OPM March 2014

MARCH 2014

www.OncPracticeManagement.com

VOLUME 4 • NUMBER 2

Oncology Practice Management ™

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

Dress Codes and Related Employee Appearance Issues

By Robert D. Orzechowski, MBA, SPHR, Chief Operating Officer, Lancaster Cancer Center, PA

O

ne of the most chal­ lenging is­ sues for human resource (HR) man­ agers is how best to align company policies regarding ap­­pearance, groom­­ ing, and hygiene with business necessity, safety, legal compliance, and reasonable accommo­ dation. This article identifies the sub­ stantive aspects of dress and appearance policies that should be considered when employers communicate their expecta­ tions to employees.

From the Editor

Managing Oncology Blindfolded: The Curse of the Health Exchanges

By Dawn Holcombe, MBA, FACMPE, ACHE, President, DGH Consulting, South Windsor, CT, Editor-in-Chief, Oncology Practice Management

I

n every state, some version of new insurance plans offered through health exchanges was unveiled at the beginning of the year…well, par­ tially unveiled. The focus of the media and plan administrators seems to be

entirely on getting the “right” patients to enroll, increasing the visibility of offerings before open enrollment ends this month, and trying to ignore the technical glitches many patients have Continued on page 6

The New Oncology Care Management Model

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

W

e all have a variety of rea­ sons for entering the nursing profession. My wish to be an oncology nurse developed from a desire to be challenged by new situations each day. In the more than 25 years

during my tenure as a nurse, I have had the opportunity to interview, hire, and manage hundreds of nurses. During this process, I have been instrumental in encouraging nurses to move toward Continued on page 22

Continued on page 21 From the publishers of

S

INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM

of n it o s D ia er VI ssoc ent O A rC y PR y the nce l MaDrug a a D N ou bity C poscted 20 o A y T t to mun S Pr rote ses…

N s h P m M TIE roug Co Code Cla A B r

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©2014 Engage Healthcare Communications, LLC

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Now enrolling Investigating ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Phase II Open-Label Study of the Efficacy and Safety of ABT-199 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion N=100

ABT-199 is an investigational agent that has not been approved by regulatory agencies for the use under investigation in this trial.

Primary Endpoint

Secondary Endpoints

• Overall response rate

• • • • • • • •

Complete remission rate Partial remission rate Duration of response Progression-free survival Time to progression Overall survival Percentage of patients who move on to stem-cell transplant Safety and tolerability of ABT-199

Key Inclusion Criteria • Adult patients ≥18 years of age • Diagnosis of CLL that meets 2008 IWCLL NCI-WG criteria (relapsed/refractory after receiving ≥1 prior line of therapy and 17p deletion) • ECOG performance score of ≤2 • Adequate bone marrow function • Adequate coagulation, renal, and hepatic function, per laboratory reference range

NCT#01889186 Reference: ClinicalTrials.gov.

@ 2013 Genentech USA, Inc. All rights reserved. BIO0001961500 Printed in USA.

To learn more about this study, please visit www.ClinicalTrials.gov.

Head March 2014 • Volume 4 • Number 2

Table of Contents PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Vice President/Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Publisher Cristopher Pires cpires@the-lynx-group.com Director, Client Services Lou Lesperance llesperance@the-lynx-group.com Editorial Directors Dalia Buffery dbuffery@the-lynx-group.com Anne Cooper acooper@the-lynx-group.com Associate Editor Lara J. Lorton Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Marie RS Borrelli The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Managers Andrea Boylston Jini Gopalaswamy Project Coordinators Jackie Luma Deanna Martinez IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

Oncology Practice Management ™

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

FROM THE EDITOR Managing Oncology Blindfolded: The Curse of the Health Exchanges...............................................................................................1

By Dawn Holcombe, MBA, FACMPE, ACHE

FEATURES Practice Management The New Oncology Care Management Model.............................................1

By Sheryl A. Riley, RN, OCN, CMCN

Practice Policies Dress Codes and Related Employee Appearance Issues…...........................1

By Robert D. Orzechowski, MBA, SPHR

Claims Processing Denials Management Isn’t Just Your Billing Department’s Concern…........................................................................................................18

By Matt Terry, MBA, BSRT (R)(T); and Candy Luna

DEPARTMENTS FDA Update…...................................................................................................10

Continued on page 4

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 reimbursment, staffing, electronic health records, REMS, and compliance with state and federal regulations.

POSTMASTER: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Oncology Practice Management™, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD. BPA Worldwide membership applied for September 2013.

March 2014

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Table of Contents

March 2014 • Volume 4 • Number 2

Oncology Practice Management™, ISSN 2164-4403 (print), is published 8 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2014 by Engage Healthcare Communications, LLC. All rights reserved. Oncology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

The ideas and opinions expressed in 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.

Oncology Practice Management ™

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

Continued from page 3

DEPARTMENTS Clinical Trial Tracker New Clinical Trials Under Way…......................................................................12 Medical Legal Update The Cost of Using Free Images for Your Website............................................16

By Caroline P. Wallitt, Esq; and Jennifer A. Kirschenbaum, Esq

Patient and Provider Access CMS Proposes to Erode Up to 3 of the 6 Medicare Part D Protected Drug Classes......................................................................................................20

By Sydney Abbott, JD

Drug Coding FDA-Approved Medications Used for the Treatment of Multiple Myeloma.............................................................................................23

EDITORIAL ADVISORY BOARD Editor-in-Chief Dawn Holcombe, MBA, FACMPE, ACHE President DGH Consulting South Windsor, CT

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

Peggy Barton, RN Practice Manager Toledo, OH

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

Risë Marie Cleland President Oplinc, Inc Portland, OR Patrick A. Grusenmeyer, ScD, FACHE President Christiana Care Health Initiatives Newark, DE

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Ruth Linné Lander, FACMPE Practice Administrator Columbus Oncology & Hematology Associates, Inc Columbus, OH

ONCOLOGY PRACTICE MANAGEMENT

I March 2014

Bonnie J. Miller, RN, BSN, OCN, FAAMA Administrative Director Women’s Cancer Center Fox Chase Cancer Center Philadelphia, PA Karna W. Morrow, CPC, RCC, CCS-P, PCS Senior Consultant CSI Coding Strategies, Inc Powder Springs, GA Robert D. Orzechowski, MBA, SPHR Chief Operating Officer Lancaster Cancer Center Lancaster, PA

Sheryl A. Riley, RN, OCN, CMCN Director of Clinical Services SAI Systems Shelton, CT Mary Pat Whaley, FACMPE, CPC Physician Advocate and Consultant www.managemypractice.com Durham, NC Carla C. Wood Balch, CPC, MS President Altos Solutions, Inc Los Altos, CA

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exhaust all possibilities.

We will…because patients are our priority.

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With continual communication and consistent follow-through, your dedicated Celgene Patient Support ® Specialist will streamline access to Celgene products by helping you and your patients with: • Benefits investigation

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• Co-pay assistance – Celgene Commercial Co-pay Program – Co-pay assistance through third-party organizations

Visit: www.CelgenePatientSupport.com Monday through Friday, 8:00 am to 7:00 pm ET

• Prescription status • Celgene free medication program • Celgene products and restricted distribution programs 4 out of 5 patients who requested assistance from Celgene Patient Support ® received their medication.

Celgene Patient Support® is a registered trademark of Celgene Corporation. © 2013 Celgene Corporation 09/13 US-CELG110059(1)

From the Editor

Managing Oncology Blindfolded…Continued from the cover encountered. However, very little attention is being spent on actually communicating with those expect­ ed to provide the care, and that is leaving oncology managers, in particular, in a real bind.

Six Top Challenges Health Exchanges Present to Oncology Managers (Private or Hospital Based) Am I in or out? Most exchange offerings are presented by insur­ ance carriers with an existing pres­ ence in the state. Many seem to rely on contractual language that grand­ fathers network panels for other insurance offerings into assumed networks for exchange insurance offerings. Still others seek to man­ age costs by narrowing networks so that healthcare providers might be excluded from some insurance offerings and not others. Very lit­ tle information is forthcoming from health plans to providers— and word from the street is that even less information is coming in response to multiple phone calls and e-mails seeking provider lists.

