (including molecular complete response), progression-free survival (PFS), and overall survival compared with lenalidomide plus dexamethasone. The recommendation for upfront triplet therapy applies to transplanteligible candidates and very fit transplant-ineligible patients, Dr Anderson added. Carfilzomib (Kyprolis) in combination with dexamethasone plus lenalidomide is included in the updated guideline as a category 2A (other) recommendation for the frontline treatment of transplanteligible patients. A new standard of care for transplant-ineligible patients with newly

NCCN GUIDELINES UPDATE

diagnosed disease is continuous lenalidomide plus dexamethasone, which was found to significantly extend PFS compared with melphalan plus prednisone and thalidomide.

ple myeloma. Ixazomib is indicated in combination with lenalidomide and dexa-

Treatment of Relapsed and/or Refractory Disease In the relapsed setting, carfilzomib plus lenalidomide and dexamethasone extended PFS by 6 months compared with lenalidomide plus dexamethasone, regardless of whether patients had high-risk or standard cytogenetics; therefore, it is included in the updated guideline as a cate gory 1 recommendation. Ixazomib, panobinostat, elotuzu mab, and daratumumab are among the new therapeutic options in cluded in the updated NCCN guideline for the treatment of patients with previously treated multi-

Ixazomib, panobinostat, elotuzumab, and daratumumab are among the new therapeutic options included in the updated NCCN guideline.

methasone for the treatment of patients with multiple myeloma who

have received at least 1 previous therapy, and is classified as a category 1 recommendation. Panobinostat added to bortezomib and dexamethasone improved the median PFS by 4 months, and increased the rates of complete response and near complete response compared with bortezomib plus dexamethasone in patients with previously treated multiple myeloma; this combination is classified as a category 1 recommendation. Elotuzumab was approved in combination with lenalidomide and dexamethasone for previously treated multiple myeloma. Daratumumab “was approved as a single agent, because it achieved about a 30% response rate even in patients whose myeloma was resistant to bortezomib and lenalidomide,” Dr Anderson said. n

ASCO MEETING HIGHLIGHTS

Liquid Biopsies Show High Correlation with Tissue Biopsy for Genetic... Continued from page 1

This finding comes from the largest study to date involving a genomic analysis of blood samples from more than 15,000 patients with 50 different tumor types, and suggests that tumor DNA shed into a patient’s blood may be informative when tissue biopsy is insufficient for genotyping, Dr Mack said. “It’s actually very typical for tissue biopsies to be insufficient for comprehensive molecular analysis,” he said. In addition, liquid biopsy may serve as a reliable method to periodically monitor disease progression, response to therapy, and the development of drug resistance, said Dr Mack. The following observations from the genomic analysis provide insight into the clinical utility of plasma ctDNA: • 49% of the cases had alterations for which FDA-approved targeted therapies exist • 27% of the cases had actionable resistance mutations • The ability of ctDNA to enhance and complement the initial biomarkers analysis in tissue was exemplified by an increase in the yield of 42% in tissue-insufficient or partially genotyped non–small-cell lung cancer (NSCLC). Liquid Biopsy Detects Mutations in Multiple Cancers In this analysis, DNA was isolated from blood, and fragmented DNA was barcoded using a high-efficiency molecular tagging approach. Target capture was conducted to identify regions of interest in 70 key cancer-associated genes. Sequence analysis was subsequently performed, followed by variant calling that included

missense mutations, small insertions and deletions, amplification events, and a limited number of fusions. “One of the advantages of using next-generation sequencing in plasma is that it reports a fairly precise

“It’s actually very typical for tissue biopsies to be insufficient for comprehensive molecular analysis.” —Philip C. Mack, PhD

mutated allele frequency. This allows you to easily discriminate the presence of germline polymorphisms from the somatic mutations, with a germline polymorphism occurring at 50% or 100% allele frequencies,” said Dr Mack. This study included 15,191 patients with advanced NSCLC (37%), breast cancer (14%), colon or rectum cancer (6%), or other cancers (14%). Each patient provided blood samples for ctDNA analysis.

The accuracy of liquid biopsies in identifying mutations was assessed using tumor tissue samples. Overall, 83.4% of alterations were detected by ctDNA analysis compared with 94% of alterations identified using data from The Cancer Genome Atlas (TCGA). DNA was isolated from blood samples when a patient’s cancer was in the advanced stage of the disease, typically during a second-line treatment or later. In 49% of the cases, the identified mutations were associated with at least 1 FDA-approved therapy. The patterns of genomic changes in ctDNA were compared with those found in 398 patients who had genetic testing. The predictive value for key abnormalities in EGFR, BRAF, KRAS, ALK, RET, and ROS1 genes by ctDNA ranged from 94.1% to 100%. This was not the case for subclonal mutations, which are associated with resistance mutations. Discordant resistance cases likely reflect the evolution of disease on therapy after the initial tissue biopsy. “Circulating tumor DNA alteration patterns were highly similar, in terms of the frequency and distribution of mutations, between TCGA tissue and this series, with correlations of variant patterns ranging from 0.85 to 0.99,” Dr Mack said. One exception was the detection of EGFR T790M resistance mutations in plasma in patients with NSCLC receiving EGFR inhibitor therapy that was absent in the tissue-based population data, because the latter group had yet to receive treatment. Overall, 27% of the cases had potentially actionable resistance Continued on page 33

