2015 OflOS ANNUAL MEETIN6 - associationdatabase.comassociationdatabase.com/aws/OHOS/asset_manager/get_file/111923/2015... · 2015 OflOS ANNUAL MEETIN6 MEETINe MATERIALS OCTOBER 16,

2015 OflOS ANNUAL MEETIN6

MEETINe MATERIALS

OCTOBER 16, 2015

COLUMBUS, OHIO

SOCIETY BOARD MEMBERS 2015 A N N U A L MEETING

Slobodan Stanisic, MD President The Christ Hospital Medical Specialists I I , 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, M D , 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'

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

2015 Annual Meeting Friday, October 16, 2015

Nationwide Hotel & Conference Center

100 Green Meadows Drive South

Lewis Center, OH 43035

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 [email protected] 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\CompanyChris Riedel AMAG Pharmaceuticals, Inc.Tom Evans AMAG Pharmaceuticals, Inc.Stephanie Rogers AmgenLinda Sell AmgenSheila Bihnmyer AmgenDeirdre Winkle ApobiologixBen Holtvogt AstellasCurtis Sosnowski AstellasBrian Jenkins AstraZenecaJoyce Bohl AstraZenecaDan McCollum AstraZenecaSamantha Terry AstraZenecaBrian Julian BayerNick Liberati BayerKevin Riley Bristol Myers SquibbKen Hyland Bristol Myers SquibbLinda Martens Bristol Myers SquibbMichelle Ruscher Bristol Myers SquibbMarsha Petosa Bristol Myers SquibbSteve Brenner Cardinal HealthCorine Toomer Cardinal HealthAlan Houston CelgeneAlan Huber CelgeneSusan Jagers CelgeneKeith Jenkins CelgeneDana Nestinger CelgeneElizabeth Pichea CelgeneDeb Silvers CelgeneLlinee Williams CelgeneJuan Lumpkin CGS AdministratorsAmy Pridemore, CMPE, CPC Columbus Oncology & Hematology AssociatesJulie Teets Columbus Oncology & Hematology AssociatesRobert Baird Dayton PhysiciansMary Jameson Dayton PhysiciansKarrie Moore Dayton PhysiciansRon Corpora EisaiDave Bowen EisaiTom Rothmann GenentechDeanna Wakeman Genomic HealthShawn Wheeler Genomic HealthSteve Drucker Genomic HealthMelanie Barnicle Hematology Oncology CenterEmily Besser Hematology Oncology Consultants, Inc.Brett Blade Hematology Oncology Consultants, Inc.Melinda Morehead Hematology Oncology Consultants, Inc.Bruce Grothen HospiraJonathan Beasley IncyteTonya Holthaus Incyte

Amy Davidson Johnson & Johnson Healthcare SystemsValerie Reeves Johnson & Johnson Healthcare SystemsLaura Francis Kettering Cancer and Blood SpecialistsKasia Harshaw Lilly OncologyMary Ramsey Lilly OncologyAzad Rastegar McKesson Specialty CareColleen Powers MerckRob Brooks MerckMary Bryant MerckMike Mills MerckJonathan Ijaz MerckKathleen Powell MerckJerry Van Stavern MerckTanya Cavins MerckBarry Tucker MerckNora Moran NovartisLaura Matthews NovartisKim Mitchell NovartisLaura Michaels NovartisChristi Pepe Ohio MedicaidJulie Brandt, CHONC Ohio Oncology & Hematology LLCKyle Dillahunt OHOSTammy Asbury Oncology Hematology Care, Inc.Danielle Williamson Oncology Hematology Care, Inc.Mark Kegelman Onyx PharmaceuticalsBob Louwers PfizerMike Mitchell PharmacyclicsRon Vela PharmacyclicsJim Gerace SandozColleen O'Donnell SandozJamilyn Perez-Aragon SandozToby Tucker SandozRandy Clark SanofiDean Masztak Seattle GeneticsTroy Schlotterbeck Seattle GeneticsJohn Ruppert Taiho OncologyJamie Young Taiho OncologyBrent Evans Takeda OncologySean Jarvis Takeda OncologySue Anderson Teva OncologyChris Smith Teva OncologySterling Jones Teva OncologyHeather King The Christ Hospital Medical Specialists IIMichael Quaranta The Christ Hospital Medical Specialists IIAmber Starnes The Christ Hospital Medical Specialists IIJames Nixon The Christ Hospital Medical Specialists IIDanielle Busken The Christ Hospital Medical Specialists IISallyann Holder The Christ Hospital Medical Specialists IIChelsea Miller The Christ Hospital Medical Specialists II