Published provider lists shown to enrollees on websites have been notoriously inaccurate. Providers need to know who they can serve, and patients in the middle of active treatment need to know if they will be able to continue treatment with their trusted caregivers.

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How am I to be paid? Providers are not receiving fee schedules for health exchange insurance offer­ ings. During the last few days of February, 1 practice in Connecticut, after multiple calls and e-mails, final­ ly reached someone in the largest private insurer in the state to get a verbal statement as to how the fee schedule was planned in relation to Medicare and Medicaid rates.

Businesses cannot stay in business if

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they provide services for 2 months with no idea of how they are going to be paid, especially when they have to purchase expensive oncolo­ gy drugs and treat with them before submitting a claim.

Providers need to know who they can serve, and patients in the middle of active treatment need to know if they will be able to continue treatment with their trusted caregivers.

3

Is my patient in or out? Of what? As patients start to appear with their insurance cards, some of the new cards make it very clear on the card itself that it is an exchange plan. Others do not. Some patients come in with printed enrollment forms, but are not recognized by the insurer when verification is done.

Not only does this add significant confusion to a previously crowded insurance marketplace, but it also adds costs in terms of time and delaying treatment for patients fac­ ing cancer. In Pennsylvania alone, the health exchange market is cov­ ered by 9 payers, offering a total of 126 different insurance packages that were not in existence in 2013.

4

Is my patient covered? For what?

Once the insurance plan is clar­ ified, patient coverage is another elusive creature. Oncology manag­ ers are having great difficulty iden­

ONCOLOGY PRACTICE MANAGEMENT

I March 2014

tifying what is covered, specifically in the insurance plan formularies.

It makes a huge difference, because many plans are building narrow for­ mularies as a response to having to open enrollment to patients with preexisting conditions. If they cannot control costs on the front end, they can attempt to do it on the back end by narrowing approved treatments and drug formularies. However, if you are a patient or a provider, especially in oncology, and you find that the chosen drug for treatment is not on a given formulary, not only does the patient then have an out-of-pocket respon­ sibility for that drug, but those pay­ ments also do not qualify against the patient’s other large deductibles and copay obligations for a given insurance plan in the exchange. This increases patients’ financial obligations as well as the likelihood that they will not be able to pay.

5

For how long is my patient covered? The biggest blind spot for oncology managers is whether their patient is covered for treat­ ment at the time treatment is pro­ vided. If patients enroll in health exchanges but have not paid their premiums consistently at any point during the year, the plan has the right to determine retroactively to 3 months that the patient is not covered. A practice or cancer cen­ ter therefore has to determine how, in its own state, it is able to broach to patients the question of whether they are current with their insur­ ance premiums. The stakes are too high not to do this. Do you ask for a cancelled check before treating? So far, because the focus of the insurers is on enrollment of patients, it has been almost impossible for oncolo­ gy groups to raise this topic with the insurers to work out alerts and realtime status of patient enrollment tied to premium payment.

From the Editor

6

Does underinsured count as uninsured? Is anyone truly uninsured under the Affordable Care Act (ACA)? What does that mean for patient assistance or “340B” programs? Patient assis­ tance programs have become an essential resource for patients and practices to ensure access to needed treatment. However, such programs have limitations depending upon whether a patient has access to “other insurance,” if they are in a federal insurance program, or if they are insured at any level. The chal­ lenge for oncology managers is how this new category of patients will be classified. Determining whether patients are in a federal program will vary by state. The burning question is whether narrow formu­ laries and narrow provider networks will create a new, large class of patients who are insured for some care, but possibly not the care they need, and whether the existence of minimal insurance then precludes those patients from certain patient assistance programs for which they might otherwise have qualified. If patients are considered eligible to sign up under the ACA and choose not to, are they then considered uninsured by choice and therefore no longer really uninsured? In par­ ticular, what will happen to hospi­ tals and their indigent population counts? Or their disproportionate share counts that allow them to qualify for 340B drug pricing (a federal program intended to allow hospitals that care for a dispropor­ tionate share of indigent patients to buy drugs for outpatient care at a much discounted rate)? If those patients don’t count, and hospitals don’t qualify for 340B, how might that affect recent hospital oncology service expansion and acquisition of formerly private oncology groups?

We do not yet have answers to these questions. States, the federal government, payers, pharmaceuti­ cal manufacturers, policy advocates, patient advocates, and providers are all seeking answers that are not yet forthcoming by any of those run­ ning the exchange programs. I was in a meeting recently with someone working with state insurance com­ missioners. Their focus regarding exchanges seemed to be on whether

happen to patients and providers as these programs unfold throughout the year.

What Can You Do in Your Group?

• Reach out to your state insur­ ance commissioner and insur­ ance advocates. Help them to understand how the process is not working, as well as the information gaps that are affect­ ing oncology patients and their access to needed treatment.

• Document requests for fee sched­ ule and formulary information to exchange plans, and report delays and lack of response to your state insurance commis­ sioner and your local senators and representatives.

• Quantify numbers of patients left on the sidelines regarding their access to cancer care relat­ ed to the exchanges and ACA. This may be crucial information as we move into the next elec­ tion cycle, no matter what your political persuasion may be. If we don’t document and track now, it will be as if it never hap­ pened 6 months from now.

• Remember, insurance exchang­ es are not insurance market­ places, no matter what they call themselves. There are a number of private insurance opportuni­ ties for every patient, and we are already hearing tales of patients finding better coverage for a lower cost in private offerings rather than in the exchanges, especially those who do not qualify for subsidies. Get the word out and help your patients (and even those who do not have cancer) understand that they have choices that are not limited to the options shown on the health exchange websites. l

The burning question is whether narrow formularies and narrow provider networks will create a new, large class of patients who are insured for some care, but possibly not the care they need.

the technology to enroll people was working and how much more we needed to get the enrollment up, especially among targeted pop­ ulations. When asked about the top 6 issues addressed above, the response was, “We are taking notes and learning for 2015.”

We cannot wait until 2015. Our oncology practices and cancer cen­ ters are operating blindly. Many have chosen not to participate in the exchanges yet, for these very reasons. Large groups announced that they would not participate in the first quarter of 2014, but are now opening up their providers to participate in the second quarter.

We still do not know what will

March 2014

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NEW FOR 2014

Oncology Practice Management, Advocacy, and Navigation An educational session for practice managers and other care providers focusing on cancer care and innovative delivery techniques.

CO-CHAIRS

MAY 9, 2014 Loews Hollywood Hotel Los Angeles, CA

Linda Bosserman, MD, FACP President Wilshire Oncology Medical Group

Vicki Kennedy, LCSW

Vice President, Program Development and Delivery Cancer Support Community

AGENDA 8:30am – 8:45am

Introductions and Opening Remarks Linda Bosserman, MD, FACP; Vicki Kennedy, LCSW

8:45am – 9:15am

Session 1: Cancer Care in Crisis: An Imperative for Change Douglas Blayney, MD, Ann & John Doerr Medical Director, Cancer Center, Stanford University Medical Center; Professor of Medicine, Stanford University School of Medicine

9:15am – 10:30am

Session 2: Innovation in Practice Management and Care Delivery: A Progress Report on Value-Based Innovation Linda Bosserman, MD, FACP, President, Wilshire Oncology Medical Group John Fox, MD, Associate Vice President of Medical Affairs, Priority Health John Sprandio, MD, Chief of Medical Oncology and Hematology, Oncology Management Services

10:30am – 10:45am

Break

10:45am – 11:45am

Session 3: Uniting the Patient, Provider, and Community Voice in Value-Based Cancer Care Terry Langbaum, Chief Administrative Officer, Kimmel Center, Johns Hopkins School of Medicine Lillie Shockney, RN, BS, MAS, Administrative Director, The Johns Hopkins Breast Center Kim Thiboldeaux, President & CEO, Cancer Support Community