ASCO MEETING HIGHLIGHTS

Aggressive End-of-Life Care Still Offered to Younger, Non-Medicare Patients with Cancer By Phoebe Starr

Underuse of Hospice Care The investigators also found that ASCO’s top 5 “Choosing Wisely” recommendations have had little or no impact on aggressive end-of-life care for patients with cancer; however, there was no change in the rates

Photo by © ASCO/Todd Buchanan 2016

ggressive end-of-life care for patients with terminal cancer and other illnesses is costly and not recommended. The American Society of Clinical Oncology (ASCO) recommends that patients with terminal cancer should receive palliative care rather than interventions that do not prolong life but do add to suffering. However, these recommendations are going unheeded in the United States. According to a study presented at the 2016 ASCO annual meeting, 75% of patients with cancer received ≥1 forms of aggressive intervention in the last 30 days of life, including chemotherapy, invasive procedures and biopsies, hospitalization, and emergency care. The study was based on an analysis of national health claims in patients aged <65 years, and is one of the first of this kind to focus on a younger, non-Medicare population. “This is one of the first and largest studies to assess end-of-life care in a non-Medicare population. Seventy to seventy-five percent of cancer patients younger than age 65 with incurable cancers received aggressive care within the last 30 days of life. One-third died in the hospital,” said lead investigator Ronald C. Chen, MD, MPH, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, who presented the study findings.

“Physicians are taught to offer some kind of treatment to help patients. Along with that, oncologists are bad at estimating life expectancy, and have difficulty with end-of-life discussions.”

“There is no one-size-fitsall approach for endof-life care, and there shouldn’t be. At every step of care, patients and their doctors must have thoughtful discussions…, including cost and side effects.”

—Ronald C. Chen, MD, MPH

—Andrew S. Epstein, MD

of any of the aggressive interventions between 2012 and the end of 2014. The recommendations were published in 2012 and stressed the value of palliative and supportive care for terminally ill patients. “This shows that recommendations by themselves may not be enough to change practice for patients with terminal disease. We need better ways of educating physicians and patients about palliative care and hospice, and we need to make these types of care more accessible,” emphasized Dr Chen. Based on claims data from the

HealthCore Integrated Research Database across 14 states, the study included 28,731 patients aged <65 years who died from metastatic lung, colorectal, breast, pancreatic, or prostate cancer between 2007 and 2014 in the United States. The investigators evaluated the rates of chemotherapy, radiotherapy, invasive procedures (eg, biopsy), emergency department visits, hospitalizations, use of intensive care, and in-hospital deaths within the last 30 days of life. The rates of chemotherapy ranged from 24.2% for prostate cancer to 32.6% for

ASCO MEETING HIGHLIGHTS

breast cancer; radiotherapy ranged from 5.8% for pancreatic cancer to 20.6% for lung cancer; and invasive procedures ranged from 25.3% for prostate cancer to 31.1% for pancreatic cancer. Approximately 66% of patients were admitted to the hospital or the emergency department. “These are patient-driven visits, and younger patients may want more aggressive treatment,” Dr Chen noted. In addition, between 15% and 20% of patients received care in the intensive care unit, and approximately 33% of patients died in the hospital. One surprising finding was that only 15% to 18% of these terminally ill patients accessed hospice care. “Studies have shown that hospice can help patients preserve their quality of life at the end of life. We think there is too much aggressive

care, and it might be related to the fact that too few of these patients enroll in hospice. It’s not clear which is the cause, but I think these are complementary findings,” said Dr Chen. End-of-Life Education Needed Dr Chen noted that this study raises more questions than it answers. When asked why there is little or no change in the use of aggressive care at the end of life, he said that patient and physician factors may be at play. “Physicians are taught to offer some kind of treatment to help patients. Along with that, oncologists are bad at estimating life expectancy, and have difficulty with end-of-life discussions,” he said. “End-of-life discussions are difficult. Oncologists need better educa-

tion to improve communication during these challenging conversations,” agreed ASCO expert in palliative care Andrew S. Epstein, MD, Medical Oncologist at Memorial Sloan Kettering Cancer Center, New York, NY. “End-of-life care is highly personal for each patient, and palliative care, including hospice, remains one of our best and most underutilized resources,” Dr Epstein added. “There is no one-size-fits-all approach for end-of-life care, and there shouldn’t be. At every step of care, patients and their doctors must have thoughtful discussions about the balance of benefits to risks, including cost and side effects. Our ultimate goal as oncologists is to help patients live the longest and best lives possible, even in their last days,” Dr Epstein said. n

Liquid Biopsies Show High Correlation with Tissue Biopsy for Genetic... Continued from page 31

targets detected in ctDNA. In a subset of 362 patients with NSCLC, 63% had tissue that was partially tested or insufficient for testing. Of the 362 patients, 120 had primary activating mutations in the tumor tissue. When plasma ctDNA analysis was conducted, an additional 51 patients were identified with actionable biomarkers, an increase of 42%. Clinical Implications Dr Mack noted that at the moment liquid biopsy is not an alternative to traditional tissue biopsy for an initial diagnosis of cancer, and should be used for patients who do not have sufficient tissue for tissue biopsy. “At this point, we cannot dispense