Paul Dieter The Hope Center for Cancer CareDavid Brown, MD Toledo ClinicPeg Diegel Toledo Clinic Cancer CenterGermaine Lawless Tri County Hematology & OncologyRuth Settle Tri County Hematology & OncologyCheryl Skinner TriHealthMichelle Weiss Weiss Oncology ConsultingLisa Miller Zangmeister Cancer CenterChristine Pfaff Zangmeister Cancer CenterHeather Walton Zangmeister Cancer CenterJean StevensDavid Fishman, MD

10/13/15

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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

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Agenda

•  Reimbursement Basics – Overview & The Rules

•  Defining Drugs – Drugs vs Biologics – Generics vs Biosimilars –  Interchangeability

•  Medicare Reimbursement •  What we still don’t know…..

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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

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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

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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

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Infusion Services

•  4 Primary Components to infusion billing: –  Evaluation & Management Codes

•  office visits, hospital visits, etc.

–  Drugs •  Therapeutic/Antineoplastic/Highly Complex/Supportive

Care

–  Administration •  Hydration, Therapeutic, Chemotherapy

–  Diagnostic •  Lab & Bone Marrow

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Today’s Focus!

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

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•  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

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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

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! 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%)

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•  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

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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

12

10/13/15

7

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

13

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

14

10/13/15

8

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

16

10/13/15

9

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

17

What we’ve known…..

•  Until HCPCS Code is Established – Not Otherwise Classified Codes for drugs

and/or biologics •  J3490 – unclassified drugs •  J3590 – unclassified biologics •  J9999 – Not otherwise classified,

antineoplastic drugs •  C9399 – Unclassified drugs or biologicals

(Medicare hospital outpatient setting)

18

Some payers only used the J3490

10/13/15

10

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

19

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

10/13/15

11

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

21

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

10/13/15

12

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

23

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)

24

10/13/15

13

Biologic

•  Some you will recognize….

! Avastin ! Rituxan ! Remicade ! Herceptin ! Neulasta

25

!  Enbrel !  Humira !  Aranesp !  Procrit !  Lucentis

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

26

10/13/15

14

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

28

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15

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

29

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241718.htm

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.”

30

10/13/15

16

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”

31

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

32

10/13/15

17

Standard and Abbreviated Pathways for Drug Approval in US

33

Drug Development Process

34

10/13/15

18

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

36

CMS ASP File Addition - October 2015

10/13/15

19

From CGS Website

37

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

38

10/13/15

20

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,"

39

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

40

10/13/15

21

Questions???

Michelle Weiss, CHONC Weiss Oncology Consulting

[email protected] www.weissconsulting.org

41

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

42

1

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

2

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

3

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

4

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

5

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


•  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

6

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


•  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

7

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

8


•  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.


•  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/

9

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


•  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

10


• 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


•  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

11

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

12


•  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

13


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


•  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)

14


•  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


•  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

15

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)

16

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

17

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

18

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

19

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)

20

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

21

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

22

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

Merit-Based Incentive Payment System (MIPS)

•  April 15, 2015---Congress and President Obama approved one of the most bipartisan and significant bills in the history of U.S. healthcare reform, the so-called “doc fix” bill

•  Replacement for the SGR formula •  Pay for Performance Merit-Based Incentive

Payment System

23


•  MIPS annually measures Medicare Part B providers in four performance categories to derive a "MIPS score" (0 to 100), which can significantly change a provider's Medicare reimbursement in each payment year


•  The performance categories are: •  VBM-measured quality (up to 30

points) •  VBM-measured resource use (30

points), •  Meaningful Use (25 points) •  New category named "clinical practice

improvement" (15 points)

