OPM February 2013 Vol3 No1 by Value-Based Cancer Care

Oncology Practice Management ™

process improvements to enhance patient care™

www.OncPracticeManagement.com

February 2013

When Hospital Employment Is Not an Option Teri U. Guidi, MBA, FAAMA President and CEO, Oncology Management Consulting Group, Pipersville, PA

ayers, just like the rest of us, do not want to pay more than they have to for anything. Over the years, payers have used countless strategies to reduce their costs. Some have worked, some have not. The most successful efforts include Medicare’s 2005 shift in drug reimbursement methodology from average wholesale price (AWP) to average sales price (ASP). At the time, the Office of Inspector General (OIG) estimated that the median price difference between ASP and AWP was 49%.1 In 2006, the Medicare Payment Advisory Commission issued Continued on page 6

Volume 3 • Number 1

Implementing EHR in Your Practice Requires Research, Training, and Patience By Wayne Kuznar

Atlanta, GA—Implementing electronic health record (EHR) technology requires a commitment from every person in a medical practice to reap the benefits of the technology. At the 2012 annual meeting of the American Society of Hematology, Mark A. Sitarik, MD, outlined the principles of successful adoption and implementation of health information technology

(IT), from selection to clinical decision support. As the Medical Director for iKnowMed at McKesson Specialty Health, Dr Sitarik offered an insider’s perspective, explaining that expectations for ease of use must be realistic. EHR will not make you faster, he said, but rather it will improve efficiencies in your practice. Continued on page 14

How Does Oncology Fit in an ACO World? By Gail Thompson

Dallas, TX—On a regular basis, news headlines across the country announce the opening of another accountable care organization (ACO)—a phrase that was rarely, if ever, heard before the passage of the Affordable Care Act. This game-chang-

ing healthcare reform element created the mechanism for Medicare providers to establish ACOs. At the 2012 Cancer Care Business Summit (CCBS), Ronald Barkley, MS, JD, President of the Cancer Center Business Development Group, Bedford, Continued on page 12

From the publishers of

of n it o s d ia ter vi ssocCen age o A r er Pr y thence Covncer a l 2 d n ou bity C ima r Ca ....3 a o y un in ve ts? t n ght t mm he M Co tien e ti u o l t an Pa a Bro C Wil Pl

INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM

This is the biologic medicine That the patient counts on That the nurse trusts That the pharmacist has confidence in That the doctor relies on Because it was manufactured knowing the patient’s treatment depends on it. Building confidence in the quality and supply of biologic medicines starts with a deeper understanding of how these medicines are made. After all, there’s so much at stake.

That’s why manufacturing matters. Learn more at buildingbiologics.com

From the Editor

A New Year, What Will It Bring? By Dawn Holcombe, MBA, FACMPE, ACHE

e have survived yet another bout with the Medicare Sustainable Growth Rate, the “fiscal cliff ” deductions, as well as significant cuts from Medicare, and the year has only started. It is difficult enough to manage an oncology medical practice today: to balance staffing, physician, supply, patient, billing, contracting, regulatory, Occupational Safety and Health Administration, purchasing, and drug management issues. Since approximately 2002, a new layer of concerns and the need for involvement has surfaced—a need to watch the political winds, to listen to the fiscal debates, to understand healthcare reform. At times, it may become overwhelming. It also is invigorating. These are the times when good leadership and management skills will rise to the surface, when business acumen and

strategic direction become more valuable than gold. Oncology practice managers will know the business of oncology from the inside out. You will be in demand. We may see large, clinically integrated organizations emerge from the fertile soil of the current accountable care organizations. We do not yet know whether stable and sizable oncology practices will have survived the turmoil of 2013—and maybe even 2014—to be there to connect with these that may span cities, states, or even regions. I like to think that they will. We do know that 2013 will continue to be a year of negotiating and establishing strong business practices, with an eye toward proving value: to patients, to contractors, to potential business partners, and to referral sources. We also know that

Editorial Advisory Board

Editor-in-Chief Bruce A. Cutter, MD President Cutter HealthCare Consulting Spokane, WA

Ronald Barkley, MS, JD President Cancer Center Business Development Group Bedford, NH

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

Risë Marie Cleland President Oplinc, Inc Lawton, OK

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

Dawn Holcombe, MBA, FACMPE, ACHE President DGH Consulting South Windsor, CT

Peggy Barton, RN Practice Manager Toledo Clinic, OH

strong business leaders of oncology (physicians and administrators) will be in demand and will want to sit at the table as the new future of healthcare is shaped. The key will be to understand not only the oncology business but also to envision how the full continuum of care flows around and through oncology as a disease state, and to help build a new healthcare model that builds from strengths and eliminates weaknesses. I am very optimistic that we can do this—that we have the drive and wits to go into 2013 with excitement and hope. Our patients are counting on us to lead the way, and to continue the fight against cancer, adapting to this new world along the way. Things will never be the same again, but that will be a good move, eventually. l

Patrick A. Grusenmeyer, ScD, FACHE President Christiana Care Health Initiatives Newark, DE

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

Cindy C. Parman, CPC, CPC-H, RCC CSI Coding Strategies, Inc Powder Springs, GA Jeffrey A. Scott, MD Senior Vice President Cardinal Health Dublin, OH Carla C. Wood, CPC, MS President Altos Solutions, Inc Los Altos, CA

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

February 2013

www.OncPracticeManagement.com

In This Issue

PUBLISHING STAFF Publisher Nicholas Englezos nick@engagehc.com 732-992-1884 Editorial Director Dalia Buffery dalia@engagehc.com 732-992-1889 Managing Editor Lisa Neuman lneuman@the-lynx-group.com 732-992-1885 Associate Publisher American Health & Drug Benefits Maurice Nogueira maurice@engagehc.com 732-992-1895 Associate Publisher Cristopher Pires cris@engagehc.com 732-992-1896 Associate Publisher Joe Chanley joe@engagehc.com 732-992-1524 Associate Editor Lara J. Lorton lara@engagehc.com 732-992-1892 Editorial Assistant Jennifer Brandt jbrandt@the-lynx-group.com 732-992-1536 Production Manager Marie R. S. Borelli National Accounts Manager Zach Ceretelle Quality Control Director Barbara Marino Business Manager Blanche Marchitto 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 cancer patients deserve, providers must master the ever-changing business of oncology. Oncology Practice Management will offer 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 A New Year, What Will It Bring?.............................................. 3 By Dawn Holcombe, MBA, FACMPE, ACHE

Features When Hospital Employment Is Not an Option.....................1 By Teri U. Guidi, MBA, FAAMA

Implementing EHR in Your Practice Requires Research, Training, and Patience........................................1 By Wayne Kuznar

How Does Oncology Fit in an ACO World?..........................1 By Gail Thompson

ASCO Prepares for the Future of Oncology Practice.................................................................24 By Lisa Neuman

Drug Coding FDA-Approved Medications Used for Supportive Care in Cancer Treatment..........................26 Departments Medical Legal Update

Understanding Bankruptcy as a Tool for the Continued Operation of a Medical Practice.....................18 By Michael A. Sabella, Esq, and Jennifer Kirschenbaum, Esq

Patient and Provider Access Brought to you by the Association of Community Cancer Centers

Essential Health Benefits: Will the Minimum Coverage Plan Cover Cancer Patients?…....................... 32 By Sydney Abbott, JD

Physician Wealth Management

Hospital Employment of Oncologists.........................................35 By Ron Lebow, Esq, Carey F. Kalmowitz, Esq, and Lawrence B. Keller, CFP®

Oncology Practice Management™, ISSN 2164-4403 (print), is published 6 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2013 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. 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.

Oncology Practice Management

I February 2013

We Will

exhaust all possibilities.

We will…because patients are our priority. Celgene Patient Support® provides free and personalized assistance with patients’ access and reimbursement needs. 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

To Contact Celgene Patient Support®:

• Prior authorization

Call: 1-800-931-8691

• Appeal support

E-mail: patientsupport@celgene.com

• Medicare

Fax: 1-800-822-2496

• 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.

Practice-Hospital Alignment

When Hospital Employment Is…Continued from page 1 a report noting that Medicare expenditures for Part B drugs declined 14% between 2004 and 2005.2 Like Mary’s little lamb, wherever Medicare went, the others surely followed. Today, in our experience, the majority of nonfederal contracts for infusion drugs are based on ASP. In another now-familiar tactic, payers set the rules on the “appropriate” use of various drugs based on US Food and Drug Administration labeling or on published materials, such as guidelines from the National Comprehensive Cancer Network. One result of these strategies is the rapidly rising trend of free-standing oncology practices aligning in some manner with hospitals. The next generation of tactics is now emerging, and it includes a variety of payment methodologies that would replace fee-for-service, or buy and bill, approaches, such as bundled payment packages and case rates, pay for quality, and shared-savings arrangements. As with any change in healthcare, this new generation will take time to fully replace the historical status quo. Furthermore, many of today’s options for physician-hospital alignments will likely continue to be valid in the evolving new world. Therefore, it is neither too early nor a waste of time to forge relationships now. Presently, there are almost innumerable ways for practices to align with hospitals. And, arguably, employment is the simplest. But for many, employment is simply not an option. Some states— California, Colorado, Illinois, Iowa, New Jersey, New York, Ohio, and Texas—have laws regarding the corporate practice of medicine that limit or prevent such employment. Just as important, however, are

valid physician concerns about becoming employed by a hospital. These concerns include a loss of control over operations and staff, compensation, job security, and performance expectations. When employment is not an option, there are still many other possibilities that can include a variety of complicated agreements for things such as new management companies; new joint ventures for real estate, facilities, and/or equipment ownership; management services agreements; and professional services agreements. Regardless of

The list of operational control items to work out in advance also should include scheduling parameters, staff training and credentialing, patient registration processes, clinical documentation requirements, charge capture/entry details, and more.

the components of the new alignment, the means of compensating physicians must be clearly defined in a manner that is compliant with all applicable laws, and the details must be very carefully articulated if the alignment is to be successful for all parties. The categories of detail to address include control, performance expectations, compensation

Oncology Practice Management

I February 2013

or revenue distribution, and the methodology for establishing each.

Control Whether the new model will be a management services agreement, a professional services agreement, or a comanagement agreement, many things have to be controlled. One of the most important is staff. Physicians are generally accustomed to making staffing decisions—what roles need to be filled, how many staff members are needed for each role, and, of course, who should be hired (or fired). When the model calls for using hospital-employed staff, these issues can become prickly, because the hospital will likely have policies and procedures that do not allow for quick decisions and actions. Furthermore, hospitals are often under pressure to keep the total complement of full-time equivalents at a given level despite what may seem to be a clear—or even dire—need for additional staff. In addition, when staff will transition from being employed by the practice to being employed by the institution, advance negotiation is required around the issues of pay scale, benefits packages, bonus op portunities, and seniority. The control of basic operations can be another sticking point that must be very specifically addressed before finalizing the deal. This is not only so that the physicians (and transferring staff ) remain satisfied with daily work life, but also because when the new agreement holds the physicians accountable in one manner or another for operational efficiency, there must be an appropriate latitude of power. For example, if an infusion suite is to run on time with maximum throughput, then lab and pharContinued on page 8

THIRD ANNUAL

Association for Value-Based Cancer Care Conference Influencing the Patient-Impact Factor

This activity is jointly sponsored by the Florida Society of Clinical Oncology, Medical Learning Institute Inc, Association for Value-Based Cancer Care, Inc., Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

May 2-5, 2013 • Westin Diplomat • Hollywood, Florida CONFERENCE CO-CHAIRS

AGENDA* THURSDAY, MAY 2, 2013 8:00 am - 5:00 pm

Registration

FRIDAY, MAY 3, 2013

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

Gary M. Owens, MD President Gary Owens Associates

Burt Zweigenhaft, BS President and CEO OncoMed

7:00 am - 8:00 am

Simultaneous Symposia/Product Theaters

8:15 am - 9:15 am

Session 1: Welcome, Introductions, and Opening Remarks Conference Co-Chairs - Craig K. Deligdish, MD; Gary M. Owens, MD; Burt Zweigenhaft, BS

9:15 am - 10:15 am

Keynote Address

10:15 am - 10:30 am

Break

10:30 am - 11:45 am

Session 2: Trends in Treatment Decision-Making: Pathways and Stakeholder Collaborations Marcus Neubauer, MD; Michael Kolodziej, MD

12:00 pm - 1:00 pm

Exclusive Lunch Symposium/Product Theater

1:15 pm - 2:00 pm

Session 3: Cost of Cure: When, How, and How Much? John Fox, MD; John Hennessy

2:00 pm - 2:45 pm

Session 4: Where Is Oncology Care Headed in the Future? Jayson Slotnick, JD, MPH (Moderator); Barbara L. McAneny, MD

Upon completion of this activity, the participant will be able to: • Discuss the current trends and challenges facing all stakeholders in optimizing value in cancer care delivery. • Define the barriers associated with cost, quality, and access as they relate to healthcare reform and what solutions are currently being considered. • Compare and contrast the different approaches/tools providers and payers are utilizing to manage and deliver care collaboratively. • Examine the current trends in personalized care and companion diagnostics. • Analyze the patient issues around cost, quality, and access to care.

2:45 pm - 3:30 pm

Session 5: What Will the Cancer Delivery System Look Like in 2015? Ted Okon; John D. Sprandio, MD

TARGET AUDIENCE

PROGRAM OVERVIEW

Following on the success of our Second Annual Conference, AVBCC will be coming to Hollywood, Florida, on May 2-5, 2013. We continue to be guided by the expertise of leaders in these fields providing attendees with a thorough understanding of the evolution of the value equation as it relates to cancer therapies. Our goal is to be able to assist them in implementing, improving, and sustaining their organizations and institutions, while improving access for patients and ultimately quality patient care.

LEARNING OBJECTIVES

This conference is intended for medical oncologists, practice managers/administrators, and managed care professionals. Stakeholders in a position to impact cancer patient care, such as advanced practice nurses, pharmacists, and medical directors, are also invited to join this exciting forum.

DESIGNATION OF CREDIT STATEMENTS SPONSORS

COMMERCIAL SUPPORT ACKNOWLEDGMENT

Grant requests are currently being reviewed by numerous supporters. Support will be acknowledged prior to the start of the educational activities.

3:30 pm - 3:45 pm

Break

3:45 pm - 4:30 pm

Session 6: Employers and Oncology Care F. Randy Vogenberg, PhD, RPh (Moderator); Bridget Eber, PharmD; Patricia Goldsmith; Darin Hinderman

4:30 pm - 5:15 pm

Session 7: Advanced Care Directives: Palliative Care, Hospice, Ethics J. Russell Hoverman, MD, PhD; Thomas Smith, MD, FACP, FASCO

5:15 pm - 5:45 pm

Summary/Wrap-Up of Day 1

6:00 pm - 8:00 pm

Cocktail Reception in the Exhibit Hall

SATURDAY, MAY 4, 2013 7:00 am - 8:00 am

Opening Remarks

8:30 am - 9:15 am

Session 8: The Role of Government in the Future of Oncology Care Jayson Slotnick, JD, MPH

9:15 am - 10:00 am

Session 9: Medicaid: A Healthcare Delivery System Review Matthew Brow

10:00 am - 10:15 am

Break

10:15 am - 11:00 am

Session 10: Payer, Government, and Industry Insights: Balancing Cost and Quality Kip Piper

11:00 am - 11:45 am

Session 11: National Coalition for Cancer Survivorship: Medication Nonadherence Issues Pat McKercher; Lillie Shockney, RN, BS, MAS

PHYSICIAN CREDIT DESIGNATION

The Medical Learning Institute Inc designates this live activity for a maximum of 17.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Medical Learning Institute Inc and the Center of Excellence Media, LLC. The Medical Learning Institute Inc is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

REGISTERED NURSE DESIGNATION

Simultaneous Symposia/Product Theaters

8:15 am - 8:30 am

12:00 pm - 1:00 pm

Exclusive Lunch Symposium/Product Theater

1:15 pm - 3:00 pm

Session 12: Meet the Experts Networking Roundtable Session

3:00 pm - 3:45 pm

Session 13: Personalized Medicine, Companion Diagnostics, Molecular Profiling, Genome Sequencing—The Impact on Cost, Treatment, and the Value Proposition Mark S. Boguski, MD, PhD; Gary Palmer, MD, JD, MBA, MPH

3:45 pm - 4:15 pm

Summary/Wrap-Up of Day 2

4:30 pm - 6:30 pm

Cocktail Reception in the Exhibit Hall

Medical Learning Institute Inc. Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 17.25 contact hours.

