2015 Oflos ANNUAL MEETIN6 Meetine MATERIALS OCTOBER

2015 OflOS ANNUAL MEETIN6

MEETINe MATERIALS

OCTOBER 16, 2015

COLUMBUS, OHIO SOCIETY BOARD MEMBERS 2015 ANNUAL MEETING

Slobodan Stanisic, MD President The Christ Hospital Medical Specialists II, Cincinnati, Ohio

Scott Blair, MD Trustee Columbus Oncology Associates, Columbus, Ohio

Cheryl Skinner, MD President Elect Lebanon Hematology Oncology, Lebanon, Ohio

Charles Bane, MD Secretary Dayton Physicians LLC, Dayton, Ohio

David Fishman, MD Trustee David J. Fishman, MD, Inc., Cleveland, Ohio

Nashat Gabrail, MD Trustee Gabrail Cancer Center, Canton, Ohio

David Brown, MD Trustee Toledo Clinic Cancer Centers, Toledo, Ohio Ohio ^ Hematology Oncology^ iSociety

SPONSORS

'isto'

CardlnalHealth Essential to care' 2015 Annual Meeting Friday, October 16, 2015 Nationwide Hotel & Conference Center 100 Green Meadows Drive South Lewis Center, OH 43035

AGENDA

8:30-10:00 Meeting Registration

9:00-10:00 Reimbursement and Biosimilars Michelle Weiss Weiss Oncology Consulting

10:00-10:30 Break\Exhibits

10:30-11:30 ICD-10: Issues in Implementation Jean Stevens, RHIT, CCS-P, AHIMA approved ICD-10 Trainer

11:30-12:30 Lunch\Exhibits

12:30-1:30 The High Cost of Hope Mary Jameson, MBA Dayton Physicians LLC

1:30-2:30 MyCGS Juan Lumpkin CGS Administrators

2:30-2:45 Break

2:45-3:30 MyCare Ohio: Serving Ohio’s Dual Eligibles Christi Pepe Ohio Department of Medicaid

Ohio Hematology Oncology ^Society

2015 ANNUAL MEETING MEMBERS SPONSORS and EXHIBITORS MEMBERS, SPONSORS, AND EXHIBITORS

AMAG Pharmaceuticals OHOS Bronze Member 100 Hayden Avenue Exhibitor Lexington, MA 02421 Phone: 617-498-7700 Websites: www.amagpharma.com and www.feraheme.com

Company contacts: Chris Riedel [email protected] Ryan Weisenseel [email protected]

AMAG Pharmaceutcials is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeuitic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. AMAG recently received approval from the FDA to market Feraheme™ (ferumoxytol) Injection for the treatment of iron deficiency anemia in adult chronic kidney disease patients. For additional company or product information please visit www.amagpharma.com.

Amgen OHOS Silver Member One Amgen Center Drive Exhibitor Thousand Oaks, CA 91320 Website: www.amgen.com

Company contact: Lisa Dunn [email protected]

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

Astellas Oncolgy Inc. OHOS Silver Member 1 Astellas Way Exhibitor Three Parkway North Northbrook, IL 60062 Website: www.astellas.us

Company contact: Curtis Sosnowski, Sr. Access & Reimbursement Manager – Great Lakes 248-705-1675 (cell) 248-922-9097 (office) [email protected]

Astellas Pharma US, Inc., located in Northbrook, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. For more information about Astellas Pharma US, Inc., please visit our website at www.astellas.us.

AstraZeneca OHOS Silver Member 1800 Concord Pike Exhibitor Wilmington DE 19850 Phone: 1-800-236-9933 Website: www.astrazeneca-us.com

Company contacts: Jeff Catalfino [email protected] Joyce Bohl [email protected] Brian Jenkins [email protected] Brad Kranson [email protected] Samantha Terry – Field Reimbursement Manager [email protected]

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases.

For patients and physicians, we provide medicines for some of the world’s most serious diseases. For the people who pay for health care, we work to make sure that our medicines offer real value for money. For our employees, we provide a culture in which they can feel appreciated, energized and rewarded for their contribution. For our shareholders, we aim to deliver value through our continued focus on innovation and running our business efficiently. For the wider community, we want to be valued for the contribution our medicines can make to society and trusted for the way in which we do business.

We work closely with all our stakeholders to understand their challenges and how we can combine our skills and resources to achieve a common goal: improved health.

AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Bayer Healthcare OHOS Silver Member 100 Bayer Blvd. Whippany, NJ 07981 Phone: 866-NEXAVAR (866-639-2827) Website: www.bayerpharma.com

Company contact: Dale Gray, Field Reimbursement Manager 502-553-3256 [email protected]

About Oncology at Bayer - Bayer is committed to delivering Science for a Better Life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

Bristol Myers Squibb Oncology OHOS Gold Member 777 Scudders Mill Road Sponsor Plainsboro, New Jersey 08543-4500 Exhibitor Phone: 609-897-2000 Website: www.bms.com

Company contacts: Roger Pawar [email protected] Marcelo Molina [email protected] Cary Harris [email protected] Linda Martens [email protected]

Bristol-Myers Squibb is a global BioPharma company firmly focused on its Mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Around the world, our medicines help millions of people in their fight against such diseases as cancer, cardiovascular disease, hepatitis B and C, HIV/AIDS and rheumatoid arthritis.

Cardinal Health OHOS Silver Member 7000 Cardinal Place Sponsor Dublin, OH 43017 Exhibitor Phone: 614-757-5000 Website: www.cardinal.com

Company contact: Steve Brenner, Director, Sales, Oncology Specialty Solutions 614-551-3408 [email protected]

Cardinal Health Specialty Solutions is a business of Cardinal Health, a Fortune 21 healthcare services company headquartered in Dublin, Ohio. With more than 30,000 employees worldwide, Cardinal Health is one of the largest healthcare companies in the world. Cardinal Health Specialty Solutions puts intelligence into action by offering solutions that help healthcare professionals, payors and the pharmaceutical and biotech industries in specialty healthcare, solve tomorrow's problems today. We help our customers alleviate day-to-day administrative burdens, optimize business functions and utilize innovative solutions that drive business forward.