“One of the advantages of using next-generation sequencing in plasma is that it reports a fairly precise mutated allele frequency. This allows you to easily discriminate the presence of germline polymorphisms from the somatic mutations, with a germline polymorphism occurring at 50% or 100% allele frequencies.” —Philip C. Mack, PhD

with that initial tumor biopsy. The initial biopsy and subsequent pathology are what allow us to determine what type of cancer it is.” Commenting on the study during the meeting, Richard Schilsky,

ASCO Chief Medical Officer, said that these results are certainly encouraging, but he added that they do not yet indicate that using a liquid biopsy will improve patient outcomes overall. n

ASCO MEETING HIGHLIGHTS

Atezolizumab Could Be Start of “Seismic Shift” in Metastatic Bladder Cancer Therapy By Wayne Kuznar

tezolizumab (Tecentriq) shows promise as primary therapy in patients with cisplatin-ineligible, locally advanced metastatic urothelial (bladder) cancer, according to data from the IMvigor210 study presented at the 2016 American Society of Clinical Oncology annual meeting. Preliminary results also showed encouraging overall survival data, said Arjun V. Balar, MD, Co-Leader of the Genitourinary Cancers Program, Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY, who presented the results. “I think these data make a compelling argument for atezolizumab to be a potential new standard of care in patients with cisplatin-ineligible metastatic urothelial cancer. Moreover, it could represent the beginning of a seismic shift in our treatment approach for all patients with metastatic disease, irrespective of their eligibility for cisplatin,” Dr Balar said. Atezolizumab was approved in May 2016 for the treatment of patients with locally advanced or metastatic urothelial cancer that progressed during or after platinumcontaining chemotherapy. Cisplatin-based chemotherapy is currently the standard of care in the first-line setting, but many patients with metastatic bladder cancer are ineligible for cisplatin therapy because of a poor performance status or an impaired renal function; therefore, these patients receive non–cisplatin-based regimens or best supportive care, according to Dr Balar. However, response durations are short with these regimens.

“These data make a compelling argument for atezolizumab to be a potential new standard of care. Moreover, it could represent the beginning of a seismic shift in our treatment approach.” —Arjun V. Balar, MD

Atezolizumab Improves Response Rates Atezolizumab is a humanized monoclonal antibody that selectively targets PD ligand 1 (PD-L1). By inhibiting its interactions with PD-1 and B7.1 receptors, “it can reinvigorate exhausted T-cells and unleash antitumor immunity,” Dr Balar said. Cohort 1 of the IMvigor210 study included 119 cisplatin-ineligible, chemotherapy-naïve patients (median age, 73 years) with metastatic disease. The bladder (or urethra) was the primary tumor site in 71% of the patients, and 66% had metastatic disease at visceral sites. Renal im-

pairment was the most common contraindication to cisplatin. Atezolizumab 1200 mg was given intravenously every 3 weeks until disease progression. At the time of data cutoff in March 2016, 98 patients discontinued treatment, with disease progression being the most common (75 patients) reason. At a median duration follow-up of 14.4 months, the objective response rate was 24%, and 7% of the patients achieved a complete response. Similar responses were observed when response rates were stratified by PD-L1 expression. In the subgroup of patients whose tumors underexpressed PD-L1, the overall response rate was 21% and the complete response rate was 8%. “Across the board, we see complete responses in all IC [immune-cell] subgroups. Activity of this level in this patient population is unprecedented,” said Dr Balar. “Responses were rapid, at a median time of 2.1 months,…and they are durable,” he added. The median duration of response was not yet reached in any PD-L1 subgroup, and 75% of the responses are ongoing. Tumor regression was observed across all immune-cell subgroups. The estimated median overall survival for the entire study population was 14.8 months, and the estimated 12-month survival rate was 57%. Atezolizumab was generally welltolerated––only 6% of patients discontinued treatment because of an adverse event. Treatment-related all-grade and grade 3 or 4 adverse events occurred in 66% and 15% of patients, respectively. One patient died from sepsis. n

ASCO MEETING HIGHLIGHTS

Alectinib May Be New First-Line Treatment for Patients with NSCLC and ALK Mutation By Wayne Kuznar

ew data from an interim analysis of the head-to-head, open-label, phase 3, Japanese study J-ALEX show that alectinib (Alecensa) significantly improved progression-free survival (PFS) compared with crizotinib (Xalkori) in the frontline setting, said Hiroshi Nokihara, MD, PhD, of the National Cancer Center Hospital, Tokyo, Japan. “Based on these results, we believe that alectinib is the new standard first-line therapy for ALK-positive NSCLC,” Dr Nokihara said at the 2016 American Society of Clinical Oncology annual meeting. Alectinib, an oral anaplastic lymphoma kinase (ALK) inhibitor, was approved in December 2015 for advanced, ALK-positive non–smallcell lung cancer (NSCLC) that progressed after crizotinib therapy. Study Details Overall, 207 Japanese patients with advanced or recurrent NSCLC and ALK mutation who had never received an ALK inhibitor were randomized to alectinib 300 mg twice daily or to crizotinib 250 mg twice daily, with a follow-up of 12 months in the alectinib group and 12.2 months in the crizotinib group. Treatment continued until disease progression or unacceptable toxicity. The primary end point was median PFS. At baseline, 27.9% of patients in the crizotinib group had brain metastases compared with 13.6% in the alectinib group; other baseline characteristics were similar between the 2 groups. Although the study investigated the optimal first-line therapy for patients with NSCLC and ALK

mutation, approximately 33% of patients in each group had received 1 line of chemotherapy. Alectinib Outperforms Crizotinib in the First-Line Setting The investigator-assessed overall response rate (ORR) was 85.4% in the alectinib group compared with 70.2% in the crizotinib group. When assessed by an independent review, the ORR was 91.6% in the alectinib group versus 78.9% in the crizotinib group.