11:45am – 1:00pm

Lunch/Meet the Experts Roundtables John Fox, MD, Associate Vice President of Medical Affairs, Priority Health Lillie Shockney, RN, BS, MAS, Administrative Director, The Johns Hopkins Breast Center John Sprandio, MD, Chief of Medical Oncology and Hematology, Oncology Management Services

1:00pm – 1:45pm

Keynote Address Michael A. Kolodziej, MD, National Medical Director, Oncology Solutions, Aetna

1:45pm – 2:00pm

Closing Remarks

AVBCC2014May9agenda Asize_20714

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FDA Update

OCT. 29 - NOV. 1, 2014

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A N N IV E RS A RY

SEPTEMBER 18-21, 2014

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First Drug Combination their side effects became intolerable, granted accelerated approval to ibru­ Approved for Unresectable at which point they began using the tinib for the treatment of patients or Metastatic Melanoma combination. Overall, 76% of pa­ with mantle-cell lymphoma, a rare The US Food and Drug Admin­ tients receiving the combination had and aggressive type of hematologic istration (FDA) approved the use of an objective response for an average cancer; this approval, too, was for dabrafenib (Tafinlar; GlaxoSmith­ of 10.5 months compared with 54% patients who had received at least 1 Kline) plus trametinib (Mekinist; of patients receiving dabrafenib alone previous therapy.

GlaxoSmithKline) as a new combi­ who had an objective response last­ The approval of ibrutinib for the AVBCC LEADERSHIP nation therapy for theFOURTH treatment of ingCONFERENCE 5.6 months. Clinical trials are Burttreatment of patients with CLL was ANNUAL Zweigenhaft, BS CEO patients with advanced melanoma ongoing to determine whether this President also and done under the priority review OncoMed that is unresectable or metastatic. combination will also result in process of the FDA, based on the The 2 drugs were individually improved survival. demonstration of the drug to have Deligdish, MD improvement on the approved by the FDA in 2013 for The FDA approved this combi­ Craig a K.significant Hematologist/Oncologist Loews Hollywood Hotel melanoma. Da­brafenib was initially nation under its accelerated pro­ Oncology safetyResource or efficacy of patients with Networks Los with Angeles, approved for patients melano­California gram, and also reviewed it under its this serious condition. Ibrutinib also ma whose tumors express the BRAF priority review. (January 8, 2014) received an orphan drug designa­ HELD IN PARTNERSHIP WITH Gary M. Owens, MD V600E mutation. The dabrafenib­ tion by the FDA. President Gary Owens Associates trametinib combination is indicat­ Ibrutinib Approved for The new FDA indication for ibru­ ed for patients with melanoma who Chronic Lymphocytic tinib for CLL is based on the results of www.regonline.com/avbcc2014 also have the BRAF V600E or Leukemia a clinical trial with 48 previously BRAF V600K mutation. Approx­ The FDA approved a new indi­ treated patients with CLL. Patients imately 50% of skin melanomas cation for ibrutinib (Imbruvica; were diagnosed with CLL, on aver­ CONFERENCE CO-CHAIRS YEAR have a BRAF mutation.

Pharmacyclics) for the treatment of PROGRAM age, 6.7DIRECTOR years before enrolling in the D. Shockney, RN, BS,received MAS The FDA approval was based onY EAR patients with chronic lymphocytic Lillie study and had 4 previous University Distinguished Service Associate Professor of Breast Cancer results of a clinical trial of 162 patients leukemia (CLL) who have received at therapies. Patients received oral ibru­ Departments of Surgery and Oncology with unresectable or metastatic mela­ least 1 previous therapy. The ap­proval Administrative tinib until progression or Director,disease The Johns Hopkins Center noma with the BRAF V600E or was granted under the FDA’s acceler­ Breast unacceptable toxicity.

Overall re­ Administrative Director, Johns Hopkins Cancer Programs FIFTH the ANNUAL BRAF V600K mutation; majority ated approval process to expedite Survivorship sponse was JHU seen inofnearly Associate Professor, School Medicine58% of the & of the patients were treatment-naïve. access patients,of Surgery, with Oncology a response duration of Navigation andto patients with CLL to this Departments Gynecology and Obstetrics Associate Professor, JHU School of Nursing They received dabrafenib as a single promising new medication.

5.6 months to 24.2 months during Baltimore, MD Survivorship Conference agent until their disease progressed or In November 2013, the FDA the study. (February 12, 2014) l

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A N N I V E R S A RY

Sharon Gentry, RN, MSN, AOCN, CBCN

Walt Disney World Dolphin Hotel Orlando, Florida

www.regonline.com/aonn2014

WCMC CONFERENCE CHAIR

THIRD ANNUAL CONFERENCE

Sanjiv S. Agarwala, MD

WORLD CUTANEOUS MALIGNANCIES CONGRESS

™

GLOBAL BIOMARKERS CONSORTIUM Clinical Approaches to Targeted Technologies TM

WORLD CUTANEOUS Marriott Marquis San Francisco MALIGNANCIES San Francisco, California CONGRESS www.CutaneousMalignancies.com TM

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www.GlobalBiomarkersConsortium.com

ONCOLOGY PRACTICE MANAGEMENT

I March 2014

Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC

Professor of Medicine Temple University School of Medicine Chief, Medical Oncology & Hematology St. Luke’s Cancer Center Bethlehem, PA

GBC CONFERENCE CHAIRS Jorge E. Cortes, MD

Chair, CML and AML Sections D.B. Lane Cancer Research Distinguished Professor for Leukemia Research Department of Leukemia, Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX

Roy S. Herbst, MD, PhD

Ensign Professor of Medicine Professor of Pharmacology Chief of Medical Oncology Director, Thoracic Oncology Research Program Associate Director for Translational Research Yale Cancer Center New Haven, CT

CONF_AsizePMC_11714

OL OLOG

Clinical Trial Tracker

New Clinical Trials Under Way

T

he following clinical trials are currently recruiting patients with melanoma for inclusion in several investi­ gations. Each trial description includes the NLM Identifier to use as reference with Clinical Trials.gov.

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Carboplatin, Paclitaxel, and Bevacizumab with or without Everolimus in Patients with Metastatic Malignant Melanoma The objective of this phase 2 trial is to determine whether the addi­ tion of everolimus to combination therapy with carboplatin, pac­ litaxel, and bevacizumab offers sufficient promise of an impact on progression-free survival in patients with metastatic malignant melano­ ma so that further testing will be recommended. Tumor response rate, overall survival time, and safe­ ty profile are among other objec­ tives that will be studied.

Patients who are aged ≥18 years with histologically confirmed stage IV disease may be eligible to partic­ ipate if additional criteria are met.

The study will be conducted at 310 sites in the United States. For more information, contact Study Chair­ man Robert McWilliams, MD, at 507-538-7623. The NLM Identifier is NCT00976573.

2

Comparing Com­ bination of LGX818 plus MEK162 and LGX818 Monotherapy versus Vemurafenib in Patients with BRAFMutated Melanoma (COLUMBUS) The purpose of this prospective, randomized, open-label, multicenter, parallel-group, phase 3 study is to compare the efficacy and safety of LGX818 plus MEK162 combination therapy and LGX818 monotherapy versus vemurafenib in patients with

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locally advanced unresectable or metastatic melanoma with a BRAF V600 mutation. Approximately 900 patients will be randomized 1:1:1 to 1 of the 3 treatment arms.

Patients aged ≥18 years with American Joint Committee on Cancer stage IIIB, IIIC, or IV locally advanced, unresectable, or metastat­ ic cutaneous melanoma and evi­ dence of at least 1 measurable lesion as detected by radiograph or photo­ graph may be eligible for inclusion if several other criteria are met.