Celgene OHOS Gold Member 86 Morris Avenue Sponsor Summit, NJ 07901 Exhibitor Phone: 908-673-9000 Website: www.celgene.com

Company contacts: Keith D. Jenkins (Senior Regional Account Manager) 240-215-7779 [email protected] Andrew Sawyer (Regional Sales Director, Ohio Valley) [email protected] Allyson Dusza (Hematology Oncology Consultant) 614-562-0873 [email protected] Alan Huber (Hematology Oncology Consultant) 419-351-3089 [email protected]

Our mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocyte leukemia (CLL), non-Hodgkin's lymphoma (NHL), glioblastoma, and ovarian, pancreatic and prostate cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

Eisai, Inc. OHOS Bronze Member 100 Tice Blvd. Exhibitor Woodcliff Lake, NJ 07677 Phone: 888-793-4724 Website: www.eisai.com

Company contact: Ron Corpora, Director, National Reimbursement 330-929-2041 [email protected]

As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.

Genentech, Inc. OHOS Gold Member 1 DNA Way Sponsor South San Franscico, CA 94080 Website: www.gene.com

Company contact: Tom Rothmann, Field Reimbursement Manager 614-207-8819

Genentech is a leading biotechnology company that discovers, develops, manufactures, and commercializes biotherapeutics for significant unmet medical needs. Fifteen of the currently approved biotechnology products originated from or are based on Genentech science. Oncology products include Avastin, Herceptin, Rituxan, Tarceva, and CathFlo.

Genomic Health OHOS Bronze Member 301 Penobscot Dr. Exhibitor Redwood City, CA 94063 Phone: 866-ONCOTYPE (866/662-6897) Website: www.genomichealth.com

Company contacts: Deanna Wakeman, ROL-Columbus 888-604-5693 [email protected] Ricardo Berns, ROL-Cincinnati 866-218-2954 [email protected] Melissa Zepp, ROL-Cleveland 440-420-6940 [email protected] John Heropoulos, ROL-Akron Canton 330-327-5627 [email protected] Diane Schulte, ROL-Ann Arbor, MI 650-722-7090 [email protected]

Genomic Health, Inc. is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions. Its lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multigene expression test developed for the assessment of risk of recurrence in patients with stage II & stage III A/B disease. As of December 31, 2010, more than 10,000 physicians in over 60 countries had ordered more than 190,000 Oncotype DX tests. Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional stages of breast and colon cancers. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit www.genomichealth.com.

Hospira Exhibitor Website: www.hospira.com

Hospira is the world's leading provider of injectable drugs and infusion technologies. Through our broad, integrated portfolio, we are uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs.

Through our offering of high-quality, lower-cost generic medications, we continue to help reduce the overall costs of healthcare — to improve both the affordability of care for patients and the financial strength of the global healthcare system.

Company contact: Bruce Grothen [email protected]

Incyte Corporation OHOS Silver Member Experimental Station Exhibitor Route 141 & Henry Clay Road Building E336 Wilmington, DE 19880 Phone: 855-4-INCYTE (855-446-2983) Website: www.incyte.com

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs for oncology and inflammation. Our first commercial product Jakafi® (ruxolitinib), an oral JAK1 and JAK2 inhibitor, was approved by the FDA in November 2011. To learn about Jakafi, please go to www.Jakafi.com or visit www.incyte.com.

Janssen Biotech, Inc. OHOS Bronze Member Phone: 1-800-JANSSEN (800-526-7736) Exhibitor Website: www.janssenbiotech.com

Company contact: Bert Wickey, Director Healthcare Policy & Advocacy (OH) 330-764-1902 office [email protected]

For more than 30 years, Janssen Biotech, Inc. has delivered on the promise of new treatments and new ways to improve the health of individuals with serious disease.

Built upon a rich legacy of innovative "firsts" Janssen Biotech, Inc. pursues innovative solutions in the therapeutic areas of immunology, oncology and nephrology. With the same unwavering passion for new challenges, we dedicate ourselves to delivering solutions for these disease states where unmet needs continue to exist.

Rooted in rich scientific collaborations and community-based relationships, we have access to some of the top minds in science today, allowing us to advance the treatment of patients through our innovative medicines. Our discoveries lead us not only to new treatments, but also to new ways to empower patients and expand their access to quality care – because we believe that changing lives for the better takes more than medicine. Janssen produces ZYTIGA® (abiraterone acetate), PROCRIT® (Epoetin alfa) and DOXIL® (doxorubicin HCl liposome injection).

Lilly Oncology OHOS Silver Member Phone: 1-800-LillyRx Exhibitor Website: www.lilly.com

Company contact: Kasia Harshaw (Payer Services, OH&KY) 502-645-1984 [email protected]

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life- changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

McKesson Specialty Health OHOS Bronze Member 10101 Woodloch Forest Exhibitor The Woodlands, TX 77380 Phone: 800-482-6700 800.482.6700 [email protected]

Company contact: Alyssa Zimmerman- Account Executive 330-620-4678 [email protected]

McKesson Specialty Health, a business unit of McKesson Corporation, empowers Oncologists in the community treatment setting to focus on patient care by providing distribution, technology, clinical and educational solutions that improve profitability, maximize practice efficiencies, and reduce administrative burden.

Merck Oncology OHOS Gold Member 351 Sumneytown Pike Sponsor North Wales, PA 19454-2505 Exhibitor Phone: 800-737-2088 Website: www.merck.com

Company contact: Mike Mills, Reimbursement Manager 757- 810-5903 [email protected]

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships.

Novartis Oncology OHOS Silver Member One Health Plaza Exhibitor East Hanover, NJ 07936-1016 Phone: 800-631-8184 Website: www.novartisoncology.com and www.oncologyaccessnow.com

Company contacts: Laura Michaels 248-568-6725 [email protected]

David Mecurio, Reimbursement 716-481-7770 [email protected]

Novartis Oncology has become one of the world's leading oncology companies; discovering, developing and producing broadly available novel therapies that improve and extend the lives of patients with cancer. The Novartis portfolio covers oncology, hematology, and rare disease markets. Our Oncology franchise supports recently approved Zykadia, as well as Afinitor and Sandostatin LAR; our Hematology franchise supports Gleevec, Tasigna and Exjade; and Signifor in Rare Disease.