SUNDAY, MAY 5, 2013

REGISTERED PHARMACY DESIGNATION

8:15 am - 8:30 am

Opening Remarks

8:30 am - 9:15 am

Session 14: Cancer Rehabilitation: The Next Frontier in Survivorship Care Julie Silver, MD

9:15 am - 10:00 am

Session 15: Current and Future Considerations for the Oncology Practice Manager Dawn Holcombe, MBA, FACMPE, ACHE; Leonard Natelson

The Medical Learning Institute Inc is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Completion of this knowledge-based activity provides for 17.25 contact hours (1.725 CEUs) of continuing pharmacy education credit. The Universal Activity Number for this activity is (To be determined).

CONFERENCE $375.00 until March 15, 2013 REGISTRATION $425.00 after March 15, 2013 REGISTER TODAY AT

www.regonline.com/avbcc2013

7:00 am - 8:00 am

Simultaneous Symposia/Product Theaters

10:00 am - 10:15 am

Break

10:15 am - 11:00 am

Session 16: Access to Drugs—Shortages, Biosimilars Douglas Burgoyne, PharmD; James T. Kenney, Jr., RPh, MBA

11:00 am - 11:45 am

Session 17: Perspectives from Oncology Group Practices—Successes, Issues, and Challenges Thomas Marsland, MD; David Eagle, MD

11:45 am - 12:00 pm

Summary and Conclusion of Conference

*Agenda is subject to change. AVBCCAsize20413

Practice-Hospital Alignment

When Hospital Employment Is…Continued from page 6 macy turnaround times must be swift. If the physicians do not have the influence necessary to ensure quick service, they will not be able to meet the expectations around patient wait times and satisfaction. Interdepartmental influence is even more critical in comanagement agreements that include performance measures that can only be accomplished with the cooperation of others. In most cases, nonemployment agreements offer greater flexibility to modify institutional policies than straight employment, because any variance can be attributed to a contract rather than being an exception to the rule. The list of operational control items to work out in advance also should include scheduling parameters, staff training and credentialing, patient registration processes, clinical documentation requirements, charge capture/ entry details, nursing roles beyond face time with patients (eg, calling in prescriptions), attendance at internal and external meetings, and—perhaps the most difficult of all—information technology, from scheduling systems and order entry to electronic medical records. All of these factors make the issue of control important, as well as complicated. The ultimate challenge in terms of control, however, is the simple issue of trust. Can both parties become comfortable with ceding control to the other?

Performance Expectations Under any type of arrangement, there needs to be a very clear delineation of expectations from all parties. These expectations often include productivity expectations (such as when there is a professional services agreement), as well as managerial expectations and good

citizenship expectations. Clinical productivity is often a difficult nut to crack. There are numerous physician production surveys available for use in determining baseline and bonus goals using work relative value units (RVUs) and various types of encounters. In general, we prefer to use work RVUs, although those present some challenges, particularly for medical oncology. Most benchmark data include the work RVUs associated not only with physician evaluation and management services, but also the work RVUs associated with the admin-

In most cases, nonemployment agreements offer greater flexibility to modify institutional policies than straight employment, because any variance can be attributed to a contract rather than being an exception to the rule.

istration of chemotherapy. Most hospitals do not have a dependable mechanism for tracking the infusion work RVUs for physicians, because most infusion suites treat patients for many physicians, not just for the medical oncologists. Therefore, one needs to adjust the benchmark figures in some manner. Whether using work RVUs or encounters, all parties need to be comfortable with the methodology for establishing targets and goals,

Oncology Practice Management

I February 2013

as well as with the methodology for assigning financial value to the metric(s). That methodology should be transparent to all—data sources, selection of percentiles, and so forth—and the agreement should address the frequency of revision. Managerial expectations can vary as widely as one’s imagination, on everything from staffing and operational management to budgetary responsibility and the implementation of quality initiatives. The scope is generally narrower with simple management agreements to run a specific department or service, and far more broad in comanagement agreements that strive to impact the entire performance of a service line. Comanagement agreements certainly require a far more significant time commitment for physicians than simple management agreements, but the former also offer physicians greater financial opportunity, as discussed below. Typical management responsibilities center around managing the infusion suite or the radiation department, taking on the full role and expectations that a hospital-employed manager or director would perform. This includes not just giving direction but actually performing the required tasks to run the department. Perhaps the single greatest obstacle for physicians who take on managerial responsibilities is their ability to make things happen within the structure and infrastructure of the institution. Perhaps the greatest obstacle for institutions is developing whatever is necessary to allow physicians to succeed.

Compensation or Revenue Distribution Compensation for clinical pro Continued on page 10

*The VELCADE Reimbursement Assistance Program does not file claims or appeal claims for callers, nor can it guarantee that you will be successful in obtaining reimbursement

VELCADE and Millennium are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners. Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright ÂŠ 2010, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA

V-10-0196

11/10

Practice-Hospital Alignment

When Hospital Employment Is…Continued from page 8 Table. Sample Comanagement Opportunities Performance item

Metric

Base goal

Threshold goal

Maximum goal

Patient satisfaction

Percentile score on a specified survey item

75%

80%

90%

Pathway development

Number or list of specified pathways

None

Clinical trial accruals

Number of eligible patients enrolled

Hospice referrals

Percentage of eligible patients referred

10%

25%

50%

Reduce staff overtime

Hours of paid overtime

10%

15%

20%

duction under a professional ser vices agreement is relatively straightforward when it is structured as a set dollar amount for physician-performed services (see work RVUs above) compared with compensation for management responsibilities. In most simple management services agreements, compensation is based on fair market value for a physician’s time. There also can be performance bonuses available, but, again, these must be at fair market value. An institution is not permitted to pay physicians in any manner that is tied to the services ordered by those physicians, whether by volume or by revenue. In the simplest of terms, compensation for management services will be compensated similarly to what the hospital would pay directly employed staff to perform the same duties. In comanagement agreements, there is typically a fixed payment for management responsibilities (often approximately 20%-25% of the total potential compensation to participating physicians), and there are performance bonuses for achieving specified results. Those results must be very clearly artic-

ulated (Table), and they must be completely measurable to determine the degree to which they were achieved.

Perhaps the single greatest obstacle for physicians who take on managerial responsibilities is their ability to make things happen within the structure and infrastructure of the institution. There are almost countless opinions regarding the total pool of dollars available, and, to date, there have been no major audits around this (although we expect that sooner or later the OIG or the US General Accountability Office will take on this issue). The OIG has, however, released an “advisory opinion” addressing the terms

Oncology Practice Management

I February 2013

of a comanagement agreement between a cardiology group and a hospital, which is a must-read for anyone considering this model.3 When the alignment model in cludes jointly owned business entities, such as management services organizations, the laws and regulations are well established and, essentially, these require the distribution of revenue to owners in direct proportion to the ownership share that each holds. Furthermore, the ownership share must be related to the proportion of total investment in the business entity. These agreements require a thorough review by a qualified attorney to ensure that there are no breaches of the various antikickback and self-referral regulations. l

References

1. US Department of Health and Human Services, Office of Inspector General. Medicaid Drug Price Comparison, Average Sales Price to Average Wholesale Price. Publication OEI-03-05-00200. Washington, DC: US Dept of Health and Human Services; 2005:ii. 2. Medicare Payment Advisory Commission. Report to the Congress: Effects of Medicare Payment Changes in Oncology Services. Washington, DC: Medicare Payment Advisory Commission; 2006:10. 3. US Department of Health and Human Services, Office of Inspector General. OIG Advisory Opinion 12-22. Issued December 31, 2012; posted January 7, 2013. https://oig.hhs.gov/fraud/docs/advisoryopinions/2012/AdvOpn12-22.pdf. Accessed January 29, 2013.

VISIT THE NEW ONLINE RESOURCE FOR NURSES AND THE ENTIRE MULTIPLE MYELOMA CARE TEAM

“Quality care is everyone’s business.” Beth Faiman, RN, MSN, APRN, BC, AOCN Nurse Practitioner, Multiple Myeloma Program Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Value-BasedCare IN Myeloma

™

RESOURCE CENTER FOR PAYERS, PROVIDERS, AND THE ENTIRE CANCER CARE TEAM

Value-Based Care in Myeloma delivers exclusive interviews and perspectives related to cost, quality, and access issues. Special sections for VA-based clinicians, advanced practice nurses, and pharmacists will also focus on the unique challenges in the management of multiple myeloma.

Wellness-Based Cancer Care Business Healthcare: Summit Economic Incentives and Benefit Design

How Does Oncology Fit in an ACOâ&#x20AC;ŚContinued from page 1 NH, discussed the role of oncology in the development of ACOs. Whether an oncology practice is independent or hospital-based, ACO activity is likely to have some degree of impact on the strategic plan, daily operations, and patient mix. How quickly that happens remains to be seen. Mr Barkley opened with a general review of ACOs and why cancer management will be important to that system. The $128-billion annual cancer spending in the United States is second only to the amount spent for cardiovascular conditions. Cancer treatment costs represent about 10% of healthcare expenditures, but only about 1% of the patient population. The average annual cost for 1 patient with cancer is $80,000 to $110,000 compared with an average $6800 cost per person for all patients. Through more effective clinical management, it has been shown that cancer-related spending potentially could be reduced by 7% to 13%. Mr Barkley noted that the bottom line is that potential savings in oncology may possibly yield more savings than the total potential savings for all primary care combinedâ&#x20AC;&#x201D;a fact that is bound to draw the attention of anyone or any group being held accountable for achieving savings (ie, value) in healthcare.

ACOs and Medicare The ACO is the vehicle through which the Centers for Medicare & Medicaid Services seeks to transition healthcare delivery from volume-based to value-based. The ACO structure is predominantly oriented toward primary care: Medicare beneficiaries are attributed to specific primary care providers associated with the ACO. These ACO providers will share cost-savings below the traditional fee-for-service expenditure benchmarks, so initiatives with strong

potential for substantial savings will, by necessity, have high visibility for ACOs. Ultimately, ACOs will be responsible for the total costs of care in their defined market, including oncology costs.

Whether an oncology practice is independent or hospital-based, ACO activity is likely to have some degree of impact on the strategic plan, daily operations, and patient mix. How quickly that happens remains to be seen.

As of October 2012, there were already 350 ACOs in the country, with more being added on a regular basis. Mr Barkley pointed out that although the ACO is a Medicare construct, a majority (200) of the current ACOs have been developed for the commercial market. However, there are already another 400 applications in process for Medicare ACOs hoping to be launched in 2013. Commercial ACOs appear very similar to Medicare-focused ACOs, but more often involve a commercial health plan in addition to the physicians and/or hospital, whereas a Medicare ACO would typically involve only medical providers. Both ACO models involve customized contractual arrangements, but in the commercial ACO the contract often stipulates that the health plan pays

Oncology Practice Management

I February 2013

something different (eg, a premium or new fee) to providers in return for the providers achieving both improved outcomes and reduced costs.

Industry Survey Findings Mr Barkley presented the findings of the 2012 CCBS Industry Survey, an annual survey that brings to the CCBS key findings on the hot topics of the year. The 2012 survey included focused interviews conducted with 64 industry leaders across the country regarding ACO activity and, particularly, the role (or lack thereof) of oncology in current ACO activity. The survey interview participants included 40 representatives from Medicare ACOs, 7 from commercial ACOs, and 17 industry thought leaders on ACOs. Of those interviewed, 31.3% were based in the Northeast, 21.9% in the Southeast, 20.3% in the Midwest, 14.1% in the West, and 9.4% in the Southwest. The only national representation (3%) came from commercial ACOs. The majority of responders indicated that specialties, including oncology, were involved in ACOs, and that oncology was indeed a focus. More than one third (38%) noted that oncology as a specialty was included in the leadership of their ACO; another third (33%) indicated that oncology was not specifically included in their leadership, but that other specialties were; and 84.6% of those responses noted that cardiology was the other predominant specialty. Not surprisingly, there was less consensus with regard to financial compensation related to oncology and whether oncologists were participating in any ACO shared-savings. The majority (28%) of the responders noted that oncologists at some point could participate in savings, but that the specialist pay formula was not yet determined. The remaining responders were divided regarding the

Cancer Care Business Summit

question of shared-savings in relation to specialists, who often take risks not taken in primary care.

Role of Oncology in ACOs Why should oncology as a clinical specialty get involved with ACO development and discussion, if the financial expectations are so uncertain? Because no matter what oncologists do, their business will be affected by successful ACO development, Mr Barkley noted. Current ACO development is much different from the old hospital-physician alignments that occurred in the 1990s. Greater information technology and decision support tools exist than they did back then. The emphasis on these new integrations is far more focused on care coordination and patient-centered orientation. The new expectations related to outcomes mean that all aspects of the healthcare continuum will be examined, and cost-effectiveness evaluated. Whether or not a specialty participates, they will be evaluated as an element of health system costs, and primary care referrals for specialist services will be shifted away from providers that either are not “in the ACO network” or are found to be less cost-effective than alternative options, even if all of the specialists are outside of the ACO network. A specialist’s participation in an ACO activity may evolve to measures and evaluations of the provider to which they may not be privy unless they participate—even if they are not allowed to participate financially in the shared-savings model. Mr Barkley suggested that most ACOs have not yet finalized the details of the shared-savings models; most are too new in development to have any basis upon which to discuss real savings, but that does not mean that the expectation and movement toward seeking savings is not already a game changer in markets where ACOs are becoming active.