24


•  The MIPS score's maximum impact on reimbursement increases from +/- 4% for the 2019 payment year to +/- 9% for the 2022 and subsequent payment years

•  May indicate significant potential adjustments to provider organizations' Medicare reimbursements •  Operating margins in the single-digit

percentages may be negatively impacted


•  When will it arrive?? •  Probably 2017

•  The measurement or performance period determining the MIPS score must end prior to and as close as possible to the applicable payment year

•  Based on past experience with Medicare programs such as MU and VBM, there is typically a two-year lag from performance year to payment year

25


•  The MIPS score would then adjust reimbursements in the 2019 payment year

•  CMS will define the performance years and other details of the MIPS program in a final rule anticipated to be published in the Federal Register by the end of 2016


•  For the 2015 and 2016 performance years (and the respective 2017 and 2018 payment years), the VBM, PQRS, and MU programs will continue as separate and distinct measurement and payment adjustment programs

26


•  Who is eligible for MIPS? •  For the first two years of MIPS, the

following Medicare Part B providers are deemed eligible professionals: • Physicians • Physician assistants • Nurse practitioners • Clinical nurse specialists • Nurse anesthetists


•  For the third and succeeding years, the following providers also become MIPS-eligible: •  Physical or occupational therapists •  Speech-language pathologists •  Audiologists •  Nurse midwives •  Clinical social workers •  Clinical psychologists •  Dietitians or nutrition professionals

27


•  Three notable exclusions of providers from MIPS eligibility •  Providers participating in an "alternative

payment model” are not subject to MIPS •  CMS will define a low-volume threshold

that includes a combination of minimum Medicare patients, service volume, and/or billings below which a provider is excluded from MIPS


•  Third, providers who enroll in Medicare for the first time during a performance year are exempt from MIPS until the subsequent performance year

28


•  2015 MIPS Timeline •  April 16, 2015 - MIPS legislation

passed •  July 8, 2015 - CMS solicits initial public

comments on MIPS •  September 8, 2015 - CMS initial public

period ends •  By December 31, 2015 - CMS to

release RFI seeking more comments


•  2016 MIPS Timeline •  Estimated July 2016 - Proposed 2017

MIPS rule •  Estimated November 2016 - Final 2017

MIPS rule

29

Diagnosis Coding

•  With a new reimbursement model on the horizon, accurate diagnosis coding can support medical necessity and contribute to increased payment

•  Embrace the specificity of ICD-10 and use that detail to your advantage •  Acuity and severity of illness are key

Questions????

Thank You

10/13/15

1

The High Cost of HOPE Financial Survival in Cancer Care with Financial Advocacy

Mary Jameson, MBA

* HOPE

* HOPE

* HOPE

10/13/15

2

Jacqueline Brim

Jacqueline Brim

Mel Brim

Mel Brim

10/13/15

3

Financial Impact of Cancer Care

*80% of all employer sponsored healthcare plans in 2015 have deductibles.

*25% of those plans have deductibles ranging from $6,000 to $10,000

*85% of all plans sold on the Accountable Care Health Insurance Exchange were high deductible plans.

*  *Today’s average plans have higher and/or variable co-‐pays and cost shares associated with them. *  *Annual costs per worker rose almost 230% between

2006 and 2015 *  Cancer patients are 2.5 times more likely to file

bankruptcy

More Impact

10/13/15

4

Losing Hope…..

Cancer Care and Medicare

Income *  Avg monthly Social Security income: $ 1,290 per mo

Expense *  Avg monthly Medicare Premium w/ Part D $ 117 per mo *  Avg cost share * : $ 2,000 per mo

$ 2,117 per mo *Based on an average $10,000 monthly regimen

Net Loss: $827

Losing Hope…..