Oncology Supply / ION Solutions OHOS Gold Member 2801 Horace Shepard Drive Sponsor Dothan, AL 36303 Phone: 800-633-7555 Website: www.oncologysupply.com

Company contact: John Misitis 724-712-0004 [email protected]

Oncology Supply has been serving community-based practices since 1978 and has grown to be the nation's largest chemotherapy distributor. We understand the challenges faced by oncology practices today and are committed to consistently provide competitive pricing and unparalleled service to our customers. Oncology Supply is the exclusive distributor for (ION) International Oncology Network.

Pfizer OHOS Silver Member 235 East 42nd Street Exhibitor New York, NY 10017 Phone: 212-733-2323 Website: www.pfizeroncology.com

Company contact: Bob Louwers, Oncology Key Account Manager 614-800-1556 Bob.louwers@pfizer.com Kurt J. DeGroot, Field Reimbursement Manager 626-660-4400 [email protected]

Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. This independent business unit within Pfizer Inc. was established to enhance innovation while still drawing on the expertise and resources of the world’s largest research-based pharmaceutical company.

Pharmacyclics OHOS Silver Member 999 East Arques Avenue Exhibitor Sunnyvale, CA 94085 Website: www.pharmacyclics.com

IMBRUVICA™ patient assistance YOU&i Support™ Website: www.youandisupport.com Phone: 877-877-3536

Company contact: Mike Mitchell, National Account Executive 908-285-3587

Sanofi Oncology OHOS Bronze Member 55 Corporate Drive Exhibitor Bridgewater, NJ 08807 Website: www.sanofi.us Patient Assistance Program: www.visitspconline.com or 888-847-4877.

Company contact: Randy Clark, Senior Oncology Account Specialist 614-519-6164 [email protected]

At Sanofi Oncology, the patient is our inspiration. We are dedicated to translating science into effective therapeutics that address unmet medical needs for cancer and organ transplant patients. Through our global organization of talented and passionate employees, we are building a renewed and diversified portfolio, driven by the principles of innovation, personalization and patient access to medicines. We believe that delivering innovative treatment solutions requires collaboration with external experts, which is why we partner our own internal expertise with the best experts in scientific discovery and clinical research around the world.

Oncology-Hematology Related Products: Zaltrap® (ziv-aflibercept), Jevtana® (cabazitaxel), Mozobil (Plerixafor), Leukine (Sargramostim), Elitek™ (rasburicase), Eligard® (leuprolide acetate for injectable suspension), Thymoglobulin® (anti-thymocyte globulin (Rabbit)), Clolar® (clofarabine)

Sandoz OHOS Gold Member Website: www.Sandoz.com Exhibitor

Sandoz, the generic pharmaceuticals division of Novartis, is a worldwide leader in generics. With a history of more than 120 years, Sandoz is a trusted leader with a reputation for exceptional quality. Our strategic and customer-focused approach to developing, producing and marketing high-quality affordable medicines following the loss of patent protection, has successfully made us one of the two largest and most respected generics companies worldwide. Our medicines are already available to 90 percent of people across the world and we are committed to further increasing global access to affordable healthcare.

Company contacts: Jim Gerace [email protected] Colleen O’Donnell [email protected] Toby Tucker [email protected]

Seattle Genetics OHOS Bronze Member 21823 30th Drive, SE Exhibitor Bothell, WA 98021

Seattle Genetics is a biotechnology company focused on developing and commercializing monoclonal antibody-based therapies for the treatment of cancer. Seattle Genetics has collaborations and co-development agreements for its antibody-drug conjugate (ADC) technology with a number of leading biotechnology and pharmaceutical companies. Find more information at www.seattlegenetics.com.

Company contacts: Dean Masztak, Associate Director Managed Markets 269-568-0492 [email protected] Petey Revell, Sr. Oncology Account Manager 513-795-9811 [email protected] Troy Schlotterbeck, Sr. Oncology Account Manager 614-309-6644 [email protected] Aleta Conti, Sr. Oncology Account Manager 216-409-9918 [email protected]

Taiho Oncology Ohos Bronze Member 202 Carnegie Center, Suite 100 Exhibitor Princeton, NJ 08540 Website: www.taihooncology.com

Company contact: Jamie Young, Director of Market Access, Midwest Region 614-940-1323 [email protected]

Taiho Oncology, Inc., a division of Taiho Pharmaceutical Co., Ltd. and Otsuka Holdings Co., Ltd., has built a world class clinical development organization that works urgently to develop innovative cancer treatments. Taiho has an oral oncology pipeline consisting of both novel antimetabolic agents and selectively targeted agents. Advanced technology, dedicated researchers, and state of the art facilities are helping us to define the way the world treats cancer. Taiho Oncology is committed to making products successfully developed and approved for marketing, commercially available to cancer patients in need. It’s our work; it’s our passion; it’s our legacy.

Takeda Oncology OHOS Silver Member 40 Landsdowne Street Exhibitor Cambridge, MA 02139 Phone: 617-679-7000 Website: www.takedaoncology.com

Company contacts: Sabina McCafferty, Health Systems Manager 614-906-2016 Brent Evans, Regional Account Executive 440-506-8663

Takeda Oncology combines the innovative science of a leading American biopharmaceutical company with the global assets – both intellectual and fiscal – of Japan's largest pharmaceutical company. Our mission is to deliver extraordinary medicines to patients with cancer worldwide through our science, innovation, and passion. We are focused exclusively in oncology to improve the treatment of cancer around the world. The Takeda oncology pipeline has more than 15 investigational compounds targeting a broad range of cancers.

Our parent company, Takeda Pharmaceutical Company Limited, is a research-based global pharmaceutical company. It has what is arguably the most impressive track record of endurance in the industry, having been established in 1781. Velcade® (bortezomib) is approved for the treatment of patients with multiple myeloma. Velcade is also approved for the treatment of patients with mantle cell lymphoma who have already received other treatments. Velcade® is for subcutaneous or intravenous use only.