Challenges and Solutions The big challenges for emerging ACOs, according to Mr Barkley, are bridging the gaps in communication across diverse provider groups, and addressing a lack of coordination in care “handoffs” between providers. Patient navigation. Patient navigators are emerging as one possible solution, but where these services should be housed and funded (ie, the health plan, hospital, primary care, specialist for one disease) is still very much in flux. Oncologists

emergency department by patients with cancer, (2) providing proactive counseling of patients with cancer and treatment of side effects to keep patients from developing the severity of symptoms that could send them to the emergency department, and (3) developing triage protocols and communications that enable patient access to providers on a 24-hour, 7-day-a-week basis to manage patient care proactively (which includes, at its most basic level, phone triage that involves talking to the patient even during lunch breaks and other hours the office may be closed for routine patient communications). End-of-life care. Patient care at the end of life is one of the most costly periods of the healthcare process, and oncology is obviously a key area affected by a review of end-of-life costs. Proactive treatment expectations from ACOs and other programs that are developing value-based treatment evaluations for end of life in oncology could include a treatment focus toward keeping patients out of the hospital and the emergency department during this period, the timely use of palliative care and hospital services, as well as recalibrating patient and family expectations of treatment and options. Prepare for the future. How do oncologists prepare for a game-changing situation where they may not be invited to the table, they may not see any of the shared-savings generated, and they may be subject to significant shifts of patients with cancer from referring primary care physicians who are an integral part of these new ACOs? Mr Barkley had 7 suggestions:

Regardless of the specialty, all care providers are, by necessity, developing new strategies for bringing value (in its many definitions and forms) into their practices.

will need to develop processes for integrating these communication and care-management improvements into their practice (both incoming and outgoing). Even oncology groups that are developing their own oncology medical home concepts are faced with building these bridges between the nononcology clinical issues and patient care coordination gaps. Value. Oncology is not alone. Regardless of the specialty, all care providers are, by necessity, developing new strategies for bringing value (in its many definitions and forms) into their practices. The overriding goals when moving into a value-focused environment include (1) avoiding the unnecessary use of the

February 2013

Accept that this is a time of transition and the ACO paradigm is not going away

Perform an honest organizational self-assessment: move to fix any

Continued on page 14

www.OncPracticeManagement.com

Cancer Care Business Summit

How Does Oncology Fit in an ACO…Continued from page 13 gaps in strengths or actual weaknesses

Explore opportunities: be proac tive in outreach to emerging ACO leadership and discuss the role you can play in bending the cancer-cost curve in their market

Propose to take on a leadership role within the emerging ACO as a

representative of oncology: prepare to integrate any oncology medical-home efforts you may have already started

be measured and how savings would be measured, then make sure you can deliver

5 6

Engage your major health plans upfront

Address your informatics infrastructure: recognize what clinical and business data elements need to

Do not agree to too much volunteer work: remember that both you and the practice need to be appropriately paid for value and quality services rendered, even as the payment model is in flux. l

Electronic Health Records

Implementing EHR in Your Practice…Continued from page 1 Assessing Your Needs When making a decision to purchase an EHR, finding the right system begins with a practice needs assessment, he advised. Do you need a system with embedded transcriptions, or one that is compatible with voice recognition software that can help you write your notes? Consider the functions that you need the software to perform, whether it is management of in-office infusions, inventory management, scheduling, or order generation for external providers. “Do you need a robust way to tell nurses what to give, and when to give it? Some packages do it better than others,” he said. Dr Sitarik, who is also a hematologist/oncologist at Rocky Mountain Cancer Centers in Boulder, CO, also advised the listeners to keep in mind that most EHRs do not have clinical decision support built into them, “but it is the wave of the future,” he said. An infrastructure needs assessment takes the capability of your hardware and the size and reliability of your bandwidth into account, as well as the level of IT support you

have locally, which is separate from the support that is provided with the software. “Realize that all software is a work in progress—there is no perfect solution,” Dr Sitarik said. “Waiting for the best last version is an exercise in frustration.” The chosen vendor should be financially viable and be able to offer the level of “at-the-elbow” support that you need. Know how often you will need to upgrade your software, and ensure that the vendor has a plan for data backup, because your data have to survive.

Get Your Staff Involved The successful implementation of an EHR requires that all of the staff are involved early on. An administrative champion and a physician champion will ease acceptance into the practice. Investing in adequate hardware and IT support is also crucial. Appropriate training of everyone in the practice is necessary for efficiency, so take advantage of on-site vendor support. A Paradigm Shift “EHR implementation represents

Oncology Practice Management

I February 2013

a paradigm shift from physician-centric to patient-centric workflows,” Dr Sitarik said. “This is an opportunity to put the right person with the right training in the right job at the right time.” Clinical decision support, if offered, reduces the risk of nonreimbursement of services, reduces treatment variability by offering treatment pathways for individual disease types, improves treatment quality by fostering evidence-based treatment, and reduces costs, Dr Sitarik said. The characteristics of ideal decision support are: • It is offered in real time • It is contextual • It is referenced • It determines eligibility in a clinical trial • It is integrated with nationally accepted guidelines • It is integrated with payer systems for precertification. Once you are ready to go live with your EHR system, Dr Sitarik advises temporarily reducing your patient load so that the staff has time to learn and fully optimize the system. l

ANNUAL CONFERENCE

"! ! !

! Professor Rob Coleman, MBBS, MD, FRCP Yorkshire Cancer Research Professor of Medical Oncology Director, Sheffield Cancer Research Centre Associate Director, National Institute for Health Research Cancer Research Network Department of Oncology, Weston Park Hospital Sheffield, United Kingdom

* 3:00 pm - 7:00 pm

Registration

5:30 pm - 7:30 pm

Welcome Reception and Exhibits

7:00 am - 8:00 am

Symposium/Product Theater

8:15 am - 8:30 am

Welcome to the Second Annual Conference of the Global Biomarkers Consortiumâ&#x20AC;&#x201D;Setting the Stage for the Meeting Professor Rob Coleman, MBBS, MD, FRCP

8:15 am - 11:45 am

General Session I â&#x20AC;˘ Personalized Medicine in Oncology: Evolution of Cancer Therapy from Nonspecific Cytotoxic Drugs to Targeted Therapies â&#x20AC;˘ Taking Stock of Molecular Oncology Biomarkers â&#x20AC;˘ Genomics â&#x20AC;˘ Bioinformatics â&#x20AC;˘ Validating Biomarkers for Clinical Use in Solid Tumors - Professor Rob Coleman, MBBS, MD, FRCP â&#x20AC;˘ Validating Biomarkers for Clinical Use in Hematologic Malignancies Jorge E. Cortes, MD â&#x20AC;˘ The Challenges of Biomarker-Based Clinical Trials â&#x20AC;˘ Keynote Lecture: Understanding Cancer at the Molecular Level

12:00 pm - 1:00 pm

Symposium/Product Theater/Exhibits

1:15 pm - 4:30 pm

This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

General Session II â&#x20AC;˘ Introduction to Case Studies - Jorge E. Cortes, MD â&#x20AC;˘ Case Studies: Optimal, Value-Based Use of Molecular Biomarkers in Oncology: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients, Part I â&#x20AC;˘ Lung Cancer â&#x20AC;˘ Breast Cancer â&#x20AC;˘ Multiple Myeloma â&#x20AC;˘ Prostate Cancer â&#x20AC;˘ Leukemia â&#x20AC;˘ Lymphoma â&#x20AC;˘ Panel Discussion: Management Controversies and Accepted Guidelines for the Personalized Management of Solid Tumors and Hematologic Malignancies â&#x20AC;˘ Keynote Lecture: The Medical-Legal Issues Surrounding the Use of Biomarkers in Oncology

4:30 pm - 6:30 pm

Meet the Experts/Networking/Exhibits

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

The only global meeting dedicated to advancing the understanding of value and clinical impact of biomarker research in oncology. Guided by the expertise of leaders in this field, participants will receive a thorough understanding of the current and future landscape of the relevance of tumor biomarkers and how to effectively personalize cancer care in the clinical setting.

This meeting will be directed toward medical oncologists and hematologists, pathologists, geneticists, advanced practice oncology nurses, research nurses, clinical oncology pharmacists, and genetic counselors involved in the management of patients with solid tumors or hematologic malignancies, and interested in the use of molecular tumor biomarkers to help optimize patient care.

Upon completion of this activity, the participant will be able to: â&#x20AC;˘ Assess emerging data and recent advances in the discovery of molecular biomarkers and their impact on the treatment of patients with solid tumors or hematologic malignancies â&#x20AC;˘ Discuss the role of molecular biomarkers in designing personalized therapy for patients with solid tumors or hematologic malignancies â&#x20AC;˘ Outline the practical aspects of integrating molecular biomarkers into everyday clinical practice in the treatment of patients with cancer

Grant requests are currently being reviewed by numerous supporters. Support will be acknowledged prior to the start of the educational activities.

7:00 am - 8:00 am

Symposium/Product Theater

8:15 am - 11:45 am

General Session III â&#x20AC;˘ Review of Saturdayâ&#x20AC;&#x2122;s Presentations and Preview of Today - Jorge E. Cortes, MD â&#x20AC;˘ Case Studies: Optimal, Value-Based Use of Molecular Biomarkers in Oncology: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients, Part II â&#x20AC;˘ Melanoma â&#x20AC;˘ Colorectal Cancer and Other GI Malignancies â&#x20AC;˘ MDS â&#x20AC;˘ Myeloproliferative Neoplasms â&#x20AC;˘ Keynote Lecture: Promises and Challenges of Personalized Medicine in Improving Cancer Care â&#x20AC;˘ Tumor Board: Challenging Cases in the Use of Biomarkers in Managing Solid Tumors (attendee-contributed cases) â&#x20AC;˘ Tumor Board: Challenging Cases in the Use of Biomarkers in Managing Hematologic Malignancies (attendee-contributed cases)

12:00 pm - 1:00 pm

Symposium/Product Theater/Exhibits

1:15 pm - 3:00 pm

General Session IV â&#x20AC;˘ Keynote Lecture: Making Personalized Medicine a Reality: The Realization of Genomic Medicine â&#x20AC;˘ The Future of Personalized Medicine: Measuring Clinical Outcomes â&#x20AC;˘ Cost-Effective Technologies That Can Drive Therapeutic Decision Making â&#x20AC;˘ Regulatory Perspectives on PMO â&#x20AC;˘ PMO: The Payerâ&#x20AC;&#x2122;s Perspective â&#x20AC;˘ Panel Discussion: Can We Afford PMO? A Value-Based Analysis â&#x20AC;˘ Practical Considerations in Incorporating PMO into Everyday Cinical Management â&#x20AC;˘ Reimbursement Challenges â&#x20AC;˘ Closing Remarks

3:00 pm

Departures

The Medical Learning Institute Inc designates this live activity for a maximum of 12.5 AMA PRA Category 1 Creditsâ&#x201E;˘. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Medical Learning Institute Inc and the Center of Excellence Media, LLC. The Medical Learning Institute Inc is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Medical Learning Institute Inc Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 12.5 contact hours.

The Medical Learning Institute Inc is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Completion of this knowledge-based activity provides for 12.5 contact hours (1.25 CEUs) of continuing pharmacy education credit. The Universal Activity Number for this activity is (To be determined).

CONFERENCE REGISTRATION

EARLY BIRD REGISTRATION NOW OPEN! $175.00 until June 30, 2013

www.globalbiomarkersconsortium.com

*Agenda is subject to change.

P O

PERSONALIZED MMEDICINE IN ONCOLOGY

eO seri Vie nc es w olo on the gy line Nu a rse t .co m

2ND ANNUAL

CONQUERING THE CANCER CARE CONTINUUM

â&#x201E;˘

CONQUERING THE CANCER CARE CONTINUUM CONQUERING CANCER CARTHE C E CONT I

A 6-part series

The publishers of The Oncology Nurse-APN/PA, The Oncology Pharmacist, and Personalized Medicine in Oncology are proud to present our 2nd annual Conquering the Cancer Care Continuum series. Upcoming topics include:

IN THIS ISSUE

â&#x20AC;˘ Palliation

â&#x20AC;˘ Pain management

www.TheOncologyNurse.com

â&#x201E;˘

Challenges Patients Face in Cancer Care: Implications for the Healthcare Team Lea Ann Hansen, PharmD, BCOP Associate Professor, Virginia Commonwealth University

cancer.1 More than half are living well beyond 5 years ancer is an illness associated with substantial physical, emotional, social, and financial ramafter diagnosis. Women comprise a majority of longifications for affected individuals and their term survivors due to the favorable outcomes with families. In a significant number of cases, the diagnosis breast, cervical, and uterine cancers.2 The number of of cancer is either preceded by a period people living with a history of cancer of gradual, nonspecific symptoms or is projected to grow considerably over discovered by routine screening, and the next 20 years for 2 major reasons. individuals are then thrust into a First, the number of Americans over whirlwind of diagnostic testing, inage 65 is predicted to double between vasive procedures, and complicated the years 2000 and 2030.3 Consetreatments with very little warning or Lea Ann Han quently, as a disease primarily of older sen, Pha Associate rmD opportunity to assimilate their circumadults, cancer will also increase. Sec, BCOP Professor, Virginia Commond, stances. Frequently, a multidisciplinary as the effectiveness of cancer onweal versity â&#x201E;˘ th Uni approach to treatment is necessary, retreatments improves, the number of he past dec ade has seen quiring patients to engage with numerpatients the utilizat a dramatic cured of the disease will in ion of spe upsurge in several ous medical teams comprising crease, and an even larger percentage cialty pha types of Medic rmacies for are Moder Lea Annthe Hansen, rapeutic all different specialties, often in different those for can will be living longer with disease nization Ac mo dalities, as â&#x20AC;&#x153;athe cer. The BCOP PharmD, t defined part D dru including cost of can a specialty locations. Many patients have beenabout $125 bill receiving multiple â&#x20AC;&#x153;linesâ&#x20AC;? of g with plan-n cer carewhile ceed $40 drug ion in 201 may rise from egotiated 0 0 to $20 prices tha relatively healthy prior to the cancer lion therapy (first-line, eventbyand second-line, etc) over time. per Themonth.â&#x20AC;? 2 Oth thethere7 bilend of the fine spe t exer health cial dru dec ade. demand plans ma gs differe fore are not sophisticated consumerstim ofe,medical overall specialtyserBy that for oncology services is expected totyiny dently. In gen drugs are accon predic ounhealthcare eral, they hig vices. Consequently, it is incumbent crease byted 48% by 2020, while the supply of oncologists t for 2 of h cost, adm to are every 5 pha inistered lars spent. 4or rma by 1 professionals to be able to facilitate patientsâ&#x20AC;&#x2122; transition will increase by only 14% based on current patterns. cy infu inje dolsion, require The purpos ction e of this arti special han to expand ersity intoBCO carePin order to minimize theirisdistress the need for a wide varietyor are used lain maxicle underscore dling, the evoluti These statistics en, PharmD, Commonwealth Univ for comple 80%, cialty pha on nia their clinical outcomes. Lea Ann Hans ssor, Virgimize from 17% toand other support personnel torequire x diseases of range the of ens health professionals spe rmacycatio Profe regim that special mo ption andnthe Associate on assumeach oral mediand can nitoring. functio term serv cology, how Anscomm Challenges exist beyond diagnosis play a part and every patient to re.2-4 t initial e in the around 50% In onmenthe itin enabling ever, the getreatment systemic treat ts would be an avera andwith most com r agen of to age scenario forperiod ance nt can treatment as well. According to the National ceive quality care that addresses all of their needs disc nts aantic mina cer disp uss nistr mon thee pot to oral ensed by he predo been renc involved admi entthroughout adheindividandthat a specialty disease, has of the illness. Patients deial ofefit macy pro the traditionally (NCI), more million llen pharges oftothe highlythan 12cha s the continuum severityben vider (SP of cancer has Cancer Institute thesyst ate the otherapy by due P) are the pointwith er, ies indic em 5: high usinchem Stud targ from of e. veno fine quality of care based on their ability to uals the United States are living a history of view ete untru nt. intra the new d en of of the patprov agents tha er the patie tion py are ient. t are adm ly monitored for cancer thera tered ora inisnnel who close lly. After adherence rates5 rence has trained perso in an The Evo a system view . Nonadhe atic redures took place lution of 15% to 97% Hill outc Healthcare omes Communications, LLC of the literature, Specialt Green e When these proce infuDrugs an one academ group of y iated with wors or in a hospital d assoc authors pro ic s and with the oncologistâ&#x20AC;&#x2122;s office Pharmac Specialtbeen y posed the critical des disease state education of Lea Ann of ber sive mo y num exten a st in Hansen criptors er hossion center, , high More of a spe There is drug to be 3 ician visitsPha rmD, BCO , ly was possible. cialty a lack of : increased phys stays, P consen patient and fami specialty ly comsus on the â&#x20AC;˘ High cos , longer hospital drug. The n rates ver, an increasing definition t (prescri Food andpitalizatio recently, howe not defined ptions cos of a ased morof one or Druse than $600 ening, and incre g Ad t more wors the term. involves the use min â&#x20AC;˘ toDifficult istration has per month Initialldisea mon situation synonymo medicatio ately one-third ) y, the.6 labe roxim ns and self-admin us n App catio wit del l medi h â&#x20AC;&#x201D; ive tality was ated Special biotechnol ry, such as the more oral teins pro uallcatio handling medi y n-rel ogy producs of allvirt Leain duced by eous therapies Ann requiring n ts, either recombin two-third istered subcutan strict tem pro-to medicatio control respon-Hansen,mo nocrmD Asstoci due ant DNA ations are lonal, ant perature ate Profes Pha ent. The direc BCibo italiztechnique â&#x20AC;&#x201D; OPdies pro hosp sor,om home environm brid adminsa or Virg cost of $100 bil- Restricted location duced wit enceâ&#x20AC;&#x201D;at as,inia but Co acquisition and h cellula for medicat thismm nonadher aris noonw and sibility for drug r hylonea ion prepar 7 The purpose of this or distribution site ger lth theUni ver to the patients ally. ation ng sity cas annu shifti â&#x20AC;&#x201D; e. en, lion is epts Th e 2007 ral conc Restricted istration if avail he -previous Lea Ann Hans location describe gene P ort network, to is BCO supp l for to mD, ticle ins ed socia me trat Phar tallment in dication their ion rch relat than 20 administhi cannt e and the resea nt time, more ries examin renc adhe cer car ed the gro regardingspatie able. At the prese en Hill incidence, risk face Gre oved for sewing import lthc ment. TheHea ion, wit ns are FDA appr therap are treat addit h er Com catio In wed. a 1). canc medi less mun oral er icatR er (Table ies for the trea adherence to ance of oral problem will be revie MP ions t of canc , LLC (82 % vs 78% 4 rs that tment of treatmenimp licationused derquen equences of this ivedtlyfrom examine conscer the first-line ). (MPR pattumo ts are s of for tors, andcan ient adh and the electronic is a metric series will subse other oral preagen sent to initia prescriptio clinical l treatment. Ac-erenceThe refirence on its article in this a number of lastsuc ll patand e, mo adhe n records bas terns over cess. for refractory tim re tha Netor are ica Atmaxi themizing poi time, and ed on ensive Cancern 20 oral me have relapsed tions are prehapp best practices thednt for adh 80% is an National Com rov in the s the ed to ere ound arbitrary cut ing by nce . cord the Food outc all comp used by ma Drug Adofmin andomes ately 25% ny adminoxim istr are inv appr ine atio , esti pipel work n (FDA) gators.) Th ent same study for firstand deve trealopm e rch line fou .1 tmenttoofcont ninue nd Orga sur th oncology resea vival at 10 Heal cancer. A is likely to be by the World othtrend number years so the er ora increased nâ&#x20AC;&#x2122;s be- 81% for those ofAdherence was defined l age istered orally, lity comes the who contin to which a perso the in responsibi nts are use adtha as the â&#x20AC;&#x153;extent ued and/orrapy versus t have relacations may notdbefor tumors With this shift ization in 2003 wing a diet, 74% for tho anticancer medi psed or thatrefr require cation, follo had medi g se disc takin possibility that initial treaially for regimensare wh act o ontinued ory tohavior, ctly, espec tment, and abo longit. Nonad has also bee ministered corre of adherence utto25% of herence onc oloall gyestim the n shown to reseates g. Over arch pipelin repeated dosinora produce sub stantial det e consists hcare Communications, LLC l compounds 1 riment in of reen Hill Healt . This G clinical is in com self