Cancer Care and Commercial Plans

Income *  Avg annual income: $ 45,000 per yr Expense *  Avg annual premium $ 4,608 per yr *  Avg cost share* : $ 7,640 per yr

$ 12,248 per yr

*based on a $7000 deductible and 16 co pays of $40

Percent of Annual Income: 27%

10/13/15

5

The New Recipe for Hope

•  Patients as Consumers •  Requirement for Transparency •  Leave Patients Satisfied

*  Ended first quarter 2012 with $900,000 in patient responsibility. *  Peer practices agree they are carrying more than

$1,000,000 in patient balances annually – largely from drug spend *  Most common drugs used have co pay assistance

available. *  Most prevalent diseases have a foundation currently

providing support. *  Financial Counselors were able to obtain assistance

averaging $100K per month-‐ helping on average 12 – 16 patients.

In the beginning….

10/13/15

6

*  Develop a position for a Financial Advocate *  Hire two Advocates in a temporary status for a period

of 6 months – and track the results. *  Goal of increasing awards by $50,000 per location per

month. *  Goal of increasing our overall collection % and

reducing our patient balances.

The Proposal

Finding Hope

•  Educating Patients •  Setting Expectations •  Sourcing Financial Support •  Giving Patients a Reason to Choose You

10/13/15

7

Thank you for choosing Dayton Physicians as your provider. We realize you have a choice in Cancer Care, And we thank you for choosing us!

Lessons from Southwest

* Financial Policy -‐We will bill your carrier -‐You will be responsible for your cost share -‐Payment is expected at the time of Service

Step 1: Transparency

10/13/15

8

* Making costs clear -‐ Verify insurance status -‐ Verify insurance contribution -‐ Provide Cost Estimation

Step 2: Cost Estimation

Step 3: Financial Assistance

* Assistance Opportunities -‐ Grants -‐ Pharma Co Pay Assistance -‐ Clinical Trial

10/13/15

9

* Statements that are clear * Access to payment options * Budget billing / recurring payment * External healthcare financing options

Addressing Patient Payments

The Financial Advocate

*  JOB SUMMARY: The Patient Financial Advocate is responsible for assisting patients and/or families to access financial resources. The Advocate assists the Financial Counselor to identify patients who may qualify for assistance through Medicaid, Co Pay Assist programs or Disease Foundations, and makes application on behalf of the patients. The Advocate is also available to patients and families to answer questions regarding their insurance, and to give estimates of co-‐pay amounts. The primary function of the Advocate is to assist patients in application for financial assistance if available from various pharmaceutical entities or foundations.

Excellent Oral and Written Communication

2 Years Experience in Healthcare Environment

High School Graduate

10/13/15

10

Patient identified for Chemo tasked

to Pre Cert

Precert evaluates, approves, and

tasks to Advocate

Advocate evaluates and prepares –

forwards package to Financial Counselor

Financial Counselor performs costs

estimation

Financial Counselor meets with patient, Educates, Submits, Arranges Payment

Approved patient is scheduled

Sources of funding

*  Amgen *  Genentech *  Novartis *  Bayer *  Bristol Meyers Squibb *  Celgene *  www.accc-‐cancer.org *  www.needymeds.com

*  American Cancer Society *  Leukemia and Lymphoma

Society *  Patient Access Network

Foundation *  Cancer care Copay Org *  Patient Advocate

(commercial) *  Chronic Disease Fund *  PSI – Patient Services

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www.needymeds.com

Example – www.needymeds.com

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•  ALWAYS prior to treatment •  EVERY patient, every time •  Plan for year end •  Re-‐evaluate, Re-‐validate

Tips for Success

Success 2015

*  Monthly awards in 2012: $100,000 *  Monthly awards in 2015 $1,300,000

•  Jan – June of 2014 Financial grants collected: $272,899 •  Jan – June of 2015 Financial grants collected: $784,000

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Financial Advocac

“I’m willing to go broke, to go home” Jacqueline Brim

CGS Administrators - Medicare Part B October 2015

© 2015 Copyright 1

CGS Administrators, LLC | October 2015

Disclaimer

This presentation was current at the time it was published or uploaded onto the CGS Web

site. Medicare policy changes frequently so links to the source documents have been

provided within the document for your reference.

This presentation was prepared as a tool to assist providers and is not intended to grant

rights or impose obligations. Although every reasonable effort has been made to assure the

accuracy of the information within these pages, the ultimate responsibility for the correct

submission of claims and response to any remittance advice lies with the provider of

services.