Additional inclusion and exclusion criteria can be found at ClinicalTrials. gov using NLM Identifier NCT01909453. The study will be con­ ducted at 209 sites internationally and in the United States. For more information, contact Novartis Pharmaceuticals at 888-669-6682.

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Utility of Novel BRAF Test for Melanoma The objective of this observa­ tional study is to obtain blood sam­ ples from patients with stage II/III and unresectable stage IIIC/stage IV malignant melanoma. Tissue and/or blood samples will be compared and analyzed to help researchers better understand the BRAF V600 muta­ tion, with the hope that this knowl­ edge will further an understanding of melanoma and help plan future treat­ ment options for patients at each stage of this disease. Approximately 220 patients will be separated into 2 groups, one for patients with stage IIIC/IV melanoma (Group 1), and another for patients with stage II/III disease (Group 2).

Depending on their assigned group, patients will have 1 blood draw or ongoing blood draws for 1 to 2 years; samples will be taken during regularly scheduled blood draws that are part of patients’ standard mela­ noma care. Patients aged ≥18 years

ONCOLOGY PRACTICE MANAGEMENT

I March 2014

who are being treated at Massachusetts General Hospital, Dana-Farber Cancer Institute, or Beth Israel Deaconess Medical Center may be eligible to participate if certain other criteria are met. For more information, contact Ryan Sullivan, MD, at 617-643-3614 or rsullivan7@partners.org. The NLM Identifier is NCT01840527.

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A Multinational, Prospective, Observational Study in Pa­tients with Unresectable or Metastatic Melanoma (IMAGE) This study will examine the safety of ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the postap­ proval setting. Patients will be sepa­ rated into 2 cohorts: The first cohort will comprise 1000 ipilimumab-treat­ ed patients who will be identified and followed prospectively, and the second cohort will comprise 800 non–ipilimumab-treated patients.

Of the patients in the second cohort, 600 will be identified and followed prospectively, and 200 will be iden­ tified and followed retrospectively.

Patients aged ≥18 years will be selected from approximately 200 US and international medical prac­ tice sites. To be eligible for inclu­ sion, patients must have been diag­ nosed with unresectable or me­­tastatic melanoma, should have received at least 1 previous therapy for their diagnosis, and must meet additional inclusion and exclusion criteria. For more information, visit www.

BMSStudyConnect.com. The NLM Identifier is NCT01511913.

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Vorinostat for the Treatment of Pa­ tients with Metastatic Melanoma of the Eye This phase 2 trial examines how well vorinostat works in treating Continued on page 14

4TH ANNUAL CONFERENCE

MAY 6-9, 2014 LOEWS HOLLYWOOD HOTEL • LOS ANGELES, CA Government and Employers Co-Chairs Jayson Slotnik, JD, MPH

F. Randy Vogenberg, PhD, RPh

Vice President of Reimbursement Strategy & Innovation United BioSource Corporation

Principal Institute for Integrated Healthcare

Personalized Medicine and Payers Co-Chairs Michael A. Kolodziej, MD National Medical Director Oncology Solutions Aetna

Grant Lawless, RPh, MD, FACP Program Director Associate Professor University of Southern California

Oncology Practice Management, Advocacy, and Navigation Co-Chairs Linda Bosserman, MD, FACP

President Wilshire Oncology Medical Group

Vicki Kennedy, LCSW

Vice President, Program Development and Delivery Cancer Support Community

AVBCC Leadership Burt Zweigenhaft, BS President and CEO OncoMed

Gary M. Owens, MD

President Gary Owens Associates

www.AVBCConline.org

Craig K. Deligdish, MD Hematologist/ Oncologist Oncology Resource Networks

HELD IN PARTNERSHIP WITH

AVBCC2014chairs Asize_13114

NEW FOR 2014! Principles in Value and Market Access Educational sessions for Product Managers, Reimbursement Specialists, Account Managers, and Marketers focusing on access, reimbursement, proving product value, and international markets.

Clinical Trial Tracker

New Clinical Trials Under Way…Continued from page 12 patients with metastatic uveal mela­ noma who harbor a GNAQ or GNA11 mutation. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes need­ ed for cell growth. Overall objective response rate, overall survival, pro­ gression-free survival, and tolerabili­ ty will be evaluated.

The study will be conducted at Memorial Sloan-Kettering Cancer Center in New York and is open to patients aged ≥18 years with a con­ firmed diagnosis of metastatic uveal melanoma. An estimated 40 pa­ tients will be enrolled. For more information and a full list of inclu­ sion criteria, contact Richard D. Carvajal, MD, at 646-888-4161 or carvajar@mskcc.org. The NLM Identifier is NCT01587352.

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Evaluation of a New Anti­ cancer Immunotherapy in Pa­ tients with Nonoperable and Progressing Metastatic Cuta­n­eous Melanoma This phase 1 study investigates the safety, immunogenicity, and clinical activity of GSK2241658A antigen-specific cancer immuno­ therapeutic, a biologic therapy for the treatment of patients with non­ operable and progressing metastatic cutaneous melanoma. Primary out­ come measures include the occur­ rence of severe toxicities, as well as the induction of objective clinical response at various time points.

Patients who are aged ≥18 years with histologically proven, measur­ able metastatic cutaneous melanoma, and who meet all inclusion and exclu­ sion criteria may be eligible to partici­ pate. The study will enroll approxi­ mately 34 patients, and will take place in the United States, Australia, and several European countries. For more information, contact the US GlaxoSmithKline Clinical Trials Call Center at 877-379-3718 or GSK

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ClinicalSupportHD@gsk.com. The NLM Identifier is NCT01213472.

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Trial of Vemurafenib with or without Bevacizumab in Patients with BRAF V600 Mutation Melanoma This phase 2 randomized, openlabel study will help researchers determine the effectiveness of using vemurafenib and bevacizumab together compared with vemu­ rafenib alone. Researchers will investigate whether using both drugs lengthens the amount of time before a patient’s melanoma pro­ gresses, increases the number of patients whose melanoma responds to treatment, and impacts the occurrence of side effects versus the use of each drug separately.

Eligible patients will be aged ≥18 years and have metastatic or unre­ sectable stage IIIC, clearly progres­ sive melanoma with a BRAF V600E or BRAF V600K mutation; measur­ able disease; Eastern Cooperative Oncology Group performance sta­ tus of 0, 1, or 2; and no more than 2 previous systemic treatment regi­ mens for metastatic disease (certain previous therapies are permitted).

The study will be conducted in Massachusetts and the District of Columbia. For more information, contact Michael B. Atkins, MD, at 617-632-9250 or F. Stephen Hodi, MD, at 617-632-5053. The NLM Identifier is NCT01495988.

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Ipilimumab or High-Dose Interferon Alfa-2b for Patients with High-Risk Stage III-IV Melanoma that Has Been Removed

by Surgery The objective of this study is to evaluate recurrence-free survival among patients randomized to receive postoperative high-dose or low-dose ipilimumab versus those randomized to receive high-dose

ONCOLOGY PRACTICE MANAGEMENT

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interferon alfa-2b. Patients aged ≥18 years with recurrent melanoma or stage IIIB, IIIC, or IV disease that has been completely surgically resected may be eligible to partici­ pate if other criteria are met. Overall survival, safety, tolerability, and quality of life will also be studied.

The study will take place at 712 sites in the United States and 7 sites in Canada. For more information, contact Principal Investigator Ahmad A. Tarhini, MD, PhD, at 412-647-8073. The NLM Identifier is NCT01274338.

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Ipilimumab with or without Dabrafenib, and/or Tram­e­ti­nib for Patients with Meta­s­tatic or Unresectable Melanoma In this randomized phase 1 trial, investigators will evaluate the safe­ ty and tolerability of ipilimumab after lead-in BRAF and MEK inhib­ itors, alone or in combination, in patients with metastatic or unre­ sectable melanoma with a BRAF V600 mutation. Treatment arms include ipilimumab with a 25-day lead-in of dabrafenib and trame­ tinib, ipilimumab with a 25-day lead-in of trametinib alone, ipilim­ umab with a 25-day lead-in of da­brafenib alone, and ipilimumab without a lead-in therapy. Response rates, as well as safety and tolerabil­ ity, will also be studied.