The Velcade Reimbursement Assistance Program (VRAP) provides one-to-one case manager support for patients, healthcare providers, and caregivers. The program addresses reimbursement issues related to the use of Velcade® for both patients and physicians. To learn more about the menu of services VRAP can offer don’t hesitate to contact your regionally dedicated Case Manager at 1-866-VELCADE (835-2233), Option 2. Our team is available 8:00am to 8:00pm EST, Monday through Friday.

Teva OHOS Silver Member 41 Moores Road Exhibitor Frazer, PA 19355 Website: www.Cephalononcology.com

Company contacts: Sue Anderson 614-937-6606 [email protected] Chris Smith [email protected] 513-706-8066 Stephen Ingram [email protected] 678-492-9950

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $18.1 billion in net sales in 2011.

FirstName LastName Practice\Company Chris Riedel AMAG Pharmaceuticals, Inc. Tom Evans AMAG Pharmaceuticals, Inc. Stephanie Rogers Amgen Linda Sell Amgen Sheila Bihnmyer Amgen Deirdre Winkle Apobiologix Ben Holtvogt Astellas Curtis Sosnowski Astellas Brian Jenkins AstraZeneca Joyce Bohl AstraZeneca Dan McCollum AstraZeneca Samantha Terry AstraZeneca Brian Julian Bayer Nick Liberati Bayer Kevin Riley Bristol Myers Squibb Ken Hyland Bristol Myers Squibb Linda Martens Bristol Myers Squibb Michelle Ruscher Bristol Myers Squibb Marsha Petosa Bristol Myers Squibb Steve Brenner Cardinal Health Corine Toomer Cardinal Health Alan Houston Celgene Alan Huber Celgene Susan Jagers Celgene Keith Jenkins Celgene Dana Nestinger Celgene Elizabeth Pichea Celgene Deb Silvers Celgene Llinee Williams Celgene Juan Lumpkin CGS Administrators Amy Pridemore, CMPE, CPC Columbus Oncology & Hematology Associates Julie Teets Columbus Oncology & Hematology Associates Robert Baird Dayton Physicians Mary Jameson Dayton Physicians Karrie Moore Dayton Physicians Ron Corpora Eisai Dave Bowen Eisai Tom Rothmann Genentech Deanna Wakeman Genomic Health Shawn Wheeler Genomic Health Steve Drucker Genomic Health Melanie Barnicle Hematology Oncology Center Emily Besser Hematology Oncology Consultants, Inc. Brett Blade Hematology Oncology Consultants, Inc. Melinda Morehead Hematology Oncology Consultants, Inc. Bruce Grothen Hospira Jonathan Beasley Incyte Tonya Holthaus Incyte Amy Davidson Johnson & Johnson Healthcare Systems Valerie Reeves Johnson & Johnson Healthcare Systems Laura Francis Kettering Cancer and Blood Specialists Kasia Harshaw Lilly Oncology Mary Ramsey Lilly Oncology Azad Rastegar McKesson Specialty Care Colleen Powers Merck Rob Brooks Merck Mary Bryant Merck Mike Mills Merck Jonathan Ijaz Merck Kathleen Powell Merck Jerry Van Stavern Merck Tanya Cavins Merck Barry Tucker Merck Nora Moran Novartis Laura Matthews Novartis Kim Mitchell Novartis Laura Michaels Novartis Christi Pepe Ohio Medicaid Julie Brandt, CHONC Ohio Oncology & Hematology LLC Kyle Dillahunt OHOS Tammy Asbury Oncology Hematology Care, Inc. Danielle Williamson Oncology Hematology Care, Inc. Mark Kegelman Onyx Pharmaceuticals Bob Louwers Pfizer Mike Mitchell Pharmacyclics Ron Vela Pharmacyclics Jim Gerace Sandoz Colleen O'Donnell Sandoz Jamilyn Perez-Aragon Sandoz Toby Tucker Sandoz Randy Clark Sanofi Dean Masztak Seattle Genetics Troy Schlotterbeck Seattle Genetics John Ruppert Taiho Oncology Jamie Young Taiho Oncology Brent Evans Takeda Oncology Sean Jarvis Takeda Oncology Sue Anderson Teva Oncology Chris Smith Teva Oncology Sterling Jones Teva Oncology Heather King The Christ Hospital Medical Specialists II Michael Quaranta The Christ Hospital Medical Specialists II Amber Starnes The Christ Hospital Medical Specialists II James Nixon The Christ Hospital Medical Specialists II Danielle Busken The Christ Hospital Medical Specialists II Sallyann Holder The Christ Hospital Medical Specialists II Chelsea Miller The Christ Hospital Medical Specialists II Paul Dieter The Hope Center for Cancer Care David Brown, MD Toledo Clinic Peg Diegel Toledo Clinic Cancer Center Germaine Lawless Tri County Hematology & Oncology Ruth Settle Tri County Hematology & Oncology Cheryl Skinner TriHealth Michelle Weiss Weiss Oncology Consulting Lisa Miller Zangmeister Cancer Center Christine Pfaff Zangmeister Cancer Center Heather Walton Zangmeister Cancer Center Jean Stevens David Fishman, MD 10/13/15

Reimbursement and Biosimilars

Presented by, Michelle Weiss, CHONC Weiss Oncology Consulting October 16, 2015

Disclaimer

• This program is presented for informational purposes only • The speaker is not a pharmacist or a clinician • This program’s focus is to unveil the challenges with reimbursement for a biosimilar product • Laws, regulations and coverage policies are complex and ever-changing, attendees should do their own research related to proper coding and billing of biosimilars • Contact your legal counsel for specific questions

1 10/13/15

Agenda

• Reimbursement Basics – Overview & The Rules • Defining Drugs – Drugs vs Biologics – Generics vs Biosimilars – Interchangeability • Medicare Reimbursement • What we still don’t know…..

AMA CPT®

CPT® American Medical Association. All Rights Reserved • Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not par of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. – AMABookstore.com – Your Trusted Source for CPT® – Order online or call toll free (800) 621-8335

2 10/13/15

The Rules…..

• Foundation – Code Sets – CPT = Current Procedural Terminology • foundation for the rules for billing services – You must follow the rules – But everything in CPT isn’t necessarily paid – Maintained by the American Medical Association – HCPCS = Healthcare Common Procedure Coding System • Primarily used in oncology to identify drugs – Maintained by CMS

The Rules….