“Based on these results, we believe that alectinib is the new standard first-line therapy for ALK-positive NSCLC.” —Hiroshi Nokihara, MD, PhD

The median PFS was significantly superior with alectinib versus crizotinib: at the time of data analysis, the median PFS had not been reached in the alectinib group, but the lower 95% confidence interval was 20.3 months. The median PFS with crizotinib was 10.2 months, with a hazard ratio (HR) of 0.34 (P <.001) in favor of alectinib. In the subgroup of patients with brain metastases at baseline, the HR for PFS was 0.08 with alectinib versus crizotinib.

In addition to a superior PFS, 26.2% of patients in the alectinib group had grade 3 or 4 adverse events versus 51.9% in the crizotinib group, and 8.7% of patients discontinued the study because of adverse events in the alectinib group versus 20.2% in the crizotinib group. Furthermore, treatment interruption because of adverse events was less common with alectinib (29.1%) than with crizotinib (74.0%). The only adverse event reported in >30% of patients in the alectinib group was constipation; nausea, diarrhea, vomiting, visual disturbance, dysgeusia, constipation, elevation in alanine aminotransferase (ALT) levels, and elevation in aspartate aminotransferase levels each occurred in >30% of patients. Overall, 8 patients in each treatment group withdrew from the study because of interstitial lung disease. In the crizotinib group, 5 patients discontinued treatment because of impaired hepatic function, and 4 patients discontinued treatment after an increase in ALT levels. Addressing whether alectinib therapy should now be considered the new frontline standard in ALK-positive NSCLC based on the J-ALEX study, discussant Shirish M. Gadgeel, MD, Leader of the Thoracic Oncology Multidisciplinary Team, Karmanos Cancer Center, Detroit, MI, gave a cautious “yes.” The superior efficacy and toxicity profile with alectinib are persuasive, said Dr Gadgeel, but “there’s clearly a note of caution in that these results are based on an interim analysis, though planned, and we still await the results of the global ALEX study.” n

ASCO MEETING HIGHLIGHTS

Three-Drug Regimen with Daratumumab a New Standard of Care for Relapsed or Refractory Multiple Myeloma By Wayne Kuznar

dding the recently approved daratumumab (Darzalex), a human, CD38-direct monoclonal antibody, to a standard regimen of bortezomib (Velcade) and dexamethasone improved progression-free survival (PFS) by >60% compared with the standard regimen in patients with relapsed or refractory multiple myeloma, according to Antonio Palumbo, MD, Chief of the Multiple Myeloma Unit, University of Torino, Italy. Dr Palumbo presented new data at the 2016 American Society of Clinical Oncology (ASCO) annual meeting. The 61% improvement in PFS is “unprecedented in randomized studies that compare novel treatments for relapsed or refractory multiple myeloma,” he emphasized, saying that based on these data, the 3-drug regimen should be considered a new standard of care for this patient population. Daratumumab received accelerated approval by the FDA in November 2015 based on results from a nonrandomized, phase 2 clinical trial.

Phase 3 CASTOR Study Dr Palumbo presented data from an interim analysis of the ongoing, randomized, controlled, phase 3 CASTOR clinical trial after approximately 177 PFS events. At the time of the last follow-up, he said, the median PFS had not yet been reached in patients who received daratumumab. Overall, 498 patients in the phase 3 study received ≥1 previous lines of therapy; the patients were randomized to standard therapy with bortez omib and dexamethasone or to the

3-drug regimen of bortezomib, dexamethasone, and daratumumab 16 mg/kg intravenously weekly during cycles 1 to 3, then every 3 weeks during cycles 4 to 8. After complet-

The 3-drug regimen should be considered a new standard of care. The 61% improvement in PFS is “unprecedented in randomized studies that compare novel treatments for relapsed or refractory multiple myeloma.” —Antonio Palumbo, MD

ing 8 cycles in the experimental arm, daratumumab was given monthly until disease progression. The daratumumab arm had a 61% improvement in PFS, and was not

yet reached in the 3-drug arm compared with PFS of 7.2 months in the 2-drug arm. Randomization to daratumumab doubled the very good partial response rate, from 29% to 59% (P <.001) and the complete response rate from 9% to 19% (P = .001). The safety profile of the 3-drug regimen was consistent with the safety profile of these drugs. “Daratumumab did not significantly increase any toxicity that was already present in the combination bortezomib and dexamethasone [arm],” Dr Palumbo said. The rates of thrombocytopenia and peripheral neuropathy were higher with the 3-drug regimen (59% and 47%, respectively) versus the 2-drug regimen (44% and 38%, respectively); this was attributed to the longer exposure to bortezomib in the 3-drug arm. Although the study examined the 3-drug regimen after ≥1 lines of previous therapy, exploring combination regimens in the early phases of disease is important, Dr Palumbo said. In multiple myeloma, daratumu mab “is likely to score high” on the Abacus value framework, said Deborah Schrag, MD, MPH, Chief, Division of Population Sciences, DanaFarber Cancer Institute, Boston. “It has high efficacy and a novel mechanism of action.” To recommend a fair launch price, Abacus incorporates drug efficacy, cost, toxicity, the novelty of the mechanism of action, the costs of developing the drug, the rarity of the disease, and the burden of the disease. n