Patients aged ≥18 years with con­ firmed unresectable or metastatic malignant melanoma harboring a confirmed BRAF V600 mutation may be eligible to participate if other criteria are met. The study will be conducted in Boston, MA, at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital.

For more information, contact Principal Investigator Jason J. Luke, MD, at 617-632-4715 or jason_ luke@dfci.harvard.edu. The NLM Identifier is NCT01940809. l

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Faculty Perspectives

™

Medical Legal Update

The Cost of Using Free Images for Your Website

By Caroline P. Wallitt, Esq; and Jennifer A. Kirschenbaum, Esq

P

racticing medi­ cine is no long­ er exclusively char­­acterized as pro­ viding patient care. A physician is now re­quired to be a skilled clinician, a marketing guru, an entrepreneur, an ac­countant, and a legal savant, given Jennifer A. the level of financial Kirschenbaum hurdles and oversight that are required to run a successful practice today. With the advent of digital media marketing, a physician must also now add “web designer” to his or her skill set. While private practitioners and institutions may have little in common in the way of operations, a common factor between them is that each seemingly must have a website or other online pres­ ence in order to compete in today’s marketplace.

Whether this task is tackled by senior management or is delegated to a hired intern, many physicians are involved at least to some extent in their website development and the creation and posting of market­ ing content. Understandably, strictly sticking to substance often results in a dull website, which could poten­ tially hamper ongoing marketing efforts and the original intended result of the marketing in the first place: to increase patient flow. To entice potential patients and referral sources, many practices seek to create website content with character, using images to add color and points of interest to the presentation. However, an often-overlooked consideration is whether the images that are chosen for a website are protected intellectual property, and whether their use with­ out permission could lead to potential exposure for an unaware user.

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Empowered by recent court deci­ sions, image owners are increasingly filing claims for copyright infringe­ ment. Under the law, anyone who violates any of the exclusive rights of a copyright owner has committed copyright infringement. The law does not require that the defen­ dant commit the infringement will­ fully—the infringing act itself is enough to impose liability, meaning that a company that unknowingly

The infringing act itself is enough to impose liability, meaning that a company that unknowingly uses copyrighted images without the owner’s permission can be held liable for infringement. uses copyrighted images without the owner’s permission can be held liable for infringement. As for dam­ ages, an infringer is liable for either: (1) the copyright owner’s actual damages and any additional profits of the infringer; or (2) statutory damages, which can be adjusted upward or downward based on the infringer’s culpability, or level of willfulness. Copyright owners often opt to sue for statutory damages, available only in limited circum­ stances, when the actual damages and additional profits are difficult to calculate.

As an example, in October 2013, a jury awarded microscopic pho­ tographer Andrew Paul Leonard

ONCOLOGY PRACTICE MANAGEMENT

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$1.6 million in actual damages for his copyright infringement claims against Stemtech International, Inc, a manufacturer of nutritional supplements that are sold through a network of more than 40,000 inde­ pendent distributors (Andrew Paul Leonard v. Stemtech Health Sciences, Inc [C.A. No. 08-067-LPS-CJB]).

Stemtech made the fateful mis­ take of copying 2 images—with­ out Leonard’s permission—for use in all of its promotional materials, including brochures, videos, DVDs, and websites. Stemtech was aware that it was using copyrighted imag­ es, because it had previously paid Leonard annual licensing fees for the use of his images.

From the facts that could be gleaned from the court docket as of this writing, with the official trial transcript set to be publicly released early this year, this unique case epitomizes the worst-case scenario for a company that copies online images for its own use without obtaining the proper permission to use them. The jury concluded that Stemtech was liable not only for its own direct copyright infringement, but it was also liable for the vicar­ ious and contributory copyright infringement for all of its indepen­ dent distributors who had also used Leonard’s images in their market­ ing materials, which contributed exponentially to Stemtech’s mon­ etary exposure. Because Stemtech’s marketing policies require that its independent distributors use only its replicated website and market­ ing materials to market or sell its products, Stemtech ended up using each copyrighted image abundantly for multiple years. Another fac­ tor that caused the actual damages to skyrocket was the jury’s likely acceptance of the $1500 fair market

Medical Legal Update

value rate for Leonard’s licensing fee, rather than the average licens­ ing fees of ~$125 and ~$226 for each of the 2 respective images that were actually charged by Leonard during the relevant time period.

It should be noted, however, that Leonard v. Stemtech is still not over; the 2 parties are currently briefing postjudgment issues and there is always the prospect of an appeal.

Granted, it is unlikely that anoth­ er company would be liable for the $1 million-plus in damages that the jury awarded Leonard without achiev­ ing the perfect storm of damage variables—a high fair market value licensing fee, numerous instances of infringement resulting from the distributors’ use of the images in their own marketing materials, mul­ tiple years of violations, and actual knowledge of the infringing activ­ ity. A more probable scenario is a medical practice procuring an image from the Internet and using it for its own use on its website without the awareness or knowledge of whether that image is copyrighted.

Under such circumstances, it is not unusual for such activity to result in a demand for money for copyright infringement now that copyright creators (and hungry col­ lection agencies as well as plaintiffs’ attorneys) are able to use “web crawlers” to identify copyrighted images that are being used without permission. In fact, some companies use these tactics to generate “robo letters” on behalf of copyright own­ ers for collection purposes, sending demands for payment to alleged copyright infringers en masse. (In the web community, Getty Images is notorious for this practice.) It is also not unusual for such demand letters to cite copyright infringement as justification for extortion, claiming entitlement to excessive fees in exchange for warding off the threat of legal action.

Many times, the recipient of a copyright infringement demand letter is the unknowing business owner who is guilty of nothing more than haphazardly selecting images from the Internet to create a more appealing web presence. In

es that can help to avoid copyright infringement exposure entirely include either avoiding the use of copyrighted material or securing the proper licensing rights to the copyrighted material before using it. Many professionals outsource their content creation or content management, so before engaging a third party to perform such services, it is important to inquire whether the company invests in protective measures to avoid the misuse of copyrighted content, and, when possible, incorporate indemnity protection into your vendor con­ tract with the third party against any misuse that may occur as a result of its efforts. Additionally, should you find yourself in receipt of a demand letter alleging the mis­ use of copyrighted material, do not send a check without contacting an attorney and performing proper due diligence regarding the claim.

For a review of any contract with a third party that is respon­ sible for content creation or man­ agement on your behalf, or for assistance/defense of any claim of copyright infringement, contact Caroline or Jennifer to discuss your options. l

Further mitigating any potential exposure, this time for actual damages, is whether the image is used for the economic benefit of the user, and whether any profit may be tied to the image’s use.

many instances, the selected images may not contain the mandatory statutory notifier, or the copyright mark (©), which could possibly mitigate the potential exposure for statutory damages because the image is not clearly identified as protected intellectual property.

Further mitigating any poten­ tial exposure, this time for actual damages, is whether the image is used for the economic benefit of the user, and whether any profit may be tied to the image’s use, as was the case in Leonard, where the images were tied to profit because they were prominently displayed on marketing materials. Depending on the circumstances surrounding the use of a protected image, any potential exposure for the misuse of such an image may range from very minimal to somewhat defensible, as it was in Leonard.

The recommended best practic­

March 2014

Caroline P. Wallitt, Esq, is a partner of Kirschenbaum & Kirschenbaum, P.C., and specializes in representing clients, especially those in the healthcare sector, in litigation, arbitration, mediation, and prelitigation disputes. She may be reached at 516-747-6700, x305, or by e-mail at CWallitt@kirschenbaum­ esq.com. Jennifer A. Kirschenbaum, Esq, is a partner of Kirschenbaum & Kirschenbaum, P.C., and specializes in representing healthcare clients in transactional, regulatory compliance, and general practice matters. She may be reached at 516-747-6700, x302, or by e-mail at JKirschenbaum@kirschenbaumesq.com.