– Everyone, providers and payers must utilize the Code Sets – Coverage can vary • Medicare – Laws, Manual, National Coverage Determination (NCD), Local Coverage Determination (LCD), National Correct Coding Initiative Edits (NCCI) • Managed Medicare – Beneficiary MUST have at least the same benefit as traditional Medicare – Can have requirements such as pre-authorizations – Can reimburse differently than traditional Medicare • Private Payers - Can determine what they will and won’t pay for based on their own policies – Watch policies closely – If you don’t know… ASK! » And document the response! For Today’s Program – I will be using Medicare Rules as the default 6

3 10/13/15

Infusion Services

• 4 Primary Components to infusion billing: – Evaluation & Management Codes • office visits, hospital visits, etc. Today’s Focus! – Drugs • Therapeutic/Antineoplastic/Highly Complex/Supportive Care – Administration • Hydration, Therapeutic, Chemotherapy – Diagnostic • Lab & Bone Marrow

Drug Reimbursement

• Drugs reimbursed by diagnosis… – ICD-10-CM = International Classification of Diseases, 10th Revision • FDA Approved Indications – Covered by Medicare – Reimbursed if medically necessary • Off Label (unlabeled use) – Generally reimbursed if use is “medically accepted standards of medical practice” • Most use/accept NCCN Guidelines • CMS list of approved journals

• Reference for Drug Reimbursement – Medicare Claims Processing Manual, Chapter 17, Drugs and Biologicals • Reference for Drug Benefit – Medicare Benefit Policy Manual, Chapter 15 – Covered Medical and other Health Services 8

4 10/13/15

Drug Reimbursement-Terms

! ASP = Average Sales Price ! The Medicare Modernization Act (MMA) defines ASP as a manufacturer’s sales of a drug to all nonexempt purchasers, which are those entities that do not receive “best price,” such as 340B hospitals, in the United States in a calendar quarter divided by the total number of units of the drug sold by the manufacturer in that same quarter ! The ASP is the net of any price concessions such as volume, prompt pay, and cash discounts; free goods contingent on purchase requirements; chargebacks; and rebates other than those paid under the Medicaid drug rebate program ! Used primarily by Medicare and some private payers ! Many private payers create their own version of ASP

Drug Reimbursement-Terms

! WAC = Wholesale Acquisition Cost ! The list price for wholesalers, distributors, and other direct accounts before any rebates, discounts, allowances, or other price concessions that might be offered by the supplier of the product ! Used primarily by Medicare/Medicaid for new drugs until a full quarter of ASP data has been collected

! AWP = Average Wholesale Price ! A national average of list prices charged by wholesalers to purchasers; ! AWP is sometimes referred to as “sticker price” because it is not the actual price that larger purchasers normally pay ! Pricing set by the manufacturer ! No specific methodology required for determining pricing ! Pricing exceeds the real prices of drugs ! Still used occasionally by private payers (AWP = −5% to −35%)

5 10/13/15

Drug Reimbursement-Terms

• AMP – Average Manufacturer Price – Average price paid to the manufacturer by wholesalers

• WAMP – Widely Available Market Price – OIG definition: The price that a prudent physician or supplier would pay for the drug including rebates, discounts and other price concessions routinely made available

Drug Reimbursement

! Drugs Administered in the physician office or outpatient hospital setting ! Medicare – New Drug ! Private Practice (CMS 1500 Form) ! New Drug – WAC +6% or invoice pricing if the WAC is not published ! Established ASP – ASP +6% ! Outpatient Hospital – HOPPS (UB04 Form) ! New Drug – 95% of AWP ! Pass through and non pass through – ASP +6% ! Drug Packaging Threshold: $95 ! Average cost per day exceeds $95, it is separately payable

6 10/13/15

Drug Reimbursement

! Manufacturers are required to report all sales data which is used by CMS to establish ASP

! Quarterly ASP reporting & Updates ! 6 month lag in price changes ! One qtr report, one qtr analyze, one qtr release new price ! Manufacturers’ discounting/fee structures and strategies vary ! Results in some variation across industry ! OIG reported MANY mistakes by manufacturers ! Comparison of Average Sales Prices to Widely Available Market Prices for Selected Drugs

Drugs -

• HCPCS Drug Codes for private practice…. – ASP Drug Pricing File released quarterly by CMS • http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part- B-Drugs/McrPartBDrugAvgSalesPrice/index.html

• HCPCS Drug Codes for Outpatient Hospital….. – Addendum B – updated quarterly by CMS • http://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/HospitalOutpatientPPS/Addendum-A-and- Addendum-B-Updates.html

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Drugs - Historically

! Healthcare Common Procedure Coding System (HCPCS) Level II Codes – HCPCS codes - “J-codes” • 5-digit alphanumeric codes assigned to drugs by CMS. • Updated quarterly on the www.cms.gov website • J code: used to bill private and public payers for drugs • J Codes and some temporary codes such as C codes: used to bill Medicare for drugs administered in the Hospital Outpatient Department (HOPD)

– When billing for a drug, indicate the quantity of product administered to the patient expressed in the number of units described by the HCPCS code • Example – Avastin/bevacizumab = • J9035 (Injection, bevacizumab, 10 mg • 200 mg of Avastin is billed as 20 Units 15

Drugs – Just have to mention….

• PHYSICIAN ORDER • Must have a signed physician order – Order must INCLUDE “Magic Six” • Drug, dose, route of administration, frequency, duration and signature – No one except a physician has legal authority to sign an order for a drug – No one except a physician has legal authority to amend an order – Date and time stamp of the order MUST be BEFORE the drug is given unless noted as a verbal order, dated and time stamped by the nurse, and subsequently signed by the physician

– Services rendered must match the physician order

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Drugs – RAC AUDITS RAMPANT

• WATCH OUT…….. – Only bill for waste from a Single Dose Vial • Waste from a multi dose vial cannot be billed – When billing for waste, the waste must clearly be documented • IN THE PATIENT’s MEDICAL RECORD

– Never bill for overfill in a vial • CMS Final Rule – 2011 prohibits billing of “intentional overfill” – CMS sets payments based on the FDA vial or container reflected on the FDA-approved label – Cannot bill CMS for anything received for free

What we’ve known…..