THE QUERING N O C ANCER CARE

â&#x20AC;˘ Hospice care â&#x20AC;˘ Treatment planning â&#x20AC;˘ Survivorship care â&#x20AC;˘ Biosimilars in supportive care

TO VIEW THE SERIES ONLINE PLEASE LOG ON TO:

NUUM

â&#x201E;˘

Conveni ence, C The Imp halleng es a Patient ct of Specialty , and Cost Con Care Pharma cies on tainment:

C O N T I NT U U M C

CONQUERING T CANCER CAREHE

y ncer Therap ence to Ca Nonadher Impact of

CONTI

Best Prac tices in M ax

NUUM

â&#x201E;˘

imizing Ad herence to Cance r Therapy

addition to es in chroni out-administe c myeloid red subcut and childh leukemia aneous the pies for the ood acute rahome env lymphobla leukemia. 5-8 ironment are under stic that For each of FDA review the . der se s, disorWhen can prolonged cer medic oral therap been the ations are ministered y has standard adLea Ann orally in the of care for Hansen, decade or home env ronment rath a PharmD more. It is ier than in , BCOP likely that ative conseq the clinic of adherence negor uen hos ces of non pital, the rate range from adherence with other 15% to 97% 2 s at the end will be doc oral cancer of the first . For examp umented in me year of trea dic le, atio hormonal the future ns tment wit apy matur treatment as their role h adjuvant es. The pur (AHT) for in thercer, only 79% pose of thi early-stage the result s article is of patients breast can s of availab to discuss remained on a gap exceed le research adherence therapy wit ing 60 day on maxim and sugges hout s and 85% ceeding 180 t best practic izing ica wit l out hout a gap days. By yea comes. es to improv exr 5, only 27% e clinmained wit hout 60- and and 29% re180-day gap In anothe s, respective 3 r study of ly. AHT, pat tion possess ients with

ion ratio (M a me dica PR) >80% significant Direct com had a statisti ly higher municatio 10-year sur cally n with all vival rate personal bar patients abo than those riers to tak ut their ing daily the period is an rapy for a pro important longed aspect to Gr maximizin een Hill Hea g adherlthcare Com munication s, LLC

Health Policy

Time to Review Practice Policies: HIPAA Privacy and Security Regulations Released By Ross D. Margulies, JD, MPH, and Jayson Slotnik, JD, MPH Mr Margulies is an Associate at Foley Hoag, LLP, Washington, DC; Mr Slotnik is a Partner, Health Policy Strategies, LLC, Washington, DC

n January 18, 2013, nearly 3 years after its initial proposed rule, the US Department of Health and Human Services (HHS) issued the long-awaited and much-anticipated HIPAA “omnibus” rule, extending the scope of the privacy law beyond providers to their business associates and subcontractors and adding increased penalties. Regulated entities must be in compliance with the new rules by September 22, 2013, although covered entities and business associates will have up to 1 year after the 180-day compliance date to modify existing contracts to comply with these revised rules. Oncology practices should begin examining their policies now to ensure a seamless transition to these new rules. Among the most dramatic changes to existing law is that HIPAA’s privacy and security requirements will now directly apply to business associates. Business associates will now include health information organizations, e-prescribing gateways, other entities that provide data transmission services for covered entities and that require access on a routine basis, entities that offer a personal health record to individuals on behalf of a covered entity, and subcontractors. Penalties for

noncompliance will range depending on the degree of culpability, including the number of individuals affected and whether there is a history of noncompliance.

“harm” standard, which previously allowed entities to avoid breach notification if they could demonstrate that the breach posed no significant risk of harm to the individual. Under the new rule, any Ross D. Margulies impermissible use or disclosure of PHI is presumed a breach, unless a low probability that information has been compromised can be demonstrated. Oncology practices are now tasked with the arduous effort of implementJayson Slotnik ing what the HHS is calling “the most sweeping changes to the HIPAA privacy and security rules since they were first implemented.”1 l

Among the most dramatic changes to existing law is that HIPAA’s privacy and security requirements will now directly apply to business associates. Central to the new regulations (which total a whopping 563 pages) is the sharing of patient-protected health information (PHI). Patients are given new control over their PHI, including allowing patients to request a copy of their electronic medical record in an electronic format and permitting patients to instruct their provider not to share information about treatment with their health plan when the individual pays for that care out of pocket. In addition, the final rule expands the definition of a “breach” under HIPAA, thus eliminating the

Reference

1. US Department of Health and Human Services. New Rule Protects Patient Privacy, Secures Health Information. January 17, 2013. www.hhs.gov/ news/press/2013pres/01/20130117b.html. Accessed February 2, 2013.

Reprinted with permission from Am Health & Drug Benefits. 2013;6:42.

AVBCC_2013Conf_horizontal_62512_Layout 1 7/9/12 1:10 PM Page 1

THIRD ANNUAL CONFERENCE Influencing the Patient-Impact Factor

May 2-5, 2013 Westin Diplomat Hollywood, Florida

February 2013

www.OncPracticeManagement.com

Medical Legal Update

Understanding Bankruptcy as a Tool for the Continued Operation of a Medical Practice By Michael A. Sabella, Esq, and Jennifer Kirschenbaum, Esq

edical professionals who own their private practice wear 2 hats: a professional one and a business one. While they are diagnosing and treating patients, they also are running their business, which includes paying salaries and overhead. However, like every business owner, a medical practice may face a myriad of problems that can cause financial difficulties. These problems can range from medically related (eg, malpractice judgments and non payment from insurance companies and patients) to nonmedically related (eg, overhead and lawsuits from con tractors or former employees). These potential problems can all lead, individually or collectively, to the financial instability of the practice. Many medical professionals who face financial instability do not consider filing a bankruptcy petition to be a viable option, presumably because of (1) the stigma of bankruptcy, and (2) a lack of understanding of the bankruptcy process. In fact, depending on the circumstances, a bankruptcy filing may be the best way to address these issues and a preferable alternative to shutting down. In all cases, the decision to file for bankruptcy should be discussed with an attorney who specializes in bankruptcy, because many issues can arise in the context of a bankruptcy filing. The purpose of this article is to explain the bankruptcy process and to address issues related to a medical practice’s filing with regard to contractual obligations, patient care, and the handling of medical records.

Types of Bankruptcy: Dissolve or Reorganize There are 2 types of bankruptcy

filings that private providers and medical practices can avail themselves of as set forth in title 11 of the United States Code (otherwise referred to as the Bankruptcy Code)—Chapter 7 and Chapter 11. A Chapter 7 bankruptcy is a liquidation bankruptcy wherein the

Many medical professionals who face financial instability do not consider filing a bankruptcy petition to be a viable option, presumably because of the stigma of bankruptcy, and a lack of understanding of the bankruptcy process.

business will cease operating and its assets will be liquidated by a Chapter 7 trustee in order to pay the debtor’s creditors. Alternatively, a Chapter 11 bankruptcy is a reorganization bankruptcy. A Chapter 11 debtor is generally referred to as a “debtor-in-possession,” because the debtor, such as a medical practice, remains in control of the business and continues to operate it in the ordinary course. During the progression of a Chapter 11 case, the debtor is required to formulate a “plan of reorganization,” which sets forth

Oncology Practice Management

I February 2013

the payments that will be made to the debtor’s creditors, the time period that those payments will be made, and how the debtor will make the payments. While some of the things discussed here apply equally in both a Chapter 7 and a Chapter 11 context, for the purposes of this article, we will address the issues set forth below from the perspective of a potential Chapter 11 filing (reorganization) by a medical practice or provider.

The Automatic Stay One of the most desirable benefits of filing for bankruptcy protection is the automatic stay (11 USC § 360). The automatic stay goes into effect immediately upon a bankruptcy filing and essentially serves as a “stop work” order for certain civil actions that are being taken against the debtor, such as medical malpractice actions and collection actions. As long as the automatic stay is in effect, barred actions against the bankruptcy filer or debtor will be stalled and new barred actions cannot be commenced. However, the automatic stay is not infinite in duration. A creditor, or an adversary in a lawsuit, can make a motion to the bankruptcy court to vacate the stay. These motions must be done on notice to the debtor and can be opposed. It should be noted that if a medical practice files for bankruptcy, the stay will not act to stay a personal action against the practitioner as the automatic stay applies to the debtor. In addition, there are exceptions to the automatic stay. The automatic stay does not stop a criminal Continued on page 20

SAVE DATE the

NOVEMBER 14 -17, 2013

Fourth Annual Navigation and Survivorship Conference Memphis, Tennessee â&#x20AC;˘ The Peabody Memphis CONFERENCE CO-CHAIRS Program Director: Lillie D. Shockney, RN, BS, MAS University Distinguished Service Associate Professor of Breast Cancer Departments of Surgery and Oncology Administrative Director, Johns Hopkins Clinical Breast Programs Administrative Director, Johns Hopkins Cancer Survivorship Programs Department of Surgery and Oncology Associate Professor, JHU School of Medicine Departments of Surgery, Oncology, and Gynecology Associate Professor, JHU School of Nursing Johns Hopkins Avon Foundation Breast Center Baltimore, Maryland

Sharon Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC

www.AONNonline.org AONNAsize20813

Medical Legal Update

Understanding Bankruptcy as a Tool…Continued from page 18 prosecution (or the commencement of one), nor does it stop the suspension or revocation of a professional license, such as a medical license (11 USC § 362[b]: McMullen v Sevigny, 386 F3d 320, 325 [1st Cir Mass 2004]). Another exception arises in the context of a debtor that deals with the Department of Health and Human Services (HHS). Section 362(b)(28) of the Bankruptcy Code provides that the automatic stay does not prevent the Secretary of HHS from excluding a debtor from participating in the Medicare program or in any other federal healthcare program (11 USC § 362[b] [28]). By being excluded from the Medicare program, the debtor will be unable to receive payments from Medicare for services rendered to Medicare beneficiaries. Therefore, a debtor attempting to file for bankruptcy protection with the goal of preventing HHS from excluding it from a federal healthcare program would be unsuccessful. Medical professionals and their bankruptcy professionals should be aware of this section, because it may play a role in prepetition bankruptcy planning for the medical practice.

Assumption or Rejection of Unexpired Leases The largest costs for a medical practice are for the medical equipment and the office space. For example, the costs of a magnetic resonance imaging machine can run into the millions of dollars and result in high monthly lease payments. One provision of the Bankruptcy Code provides that unexpired leases, such as equipment or rental leases, may be either assumed (continued) or rejected by the debtor in bankruptcy (11 USC § 365). A Chapter 11 debtor that wishes to assume or reject a lease

will either make a motion to the bankruptcy court seeking approval, or provide for such assumption or rejection in the plan of reorganization. The bankruptcy court will need to determine whether the assumption or rejection is in the best interests of the debtor’s creditors. In a scenario where the debtor seeks to reject an equipment lease, the debtor’s motion

that was not paid during the bankruptcy case. These debts will be paid off in accordance with the reorganization plan, and the debtor will no longer have to make the lease payments that were due after the rejection date. The ability of a debtor to assume or reject a lease is a powerful one in a Chapter 11 context, and can be used to alleviate some of the financial burdens that may have pushed the medical practice into bankruptcy.

Some of the nonexclusive factors that a court will consider when determining whether to appoint an ombudsman can range from the cause of the debtor’s bankruptcy filing, the debtor’s history of patient care, and the potential for patient injury if the debtor were to drastically reduce its level of care.