For more information about the firm, visit www.kirschenbaumesq.com.

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Claims Processing

Denials Management Isn’t Just Your Billing Department’s Concern

By Matt Terry, MBA, BSRT (R)(T), Director of Oncology Business Operations; and Candy Luna, Corporate Office Manager, Revenue Cycle Inc

A

ccording to the Medical Group Management A­ s­ sociation, only 35% of pro­ viders appeal denied claims. Often, we think of denials as issues of medical necessity, but denials often occur for a variety of reasons: incor­ rect information, correct informa­ tion but in the wrong format, missed filing deadlines, or information sent to the wrong payer altogether.

Billing offices that do not pay close attention to the details of the claims processing system may spend a lot of money correcting claim errors. Correcting simple mistakes like these and refiling a claim costs approximately $15 per claim. Over time, these expenses add up and distract staff members from per­ forming their intended roles. And offices risk losing considerable reve­ nue if they assume that denialsbased nonpayment means they will never get paid.

Where and when do these claim errors originate? Determining their source is the first line of defense against denials.

Claim submission errors often originate from the time the patient is first registered in the practice database. Collecting all of the patient’s information and verifying that it is accurately put into the system seems like a simple task, but it can be complex and cumbersome.

Taking time to ensure staff mem­ bers understand and follow process­ es and policies pays off.

Claim denials can also originate with the clinical staff, including physicians. Incorrect diagnosis and procedural coding can lead to errors that billing staff members have to appeal based on their clinical

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knowledge. This means they must be educated on the procedure, the documentation that supports the procedure, and whether the docu­ mentation will support the service.

In some cases, the billing staff must

Correcting simple mistakes and refiling a claim costs approximately $15 per claim. Over time, these expenses add up and distract staff members from performing their intended roles.

reach out to clinical staff for this information; once everyone’s sala­ ries are factored in, this potentially increases the cost of an appeal.

Here are a few common reasons for a claim denial: • Patient registration errors.

These include outdated demo­ graphic or insurance information.

A periodic review of pa­ tient information can reduce the risk.

• Lack of referral/authorization.

More insurance payers are requiring preauthorization than in the past. Not understanding the requirements of each payer or neglecting to screen every patient for these requirements can lead to costly denials.

• Incorrect diagnosis codes.

Claims may be denied because a

ONCOLOGY PRACTICE MANAGEMENT

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payer required a more specific diagnosis code. Some payers will deny all claims with a diagnosis ending in “.9,” meaning unspeci­ fied. In addition, if the diagnosis code is not consistent with the current treatment course but instead applies to a past problem or issue, the claim may be denied.

• Correct coding edits. Edits are important to understand. Not applying a modifier to a service that edits another service will lead to a denial. If staff members do not understand code edits, they might mistakenly attach modifiers to every code. This is termed “hard coding.” While it may solve a problem temporari­ ly, it may also catch the atten­ tion of claim reviewers. Con­ tinuing to process claims with services that will not be paid due to edits creates additional, costly work on the back end.

• Duplicate billing. This common error may be a result of staff not paying attention to detail or not understanding how to submit claims to secondary payers. When a duplicate claim is submitted, it potentially increases overall accounts receivable and incurs increased costs to bill correctly.

• Timely filing. Staff members must be aware of timely filing deadlines for all payers, specifi­ cally the top payers. Missing deadlines will result in a loss of payment and the inability to recoup money owed.

• Changes to payers’ organiz­ ations. A payer may make chang­ es to its system (eg, requiring preauthorization for payment) without alerting participating

Claims Processing

practices. Staff members must stay informed: subscribe to and read all payer notifications and correspon­ dence to ensure your office takes proper action to amend current processes and ensure preauthoriza­ tion is obtained.

When billing offices receive numerous denials, staff may be overwhelmed by the appeals proce­ dure. Without organized tracking processes in place and the ability to educate staff members who provid­ ed incorrect information in the first place, significant progress will not be made. A sizeable number of denials can mean an increase in accounts receivable and potentially

lead to blanket appeals; that is, appealing all incoming denials without first understanding the root cause of the denial. Without under­ standing the root cause of a claim’s denial, it could likely be denied again, creating even more work.

And loose write-off policies are not the answer, either; writing off reve­ nue owed to the practice because of simple clerical errors can be very frustrating.

How can a practice determine where errors are coming from? Most billing software is able to append denial reason codes to each nonpay­ ment received. When nonpayment is posted to a patient’s account, a deni­

al reason code should also be added so formal reports can indicate where the issues are occurring. Denial codes should be set up by the system admin­ istrator and the reports tracked by billing office management.

Denials management is the pro­ cess of tracking claims denials and their reasons, working the appeals, and educating the staff who submit incorrect information. Claims deni­ als can adversely affect an office’s financial health, but if addressed properly, can be mitigated. What’s important to remember is that all staff members—not just those in charge of billing claims—must be involved in denials management. l

Your Expert Oncology Resource

Revenue Cycle Inc. delivers customized, leading-edge strategies and services.

Regardless of your practice setting, our team is able to offer an array of services customized to meet your needs.

Medical & Radiation Oncology Services • Billing, Coding & Compliance • Training & Education • Electronic Medical Record Implementation • Process Review & Development • Client Resource Center

• Remote Solutions • Front Office & Back Office Process Review • Revenue Enhancement • Regulatory Summation Updates • Proforma Creation

To speak to one of our experts, call 512.583.2000 or visit our website at www.revenuecycleinc.com.

March 2014

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Patient and Provider Access

CMS Proposes to Erode Up to 3 of the 6 Medicare Part D Protected Drug Classes

By Sydney Abbott, JD, Manager, Provider Economics and Public Policy, Association of Community Cancer Centers

T

he Centers for Medicare & Medicaid Services (CMS) re­ cently proposed a rule that would bring significant changes to the Medicare Part D and Medicare Ad­­ vantage programs.

Of all the changes proposed, oncology care providers and members of the Association of Community Cancer Centers (ACCC) are particularly concerned about the proposal to eliminate at least 2 of the 6 protected classes of drugs.

The Medicare prescription bene­ fit program, known as Part D, is a re­ sult of the Medicare Modernization Act of 2003 (MMA). Under MMA, CMS was tasked with ensuring that plans offered under Part D provided a robust formulary for patients.

CMS issued regulations requiring insurance companies that offered plans through Medicare Part D to cover all, or substantially all, of the drugs in the following 6 classes of clinical concern (ie, protected classes): immunosuppressants, anti­ convulsants, antineoplastics, anti­ depressants, antipsychotics, and antiretrovirals.

The Proposal Now, citing authority provided by the Affordable Care Act (ACA), CMS states that the former rule regarding the 6 protected classes has served its purpose by addressing a learning curve for beneficiaries, and changes should now be made to ensure efficiencies in the program.

CMS proposes to eliminate protect­

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ed class status for antidepressants and immunosuppressants in 2015, with discussion of eliminating the antipsychotic class in 2016. CMS justifies this proposal by saying the policy has driven up the cost of Medicare Part D, and cites patient protection concerns due to the potential for overutilization. The agency estimates that this proposal, if finalized, will save $1.3 billion between 2015 and 2019.

The agency’s proposal interprets the ACA to limit protected class status to only those drugs for which access to all drugs in a category or class is required within 7 days for the average person requiring treatment.

Upon consideration of the new cri­ teria, CMS found that drugs in the antidepressant and immunosuppres­ sant categories no longer need to be covered completely by Part D plans.

While CMS notes that antipsychot­ ics also fall outside of the new crite­ ria, they will remain on protected class status through 2015 while CMS further evaluates the need to protect them for 2016.