• Until HCPCS Code is Established – Not Otherwise Classified Codes for drugs and/or biologics • J3490 – unclassified drugs Some payers only used the J3490 • J3590 – unclassified biologics • J9999 – Not otherwise classified, antineoplastic drugs • C9399 – Unclassified drugs or biologicals (Medicare hospital outpatient setting)

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Drug

• Drug – Defined – Medicinal product • “small molecule drug” – Typically manufactured through chemical synthesis • Combining specific chemical ingredients in an ordered process – Drugs generally have well-defined chemical structures – Drugs can usually be analyzed to determine all its various components

Drugs

• Drugs have both Brand & Generic Name – Brand name • Trade name protected by a patent • Can be produced and sold only by the company holding the patent

– Generic/Chemical name of the drug • A term referring to the chemical makeup of a drug rather than to the advertised brand name under which the drug is sold – Examples: » Gemcitabine vs Gemzar » Avastin vs Bevacizumab » Paraplatin vs Carboplatin 20

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New Drug - Patent

• When new drugs are first made they have drug patent – protects the company that made the drug first – doesn't allow anyone else to make and sell the drug

• When the patent expires, other drug companies can start selling a generic version of the drug • first, they must test the drug and the FDA must approve it – Most drug patents are protected for 20 years

• Since generic drug makers do not develop a drug from scratch, the costs to bring a generic drug to market are less; – therefore, generic drugs are usually less expensive than brand- name drugs

Generic Drug

• A generic drug is identical, – or within an acceptable bioequivalent range to the brand name counterpart • A generic drug must be identical in… – dosage form, safety, strength, route of administration, quality, performance characteristics and intended use • FDA requires generic drugs have the same active ingredients as the original formulation – and the same high quality, strength, purity and stability as brand- name drugs – the drug application is abbreviated however generics must pass a rigorous testing process • You can search for generic equivalents by using the “Electronic Orange Book” 22

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Biologic

• Biologic – Defined – A biologic is manufactured in a living system such as a microorganism, or plant or animal cells • Most biologics are very large, complex molecules or mixtures of molecules. • “Large or complex molecule drug” – Major classes » Extracted from living systems » Produced by recombinant DNA » Vaccines » Gene Therapy

biologic

• Major kinds of biopharmaceuticals include: – Blood factors (Factor VIII and Factor IX) – Thrombolytic agents (tissue plasminogen activator) – Hormones (insulin, glucagon, growth hormone, gonadotrophins) – Haematopoietic growth factors (Erythropoietin, colony stimulating factors) – Interferons (Interferons-α, -β, -γ) – Interleukin-based products (Interleukin-2) – Vaccines (Hepatitis B surface antigen) – Monoclonal antibodies (Various) – Additional products (tumor necrosis factor, therapeutic enzymes)

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Biologic

• Some you will recognize….

! Avastin ! Enbrel ! Rituxan ! Humira ! Remicade ! Aranesp ! Procrit ! Herceptin ! Lucentis ! Neulasta

Generic Biologic?

• No such thing – Generic drugs are copies of brand-name drugs with the same ingredients – The brand-name and generic are considered bioequivalant

• Biosimilar (a similar biologic) – Not identical to their referenced products since they are derived from living organisms – Highly similar to the biologic but have allowable differences because they are made from living organisims – They can have no clinically meaningful differences in terms of safety, purity and potency from the biologic

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Biosimilar

• The FDA will only approve a biosimilar product if it has the same mechanism of action, route of administration, dosage form, and strength as the reference product • Additionally, a biosimilar can only be approved for the indications and conditions of use that have been previously approved for the reference product – Currently approved Biosimilar is Zarxio • Zarxio (filgrastim-sndz) – NOTE: 8/15 - FDA Proposed Rule requires a 4 letter suffix from the name of the licensed holder for all biological products » Comment period for proposed rule is 75 days • Pipeline is full….. – Patent expiration of 12 biologics expected by 2020 27

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Biosimilar & Interchangeability

• Biosimilars – are a type of biological product that are licensed (approved) by FDA because they are highly similar to an already FDA- approved biological product, known as the biological reference product (reference product), • and have been shown to have no clinically meaningful differences from the reference product • Interchangeable biological product – in addition to meeting the biosimilarity standard, • is expected to produce the same clinical result as the reference product in any given patient – Designation of “interchangeability” requires higher standards than “biosimilarity” alone http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ TherapeuticBiologicApplications/Biosimilars/ucm241718.htm 29

Interchangeability

• FDA Determination – In the U.S., determination of interchangeability by law requires that the biosimilar product is, in the judgment of FDA, expected to have the same clinical result as the reference product • and that a patient switched between two biologic medicines is at no greater risk for safety and efficacy than the patient who remains on the reference product without any switch

– FDA Website; • “An interchangeable biological product may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.”

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State Laws Regulate Generics

• Patient Protections are Already Law: – Under state law, prescribers have the authority to determine whether substitution is appropriate by writing Dispense as Written, or Brand Medically Necessary on the prescription pad

• States will decide the substitution law for biosimilars – Most likely all will require the FDA designation of “interchangeable”

How Do You Know?

• Lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations can be found in the “Purple Book”

• http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ TherapeuticBiologicApplications/Biosimilars/ucm411418.htm

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Standard and Abbreviated Pathways for Drug Approval in US

Drug Development Process

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Biosimilar Reimbursement

• How do we bill & what will Medicare pay? – Awaiting 2016 Physician Fee Schedule Final Rule – Due out early November 2015 • Proposed rule…. – Multiple biosimilars for the same reference product would be grouped and issued the same HCPCS code – “the payment amount for a biosimilar biological product is based on the ASP of all NCDs assigned to the biosimilar biological products included within the same billing and payment code” » Until ASP is established CMS proposes to use WAC based pricing (106% of WAC) » CMS also proposes that payment for the biosimilar may be made before a HCPCS code has been

released 35

What about the first biosimilar - Zarixo?

• MLN Matters – MM9167 – CR 9167 released 7/10/15 • Quarterly HCPCS Update

CMS ASP File Addition - October 2015

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From CGS Website

Future of biosimilars….