The Centers for Medicare & Medicaid Services (CMS) employees, agents, and staff make

no representation, warranty, or guarantee that this compilation of Medicare information is

error-free and will bear no responsibility or liability for the results or consequences of the

use of this guide.

This publication is a general summary that explains certain aspects of the Medicare

Program, but is not a legal document. The official Medicare Program provisions are

contained in the relevant laws, regulations, and rulings.

© 2015 Copyright, CGS Administrators, LLC.

2


© 2015 Copyright 2

Objectives

Discuss ongoing Medicare initiatives

Provide information regarding medical record review

contractors

Introduce resources and self-service technology options


3

ICD-10: What Next???

The U.S. health care system moved to ICD-10 October 1, 2015, for services rendered on and after October 1, 2015. Because CMS knows this is a major transition, they will be monitoring the transition in real time; watching our processing systems; and addressing any issues as they arise. If you need help with OCD-10 problems:

• Your first line for help with claims questions is the CGS Provider Contact Center.

• Contact the PCC at 1.866.276.9558 (option 1)

• For general ICD-10 information, please refer to the Road to 10 webpage located at http://www.roadto10.org/

• You may contact the ICD-10 Coordination Center, which is a dedicated group of billing, coding and IT systems experts drawn from across the CMS organization.

• They are available via email at [email protected].

• CMS named an ICD-10 Ombudsman, Dr. Bill Rogers, who can be your impartial advocate.

• You may reach him via email at [email protected].


4

http://www.roadto10.org/

mailto:[email protected]



© 2015 Copyright 3


CMS Issues Clarifying Questions and Answers Related to the

July 6, 2015 CMS/AMA Joint Announcement and Guidance

Regarding ICD-10 Flexibilities.

• CMS issued letters to Medicare Fee-for-Service providers emphasizing

the importance of readiness for ICD-10 and reminding them of the

resources available from CMS and other organizations to get ready.

• In response to questions from the health care community about specific

information provided in the letter, CMS developed a Frequently Asked

Questions (FAQ) document that provides clarification on the most

commonly asked questions related to the joint CMS/AMA

announcement.

• Please view the FAQs at

https://www.cms.gov/Medicare/Coding/ICD10/Clarifying-Questions-

and-Answers-Related-to-the-July-6-2015-CMS-AMA-Joint-

Announcement.pdf for more guidance.


5


CGS ICD-10 Local Coverage Determinations (LCDs) and

National Coverage Determinations (NCDs)

• Please keep in mind the ICD-10 versions of all LCDs and NCDs

are accessible from the CGS website.

• The Medical Policies page includes links to the CMS website

where LCDs and NCDs are maintained.

• The Part B Medical Polices page is located at

http://cgsmedicare.com/partb/medicalpolicy/index.html.

• If you have questions regarding medical policies and specific

ICD-10 codes, please contact the CMDs at

[email protected].


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https://www.cms.gov/Medicare/Coding/ICD10/Clarifying-Questions-and-Answers-Related-to-the-July-6-2015-CMS-AMA-Joint-Announcement.pdf



























http://cgsmedicare.com/partb/medicalpolicy/index.html



© 2015 Copyright 4

The Improper Payments Information Act

Improper Payments Elimination and Recovery Act

Both laws require the heads of federal agencies to annually

review the programs it administers to:


7

Identify those susceptible

to significant improper

payments

Estimate the amount of

improper payments

Submit information to

Congress

Develop an action plan to

reduce improper

payments

Improper Payments by Agency (FY 2013)

AGENCY AMOUNT

(In Billions)

Department of Health and Human Services $78.4

Department of Treasury $17.7

Social Security Administration $8.1

Department of Labor $5.7

Department of Agriculture $6.9

Department of Education $2.2

Department of Veterans Affairs $1.6

Department of Housing and Urban Development $1.0

What is the CERT Program?

The Comprehensive Error Rate Testing Program was established

by the Centers for Medicare & Medicaid Services (CMS)

Improve the processing and medical decision making involved with

the payment of Medicare claims

Assess how successful Program is at reimbursing providers correctly

• Critical to protecting the Medicare Trust Fund

Looks for Improper Payments

• Any claim that was paid when it should have been denied

• Any claim paid at the incorrect amount

– Results in overpayments and underpayments

Outcomes used to identify educational needs


8


© 2015 Copyright 5



9

• The FY 2013 improper payment rate was 10.1 percent or $36.0 billion in improper payments.