The Problem It is true that if plans are no lon­ ger required to cover all or substan­ tially all of the drugs in a class, savings will be realized through Part D. However, this does not ensure a reduction in costs across the healthcare system, since decreased access to drugs could result in increased hospitalizations and emergency room visits. This would be a substantial concern for cancer care providers in the event that the policy on protected classes is further eroded through future rule-making.

ONCOLOGY PRACTICE MANAGEMENT

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In addition, this proposed change creates a slippery slope. While Part D plans are still required to cover all or substantially all antineoplastic drugs, and oncology providers and their patients are not facing an immediate threat, the proposal by CMS certainly creates apprehen­ sion about the future of this policy.

In just 1 rule-making cycle, the CMS proposal would eliminate or directly threaten patient a­ccess to drugs in half of the protected classes that the agency once thought so important that it created a specific policy aimed at protecting patient access to them. For those with can­ cer, it is imperative that all drugs be available to patients; each patient reacts differently to medications, and changes in treatment regimens may be required as patients experi­ ence side effects or as their condi­ tion advances.

The Solution CMS should listen to the public and not erode the coverage require­ ments for protected classes. Because of the large number of patients potentially affected by this policy change, many groups are outraged and are encouraging CMS to aban­ don its proposal. In fact, the US Senate Finance Committee wrote a letter to CMS Administrator Marilyn Tavenner stating, “We are very concerned this change will lead to decreased access to medica­ tion….Unfortunately, over the course of treatment, certain medi­ cations may cause undesired side effects or become ineffective. As a result, certain beneficiaries must have a wide range of treatment Continued on page 21

Practice Policies

Dress Codes and Related Employee…Continued from the cover Policies covering these issues are generally accepted as the province of the employer, who develops them in compliance with state and federal regulations. Exceptions may exist within public sector entities or when employees are covered by a collective bargaining agreement.

Policies should be clearly written, and each policy should include a pur­ pose, summary, and scope (eg, who is covered by it, specific departments, and eligibility), as well as relevant definitions and the actual policy nar­ rative. This last part should include the basic course of action or general approach designed to achieve the results desired. Finally, these poli­ cies should direct employees to seek management’s guidance or approval if the appropriateness of any specific course of action or employee deci­ sion may be in question. In many cases, if a compromise cannot be eas­ ily agreed upon, management should reserve the right to send an employ­ ee home to correct a policy violation before returning to work.

Business necessity should be the driving force when developing such policies. This standard can range from safety (no open-toed shoes) to comfort (shorts for delivery person­ nel in hot weather) and company branding (ie, uniforms or formal business attire and a clean, profes­ sional image). In many workplaces,

attire that is too provocative must be addressed immediately by the employer to minimize harassment issues. Dress code policies reinforce company culture and values, and each job description should include clear and valid requirements for a particular dress and grooming standard.

sex or group. A more contempo­ rary dimension includes the topics of sexual orientation and trans­ gender employees. As with any accommodation, employers should make good faith efforts to identify and implement them. The excep­ tion, of course, is if the accommo­ dation creates an undue hardship for the employer.

Personal grooming and hygiene are topics usually addressed in relat­ ed policies. Topics should include standards of cleanliness, naturally occurring hair colors, hair length, absence of unpleasant body odor, use (or prohibition) of personal fra­ grances and other grooming prod­ ucts, visible body piercings, and body art. HR must have the communica­ tion skills necessary to address real or potential violations with employees in a professional manner.

Many of today’s workforces are widely diverse, and companies would be wise to reexamine their appearance and grooming policies to accommodate this diversity.

Employers should strive for a cul­ ture of respect, open communica­ tion, fair and reasonable treatment, and a genuine concern for employ­ ee safety and productivity. This is simply good business and sound management. Finally, all HR poli­ cies should receive legal review on a regular basis. l

One of the most challenging issues for HR managers is how best to align company policies regarding appearance.

Closely related issues include responding to employee requests for accommodation for health or religious reasons, or for reasons related to other factors that place the employee in a protected class.

These can include headwear, jew­ elry, hair placement or length, and allergic reactions to certain materials. Policies must also strive for fair treatment of all races, both sexes, and any employee in a pro­ tected class; policies cannot be unnecessarily burdensome for one

CMS Proposes to Erode Up to 3 of the 6…Continued from page 20 options available. By limiting the number and type of medications offered under a Part D plan, a bene­ ficiary may be forced to rely, if only temporarily, on medication that simply does not work or results in adverse side effects.”

At the start of the Part D pro­

gram, CMS recognized the impor­ tance of protecting vulnerable patients who may lose access to their drugs when transitioning into the Part D program; that is why policy was developed to protect the 6 drug classes. Erosion of this policy now will certainly have a chilling

March 2014

effect on Medicare Part D enroll­ ment, and CMS should not imple­ ment this policy.

ACCC will be submitting com­ ments on the proposed rule and will make them available to members on its website. We will keep members updated on this issue. l

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Practice Management

The New Oncology Care Management…Continued from the cover oncology care management; this is something of which I am proud.

Oncology care management is on the cutting edge of new treatments, im­ proved testing and screening, and continual advancements in research. I am newly energized about this field; for the first time in many years, there has been a true increase in survivors of most types of cancer. Even 5 to 10 years ago we could not make that type of state­ ment, and thus our focus remained on treatment options, side effect management, and transitioning to hospice care. Currently, cancer sur­ vivors total 14 million, and this number is growing every year. We have begun to treat certain cancers as a chronic illness. This extraordi­ nary feat does not come without strings though, and this incredible success is fraught with many new challenges for oncology care man­ agers. Following are some of these challenges: Lasting side effects from cancer treatments: • Chemo brain (issues with con­ centration, memory, order, or focus): It can last 6 months to years after chemotherapy; this is a lingering reminder of cancer for patients who are trying to put it behind them.

• Body image changes (related to surgeries or treatments): Patients will deal with physical and phys­ iologic changes that can have long-term effects; as survivors return to daily routines, they will face challenges that remind them of their cancer.

• Changes in lung capacity (short­ ness of breath, inability to per­ form tasks previously done with ease): Surgical treatments or medication may reduce patients’ lung capacity. If it affects their ability to return to work, patients may need to find a new job.

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• Changes in waste elimination (kidney, bladder, and bowel; appliances): Patients may have surgical treatments that leave them with an external appli­ ance; this will change how they interact with family and friends.

• Changes to the circulatory sys­ tem (heart, vascular), lymphatic system (edema, lack of circula­ tion), and nervous system (neu­ ropathies): Chemo­ therapy and radiation therapy can have a devastating and lasting effect on the heart and circulatory system, leaving patients with decreased cardiac function, decreased or poor peripheral circulation, and overall fatigue. This process could render the patient disabled and make them feel “worthless.”

• Depression and anxiety: Under­ served areas of cancer manage­ ment, depression and anxiety are not always outwardly apparent.

Disability: Patients often wonder if they will be permanently or tempo­ rarily disabled.

Return to work: Patients are con­ cerned about when they can go back, whether their diagnosis and treatment will affect how they do their job, and if their boss and col­ leagues will understand. The patient also questions whether to tell his employer or others at the office.

Change in job: Patients often are apprehensive about seeking a new job, and are unsure whether to tell prospective employers about their cancer, fearing it may negatively impact their chances of a job offer.

Also, if a new job is secured, pa­ tients are concerned about their ability to keep up with scheduled follow-up appointments, screen­ ings, and lab work.

Return to life after cancer treatment: As survivors transition back to life with family and friends, they may be apprehensive about a return

ONCOLOGY PRACTICE MANAGEMENT

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to daily activities, transitioning from their oncologist to primary care physician, keeping up with medications and their side effects, and maintaining an active lifestyle.

Assisting patients in making the transition from cancer patient to cancer survivor is critical. To do this we must also change the way we think and how we apply our care management expertise. A small per­ centage of patients will gladly walk away from cancer; they will attempt to forget it and move on with their lives. We must help them under­ stand that putting cancer emotional­ ly behind them is good, yet mainte­ nance is needed to keep the cancer from recurring. The importance of keeping posttreatment follow-up, blood work, and screening appoint­ ments, as well as being aware of signs and symptoms of recurrence, are essential parts of survivorship.