• FDA has yet to designate any biosimilar products as “interchangeable,” – it remains unclear whether CMS will treat all biosimilars equally under the Medicare program

– CMS has committed to issuing additional guidance regarding Medicare reimbursement of interchangeable products in the future

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Concerns….

• October 8, 2015 letter from the Senate to acting administrator to CMS, Andrew Slavitt requesting a hold on formal policy making until the FDA has completed regulations • Biosimilars forum policy advisor stated; – "The House, Senate and countless stakeholders have now made their concerns clear that multiple biosimilars being grouped and issued the same J-code for Medicare reimbursement purposes could result in fewer biosimilars being introduced in the United States, and ultimately in fewer treatment options for health care professionals and patients,"

Summary

• A biosimilar is not the same as a generic but is similar to it’s biologic counterpart with no clinical meaningful differences in terms of the safety, purity and potency

• There is one biosimilar product on the market today which has it’s own HCPCS code and is reimbursed ASP +6%

• There are no interchangeable biosimilars…. yet • The FDA is still in the process of rulemaking • Each state regulates the use of brand and generic drugs and will need to update laws to address biosimilars

• The Physician Fee Schedule and Hospital Outpatient Prospective Payment System 2016 Final Rules should provide additional direction from CMS

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Questions???

Michelle Weiss, CHONC Weiss Oncology Consulting [email protected] www.weissconsulting.org

References/Resources

• FDA Website on Biosimilars includes; – Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

– FDA Webinar - FDA’s Overview of the Regulatory Guidance for the Development and Approval of Biosimilar Products in the US

– Biosimilar User Fee Act (BsUFA)

– Printable Version of FY 2013 BsUFA Financial Report

– Biosimilars

– FDA Basics Webinar, June 17, 2013: Biological Products: Part 1

– FDA Basics Webinar August 19, 2013: Biological Products, Part 2: Biosimilar Biological Products

21 ICD-10 Issues in Implementation

Jean Stevens, RHIT, CCS-P AHIMA Approved ICD-10CM Trainer

Objectives

• Brief discussion of ICD-10 implementation to date and helpful hints • Medicare Flexibility Agreement • LCD and NCD coding • Documentation Considerations • New reimbursement Models

1 Y2K Again?

• Highmark, a Blue Cross and Blue Shield plan with 5.3 million members, has seen its first claims submitted in ICD-10, and have finalized claims without an issue

Y2K Again?

• Medicare, by federal mandate, must wait two weeks before issuing payment • Even after submission, Medicare claims take several days to be processed • Predictions are, results will not be apparent until December

2 Y2K Again?

• Medicaid claims can take up to 30 days to be submitted and processed by states • Review Explanations of Benefits closely to ensure correct claim payment

Helpful Hints • Stay up to date with all announcements from your payers • Commercial insurers, Medicare, Medicaid, and Workers Compensation should send updates on any issues they are experiencing with ICD-10

3 Helpful Hints

• A good strategy for the first month or two is submit claims in smaller batches • Every day or every other day • Issues with ICD-10 will be easier to work when dealing with a more manageable volume

Helpful Hints

• Separate your denials for diagnosis coding from the rest of your denials • Keep track of how much lost revenue is actually due to ICD-10 denials for reporting and/or resolving issues

4 Medicare Flexibility Agreement

• CMS announced a flexibility agreement with the AMA in early July for 12 months duration • Note the timeline • Claims will not automatically be denied by Medicare when coders use the right code family but not the most specific code applicable to the diagnosis • Does not apply to inpatient hospital services or

Medicare Flexibility Agreement

• Claims may be denied for other reasons • Outrageously inaccurate ICD-10 codes • Gender based coding • Separate administrative errors which are currently the most common reason for denials • Incorrect NPI, HCPCS Codes • Most common reason for CMS denials during end-to-end testing

5 Medicare Flexibility Agreement • Sub-Category Codes • Codes with three characters are included in ICD-10-CM as the heading of a category of codes that may be further subdivided by the use of fourth, fifth, sixth or seventh characters to provide greater specificity

Medicare Flexibility Agreement

• A three-character code is to be used only if it is not further subdivided • Hypertension-I10 • A valid code must be extended to the full number of characters required for that code, including the 7th character, if applicable

6 Other Payers Flexibility

• Private payers have not made the same formal commitment to flexibility that Medicare has, and are under no obligation to honor the terms of CMS’ agreement • Private payers may deny claims that do not meet specificity guidelines

Coding for Medicare LCD and NCD policies

• QUESTION: National Coverage Determinations (NCD) and Local Coverage Determinations (LCD) often indicate specific diagnosis codes are required. Does the recent Guidance mean the published NCDs and LCDs will be changed to include families of codes rather than specific codes? • Short Answer----NO

7 Coding for Medicare LCD and NCD policies

• As such, the recent Guidance does not change the coding specificity required by the NCDs and LCDs • Coverage policies that currently require a specific diagnosis under ICD-9 will continue to require a specific diagnosis under ICD-10 • It is important to note that these policies will require no greater specificity in ICD-10 than was required in ICD-9, with the exception of laterality, which does not exist in ICD-9.

Coding for Medicare LCD and NCD policies • LCDs and NCDs that contain ICD-10 codes for right side, left side or bilateral do not allow for unspecified side • The NCDs and LCDs are publicly available and can be found at http://www.cms.gov/ medicare-coverage-database/

8 Documentation Considerations

• Practitioners should be comfortable with providing documentation that supports the higher level of detail and granularity within ICD-10CM • Clinical notes should permit the assignment of the most specific codes

Documentation Considerations

• Not every clinical note will support the most detailed and specific code available • Every diagnosis will not be recorded with the pinpoint accuracy that is inherent to the ICD-10 set • Diagnostically complex case and Initial work-ups

9 Documentation Considerations

• CMS has warned coders that diagnosis codes that are not clearly supported by medical record documentation are not to be assigned • Expect queries by coders or CDI staff in the hospital setting

Documentation Considerations

• Other predictions: • Increased focus on payment for quality and medical necessity • Diagnosis coding will be reviewed in addition to procedural coding • Healthcare providers must ensure that the medical record contains enough specificity for the selection of the ICD-10 code that best reflects that condition