Potential Appointment of an Ombudsman Although many aspects of a Chapter 11 bankruptcy filing are standard, regardless of the debtor and its business, there are distinct differences that must be addressed if the debtor is classified as a “healthcare business.” Under the Bankruptcy Code, a healthcare business is defined as either a public or a private entity that is “primarily engaged in…the diagnosis or treatment of injury, deformity, or disease; and surgical, drug treatment, psychiatric, or obstetric care” (11 USC § 101[27A]). This is further defined to include any general or specialized hospital; any ancillary ambulatory, emergency, or surgical treatment facility; hospices; home health agencies or similar entities; and any long-term care facility, such as nursing homes (11 USC § 101[27A]). Examples of a healthcare business can range from a medical practice that operates multiple locations to a solo practice that provides plastic surgery to its patients (In re N Shore Hematology-Oncology Assocs, PC, 400 BR 7 [Bankr EDNY 2008]; In re William L. Saber, MD, PC, 369 BR 631 [Bankr D Colo 2007]; In re Med Assocs of Pinellas, LLC, 360 BR 356 [Bankr MD Fla 2007]). Therefore, potential bankruptcy filers should discuss all aspects of

will usually assert that the costs of the equipment lease are too burdensome to sustain and, therefore, it must be rejected to protect the debtor’s estate. Subsequent to any rejection, the lessor will have an unsecured claim against the debtor’s estate for the sum that was not paid before the bankruptcy filing, as well as an administrative claim for the sum

Oncology Practice Management

I February 2013

Medical Legal Update

their practice with their counsel to ensure that it is classified correctly and that the appropriate procedures are being followed pursuant to the Bankruptcy Code. One aspect of a Chapter 11 bankruptcy filing of a healthcare business is the potential for a court appointment of a patient care ombudsman (11 USC § 333). This is an individual tasked with monitoring the quality of patient care that is provided by the debtor, and representing the patients’ interests during the course of the bankruptcy case (11 USC § 333[a][1]. A court determination of whether to appoint a patient care ombudsman is a fact-intensive, case-specific inquiry. Some of the nonexclusive factors that a court will consider when determining whether to appoint an ombudsman can range from the cause of the debtor’s bankruptcy filing, the debtor’s history of patient care, and the potential for patient injury if the debtor were to drastically reduce its level of care (In re Alternate Family Care, 377 BR 754, 758 [Bankr SD Fla 2007]; In re N Shore HematologyOncology Assocs, PC, 400 BR 7,8 [Bankr EDNY 2008]). If appointed, the patient care ombudsman generally conducts in terviews with both the patients and the physicians in the medical practice or organization (11 USC § 333[b][1]). Any information that is obtained relating to the patients, including their medical records, is confidential (11 USC § 333[c][1]). Although the patient care ombudsman does not have immediate authority to review these patient records, the bankruptcy court may authorize him or her to do so subject to certain restrictions to be determined by the court (11 USC § 333[c][1]). During the course of his or her review, the patient care ombudsman reports to the bankruptcy court every 60 days regard-

Security Rules, as well as other relevant federal and state laws. For example, New York requires the retention of patient records for 6 years (NY Comp Codes R & Regs Tit 8, § 29.2[a][3]). As such, it is important for medical practitioners to work with their bankruptcy attorneys and healthcare attorneys to ensure compliance with these laws.

ing the quality of the care that is being provided to patients, and may intervene, if necessary, if a crisis arises with a patient or if there are disputes regarding a patient’s care (11 USC § 333[b][2]).

Treatment of Patient Records Another source of concern for the medical practice and for its patients is what will happen to the patient records if there is a bankruptcy filing. Although patient records legally belong to the patient, the medical practice holds the records in physical and, usually, in digital form. The Bankruptcy Code specifically addresses the treatment of patient records if the debtor is deemed a healthcare business and cannot financially maintain them in accordance with federal law (11 USC § 351). Under the Bankruptcy Code, the debtor must publish a notice in at least 1 newspaper that informs the public that the debtor has filed for bankruptcy and that the debtor’s patients have 1 year to claim their medical records before the records are destroyed (11 USC § 351[3]). During the first 180 days of that 365-day period, the debtor must mail a notice to each patient’s last known address, as well as to each patient’s insurance carrier, alerting them of the potential destruction of their medical records (11 USC § 351[3]). Before the records are destroyed, the debtor must make 1 last attempt to preserve them by submitting a request to an appropriate government agency to store the unclaimed records. If the request is not granted, the records can then be destroyed. However, if the debtor is not considered to be a healthcare business, the debtor will still need to address the issue of patient records in accordance with the Health Insurance Portability and Accountability Act (HIPAA) of 1996 Privacy and

February 2013

Conclusion Bankruptcy, often a misunderstood and dismissed option for medical professionals in a financial crunch, may, in fact, be used as a beneficial tool for the continued operation or orderly closure of a medical practice. Deciding whether bankruptcy is an option for your practice requires working with an experienced bankruptcy attorney to review relevant factors to your operations that can run the gamut of medical equipment leases to patient records. l Michael A. Sabella, Esq, is an Associate in Kirschenbaum & Kirschenbaum, PC’s Bankruptcy Department. Before joining the firm, Michael was a law clerk for the Honorable Dorothy T. Eisenberg, Federal Bankruptcy Court Judge for the Eastern District of New York. Michael received his LLM in Bankruptcy degree and JD degree from St. John’s University School of Law. To discuss whether bankruptcy may be a beneficial avenue for your medical practice, call 516-7476700 or e-mail Michael at Msabella@ Kirschenbaumesq.com. Jennifer Kirschenbaum, Esq, manages Kirschenbaum & Kirschenbaum, PC’s healthcare practice, which specializes in representing healthcare practitioners in regulatory compliance, audit defense, licensure, and transactional matters. She may be reached at 516-747-6700 x302 or by e-mail at Jennifer@Kirschenbaumesq.com.

www.OncPracticeManagement.com

AmgenAssistOnli

Need an everyday resource for answers to coverage, reim and financial assistance questions? Amgen Assist can he ®

REGISTER online or Call (888) 4ASSIST Register for FREE to fill out, submit, and track requests such as insurance verifications online. You can also manage your facility profile and view current and historical account activity

Learn about our service offerings and how Amgen Assist® Online can help your practice • Insurance Verification • Prior Authorization • Billing and Claims Support

Learn about the various financial assistance programs that may be available to your patients to manage out-of-pocket expenses

Navigator is a registered trademark of Engage Healthcare Communications, LLC, an affiliate of The Lynx Group. No part of these materials 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. 68327-R1-V1

ine.com

mbursement elp

NAVIGATOR

W E B S I T E N A V I G AT I O N M A D E E A S Y

Access to reimbursement information for specific Amgen products by local payors â&#x20AC;&#x201C; at your fingertips

Get grounded in the basics of oncology practice management and stay current with resources that cover the latest information on practical day-to-day issues

ÂŽ

Making access easier.

Practice Analysis

ASCO Prepares for the Future of Oncology Practice By Lisa Neuman

nticipating major changes in how oncology practices could be structured over the next several decades, the American Society of Clinical Oncology (ASCO) has undertaken a fullscale study of how oncology practices are structured today and how they are preparing for the future in response to increasing economic pressures and new developments in cancer care. The preliminary results of the ASCO National Census of Oncology Practices, which were released in January 2013 (Forte GJ, et al. J Oncol Pract. 2013;9:9-19), will provide the foundation for the full scope of the 3 major research projects that comprise the ASCO initiative. Ultimately, the results of this project will help to inform policymaking in oncology for the next 2 decades. According to Sandra M. Swain, MD, FACP, President of ASCO, the primary goal of these studies is to gain an understanding of “how practices are responding to environmental stressors as they continue to provide cancer care to their patients. Absent this information, policy and practice solutions will inadequately respond to the needs of the community or may inadvertently address the wrong issues. The oncology community has a responsibility to prepare for the future, which starts with gaining clarity about the present.” Launched in June 2012, the intent of this census is to systematically gather demographic information—including practice size and organization model, staffing characteristics, affiliations with hospitals and other healthcare providers, and patient characteristics—on every oncology practice in

the United States on an annual basis to help practices make informed business and clinical decisions.

Preparing for the Future The questions were designed to be broad enough to elicit in-depth responses from oncology practices on how they are adapting to the ever-growing economic, demographic, and political changes that are affecting the daily operation of oncology practices while their administrators and clinicians simultaneously remain focused on providing patients with the highest-quality cancer care. The areas that will be examined each year include: • Rising costs of cancer care • Drug shortages • Competitive forces • Payer restrictions • Staffing • Mergers • Technology implementation— electronic health records (EHRs) or electronic medical records (EMRs) • Patient volume. More than 630 US oncology practices participated in the first census, and of these practices, 542 provided full-data replies. It became apparent that, for many practice administrators, compiling all of the requested information on several questions was labor intensive and time consuming, with some of the questions either requiring input from other practice staff members or necessitating a review of the previous year’s records. Therefore, the initial findings will be built upon in subsequent surveys. ASCO plans to significantly expand participation in the next census, which will reopen in the spring, to ensure that

Oncology Practice Management

I February 2013

the data collected is representative of the entire oncology community.

Use of EHR/EMR Systems More than 60% of the responding practices use an advanced EHR/ EMR system, 16.2% use a basic EHR/EMR system, 15% plan to implement an EHR/EMR system within the next 6 months, and 8% of the practices reported no current or planned use of an EHR/EMR system in the next 12 months. Organizational and Staffing Structures Another series of questions focused on changes to a practice’s organizational structure during the previous 12 months, including practice purchases, mergers, and new affiliations with other healthcare entities; additions and/or reductions to staff; as well as salary increases and/or decreases. Larger practices (N = 159) were defined as having ≥7 physicians, and smaller practices (N = 189), 1 to 2 physicians. The responses clearly indicated that in the 12 months before the census, larger practices were more likely than smaller practices to: • Merge practices (8.9% vs 3%) • Hire new staff (70.7% vs 41.4%) • Increase salaries (61.2% vs 40.7%). Likewise, larger practices were slightly less likely to lay off staff than smaller practices (15.3% vs 16.9%). Among smaller practices, 4.5% are likely to lay off oncologists and 2.4% are likely to lay off oncology nurses sometime in the next 12 months, compared with larger practices that plan to lay off oncologists (0.8%) or oncology nurses (1.6%). Smaller practices also face

Practice Analysis

an increased likelihood of closing the practice entirely sometime in the next 12 months compared with larger practices (6.5% vs 1.5%). Among larger practices, 33.6% indicated that they are likely to hire additional oncologists and 14.2% are likely to hire more oncology nurses; those proportions were 8.9% and 5.2%, respectively, in smaller practices. Large practices are also more likely than smaller practices to purchase additional practices (3.8% vs 2.4%) sometime in the next 12 months.

Additional Findings Other preliminary findings from the 630 responding oncology practices include: • Participating practices treat an average of 1268 new patients each year • The mean number of oncology physicians in a practice is 9.0. The mean number of full-time equivalent oncology nurses is 6.7 • The majority of the practices (71%) provide hematology/ oncology, 23.4% provide medical oncology, and 20.9% provide radiation oncology services to their patients • Less than half (48.3%) of the practices provide chemotherapy services to their patients • Other services provided by some practices include social work (28.2%), clinical trial participation (26.7%), laboratory services (25.8%), and nutritional counseling (22.9%) • The majority (55.9%) of the practices are private community practices; 9.8% are private practices that are integrated with large healthcare systems • The remaining practices are academic practices (9.5%), academic community-based practices (1.8%), institutional but nonacademic practices that employ physicians (12.4%) or contract

Table. Oncology Practices Responding to the ASCO Census

Ownership type

Practices, N (%)

Private community practice characterized as a corporation, partnership, or other legal entity

335 (55.9)

Private integrated group practice that is part of a large healthcare system (including practices that own the institution in which they work, or practices captured within closed healthcare systems)

59 (9.8)

Institutional, nonacademic, employed physicians (including nonacademic hospitals, 501.a or 501.c3, or entities that are captured by part of the institution)

74 (12.4)

Academic practice (that includes academic teaching, academic research activities)

57 (9.5)

Academic community-based practice

11 (1.8)

Government (federal, state, public health, military, Veterans Affairs)

11 (1.8)

Other

31 (5.2)

Total

599 (100)

Adapted from Forte GJ, et al. American Society of Clinical Oncology National Census of Oncology Practices: preliminary report. J Oncol Pract. 2013;9:9-19. oncology practice in the United States is an unprecedented and substantial undertaking, and not without some limitations in generalizing the information. Practices vary widely throughout the country, and the low response rate on the initial census makes it difficult to extract the data in ways that can inform policymaking at this time. The census, however, will be an ongoing initiative that when combined with 2 other major research projects (the ASCO Workforce Information System and the ASCO Geographic Access to Oncology Care) should provide the data needed to inform advocacy and policy for oncology over the next several decades. l

physicians (3.5%), and government-based practices, such as military, Veterans Affairs, and federal and state departments of health (1.8%) • Overall, 57% practices are affiliated with a community hospital, 28% are affiliated with an academic medical center, and 28% are affiliated with another type of medical center • Nearly half (47.4%) of the pa tients managed by these practices are covered by Medicare, 9.2% are covered by Medicaid, 38.6% have private insurance, and 4.8% are uninsured.

Conclusion ASCO’s attempt to survey every

February 2013

www.OncPracticeManagement.com

Drug Coding Supplied by RJ Health Systems

FDA-Approved Medications Used for Supportive Care in Cancer Treatment The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with supportive care in cancer treatment. The following sections include: • Associated ICD-9-CM codes used for the classification of supportive care in cancer treatment • Drugs that have been FDA-approved in the treatment of supportive care in cancer treatment • Corresponding HCPCS/CPT® codes and code descriptions

Associated ICD-9-CM codes for supportive care in cancer treatment: 787.0 Nausea and vomiting Emesis Excludes: hematemesis NOS (578.0) vomiting: bilious, following gastrointestinal surgery (564.3) cyclical (536.2) >associated with migraine (346.2)< psychogenic (306.4) excessive, in pregnancy (643.0-643.9) habit (536.2) of newborn (779.3) psychogenic NOS (307.54) 787.01 Nausea and vomiting 787.02 Nausea alone 787.03 Vomiting alone 280 Iron deficiency anemias Includes: anemia: asiderotic hypochromic-microcytic sideropenic Excludes: familial microcytic anemia (282.49) 280.0 Secondary to blood loss (chronic) Normocytic anemia due to blood loss Excludes: acute posthemorrhagic anemia (285.1) 284.8 Other specified aplastic anemias 284.89 Other specified aplastic anemias Aplastic anemia (due to): chronic systemic disease drugs infection radiation toxic (paralytic) Use additional E code to identify cause

Oncology Practice Management

I February 2013

Drug Coding Supplied by RJ Health Systems

285 Other and unspecified anemias 285.1 Acute posthemorrhagic anemia Anemia due to acute blood loss Excludes: anemia due to chronic blood loss (280.0) blood-loss anemia NOS (280.0) 285.21 Anemia in chronic kidney disease Anemia in end-stage renal disease (ESRD) Erythropoietin-resistant anemia (EPO-resistant anemia) 285.3 Antineoplastic chemotherapy-induced anemia Anemia due to antineoplastic chemotherapy Excludes: anemia due to drug NECâ&#x20AC;&#x201D;code to type of anemia anemia in neoplastic disease (285.22) aplastic anemia due to antineoplastic chemotherapy (284.89) 288.0 Neutropenia Decreased absolute neutrophil count (ANC) Use additional code for any associated: fever >(780.61)< mucositis (478.11, 528.00-528.09, 538, 616.81) Excludes: neutropenic splenomegaly (289.53) transitory neonatal neutropenia (776.7) 288.00 Neutropenia, unspecified 288.01 Congenital neutropenia Congenital agranulocytosis Infantile genetic agranulocytosis Kostmannâ&#x20AC;&#x2122;s syndrome 288.02 Cyclic neutropenia Cyclic hematopoiesis Periodic neutropenia 288.03 Drug-induced neutropenia Use additional E code to identify drug 288.04 Neutropenia due to infection 288.09 Other neutropenia Agranulocytosis Neutropenia: immune toxic 288.5 Decreased white blood cell count Excludes: neutropenia (288.01-288.09) 288.50 Leukocytopenia, unspecified Decreased leukocytes, unspecified Decreased white blood cell count, unspecified Leukopenia NOS 288.59 Other decreased white blood cell count Basophilic leukopenia Eosinophilic leukopenia Monocytopenia Plasmacytopenia Continued on page 28

February 2013

www.OncPracticeManagement.com

Drug Coding Supplied by RJ Health Systems

Associated ICD-9-CM codes for supportive careâ&#x20AC;ŚContinued E930.7 Antineoplastic antibiotics Actinomycins, such as: Bleomycin Cactinomycin Dactinomycin Daunorubicin Mitomycin Excludes: other antineoplastic drugs (E933.1) E933.1 Antineoplastic and immunosuppressive drugs Azathioprine Busulfan Chlorambucil Cyclophosphamide Cytarabine Fluorouracil Mechlorethamine HCl Mercaptopurine Triethylenethiophosphamide (thio-TEPA) Excludes: antineoplastic antibiotics (E930.7)

Please note: The following list does not include drugs that may be listed in the Compendia for off-label uses for Supportive Care in Cancer Treatment.