In addition, we must reinforce the need to continue preventive therapies. Approximately 33% of patients with breast cancer on hor­ mone therapy, for example, stop taking their medicine before com­ pleting the full 5 years of treatment, even with strong evidence that it can decrease recurrence of cancer not only in the first 3 to 5 years, but over their lifetime. This is an oppor­ tunity to educate and advocate for our patients; we need to utilize care coaching skills to keep the door open so patients and families feel comfortable asking questions about side effects, costs, and recurrence.

The key to successful transition from cancer patient to cancer survi­ vor and ongoing education and pre­ vention for patients with cancer rests in our hands. We must contin­ ue to strive for better patient and family education, stronger commu­ nication and coaching skills, and overall im­proved engagement with patients and their families. l

Drug Coding Supplied by RJ Health Systems

FDA-Approved Medications Used for the Treatment of Multiple Myeloma The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with the treatment of multiple myeloma. Associated ICD-10-CM codes, which are slated to go into effect October 1, 2014, have also been included.

The following sections include: • Associated ICD-9-CM and ICD-10-CM codes used for the classification of multiple myeloma • Drugs that have been FDA approved in the treatment of multiple myeloma • Drugs that are Compendia-listed for off-label use for multiple myeloma 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 • Drugs listed in the Compendia section have no FDA-approved uses for multiple myeloma. However, drugs in the FDA-approved section are FDA approved for at least 1 of the multiple myeloma ICD-9-CM and ICD-10-CM codes but may also have Compendia-listed uses as well.

Associated ICD-9-CM codes for the treatment of multiple myeloma 203 Multiple myeloma and immunoproliferative neoplasms 203.0 Multiple myeloma

Kahler’s disease Myelomatosis

Excludes: solitary myeloma (238.6) The following fifth-digit subclassification is for use with category 203:

0 without mention of having achieved remission

>Failed remission<

1 in remission

2 in relapse

Associated ICD-10-CM codes (effective October 1, 2014) for the treatment of multiple myeloma C90

Multiple myeloma and malignant plasma cell neoplasms C90.00 Multiple myeloma not having achieved remission C90.01 Multiple myeloma in remission C90.02 Multiple myeloma in relapse

FDA approved for multiple myeloma

Compendia-listed off-label uses for multiple myeloma

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: code description

arsenic trioxide (Trisenox)

J9017: Injection, arsenic trioxide, 1 mg

√

96413, 96415

betamethasone acetate and sodium phosphate (Celestone Soluspan)

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

√

11900, 11901, 20600, 20605, 20610, 96372

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Drug Coding

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FDA approved for multiple myeloma

Compendia-listed off-label uses for multiple myeloma

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: code description

bortezomib (Velcade)

J9041: Injection, bortezomib, 0.1 mg

√

96409

carfilzomib (Kyprolis)

J9047: Injection, carfilzomib, 1 mg

√

96409

carmustine (BiCNU)

J9050: Injection, carmustine, 100 mg

√

96413, 96415

cisplatin (Platinol-AQ)

J9060: Injection, cisplatin, powder or solution, per 10 mg

cyclophosphamide (Cytoxan)

J8530: Cyclophosphamide, oral, 25 mg

√

N/A

cyclophosphamide (Cytoxan)

J9070: Cyclophosphamide, 100 mg

√

96409, 96413, 96415

dexamethasone (Decadron)

J8540: Dexamethasone, oral, 0.25 mg

√

N/A

dexamethasone (Decadron)

J1100: Injection, dexamethasone sodium phosphate, 1 mg

√

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

doxorubicin HCl (Adriamycin)

J9000: Injection, doxorubicin hydrochloride, 10 mg

√

96409

doxorubicin HCl liposomal (Doxil)

Q2050: Injection, doxorubicin hydrochloride, liposomal, not otherwise specified, 10 mg

epirubicin (Ellence)

J9178: Injection, epirubicin hydrochloride, 2 mg

√

96409, 96413

etoposide (VePesid)

J8560: Etoposide, oral, 50 mg

√

N/A

etoposide (Etopophos, Toposar)

J9181: Injection, etoposide, 10 mg

√

96413, 96415

hydrocortisone (Solu-Cortef)

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

√

96365, 96366, 96372, 96374

hydrocortisone (Cortef)

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

√

N/A

ifosfamide (Ifex)

J9208: Injection, ifosfamide, 1 gram

√

96413, 96415

interferon alfa-2b (Intron A)

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

√

96372, 96401

interferon alfa-n3 (Alferon N)

J9215: Injection, interferon, alfa-n3 (human leukocyte derived), 250,000 IU

√

11900, 11901

lenalidomide (Revlimid)

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

ONCOLOGY PRACTICE MANAGEMENT

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√

96413

√

√

96409, 96413, 96415

N/A

Drug Coding

FDA approved for multiple myeloma

Compendia-listed off-label uses for multiple myeloma

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: code description

lomustine (CeeNU)

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

√

N/A

lomustine (CeeNU)

S0178: Lomustine, oral, 10 mg

√

N/A

melphalan (Alkeran)

J8600: Melphalan, oral, 2 mg

√

N/A

melphalan (Alkeran)

J9245: Injection, melphalan hydrochloride, 50 mg

√

96409, 96413

methylprednisolone (Medrol)

J7509: Methylprednisolone, oral, per 4 mg

√

N/A

methylprednisolone (Depo-Medrol)

J1020: Injection, methylprednisolone acetate, 20 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Depo-Medrol)

J1030: Injection, methylprednisolone acetate, 40 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Depo-Medrol)

J1040: Injection, methylprednisolone acetate, 80 mg

√

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Solu-Medrol)

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

√

96365, 96366, 96372, 96374

paclitaxel (Taxol)

J9265: Injection, paclitaxel, 30 mg

√

96413, 96415

peginterferon alfa-2b (PegIntron)

J3590*: Unclassified biologics

√

96372

peginterferon alfa-2b (PegIntron)

S0148: Injection, pegylated interferon alfa-2b, 10 mcg

√

96372

pomalidomide (Pomalyst)

C9399*: Unclassified drugs or biologics (hospital outpatient use ONLY)

√

N/A

pomalidomide (Pomalyst)

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

√

N/A

prednisolone (eg, Millipred, Prelone)

J7510: Prednisolone, oral, per 5 mg

√

N/A

prednisone (eg, Deltasone, Orasone)

J7506: Prednisone, oral, per 5 mg

√

N/A

procarbazine (Matulane)

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

√

N/A

procarbazine (Matulane)

S0182: Procarbazine hydrochloride, oral, 50 mg

√

N/A

teniposide (Vumon)

Q2017: Injection, teniposide, 50 mg

√

96413, 96415

March 2014

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Drug Coding

FDA approved for multiple myeloma

Compendia-listed off-label uses for multiple myeloma

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: code description

thalidomide (Thalomid)

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

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

√

96413

vincristine (Vincasar PFS)

J9370: Vincristine sulfate, 1 mg

√

96409

N/A

√

MAY 6-9, 2014

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AVBCC LEADERSHIP *When billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code in Column 24D FOURTH ANNUAL CONFERENCE Burt Zweigenhaft, BS and the drug name, strength, and NDC (National Drug Code) in Box 19 or 24A to ensurePresident appropriate and CEO reimbursement.

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References Craig K. Deligdish, MD Medical Association.

• HCPCS Level II Expert 2014 • Current Procedural Terminology (CPT ® ) 2014 (copyright 2014 American Hematologist/Oncologist Loews Hollywood Hotel Resourcefor Network s All rights reserved. CPT is a registered trademark of the American Medical Association)Oncology • ICD-9-CM Professionals Volumes Los Angeles, California 1 & 2, 2014 • ICD-10-CM 2014 • FDA-approved indication (from product Prescribing Information) • Compendia references available upon request • www.ReimbursementCodes.com

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