10 Documentation Considerations • With more specificity, increased enforcement will likely follow • Healthcare providers should anticipate, and be prepared to respond to: • Aggressive payer audits, both private and public • Enforcement efforts focused on whether clinical documentation supports the ICD-10 code selected • Potential for claims of false or fraudulent billing

Documentation Considerations for Neoplasm Coding

• Key updates to the Neoplasm chapter include: • Classification improvements • Code expansions • Significant expansion in the malignant neoplasm of male breast codes • Revisions to identify laterality for some of the neoplasm sites

11 Documentation Considerations

• The ICD-10-CM Neoplasm Table is now located at the end of the Alphabetical index in the code manual and should continue to be referenced first when coding neoplasms

Documentation Considerations for Neoplasms

• Identify the site (e.g. brain stem) • State the morphology (e.g. malignant, benign, in situ, etc.) • Uncertain behavior • Unspecified behavior • Indicate the stage and any metastatic sites

12 Documentation Considerations for Neoplasms

• Detail when patient presents for treatment related to neoplasm (e.g. surgical removal, chemotherapy, immunotherapy, radiation therapy)

Documentation Considerations for Neoplasms

• Document habits that impact the disease process • There are multiple malignant neoplasms in the head, neck, respiratory categories that have this instruction: • Use additional code to identify: • alcohol abuse and dependence (F10.-) • history of tobacco use (Z87.891) • tobacco dependence (F17.-) • tobacco use (Z72.0)

13 Documentation Considerations for Neoplasms

• Detail conditions that develop as an adverse reaction to neoplastic treatment or the progression of the neoplastic disease • Neutropenic fever secondary to chemotherapy • Neoplastic anemia • Pathological fracture due to a neoplastic process • Neoplasm related pain

Documentation Considerations for Neoplasms

• For Coding Purposes: • The term "mass" is not considered a neoplastic growth • The terms growth, new growth, neoplasm or tumor, when not further specified, are coded to category D49 • Neoplasms of unspecified morphology and behavior by site • Expect a query if hospital case

14 Documentation Tips-Breast Cancer • Malignant neoplasm of the breast has 54 choices (C50.* series), and requires specification of male/ female breast, the site of the neoplasm on the breast, and laterality • In addition, a code for estrogen receptor status is required, if known • Z17.* series

Documentation Tips-Prostate Cancer • Primary malignant neoplasm of the prostate is code C61 • Secondary sites requiring more specificity: • Lungs (C78.01 right or C78.02 left) • Kidneys (C79.01 right or C79.02 left) • Adrenal glands (C79.71 right or C79.72 left)

15 Documentation Tips-Liver Cancer • Several carcinoma types are specified in ICD-10-CM that were not available in ICD-9 • C22.* series represents sites and types of malignant neoplasm of liver and intrahepatic bile duct

Documentation Tips-Lymphoma • Specify lymphomas based on the specific histology type • Mixed cellularity classical Hodgkin’s • The increased code specificity for follicular Lymphomas includes identification of the grade • Follicular lymphoma grade IIIb • State the specific lymph node(s) involved (e.g., intrathoracic, axilla, inguinal, etc.) • Identify when extranodal and solid organ sites are involved

16 Documentation Tips-Leukemia

• Specify the type (e.g. Acute, lymphoblastic) • Identify disease status as being: • In remission • Not having achieved remission • In relapse

Documentation Tips-Sickle Cell

• Sickle cell codes are combination codes • With or without crisis • With acute chest syndrome • With splenic sequestration

17 Documentation Tips-Neutropenia

• Neutropenia is identified by the underlying cause or type (e.g., congenital, drug-induced, cyclic, etc.) • Specify the medication causing a secondary neutropenia and the purpose of its use • Cytoxan for a primary malignancy upper- outer quadrant of right breast • List any related conditions such as an infection • Include information regarding any associated fever or mucositis

Documentation Tips-Pain Related to Neoplasms • Code G89.3 Pain documented as being related, associated, or due to cancer, primary or secondary malignancy, or tumor (acute or chronic) • If the reason for the encounter or admission is documented as pain control or management, then the pain code is used as the first listed diagnosis and the neoplasm is reported as an additional diagnosis

18 Documentation Tips-Pain Related to Neoplasms

• If the reason for the admission/ encounter is documented as pain control and management of the malignancy, either can be reported as the first listed diagnosis • When using G89.3 for neoplasm- related pain, an additional code for the site of the pain is not listed

Documentation Tips-Anemia Associated with Malignancy

• When a patient is admitted for anemia associated with malignancy • Document the anemia and malignancy • The appropriate code for the malignancy is sequenced as the first- listed diagnosis followed by the appropriate code for the anemia (such as code D63.0, Anemia in neoplastic disease)

19 Documentation Tips-Anemia Associated with Chemotherapy, Immunotherapy and Radiation Therapy

• Encounter is for management of an anemia associated with an adverse effect of the administration of chemotherapy or immunotherapy • Document anemia • Anemia code is sequenced first followed by the appropriate codes for the neoplasm and the adverse effect • T45.1X5, Adverse effect of antineoplastic and immunosuppressive drugs

Documentation and Coding Tip

• Current malignancy versus personal history of malignancy • When a primary malignancy has been excised but further treatment, such as an additional surgery for the malignancy, radiation therapy or chemotherapy is directed to that site, the primary malignancy code should be used until treatment is completed

20 Documentation and Coding Tip-Primary Malignancy Previously Excised

• Primary malignancy previously excised or eradicated from its site • No further treatment directed to that site and no evidence of any existing primary malignancy • Assign a code from category Z85, Personal history of malignant neoplasm, to indicate the former site of the malignancy

Documentation and Coding Tips- Primary Malignancy Previously Excised • Any mention of extension, invasion, or metastasis to another site is coded as a secondary malignant neoplasm to that site • The secondary site may be the principal or first-listed with the Z85 code used as a secondary code

21 Future Reimbursement Impacts

• Impact will be seen from coding accurately to properly reflect the severity and condition of the patient • Introducing a new value-based arrangement from CMS