FY 2014:



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Avoid “Insufficient Documentation” Errors • Be sure documentation adequately

describes the service billed • Include copies of signed orders • Verify signatures are valid, eligible and/or

present ‒ Submit a Signature Attestation

Statement when necessary

Avoid “No Documentation” Errors • Respond to all requests completely • Return documentation within 75 days • Include a copy of the bar-coded page with

the request

http://www.cgsmedicare.com/partb/pubs/news/2014/1014/cope27264.html



http://www.cgsmedicare.com/partb/cert/review_process.html


© 2015 Copyright 6



11

Avoid “Medically Unnecessary” Errors • Include all relevant medical records • Identify the reasons surgeries and/or

diagnostic tests are performed • Always check for LCDs and NCDs to verify

medical necessity is met

Avoid “Incorrect Coding” Errors • Be aware of the E/M Documentation

Guidelines ‒ Key elements of E/M level billed must be

met ‒ Document time when level of service is

based on time spent counseling/coordinating care

‒ Always follow the new patient guidelines

CERT Resources The CERT Program

www.cms.gov/cert

Government-level improper payments across various programs

http://www.paymentaccuracy.gov/

Signatures in Medical Records

MLN Matters article SE1237

• http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1237.pdf

MLN Matters article MM6698

• http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM6698.pdf

Signature Attestation Statement

• http://www.cgsmedicare.com/ohb/claims/cert/Signatures_06%2011%20(2).pdf

E/M Documentation Guidelines

1995 (general) or 1997 (specialty-focused)

• http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/EMDOC.html


12

http://www.cms.gov/medicare-coverage-database/

http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/EMDOC.html



http://www.cms.gov/cert



http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1237.pdf













http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM6698.pdf












http://www.cgsmedicare.com/ohb/claims/cert/Signatures_06 11 (2).pdf

http://www.cgsmedicare.com/ohb/claims/cert/Signatures_06 11 (2).pdf
















© 2015 Copyright 7

What is the Recovery Audit Program?

The Recovery Audit program was created to detect and

correct past improper payments

Process applies to FFS Medicare

Use same policies as MACs

• LCDs, NCDs and CMS Manuals

Reviews performed post-payment

• Automated: on-the-record review

• Semi-Automated: using data and may require medical records

• Complex: request for medical records sent to providers

Issues RAs review must be approved by CMS

• Check CMS-approved “issues” listing on RA website


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https://racb.cgi.com/Issues.aspx


14

Current CMS-approved listing of services submit to RAC review

Type in PROFESSIONAL or PHYSICIAN

CPT only copyright 2014 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS\DFARS Restrictions

Apply to Government Use.



© 2015 Copyright 8



15

The Details link will display a page giving you a description of the issue and links to related policies.


Limit the Recovery Auditors’ “look back” period

• Three years

Imaged medical records accepted on CD/DVD

Limit the number of medical record requests

• Updated August 2013

Reviews performed by qualified staff to ensure accuracy

• Physician Contractor Medical Director (CMD)

• Therapists

• Nurses

• Certified coders

Appoint a specific person for Recovery Auditors to contact

• CGI Technologies and Solutions, Inc. Call Center

– 1.877.316.RACB (7222)


16


© 2015 Copyright 9



17



18


© 2015 Copyright 10

RA Resources

The Recovery Audit Program

http://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/recovery-audit-program/

Region B Recovery Auditor

https://racb.cgi.com/

Link to issues

• https://racb.cgi.com/Issues.aspx

• Check the CGS web site for a host of special edition MLN Matters articles regarding RA reviews

Office of Inspector General (OIG)

www.oig.hhs.gov/oas/cms.asp

CERT

www.cms.gov/CERT

Questions regarding RA program? [email protected]

Please do not email personal health information (PHI)


19

What is PQRS?