Generic (brand) name

HCPCS code: code description

Possible CPTÂŽ administration code

aprepitant (Emend)

J8501: Aprepitant, oral, 5 mg

N/A

darbepoetin alfa (Aranesp)

J0881: Injection, darbepoetin alfa, 1 mcg (non-ESRD use)

96372, 96374

darbepoetin alfa (Aranesp)

J0882: Injection, darbepoetin alfa, 1 mcg (for ESRD on dialysis)

96372, 96374

dronabinol (Marinol)

J8597a: Antiemetic drug, oral, not otherwise specified

N/A

dronabinol (Marinol)

Q0167: Dronabinol, 2.5 mg oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 48-hour dosage regimen

N/A

dronabinol (Marinol)

Q0168: Dronabinol, 5 mg oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 48-hour dosage regimen

N/A

Oncology Practice Management

I February 2013

Drug Coding

Generic (brand) name

HCPCS code: code description

Possible CPTÂŽ administration code

epoetin alfa (Procrit, Epogen)

J0885: Injection, epoetin alfa, (for non-ESRD use), 1000 units

96372, 96374

epoetin alfa (Procrit, Epogen)

J0886: Injection, epoetin alfa, 1000 units (for ESRD on dialysis) (renal dialysis facilities and hospitals must use code Q4081 effective 1/1/07)

96372, 96374

epoetin alfa (Procrit, Epogen)

Q4081: Injection, epoetin alfa, 100 units (for ESRD on dialysis) (for renal dialysis facilities and hospital use)

96372, 96374

filgrastim (Neupogen)

J1440: Injection, filgrastim (G-CSF), 300 mcg

96365, 96366, 96369, 96370, 96372, 96374

filgrastim (Neupogen)

J1441: Injection, filgrastim (G-CSF), 480 mcg

96365, 96366, 96369, 96370, 96372, 96374

fosaprepitant (Emend)

J1453: Injection, fosaprepitant, 1 mg

96365, 96374

granisetron (Kytril)

J1626: Injection, granisetron hydrochloride, 100 mcg

96374

granisetron (Kytril)

Q0166: Granisetron hydrochloride, 1 mg, oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 24-hour dosage regimen

N/A

granisetron (Kytril)

S0091: Granisetron hydrochloride, 1 mg (for circumstances falling under the Medicare statute, use Q0166)

N/A

metoclopramide (Reglan)

J2765: Injection, metoclopramide HCl, up to 10 mg

96372, 96374

nabilone (Cesamet)

J8650: Nabilone, oral, 1 mg

N/A

ondansetron (Zofran)

J2405: Injection, ondansetron hydrochloride, per 1 mg

96372, 96374

ondansetron (Zofran)

Q0162: Ondansetron 1 mg, oral, FDAapproved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at the time of chemotherapy treatment, not to exceed a 48-hour dosage regimenâ&#x20AC;&#x201D;see also S0119

N/A

ondansetron (Zofran)

S0119: Ondansetron, oral, 4 mg (for circumstances falling under the Medicare statute, use HCPCS code Q0162)

N/A

palonosetron (Aloxi)

J2469: Injection, palonosetron HCl, 25 mcg

96374

pegfilgrastim (Neulasta)

J2505: Injection, pegfilgrastim, 6 mg

96372 Continued on page 30

February 2013

www.OncPracticeManagement.com

Drug Coding

Generic (brand) name

HCPCS code: code description

Possible CPT® administration code

sargramostim (Leukine)

J2820: Injection, sargramostim (GM-CSF), 50 mcg

96365, 96366, 96372

When billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code in Column 24D and the drug name, strength, and NDC (National Drug Code) in Box 19 to ensure appropriate reimbursement.

References HCPCS Level II Expert 2013 • Current Procedural Terminology (CPT® ) 2013 (CPT copyright 2013 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Volumes 1, 2, 2013 • FDA-approved indication (from product prescribing information) • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Rocky Hill, Connecticut • CMS (Centers for Medicare & Medicaid Services) CPT® indicates Current Procedural Terminology; G-CSF, granulocyte colony-stimulating factor; GM-CSF, granulocyte macrophage 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 • www.RJHealthSystems.com WCMC_2013Conf_horizontalV280612_Layout 1 8/17/12 1:37 PM Page 1

SECOND ANNUAL CONFERENCE

2013 WORLD CUTANEOUS MALIGNANCIES CONGRESS

• Melanoma • Basal Cell Carcinoma • Cutaneous T-Cell Lymphoma • Squamous Cell Carcinoma • Merkel Cell Carcinoma

July 26-28, 2013 Hyatt Regency La Jolla • at Aventine 3777 La Jolla Village Drive • San Diego, California 30

Oncology Practice Management

I February 2013

RJ Health Systems The Creators of ReimbursementCodes.com

RJ Health Systems â&#x20AC;&#x201D; the pharmaceutical specialists that healthcare professionals have turned to since 1983 for their drug information. We work with over 170 Payor organizations that touch approximately 110 million lives. RJ Health Systems has established and continuously maintains a Library of Drug Intelligence that provides the most comprehensive, trusted, and up-to-date coding and reimbursement information in the industry. ReimbursementCodes.com incorporates the CMS HCPCS and AMA CPT Drug codes into a system that crosswalks each drug code with the drugâ&#x20AC;&#x2122;s NDC and brand/generic name. Please visit www.rjhealthsystems.com to learn more about our products and services listed below:

>> >> >> >> >> >> >> >> >>

ReimbursementCodes.com Drug Diagnosis Coding CMAC PartBorPartD.com NDC Conversion Database Min/Max Dosing Advisories Notations Clinical Consulting

rjhealthsystems.com

Patient and Provider Access Brought to you by the Association of Community Cancer Centers

Essential Health Benefits: Will the Minimum Coverage Plan Cover Cancer Patients? By Sydney Abbott, JD, Manager of Provider Economics and Public Policy, Association of Community Cancer Centers

eginning in 2014, state health insurance exchanges will offer consumers a more organized and competitive market for buying health insurance. Essential health benefits (EHBs) are the minimum benefits that must be covered by any insurance policy, known as a qualified health plan, offered on the state health insurance exchanges. Once they are up and running, these exchanges will offer a choice of health plans, will certify participating plans, and will provide information to help consumers better understand their options. However, the proposed flexibility of the health exchange design raises questions about access to care for patients with cancer. After 2 prerule bulletins and months of waiting, the US De partment of Health and Human Services (HHS) finally released the proposed rule defining the EHBs package and actuarial value for health plans operating in the new health insurance exchanges. As it stands now, states may choose to develop their own state-based health exchange or default to a federally run exchange. States that opt to develop their own exchange must define the minimum, or essential, benefits provided by all of the plans operating in the state exchange. The release of this proposal gives us the first indication of the plan offerings that may be available through the health insurance

exchanges. It is imperative to ensure that the minimum benefits do not leave patients with cancer underinsured. A weak EHBs rule may leave patients unable to pay for high-cost care. Although the Affordable Care Act (ACA) mandates a set of benefit categories, it assigns the Secretary of HHS the task of describing the baseline benefits that must be included in every EHBs package, whether it is state or fed-

Without necessary cost-sharing protections, the HHS proposal could translate into a minimum benefits plan that leaves a patient with cancer grossly underinsured.

erally run. It is generally believed that cancer care will be covered by a state’s EHBs package, but the HHS has failed to propose specific rules to ensure that the coverage is comprehensive and adequate. Flexibility in Benefit Design The proposed EHBs rule leaves most of the decision-making up to the states, which may select their largest small-group plan or a num ber of other plans. It is generally ap preciated that governors have the flexibility to select and tailor a

Oncology Practice Management

I February 2013

health insurance exchange based on the plans that are already available in the state. However, it is worrisome that states may not ultimately select a benchmark plan that is robust enough to adequately cover patients with cancer. It is important to remember that under the ACA, a state may elect to identify a more robust EHBs package than is required from the HHS; however, the state will bear the cost of providing those additional benefits. I think that this option will be reserved for states that already have a history of protecting patient access to care through staterun programs. This flexibility for the states— and insurers—is particularly problematic in the proposed design for prescription drugs. In previously released EHBs bulletins, the HHS suggested requiring all plans to provide coverage of 1 drug for each drug class of the Medicare Part D’s 6 protected therapeutic classes (ie, immunosuppressant, antidepressant, antipsychotic, anticonvulsant, antiretroviral, and antineoplastic). Medicare Part D covers all or nearly all of the drugs in these 6 classes. The Association of Community Cancer Centers (ACCC), along with many state oncology societies, recommended a benefit design comparable to Medicare Part D in its official comments on the proposed EHBs rule. However, the HHS has not yet outlined this robust coverage. Instead, the HHS is proposing to allow the states to offer as little as 1 drug per US drug category. In addition, the proposed rule does not provide guidance to the states on how to handle specialty drug tiers, Continued on page 34

â&#x20AC;˘ Melanoma â&#x20AC;˘ Basal Cell Carcinoma â&#x20AC;˘ Cutaneous T-Cell Lymphoma â&#x20AC;˘ Squamous Cell Carcinoma â&#x20AC;˘ Merkel Cell Carcinoma

July 26-28, 2013

Hyatt Regency La Jolla â&#x20AC;˘ San Diego, California

PROGRAM OVERVIEW

CONFERENCE CO-CHAIRS

A 2-day congress dedicated to informing, educating, and fostering the exchange of clinically relevant information in the field of cutaneous malignancies on topics in melanoma, basal cell carcinoma, cutaneous T-cell lymphoma, squamous cell carcinoma, and Merkel cell carcinoma, including: â&#x20AC;˘ Epidemiology and genetic/environmental factors â&#x20AC;˘ Molecular biology and cytogenetics related to the pathogenesis of cutaneous malignancies â&#x20AC;˘ Risk stratification based on patient and tumor characteristics â&#x20AC;˘ Principles of cancer prevention of melanoma and basal cell carcinoma â&#x20AC;˘ Current treatment guidelines â&#x20AC;˘ Emerging treatment options for personalized therapy â&#x20AC;˘ Future strategies in management based on translational data from current clinical trials and basic research

LEARNING OBJECTIVES Upon completion of this activity, the participant will be able to: â&#x20AC;˘ Review the molecular biology and pathogenesis of cutaneous malignancies as they relate to the treatment of cutaneous T-cell lymphoma, basal cell carcinoma, Merkel cell tumors, and malignant melanoma â&#x20AC;˘ Compare risk stratification of patients with cutaneous malignancies, and how to tailor treatment based on patient and tumor characteristics â&#x20AC;˘ Summarize a personalized treatment strategy that incorporates current standards of care and emerging treatment options for therapy of patients with cutaneous malignancies

TARGET AUDIENCE This activity was developed for medical and surgical oncologists, dermatologists, radiation oncologists, and pathologists actively involved in the treatment of cutaneous malignancies. Advanced practice oncology or dermatololgy nurses, oncology pharmacists, and researchers interested in the molecular biology and management of cutaneous malignancies are also encouraged to participate.

DESIGNATION OF CREDIT STATEMENTS SPONSORS This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

COMMERCIAL SUPPORT ACKNOWLEDGMENT Grant requests are currently being reviewed by numerous supporters. Support will be acknowledged prior to the start of the educational activities.

Sanjiv S. Agarwala, MD Professor of Medicine Temple University School of Medicine Chief, Oncology & Hematology St. Lukeâ&#x20AC;&#x2122;s Cancer Center Bethlehem, Pennsylvania

REGISTERED NURSE DESIGNATION Medical Learning Institute Inc Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 12.0 contact hours.

REGISTERED PHARMACY DESIGNATION The Medical Learning Institute Inc is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Completion of this knowledge-based activity provides for 12.0 contact hours (1.2 CEUs) of continuing pharmacy education credit. The Universal Activity Number for this activity is (To be determined).

CONFERENCE REGISTRATION EARLY BIRD REGISTRATION NOW OPEN! $175.00 UNTIL APRIL 30, 2013

www.CutaneousMalignancies.com

Professor Dr. Med. Axel Hauschild Professor, Department of Dermatology University of Kiel Kiel, Germany

AGENDA* FRIDAY, JULY 26, 2013 3:00 pm â&#x20AC;&#x201C; 7:00 pm

Registration

5:30 pm â&#x20AC;&#x201C; 7:30 pm

Welcome Reception/Exhibits

SATURDAY, JULY 27, 2013 7:00 am â&#x20AC;&#x201C; 8:00 am

Breakfast Symposium/Product Theater/Exhibits

8:00 am â&#x20AC;&#x201C; 8:15 am

BREAK

8:15 am â&#x20AC;&#x201C; 8:30 am

Welcome to the Second Annual World Cutaneous Malignancies Congress â&#x20AC;&#x201D; Setting the Stage for the Meeting - Sanjiv S. Agarwala, MD

8:30 am â&#x20AC;&#x201C; 11:45 am General Session I: A Clinicianâ&#x20AC;&#x2122;s Primer on the Molecular Biology of Cutaneous Malignancies â&#x20AC;˘ Keynote Lecture Understanding the Basic Biology and Clinical Implications of the Hedgehog Pathway â&#x20AC;˘ Keynote Lecture Pathogenesis of Merkel Cell Carcinoma: An Infectious Etiology? - Paul Nghiem, MD, PhD 12:00 pm â&#x20AC;&#x201C; 1:00 pm Lunch Symposium/Product Theater/Exhibits 1:00 pm â&#x20AC;&#x201C; 1:15 pm

BREAK

1:15 pm â&#x20AC;&#x201C; 4:30 pm

General Session II: Current Treatment Guidelines in Cutaneous Malignancies â&#x20AC;˘ Case Studies Optimal, Value-Based Therapy of Cutaneous Malignancies: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients â&#x20AC;˘ Panel Discussion Management Controversies and Accepted Guidelines for the Personalized Management of Cutaneous Malignancies â&#x20AC;˘ Keynote Lecture New Combinations in Melanoma: A Role for MEK + BRAF and Antiâ&#x20AC;&#x201C;PD-1

4:30 pm â&#x20AC;&#x201C; 6:30 pm

Meet the Experts/Networking/Exhibits

PHYSICIAN CREDIT DESIGNATION The Medical Learning Institute Inc designates this live activity for a maximum of 12.0 AMA PRA Category 1 Credits â&#x201E;˘. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Medical Learning Institute Inc and the Center of Excellence Media, LLC. The Medical Learning Institute Inc is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Steven J. Oâ&#x20AC;&#x2122;Day, MD Hematology/Oncology Director of Clinical Research Director of Los Angeles Skin Cancer Institute at Beverly Hills Cancer Center Clinical Associate Professor of Medicine USC Keck School of Medicine Los Angeles, California

SUNDAY, JULY 28, 2013 7:00 am â&#x20AC;&#x201C; 8:00 am

Breakfast Symposium/Product Theater/Exhibits

8:00 am â&#x20AC;&#x201C; 8:15 am

BREAK

8:15 am â&#x20AC;&#x201C; 8:30 am

Review of Saturdayâ&#x20AC;&#x2122;s Presentations and Preview of Todayâ&#x20AC;&#x2122;s Sessions

8:30 am â&#x20AC;&#x201C; 11:45 am General Session III: Review of Emerging Treatment Options for Cutaneous Malignancies General Session IV: Challenges for the Cutaneous Malignancies Clinician â&#x20AC;˘ Panel Discussion How Can the Healthcare Team Work Best Together to Deliver Value-Based Care in Cutaneous Malignancies? 12:00 pm â&#x20AC;&#x201C; 1:00 pm Lunch Symposium/Product Theater/Exhibits 1:00 pm â&#x20AC;&#x201C; 1:15 pm

BREAK

1:15 pm â&#x20AC;&#x201C; 2:45 pm

General Session V: â&#x20AC;&#x153;Hot Dataâ&#x20AC;? â&#x20AC;&#x201D; What I Learned at Recent Meetings: Focus on Cutaneous Malignancies

2:45 pm â&#x20AC;&#x201C; 3:00 pm

Closing Remarks - Steven J. Oâ&#x20AC;&#x2122;Day, MD

*Agenda is subject to change.