CANCER DRUG CODING

Medications Used for the Treatment of Leukemia and Their Associated ICD-10 Codes By Kristin A. Esposito, CPhT Clinical Services Manager, RJ Health Systems

This detailed article of codes related to leukemia is intended to assist practice managers and other healthcare providers and payers to ensure their proper use of coding and billing information associated with the treatment of patients with leukemia. The following sections include: • Associated ICD-10-CM codes used for the classification of leukemia • Drugs that have been approved by the FDA for the treatment of leukemia • Drugs for Compendia off-label uses have no FDA-approved uses in leukemia. However, drugs that are FDA approved for at least one of the leukemia ICD-10-CM codes may also have Compendia off-label uses • Drugs that are Compendia-listed for off-label use for leukemia based on clinical studies that suggest beneficial use in some cases. Please note: If a check mark appears in the FDA column, it will NOT appear in the Compendia off-label use column • Corresponding HCPCS/CPT® codes and code descriptions • Possible CPT® administration codes for the drugs

Associated ICD-10-CM Codes: C90.1

Plasma cell leukemia C90.10 Plasma cell leukemia, not having achieved remission C90.11 Plasma cell leukemia, in remission C90.12 Plasma cell leukemia, in relapse

C90.2

Extramedullary plasmacytoma C90.20 Extramedullary plasmacytoma, not having achieved remission C90.21 Extramedullary plasmacytoma, in remission C90.22 Extramedullary plasmacytoma, in relapse

C90.3

Solitary plasmacytoma C90.30 Solitary plasmacytoma, not having achieved remission C90.31 Solitary plasmacytoma, in remission C90.32 Solitary plasmacytoma, in relapse

C91 C91.0

Lymphoid leukemia Acute lymphoblastic leukemia [ALL] C91.00 Acute lymphoblastic leukemia, not having achieved remission C91.01 Acute lymphoblastic leukemia, in remission C91.02 Acute lymphoblastic leukemia, in relapse

C91.1

Chronic lymphocytic leukemia of B-cell type C91.10 Chronic lymphocytic leukemia of B-cell type, not having achieved remission C91.11 Chronic lymphocytic leukemia of B-cell type, in remission C91.12 Chronic lymphocytic leukemia of B-cell type, in relapse

C91.3

Prolymphocytic leukemia of B-cell type C91.30 Prolymphocytic leukemia of B-cell type, not having achieved remission C91.31 Prolymphocytic leukemia of B-cell type, in remission C91.32 Prolymphocytic leukemia of B-cell type, in relapse Continued on page 42

CANCER DRUG CODING

Medications Used for the Treatment of Leukemia... Continued from page 40 C91.4 Hairy cell leukemia C91.40 Hairy cell leukemia, not having achieved remission C91.41 Hairy cell leukemia, in remission C91.42 Hairy cell leukemia, in relapse C91.5 Adult T-cell lymphoma/leukemia (HTLV-1–associated) C91.50 Adult T-cell lymphoma/leukemia (HTLV-1–associated), not having achieved remission C91.51 Adult T-cell lymphoma/leukemia (HTLV-1–associated), in remission C91.52 Adult T-cell lymphoma/leukemia (HTLV-1–associated), in relapse C91.6 Prolymphocytic leukemia of T-cell type C91.60 Prolymphocytic leukemia of T-cell type, not having achieved remission C91.61 Prolymphocytic leukemia of T-cell type, in remission C91.62 Prolymphocytic leukemia of T-cell type, in relapse C91.9 Lymphoid leukemia, unspecified C91.90 Lymphoid leukemia, unspecified, not having achieved remission C91.91 Lymphoid leukemia, unspecified, in remission C91.92 Lymphoid leukemia, unspecified, in relapse C91.A Mature B-cell leukemia Burkitt-type C91.A0 Mature B-cell leukemia Burkitt-type, not having achieved remission C91.A1 Mature B-cell leukemia Burkitt-type, in remission C91.A2 Mature B-cell leukemia Burkitt-type, in relapse C91.Z Other lymphoid leukemia C91.Z0 Other lymphoid leukemia, not having achieved remission C91.Z1 Other lymphoid leukemia, in remission C91.Z2 Other lymphoid leukemia, in relapse C92 C92.0 C92.1 C92.2 C92.3 C92.4

Myeloid leukemia Acute myeloblastic leukemia C92.00 Acute myeloblastic leukemia, not having achieved remission C92.01 Acute myeloblastic leukemia, in remission C92.02 Acute myeloblastic leukemia, in relapse Chronic myeloid leukemia, BCR/ABL-positive C92.10 Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission C92.11 Chronic myeloid leukemia, BCR/ABL-positive, in remission C92.12 Chronic myeloid leukemia, BCR/ABL-positive, in relapse Atypical chronic myeloid leukemia, BCR/ABL-negative C92.20 Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission C92.21 Atypical chronic myeloid leukemia, BCR/ABL-negative, in remission C92.22 Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse Myeloid sarcoma C92.30 Myeloid sarcoma, not having achieved remission C92.31 Myeloid sarcoma, in remission C92.32 Myeloid sarcoma, in relapse Acute promyelocytic leukemia C92.40 Acute promyelocytic leukemia, not having achieved remission C92.41 Acute promyelocytic leukemia, in remission C92.42 Acute promyelocytic leukemia, in relapse

CANCER DRUG CODING

C92.5 Acute myelomonocytic leukemia C92.50 Acute myelomonocytic leukemia, not having achieved remission C92.51 Acute myelomonocytic leukemia, in remission C92.52 Acute myelomonocytic leukemia, in relapse C92.6 Acute myeloid leukemia with 11q23-abnormality C92.60 Acute myeloid leukemia with 11q23-abnormality, not having achieved remission C92.61 Acute myeloid leukemia with 11q23-abnormality, in remission C92.62 Acute myeloid leukemia with 11q23-abnormality, in relapse C92.9 Myeloid leukemia, unspecified C92.90 Myeloid leukemia, unspecified, not having achieved remission C92.91 Myeloid leukemia, unspecified, in remission C92.92 Myeloid leukemia, unspecified, in relapse C92.A Acute myeloid leukemia with multilineage dysplasia C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission C92.A1 Acute myeloid leukemia with multilineage dysplasia, in remission C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse C92.Z Other myeloid leukemia C92.Z0 Other myeloid leukemia, not having achieved remission C92.Z1 Other myeloid leukemia, in remission C92.Z2 Other myeloid leukemia, in relapse C93 C93.0 C93.1 C93.3 C93.9 C93.Z

Monocytic leukemia Acute monoblastic/monocytic leukemia C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission C93.01 Acute monoblastic/monocytic leukemia, in remission C93.02 Acute monoblastic/monocytic leukemia, in relapse Chronic myelomonocytic leukemia C93.10 Chronic myelomonocytic leukemia, not having achieved remission C93.11 Chronic myelomonocytic leukemia, in remission C93.12 Chronic myelomonocytic leukemia, in relapse Juvenile myelomonocytic leukemia C93.30 Juvenile myelomonocytic leukemia, not having achieved remission C93.31 Juvenile myelomonocytic leukemia, in remission C93.32 Juvenile myelomonocytic leukemia, in relapse Monocytic leukemia, unspecified C93.90 Monocytic leukemia, unspecified, not having achieved remission C93.91 Monocytic leukemia, unspecified, in remission C93.92 Monocytic leukemia, unspecified, in relapse Other monocytic leukemia C93.Z0 Other monocytic leukemia, not having achieved remission C93.Z1 Other monocytic leukemia, in remission C93.Z2 Other monocytic leukemia, in relapse

C94 C94.0 C94.2

Other leukemias of specified cell type Acute erythroid leukemia C94.00 Acute erythroid leukemia, not having achieved remission C94.01 Acute erythroid leukemia, in remission C94.02 Acute erythroid leukemia, in relapse Acute megakaryoblastic leukemia C94.20 Acute megakaryoblastic leukemia, not having achieved remission C94.21 Acute megakaryoblastic leukemia, in remission C94.22 Acute megakaryoblastic leukemia, in relapse Continued next page

CANCER DRUG CODING

Medications Used for the Treatment of Leukemia... Continued from page 43 C94.3 C94.4 C94.6 C94.8

Mast cell leukemia C94.30 Mast cell leukemia, not having achieved remission C94.31 Mast cell leukemia, in remission C94.32 Mast cell leukemia, in relapse Acute panmyelosis with myelofibrosis C94.40 Acute panmyelosis with myelofibrosis, not having achieved remission C94.41 Acute panmyelosis with myelofibrosis, in remission C94.42 Acute panmyelosis with myelofibrosis, in relapse Myelodysplastic disease, not classified Other specified leukemias C94.80 Other specified leukemias, not having achieved remission C94.81 Other specified leukemias, in remission C94.82 Other specified leukemias, in relapse

C95 C95.0 C95.1 C95.9

Leukemia of unspecified cell type Acute leukemia of unspecified cell type C95.00 Acute leukemia of unspecified cell type, not having achieved remission C95.01 Acute leukemia of unspecified cell type, in remission C95.02 Acute leukemia of unspecified cell type, in relapse Chronic leukemia of unspecified cell type C95.10 Chronic leukemia of unspecified cell type, not having achieved remission C95.11 Chronic leukemia of unspecified cell type, in remission C95.12 Chronic leukemia of unspecified cell type, in relapse Leukemia, unspecified C95.90 Leukemia, unspecified, not having achieved remission C95.91 Leukemia, unspecified, in remission C95.92 Leukemia, unspecified, in relapse FDA approved for leukemia

Compendia off-label uses for leukemia

Possible CPT ® administration codes

Generic (brand) name

HCPCS code—code description

aldesleukin (Proleukin)

J9015 - Injection, aldesleukin, per single-use vial

√

96409

amifostine (Ethyol)

J0207 - Injection, amifostine, 500 mg

√

96374

aminocaproic acid (Amicar) *J3490 - Unclassified drugs

√

96365, 96366

aminocaproic acid (Amicar) S0017 - Injection, aminocaproic acid, 5 g

√

N/A

arsenic trioxide (Trisenox)

J9017 - Injection, arsenic trioxide, 1 mg

√

96413, 96415

asparaginase Erwinia chrysanthemi (Erwinaze)

J9019 - Injection, asparaginase (Erwinaze), 1000 IU

√

96401

azacitidine (Vidaza)