For complete agenda please visit www.CutaneousMalignancies.com

Patient and Provider Access

Essential Health Benefits: Will the Minimum Coverage…Continued from page 32 nor does it address cost-sharing control for orally administered anticancer medications. It is anticipated, for example, that the bronze-level plan offered through an exchange, which will contain the minimum benefits offered, may have a 20% coinsurance, with a more than $4000 deductible. Without necessary cost-sharing protections, the HHS proposal could translate into a minimum benefits plan that leaves a patient with cancer grossly underinsured. Actuarial Value Assuming that the states elect a benefit design that adequately covers patients with cancer, those patients still may be unable to receive the most appropriate care because of a

high deductible or a high coinsurance. The way that states will determine patient cost-sharing for the various plans depends on the actuarial value associated with each plan. Actuarial value is calculated as the percentage of total average costs for the covered benefits that a plan will cover. Therefore, a plan with an actuarial value of 70% means that the patient will be responsible for 30% of the cost of all covered benefits. Under the proposed EHBs rule, nongrandfathered plans in the exchange will be awarded “medal levels” based on their actuarial value percentages, with a 2% variance allowed. For example, bronze-level plans will have an actuarial value of 60%, silver-level plans will have an

actuarial value of 70%, gold-level plans will have an actuarial value of 80%, and platinum plans will have an actuarial value of 90%. Clearly, a patient with cancer who is responsible for 40% of the cost of care will be quickly limited in the treatment that patient receives. Final Rule Expected The ACCC aired its concerns for patients and providers by submitting official comments to the HHS on the proposed rule, and the HHS is in the process of reviewing the comments from all of the stakeholders and will release final guidance on the EHBs shortly. As always, the ACCC will keep its members informed of any developments. l

presents

Defining and Creating Clinical Excellence

April 10-12, 2013 Bally’s Hotel & Casino • Las Vegas, NV

www.aameda.org

3 Conferences – Oncology, Cardiovascular, Neuroscience – 1 Dynamic Location

Oncology track highlights: • Quality Metrics • Developing a Cancer Program • • 2013 Contracting Strategies • Building a Dashboard • • Rural Cancer Care • Multidisciplinary Clinical Care • • Growing Clinical Trial Enrollment • 34

AAMA JOP Ad.indd 1

Oncology Practice Management

I February 2013

12/12/12 11:40 AM

Physician Wealth Management With Lawrence B. Keller, CFP®

Hospital Employment of Oncologists By Ron Lebow, Esq, Carey F. Kalmowitz, Esq, and Lawrence B. Keller, CFP®

ospitals are employing phy sician specialists of all types, and oncologists are no exception. Oncology practices are increasingly being recognized as an integral acquisition for a hospital to ensure a profitable physician network. This article outlines some key considerations when reviewing and negotiating hospital employment offers and agreements.

Compensation It is important to remember when reviewing an offer from a hospital or a health system that you bring to the table much more than your individual productivity and revenue. The sum of all parts is worth more than any one provider alone. Your practice is an integral component of a lucrative network of services and referral relationships. For example, urologists can be recruited and rewarded if oncology income remains within the network, and reconstructive breast surgeons can be assured a stream of referrals. Revenues enjoyed by the hospital from advanced diagnostic testing will also be increased by your presence. What is the implication of this? Ask the hospital for more money (the worst they can do is say no—or they may meet you in the middle with a compromise). If a base salary increase is not accepted (or even if it is), a minimum bonus guarantee for a certain period of time may be provided. Alternatively, a profit pool may be established that sets aside specified revenues for apportionment among the “network” of complementary providers that exist within this referral stream. Any approach will have to be carefully analyzed and properly structured to ensure

compliance with the law, but the effort to negotiate could be worth the reward.

Compensation and Bonus Models—and Their Pitfalls Base compensation and/or bonuses are usually (although not always) contingent on meeting certain quantitative benchmarks—meeting and/or exceeding a work Relative Value Unit (RVU) threshold; meeting and/or exceeding a revenue threshold based on personal collections; or achieving surplus revenues at a particular practice office in excess of all the expenses attributable to the site, including base compensation and overhead (ie, a profit-bonus methodology). The most common methodology is an RVU threshold. A work RVU threshold is the preferred methodology for the employee, because it insulates the physician from collection failures. As long as the code billing is generated, the physician is given credit. Current Procedural Terminology® codes have an RVU assigned to them that relate to their compensation value, and these code values can increase or decrease. A code with a higher work RVU takes more time and/or requires more intensity. Some radiation oncology codes, such as treatment codes, have no associated physician work, and there are reductions looming for medical and radiation oncology. Accordingly, any compensation based on reaching or exceeding annual work RVUs should consider these risks. For example, the parties could consider establishing a base salary commitment based on 90% of the previous year’s work RVUs, or otherwise could provide a “cushion” amount to allow for loss before

February 2013

Ron Lebow, Esq

Casey F. Kalmowitz, Esq

any salary reductions would take effect. A bonus is usually paid as a dol lar amount for each individual work RVU in excess of an annual threshold, or as a percentage of collections in excess of an annual collection threshold. If a bonus Lawrence B. Keller, CFP® is not offered, it is critical to ask for one based on the foregoing common approaches. It also should be requested that the bonus be estimated and paid quarterly, even though the bonus is based on annual achievement benchmarks. Reconciliation can be conducted at the close of the year, but a higher income stream over the course of the year is warranted. In the event of termination, however, 2 often-overlooked pitfalls include (1) falling short of the annual threshold, or (2) not receiving credit for the accounts receivable collected after you leave. Regarding the former, the establishment of an annual bonus based on an annual threshold could result in the loss of any bonus-earning potential in the event that termination occurs short of the 12-month measuring period, because the threshold has not yet Continued on page 38

www.OncPracticeManagement.com

HalavenReimbursem

Your source for reimbursement information related to Halaven

CODING & BILLING Coding & Pricing

Billing Forms

HCPCS Level II Codes CPT Drug Administration Code ICD-9-CM Diagnosis Codes National Drug Codes Revenue Codes Billing for Wastage Medicare Reimbursement Rate

Annotated CMS 1500 (08/05) Form Annotated UB-04 Form Checklist for Claims Submission CMS 1500 (08/05) Form UB-04 Form

COVERAGE POLICY Physician Office

Hospital Outpatient

Medicare Medicaid Commercial Payors

RESOURCES Patient Assistance Program Coverage Scenarios FAQ FDA Approval Letter

Prescribing Information Eisai Assistance Program Enrollment Form Insurance Verification Form

Navigator is a registered trademark of Engage Healthcare Communica may be reproduced or transmitted in any form or by any means now recording, or any informational storage and retrieval system, without w

Eisai cannot guarantee payment of any claim. Coding, coverage, an and setting of care. Actual coverage and reimbursement decision For additional information, customers should consult with their requirements. It is the sole responsibility of the provider to select seeking reimbursement. All services must be medically appropria

ment.com

n (eribulin mesylate) Injection 速

ations, LLC, an affiliate of The Lynx Group. No part of these materials or hereafter known, electronic or mechanical, including photocopy, written permission from the Publisher.

nd reimbursement may vary significantly by payor, plan, patient, ns are made by individual payors following the receipt of claims. r payors for all relevant coding, reimbursement, and coverage t the proper code and ensure the accuracy of all claims used in ate and properly supported in the patient medical record.

NAVIGATOR

W E B S I T E N A V I G AT I O N M A D E E A S Y

98% of calls answered within 10 seconds or less Full-time pharmacists on duty during hours of operation (Monday through Friday, 8AM to 8PM ET) Dedicated EAP team with an average of more than 9 years of healthcare, reimbursement, and/or call center experience On-staff Certified Professional Coders (CPCs) provide an additional level of expertise Regionally aligned EAP hotline agents are well-versed in local payor and plan knowledge Insurance verification and coverage options with an approximate 24- to 48-hour turnaround for all queries

Physician Wealth Management

Hospital Employment of Oncologists…Continued from page 35 been reached. This means that a physician can work hard to the very last day, but a critical component of his or her overall compensation package is forfeited. To avoid this unfair result, the annual work RVU, or collection threshold, should be prorated as of the effective employment termination date based on that portion of the 12-month measuring period worked. If employment is terminated 6 months into a given 12-month period, then the threshold should be cut in half for purposes of calculating the bonus earned at such time. In addition, if the bonus calculation (or the base salary for that matter) is based on collections, any accounts receivable attributable to the services rendered during the term of employment that are collected after it ends are usually not credited to the physician for purposes of calculating additional payments. Third-party payer delays outside of the physician’s control should not deprive a former employee of what has been rightfully earned. Accordingly, accounts receivable collected after termination should be tracked for a certain period (eg, 6 months to 1 year).

Personal Financial Exposure It is becoming increasingly common in hospital acquisitions of existing practices that the hospital will offer a salary guarantee and fund the practice budget (as well as any cost overruns, unanticipated expenses, and cash flow shortfalls). This deal helps the physician to maintain a steady income in the face of claims reimbursement cuts, notwithstanding the ebbs and flows of collections. No one has to go without a paycheck, mortgage their property, or run to a bank to get a line of credit.

However, this “deal with the devil” comes at a potential risk. Although the health system hopes to leverage its power to ensure favorable payer rates, it may anticipate a period of time in which reimbursement levels are threatened because of factors outside of its control, and it may further plan on spending money for practice expansion; recruitment; electronic medi-

To hedge this risk, the hospital may consider your existing practice as a “profit center,” and hold the practice owners personally responsible for any deficits attributable to its office.

cal record implementation; capital equipment acquisition; real estate acquisition, renovation, or expansion; and clinical integration of the oncology network. In short, the outlook for achieving the desired profitability could be a 3- to 5-year long-term game. To hedge this risk, the hospital may consider your existing practice as a “profit center,” and hold the practice owners personally responsible for any deficits attributable to its office. For example, the deficit is tracked for several years, and, if the agreement renews, it is then treated as the personal debt of the physicians to be forgiven over time, as long as the physicians in the practice remain on board for another several years.

Oncology Practice Management

I February 2013

This “forgiveness” option is not always provided. If the physicians leave at any time, the agreement may stipulate that they personally owe the deficit. This risk should be reviewed carefully, and the forgiveness time periods and terms should be evaluated carefully. By contrast, if the physicians are going to assume such risk, there must be some reward when the practice goes from “red” on the balance sheet into the “black,” where it is achieving a profit (ie, the profit-bonus methodology). In any event, the options for sharing the risk should be discussed so that the physicians are not entirely on the hook should things not progress as planned. Posttermination accounts receivable collections also should be credited toward reducing any deficit balance. In the event of death or disability, the imposition of such debt obligation may be eliminated because you no longer maintain the capacity to earn an income to pay it back and you did not voluntarily resign employment.

Restrictive Covenant If the relationship ends, the hospital may expect to protect its investment by precluding you from working where you have developed your practice over decades, knowing that this obviously will discourage you from terminating your employment with the health system. Although the hospital’s concerns may be valid, you cannot always expect to just pick up and maintain a viable practice far away from where you live, what you have become accustomed to, and the referral sources you know. Efforts should be made to reduce the scope of the covenant and provide for its nullification under certain circumstances. For instance, if

Physician Wealth Management

the hospital terminates you without cause (ie, without fault on your part), fails to renew the agreement, or offers to renew it but under noncomparable adverse terms, then the covenant would not apply. It may also be designed to preclude employment or affiliation with another hospital or health system while not prohibiting employment by an independent private practice.

Real Estate Leverage If a facility has been established that has undergone all of the necessary construction, withstood the test of certifying and credentialing authorities, contains high-value capital equipment, and has a viable location convenient for both referral sources and patients, then the hospital will most likely want to maintain the site and leverage it for possible expansion. If the practice has ownership of the property, then any deal concerning the continuing control and utilization of the site will be made concurrent with the employment relationship. The practice should carefully consider whether it wishes to maintain ownership of the property and sublease it to the hospital, or whether it should sell the property to the hospital. The better the deal for the hospital on the real estate end, the better negotiations may go for the physicians on the employment end.

Conclusion These are just a few considerations that should be taken into account when evaluating and negotiating employment by a hospital or health system. Every practice, agreement, and circumstance is fact-specific, and it is critical to involve competent and experi-

Health Law Partners, PC (“HLP”). Mr Kalmowitz is admitted to the Michigan Bar and the New York Bar. He practices in all areas of healthcare law, with specific concentration on the corporate and financial aspects of healthcare, including structuring revenue-enhancing transactions among physicians and other healthcare providers, certificates of need, compliance investigations, corporate fraud and abuse/Stark law, and third-party payment and reimbursement. Mr Lebow is admitted to the New York Bar and the New Jersey Bar and practices out of HLP’s New York City and Long Island offices in all areas of health law for clients located across the country, focusing primarily on business, contract, corporate, regulatory, and related matters. He has extensive experience in drafting and negotiating agreements and structuring arrangements for physicians and hospitals. They can be reached for comments or questions at 516-492-3390 or by e-mail at ckalmowitz@thehlp.com and rlebow@thehlp.com, respectively.

If the practice has ownership of the property, then any deal concerning the continuing control and utilization of the site will be made concurrent with the employment relationship.

enced legal and financial healthcare industry experts. At the end of the day, both sides stand to gain from making a deal happen, but a deal that is not fair to both sides is not a deal that should be made. l

Lawrence B. Keller, CFP®, is the founder of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached for comments or questions at 516-6776211, or by e-mail at Lkeller@physi cianfinancialservices.com.