J9025 - Injection, azacitidine, 1 mg

√

96401, 96409, 96413

Bacillus Calmette-Guérin (BCG) vaccine

90585 - Bacillus Calmette-Guérin (BCG) vaccine for tuberculosis, live, for percutaneous

√

90471, 90472

Continued on page 46

CANCER DRUG CODING

Medications Used for the Treatment of Leukemia... Continued from page 44 FDA approved for leukemia

Compendia off-label uses for leukemia

Possible CPT ® administration codes

Generic (brand) name

HCPCS code—code description

Bacillus Calmette-Guérin (Tice BCG, TheraCys)

90586 - Bacillus Calmette-Guérin (BCG) vaccine for bladder cancer, live, for intravesical use

√

51720

Bacillus Calmette-Guérin (Tice BCG, TheraCys)

J9031 - BCG (intravesical), per installation

√

51720

bendamustine (Bendeka, Treanda)

J9033 - Injection, bendamustine HCl, 1 mg

√

96409, 96413

betamethasone acetate & sodium phosphate (Celestone Soluspan)

J0702 - Injection, betamethasone acetate, 3 mg, and betamethasone sodium phosphate, 3 mg

√

11900, 11901, 20600, 20605, 20610, 96372

blinatumomab (Blincyto)

J9039 - Injection, blinatumomab, 1 microgram

√

96413, 96415

bosutinib (Bosulif)

*C9399 - Unclassified drugs or biological (Hospital outpatient use only)

√

N/A

bosutinib (Bosulif)

*J8999 - Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

busulfan (Busulfex)

J0594 - Injection, busulfan, 1 mg

√

96415, 96416

busulfan (Myleran)

J8510 - Busulfan, oral, 2 mg

√

N/A

carboplatin (Paraplatin)

J9045 - Injection, carboplatin, 50 mg

chlorambucil (Leukeran)

*J8999 - Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

chlorambucil (Leukeran)

S0172 - Chlorambucil, oral, 2 mg

√

N/A

cladribine (Leustatin)

J9065 - Injection, cladribine, per 1 mg

√

96413, 96415

clofarabine (Clolar)

J9027 - Injection, clofarabine, 1 mg

√

96413, 96415

cyclophosphamide (Cytoxan)

J8530 - Cyclophosphamide, oral, 25 mg

√

N/A

cyclophosphamide (Cytoxan)

J9070 - Cyclophosphamide, 100 mg

√

96409, 96413, 96415

cytarabine (Cytosar-U)

J9100 - Injection, cytarabine, 100 mg

√

96409, 96413, 96415, 96450

dasatinib (Sprycel)

*J8999 - Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

daunorubicin (Cerubidine)

J9150 - Injection, daunorubicin, 10 mg

√

96409, 96413

decitabine (Dacogen)

J0894 - Injection, decitabine, 1 mg

√

96409, 96413, 96415

96413, 96415

dexamethasone (Decadron) J8540 - Dexamethasone, oral, 0.25 mg

√

N/A

dexamethasone (eg, Decadron)

√

11900, 11901, 20600, 20605, 20610, 96372, 96374

J1100 - Injection, dexamethasone sodium phosphate, 1 mg

Continued on page 48

CANCER DRUG CODING

Medications Used for the Treatment of Leukemia... Continued from page 46 FDA approved for leukemia

Compendia off-label uses for leukemia

Possible CPT ® administration codes

Generic (brand) name

HCPCS code—code description

doxorubicin (Adriamycin)

J9000 - Injection, doxorubicin hydrochloride, 10 mg

epirubicin (Ellence)

J9178 - Injection, epirubicin HCl, 2 mg

√

96409, 96413

etoposide (Vepesid)

J8560 - Etoposide, oral, 50 mg

√

N/A

etoposide (Toposar)

J9181 - Injection, etoposide, 10 mg

√

96413, 96415

filgrastim (Neupogen)

J1442 - Injection, filgrastim (G-CSF), 1 microgram

√

96365, 96366, 96369, 96370, 96372, 96374

fludarabine (Fludara)

J9185 - Injection, fludarabine phosphate, 50 mg

√

96413

hydrocortisone (Solu-Cortef)

J1720 - Injection, hydrocortisone sodium succinate, up to 100 mg

√

96365, 96366, 96372, 96374

hydroxyurea (Hydrea)

*J8999 - Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

hydroxyurea (Hydrea)

S0176 - Hydroxyurea, oral, 500 mg

√

N/A

ibrutinib (Imbruvica)

*J8999 - Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

idarubicin (Idamycin)

J9211 - Injection, idarubicin hydrochloride, 5 mg

√

96409

idelalisib (Zydelig)

*C9399 - Unclassified drugs or biological (Hospital outpatient use only)

√

N/A

idelalisib (Zydelig)

*J8999 - Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

ifosfamide (Ifex)

J9208 - Injection, ifosfamide, 1 gram

imatinib (Gleevec)

*J8999 - Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

imatinib (Gleevec)

S0088 - Imatinib, 100 mg

√

N/A

interferon alfa-2b (Intron A)

J9214 - Injection, interferon alfa-2b, recombinant, 1 million units

√

96372, 96401

irinotecan (Camptosar)

J9206 - Injection, irinotecan, 20 mg

mechlorethamine (Mustargen)

J9230 - Injection, mechlorethamine hydrochloride (nitrogen mustard), 10 mg

melphalan (Alkeran)

J8600 - Melphalan, oral, 2 mg

√

N/A

melphalan (Alkeran)

J9245 - Injection, melphalan hydrochloride, 50 mg

√

96409, 96413

mercaptopurine (Purinethol, Purixan)

*J8999 - Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

mercaptopurine (Purinethol, Purixan)

S0108 - Mercaptopurine, oral, 50 mg

√

N/A

96409

√

96413, 96415

96413, 96415 96409

√

CANCER DRUG CODING

FDA approved for leukemia

Compendia off-label uses for leukemia

Possible CPT ® administration codes

Generic (brand) name

HCPCS code—code description

mercaptopurine (Purixan)

*C9399 - Unclassified drugs or biological (Hospital outpatient use only)

√

N/A

methotrexate

J8610 - Methotrexate, oral, 2.5 mg

√

N/A

methotrexate

J9250 - Methotrexate sodium, 5 mg

√

96372, 96374, 96401, 96409, 96450

methotrexate

J9260 - Methotrexate sodium, 50 mg

√

96372, 96374, 96401, 96409, 96450

methylprednisolone (Depo-Medrol)

J1020 - Injection, methylprednisolone acetate, 20 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone acetate (Depo-Medrol)

J1030 - Injection, methylprednisolone acetate, 40 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone acetate (Depo-Medrol)

J1040 - Injection, methylprednisolone acetate, 80 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Medrol)

J7509 - Methylprednisolone, oral, per 4 mg

√

N/A

methylprednisolone sodium succinate (Solu-Medrol)

J2920 - Injection, methylprednisolone sodium succinate, up to 40 mg

√

96365, 96366, 96372, 96374

methylprednisolone sodium succinate (Solu-Medrol)

J2930 - Injection, methylprednisolone sodium succinate, up to 125 mg

√

96365, 96366, 96372, 96374

mitoxantrone (Novantrone)

J9293 - Injection, mitoxantrone hydrochloride, per 5 mg

√

96409, 96413

nelarabine (Arranon)

J9261 - Injection, nelarabine, 50 mg

√

96413, 96415

nilotinib (Tasigna)

*J8999 - Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

obinutuzumab (Gazyva)

J9301 - Injection, obinutuzumab, 10 mg

√

96413, 96415

ofatumumab (Arzerra)

J9302 - Injection, ofatumumab, 10 mg

√

96413, 96415

omacetaxine mepesuccinate (Synribo)

J9262 - Injection, omacetaxine mepesuccinate, 0.01 mg

√

96401

pegaspargase (Oncaspar)

J9266 - Injection, pegaspargase, per single-dose vial

√

96401, 96413, 96415

pentostatin (Nipent)

J9268 - Injection, pentostatin, per 10 mg

√

96409, 96413

ponatinib (Iclusig)

*C9399 - Unclassified drugs or biological (Hospital outpatient use only)

√

N/A

ponatinib (Iclusig)

*J8999 - Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A Continued next page

CANCER DRUG CODING

Medications Used for the Treatment of Leukemia... Continued from page 49 FDA approved for leukemia

Compendia off-label uses for leukemia

Possible CPT ® administration codes

Generic (brand) name

HCPCS code—code description

prednisolone (eg, Millipred)

J7510 - Prednisolone, oral, per 5 mg

√

N/A

prednisone (eg, Deltasone)

J7512 - Prednisone, immediate release or delayed release, oral, 1 mg

√

N/A

rituximab (Rituxan)

J9310 - Injection, rituximab, 100 mg

√

96413, 96415

sodium phosphate P-32

A9563 - Sodium phosphate P-32, therapeutic, per millicurie

√

79101

temozolomide (Temodar)

J8700 - Temozolomide, oral, 5 mg

teniposide (Vumon)

Q2017 - Injection, teniposide, 50 mg

topotecan (Hycamtin)

J9351 - Injection, topotecan, 0.1 mg

venetoclax (Venclexta)

*C9399 - Unclassified drugs or biological (Hospital outpatient use only)

√

N/A

venetoclax (Venclexta)

*J8999 - Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

vinCRIStine (Vincasar PFS)

J9370 - Vincristine sulfate, 1 mg

√

96409

vinCRIStine liposome (Marqibo)

J9371 - Injection, vincristine sulfate liposome, 1 mg

√

96413

zidovudine (Retrovir)

*J8499 - Prescription drug, oral, nonchemotherapeutic, not otherwise specified

√

N/A

zidovudine (Retrovir)

S0104 - Zidovudine, oral, 100 mg

√

N/A

√

N/A 96413, 96415

√ √

96413

*When billing a nonclassified medication using a CMS 1500 claim form you must include both the HCPCS code in Item 24D and the drug name, strength, and NDC (National Drug Code) in Box 19 or Item 24A (shaded area) in order to ensure appropriate reimbursement. Please note: Check with payer regarding correct placement of medication information. References • HCPCS Level II Expert 2016 • Current Procedural Terminology (CPT ®) 2016 • CPT Copyright © 2016 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association • ICD-10-CM for Professionals Volumes 1 & 2 2016 • FDA-approved indication (product Prescribing Information) • Compendia references available upon request • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Rocky Hill, CT • CMS (Centers for Medicare & Medicaid Services) G-CSF indicates granulocyte colony-stimulating factor; HCPCS, Healthcare Common Procedure Coding System.

This information was supplied by

30 Cold Spring Road, Rocky Hill, CT 06067 • T: (860) 563-1223 F: (860) 563-1650