Carey F. Kalmowitz, Esq, and Ron Lebow, Esq, are partners of The

GBC_2013Conf_horizontal3_62512_Layout 1 8/16/12 1:06 PM Page 1

SECOND ANNUAL CONFERENCE

GLOBAL BIOMARKERS CONSORTIUM ™ Clinical Approaches to Targeted Technologies ™ October 4-6, 2013

The Seaport Boston Hotel • 1 Seaport Lane • Boston, MA 02210

February 2013

www.OncPracticeManagement.com

ZYTIGA® (abiraterone acetate) Tablets

Brief Summary of Prescribing Information. INDICATIONS AND USAGE ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. CONTRAINDICATIONS Pregnancy: ZYTIGA can cause fetal harm when administered to a pregnant woman. ZYTIGA is not indicated for use in women. ZYTIGA is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss [see Use in Specific Populations]. WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1) in full Prescribing Information]. In the two randomized clinical trials, grade 3 to 4 hypertension occurred in 2% of patients, grade 3 to 4 hypokalemia in 4% of patients, and grade 3 to 4 edema in 1% of patients treated with ZYTIGA [see Adverse Reactions]. Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in the incidence and severity of these adverse reactions. Use caution when treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, e.g., those with heart failure, recent myocardial infarction or ventricular arrhythmia. Use ZYTIGA with caution in patients with a history of cardiovascular disease. The safety of ZYTIGA in patients with left ventricular ejection fraction < 50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials [see Clinical Studies (14) in full Prescribing Information]. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with ZYTIGA. Adrenocortical Insufficiency: Adrenal insufficiency occurred in the two randomized clinical studies in 0.5% of patients taking ZYTIGA and in 0.2% of patients taking placebo. Adrenocortical insufficiency was reported in patients receiving ZYTIGA in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations [see Warnings and Precautions]. Hepatotoxicity: In the two randomized clinical trials, grade 3 or 4 ALT or AST increases (at least 5X ULN) were reported in 4% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. Patients whose baseline ALT or AST were elevated were more likely to experience liver test elevation than those beginning with normal values. Treatment discontinuation due to liver enzyme increases occurred in 1% of patients taking ZYTIGA. No deaths clearly related to ZYTIGA were reported due to hepatotoxicity events. Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced ZYTIGA dose of 250 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt ZYTIGA treatment and closely monitor liver function. Re-treatment with ZYTIGA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [see Dosage and Administration (2.2) in full Prescribing Information]. The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown. Increased ZYTIGA Exposures with Food: ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. The safety of these increased exposures when multiple doses of abiraterone acetate are taken with food has not been assessed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

ZYTIGA® (abiraterone acetate) Tablets ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Hypertension, Hypokalemia, and Fluid Retention due to Mineralocorticoid Excess [see Warnings and Precautions]. • Adrenocortical Insufficiency [see Warnings and Precautions]. • Hepatotoxicity [see Warnings and Precautions]. • Increased ZYTIGA Exposures with Food [see Warnings and Precautions]. Clinical Trial Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Two randomized placebo-controlled, multicenter clinical trials enrolled patients who had metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy. In both Study 1 and Study 2 ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arms. Placebo plus prednisone 5 mg twice daily was given to control patients. The most common adverse drug reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion. The most common laboratory abnormalities (>20%) reported in the two randomized clinical trials that occurred more commonly (≥2%) in the abiraterone acetate arm were anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia. Study 1: Metastatic CRPC Following Chemotherapy: Study 1 enrolled 1195 patients with metastatic CRPC who had received prior docetaxel chemotherapy. Patients were not eligible if AST and/or ALT ≥ 2.5X ULN in the absence of liver metastases. Patients with liver metastases were excluded if AST and/or ALT > 5X ULN. Table 1 shows adverse reactions on the ZYTIGA arm in Study 1 that occurred with a ≥2% absolute increase in frequency compared to placebo or were events of special interest. The median duration of treatment with ZYTIGA was 8 months. Table 1: Adverse Reactions due to ZYTIGA in Study 1 ZYTIGA with Placebo with Prednisone (N=791) Prednisone (N=394) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % Musculoskeletal and connective tissue disorders 29.5 4.2 23.4 4.1 Joint swelling/discomfort2 Muscle discomfort3 26.2 3.0 23.1 2.3 General disorders Edema4 26.7 1.9 18.3 0.8 Vascular disorders Hot flush 19.0 0.3 16.8 0.3 Hypertension 8.5 1.3 6.9 0.3 Gastrointestinal disorders Diarrhea 17.6 0.6 13.5 1.3 Dyspepsia 6.1 0 3.3 0 Infections and infestations Urinary tract infection 11.5 2.1 7.1 0.5 Upper respiratory tract infection 5.4 0 2.5 0 Respiratory, thoracic and mediastinal disorders Cough 10.6 0 7.6 0 Renal and urinary disorders Urinary frequency 7.2 0.3 5.1 0.3 Nocturia 6.2 0 4.1 0 Injury, poisoning and procedural complications Fractures5 5.9 1.4 2.3 0 Cardiac disorders Arrhythmia6 7.2 1.1 4.6 1.0 Chest pain or chest discomfort7 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.3 1 Adverse

events graded according to CTCAE version 3.0 terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 3 Includes terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness 2 Includes

ZYTIGA® (abiraterone acetate) Tablets

4 Includes

1 Adverse

terms Edema, Edema peripheral, Pitting edema, and Generalized edema 5 Includes all fractures with the exception of pathological fracture 6 Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia 7 Includes terms Angina pectoris, Chest pain, and Angina unstable. Myocardial infarction or ischemia occurred more commonly in the placebo arm than in the ZYTIGA arm (1.3% vs. 1.1% respectively). 8 Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction, Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased Table 2 shows laboratory abnormalities of interest from Study 1. Grade 3-4 low serum phosphorus (7%) and low potassium (5%) occurred at a greater than or equal to 5% rate in the ZYTIGA arm. Table 2: Laboratory Abnormalities of Interest in Study 1 Abiraterone (N=791) Placebo (N=394) Laboratory All Grades Grade 3-4 All Grades Grade 3-4 Abnormality (%) (%) (%) (%) Hypertriglyceridemia 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Hypokalemia 28.3 5.3 19.8 1.0 Hypophosphatemia 23.8 7.2 15.7 5.8 High ALT 11.1 1.4 10.4 0.8 High Total Bilirubin 6.6 0.1 4.6 0 Study 2: Metastatic CRPC Prior to Chemotherapy Study 2 enrolled 1088 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥ 2.5X ULN and patients were excluded if they had liver metastases. Table 3 shows adverse reactions on the ZYTIGA arm in Study 2 that occurred with a ≥ 2% absolute increase in frequency compared to placebo. The median duration of treatment with ZYTIGA was 13.8 months. Table 3: Adverse Reactions in ≥5% of Patients on the ZYTIGA Arm in Study 2 ZYTIGA with Placebo with Prednisone (N=542) Prednisone (N=540) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % General disorders Fatigue 39.1 2.2 34.3 1.7 Edema2 25.1 0.4 20.7 1.1 Pyrexia 8.7 0.6 5.9 0.2 Musculoskeletal and connective tissue disorders Joint swelling/ discomfort3 30.3 2.0 25.2 2.0 Groin pain 6.6 0.4 4.1 0.7 Gastrointestinal disorders Constipation 23.1 0.4 19.1 0.6 Diarrhea 21.6 0.9 17.8 0.9 Dyspepsia 11.1 0.0 5.0 0.2 Vascular disorders Hot flush 22.3 0.2 18.1 0.0 Hypertension 21.6 3.9 13.1 3.0 Respiratory, thoracic and mediastinal disorders Cough 17.3 0.0 13.5 0.2 Dyspnea 11.8 2.4 9.6 0.9 Psychiatric disorders Insomnia 13.5 0.2 11.3 0.0 Injury, poisoning and procedural complications Contusion 13.3 0.0 9.1 0.0 Falls 5.9 0.0 3.3 0.0 Infections and infestations Upper respiratory tract infection 12.7 0.0 8.0 0.0 Nasopharyngitis 10.7 0.0 8.1 0.0 Renal and urinary disorders Hematuria 10.3 1.3 5.6 0.6 Skin and subcutaneous tissue disorders Rash 8.1 0.0 3.7 0.0

events graded according to CTCAE version 3.0 terms Edema peripheral, Pitting edema, and Generalized edema 3 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 2 Includes

Table 4 shows laboratory abnormalities that occurred in greater than 15% of patients, and more frequently (>5%) in the ZYTIGA arm compared to placebo in Study 2. Grade 3-4 lymphopenia (9%), hyperglycemia (7%) and high alanine aminotransferase (6%) occurred at a greater than 5% rate in the ZYTIGA arm. Table 4: Laboratory Abnormalities in > 15% of Patients in the ZYTIGA Arm of Study 2 Abiraterone (N = 542) Placebo (N = 540) 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Laboratory Abnormality Grade % % % % Hematology Lymphopenia 38.2 8.7 31.7 7.4 Chemistry Hyperglycemia1 56.6 6.5 50.9 5.2 High ALT 41.9 6.1 29.1 0.7 High AST 37.3 3.1 28.7 1.1 Hypernatremia 32.8 0.4 25.0 0.2 Hypokalemia 17.2 2.8 10.2 1.7 1Based on non-fasting blood draws Cardiovascular Adverse Reactions: In the combined data for studies 1 and 2, cardiac failure occurred more commonly in patients treated with ZYTIGA compared to patients on the placebo arm (2.1% versus 0.7%). Grade 3-4 cardiac failure occurred in 1.6% of patients taking ZYTIGA and led to 5 treatment discontinuations and 2 deaths. Grade 3-4 cardiac failure occurred in 0.2% of patients taking placebo. There were no treatment discontinuations and one death due to cardiac failure in the placebo group. In Study 1 and 2, the majority of arrhythmias were grade 1 or 2. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arms and no deaths in the placebo arms. There were 7 (0.5%) deaths due to cardiorespiratory arrest in the ZYTIGA arms and 3 (0.3%) deaths in the placebo arms. Myocardial ischemia or myocardial infarction led to death in 3 patients in the placebo arms and 2 deaths in the ZYTIGA arms. DRUG INTERACTIONS Effects of Abiraterone on Drug Metabolizing Enzymes: ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) in full Prescribing Information]. In vitro, ZYTIGA inhibits CYP2C8. There are no clinical data on the use of ZYTIGA with drugs that are substrates of CYP2C8. However, patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate. Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelﬁnavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Avoid or use with caution, strong inhibitors and inducers of CYP3A4 during ZYTIGA treatment [see Clinical Pharmacology (12.3) in full Prescribing Information]. USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications].: ZYTIGA can cause fetal harm when administered to a pregnant woman based on its mechanism of action and ﬁndings in animals. While there are no adequate and well-controlled studies with ZYTIGA in pregnant women and ZYTIGA is not indicated for use in women, it is important to know that maternal use of a CYP17 inhibitor could affect development of the fetus. Abiraterone acetate caused developmental toxicity in pregnant rats at exposures that were lower than in patients receiving the recommended dose. ZYTIGA is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with ZYTIGA.

ZYTIGA® (abiraterone acetate) Tablets

In an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6-17). Findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/ day. Doses ≥10 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 0.03, 0.1 and 0.3 times, respectively, the AUC in patients. Nursing Mothers: ZYTIGA is not indicated for use in women. It is not known if abiraterone acetate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ZYTIGA, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of ZYTIGA in pediatric patients have not been established. Geriatric Use: Of the total number of patients receiving ZYTIGA in phase 3 trials, 73% of patients were 65 years and over and 30% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Patients with Hepatic Impairment: The pharmacokinetics of abiraterone were examined in subjects with baseline mild (n = 8) or moderate (n = 8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone after a single oral 1,000 mg dose of ZYTIGA increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function. No dosage adjustment is necessary for patients with baseline mild hepatic impairment. In patients with baseline moderate hepatic impairment (ChildPugh Class B), reduce the recommended dose of ZYTIGA to 250 mg once daily. If elevations in ALT or AST >5X ULN or total bilirubin >3X ULN occur in patients with baseline moderate hepatic impairment, discontinue ZYTIGA treatment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information]. The safety of ZYTIGA in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA. For patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Clinical Pharmacology (12.3) in full Prescribing Information]. Patients with Renal Impairment: In a dedicated renal impairment trial, the mean PK parameters were comparable between healthy subjects with normal renal function (N=8) and those with end stage renal disease (ESRD) on hemodialysis (N=8) after a single oral 1,000 mg dose of ZYTIGA. No dosage adjustment is necessary for patients with renal impairment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information]. OVERDOSAGE There have been no reports of overdose of ZYTIGA during clinical studies. There is no specific antidote. In the event of an overdose, stop ZYTIGA, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function. Storage and Handling: Store at 20oC to 25oC (68oF to 77oF); excursions permitted in the range from 15oC to 30oC (59oF to 86°F) [see USP controlled room temperature]. Based on its mechanism of action, ZYTIGA may harm a developing fetus. Therefore, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves [see Use in Specific Populations].

• Patients receiving GnRH agonists should be informed that they need to maintain this treatment during the course of treatment with ZYTIGA and prednisone. • Patients should be informed that ZYTIGA must not be taken with food and that no food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. They should be informed that the tablets should be swallowed whole with water without crushing or chewing. Patients should be informed that taking ZYTIGA with food causes increased exposure and this may result in adverse reactions. • Patients should be informed that ZYTIGA is taken once daily and prednisone is taken twice daily according to their physician’s instructions. • Patients should be informed that in the event of a missed daily dose of ZYTIGA or prednisone, they should take their normal dose the following day. If more than one daily dose is skipped, patients should be told to inform their physician. • Patients should be apprised of the common side effects associated with ZYTIGA, including peripheral edema, hypokalemia, hypertension, elevated liver function tests, and urinary tract infection. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. • Patients should be advised that their liver function will be monitored using blood tests. • Patients should be informed that ZYTIGA may harm a developing fetus; thus, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves. Patients should also be informed that it is not known whether abiraterone or its metabolites are present in semen and they should use a condom if having sex with a pregnant woman. The patient should use a condom and another effective method of birth control if he is having sex with a woman of child-bearing potential. These measures are required during and for one week after treatment with ZYTIGA.

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) • Patients should be informed that ZYTIGA and prednisone are used together and that they should not interrupt or stop either of these medications without consulting their physician.

Manufactured by: Patheon Inc. Mississauga, Canada Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044 © Janssen Biotech, Inc. 2012 Revised: December 2012 2000005445 K08Z121174A

INDICATION and IMPORTANT SAFETY INFORMATION about ZYTIGA® (abiraterone acetate) INDICATION ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). IMPORTANT SAFETY INFORMATION

K08Z121176

Contraindications ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant. Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly. Adrenocortical Insufficiency (AI) AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations. Hepatotoxicity Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function. Increased ZYTIGA® Exposures with Food ZYTIGA® must be taken on an empty stomach. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. Adverse Reactions The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion. The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia. Drug Interactions ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on its use with drugs that are substrates of CYP2C8. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate. Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors or inducers on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution during treatment with ZYTIGA®. Use in Specific Populations Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C). Please see Brief Summary of Prescribing Information on adjacent pages.

1/13

K08Z121119

Our goal is to make access to ZYTIGA®(abiraterone acetate) simple, convenient, and easy. Support for you:

Support for your patients:

• Rapid assessment of patient eligibility/coverage • Prior authorization support • Concise beneﬁt summary • Identiﬁcation of specialty pharmacy provider

• Access to the ZytigaOne™ Instant Savings Program • Referral to a patient assistance program • Coordination with SPP for processing/delivery of medication • Educational materials and prescription reminders

Benefit Investigation

Care Coordination

Take advantage of ZytigaOne™ Support today.

1-855-ZYTIGA-1 (998-4421) Monday–Friday, 8:00 AM–8:00 PM ET ACCESS TO ZYTIGA® SIMPLIFIED FOR YOU AND YOUR PATIENTS Also available online at janssenaccessone.com

Please see Important Safety Information on back, and Brief Summary of Prescribing Information on adjacent pages. Patient insurance benefit investigation is provided as a service by TheraCom, LLC and The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, TheraCom, LLC, and The Lash Group, Inc., assist healthcare professionals in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer and patient information provided by the healthcare provider under appropriate authorization following the provider’s exclusive determination of medical necessity. Importantly, insurance verification is the ultimate responsibility of the provider. Third-party reimbursement is affected by many factors. Therefore, TheraCom, LLC, The Lash Group, Inc., and Janssen Biotech make no representation or guarantee that full or partial insurance reimbursement or any other payment will be available. This information is provided as an information service only. While TheraCom, LLC, and The Lash Group, Inc., try to provide correct information, they and Janssen Biotech make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall TheraCom, LLC, The Lash Group, Inc., or Janssen Biotech or its employees or agents be liable for any damages resulting from or relating to the services. All providers and other users of this information agree that they accept responsibility for the use of this service. Janssen Biotech assumes no responsibility for, and does not guarantee the quality, scope, or availability of the services including but not limited to reimbursement support services, patient education, and other support services. Each provider, not Janssen Biotech, is responsible for the services they provide. These support services have no independent value to providers apart from the product and are included within the cost of the product. © Janssen Biotech, Inc. 2013

1/13

K08Z121119