The Physician Quality Reporting System is a reporting program that

uses a combination of incentive payments and payment adjustments to

promote reporting of quality information by eligible professionals

Report the level of quality provided during patient encounters

• Applies to Medicare Fee-for-Service patient

– Includes Railroad and Medicare Secondary Payer

PQRS is a federally-mandated program

No sign-up or registration required

• 2015 PQRS Implementation Guide

• View quality measures and measures groups

– Report 9 measures across 3 National Quality Strategy domains

– Measures groups may only be reported through Registries


20




















http://www.oig.hhs.gov/oas/cms.asp

http://www.cms.gov/CERT




What is PQRS?

2016 PQRS Negative Payment Adjustment and the Informal

Review Process

• In 2016, CMS will apply a negative payment adjustment to

those that did not satisfactorily report PQRS in 2014.

• Individual eligible professionals (EPs)

• Comprehensive Primary Care (CPC) practice sites

• Group practices participating in the group practice reporting

option (GPRO)

• Including Accountable Care Organizations (ACOs)

• Individuals and groups that receive the 2016 negative payment

adjustment will not receive a 2014 PQRS incentive payment.


21

What is PQRS?

Those who believe they have been incorrectly assessed the 2016 PQRS

negative payment adjustment may submit an informal review.

• Between September 9, 2015 and November 9, 2015

• Requesting CMS investigate incentive eligibility and/or payment

adjustment determination.

• All informal review requestors will be contacted via email of a final

decision by CMS within 90 days of the original request for an

informal review.

• All decisions will be final and there will be no further review.

• All informal review requests must be submitted electronically via the

Quality Reporting Communication Support Page (CSP), which is

located at

https://www.qualitynet.org/portal/server.pt/community/pqri_home/212.


22

https://www.qualitynet.org/portal/server.pt/community/pqri_home/212



What is Value-Based Payment Modifier?

PQRS is the basis for Value-Based Modifier

Provides comparative performance information to physicians

Goal is to improve the quality and efficiency of medical care

CMS is moving toward physician reimbursement that

rewards value rather than volume

VM phase-in period

‒ Groups of 100+ EPs in CY 2015:

‒ -1% reduction (based on CY 2013 data)

‒ Groups of 10-99 EPs in CY 2016:

‒ -2% reduction (based on CY 2014 data)


23

What is Value-Based Payment Modifier?

VM phase-in period (con’t)

‒ Groups of < 9 and individual EPs in CY 2017

o Based on CY 2015 reporting

Solo EPs and groups of < 9: -2%

Groups with 10+ EPs: -4%

‒ Applies to ACOs in CY 2017

‒ Applies to Non-physician EPs in CY 2018

Actions to take NOW

‒ Refer to What To Do in 2015 For The 2017 VM located at

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-

Payment/PhysicianFeedbackProgram/Downloads/What-To-Do-In-2015-For-

The-2017-VM.pdf


24

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/What-To-Do-In-2015-For-The-2017-VM.pdf





























PQRS and VM Resources

The Physician Quality Reporting System

http://www.cms.gov/PQRS/ - Links for information on:

• How to Get Started

• CMS Sponsored Calls

• Measures Codes

– 2015 PQRS Individual Claims Registry Measure Specification Supporting Documents (under Related Links)

» List of QDCs and definitions

• Registry and EHR Reporting

• Payment Adjustment Information

American Medical Association (AMA) PQRS web page

• http://www.ama-assn.org/ama/pub/physician-resources/clinical-practice-improvement/clinical-quality/physician-quality-reporting-system-2013.page

Value-based Payment Modifier

• http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/ValueBasedPaymentModifier.html


25

PQRS and VM Assistance

Contact the QualityNet Help Desk for PQRS assistance,

such as:

• How to begin participating

• Accessing feedback reports

• Explanation of feedback reports

– 1.866.288.8912, 7:00 a.m. - 7:00 p.m. CT, M-F

– [email protected]

Contact the Physician Value Help Desk with VM questions

– 1.888.734.6433 (Option 3)

– 8:00 a.m. - 8:00 p.m. ET

– Monday – Friday


26

http://www.cms.gov/PQRS/

http://www.cms.gov/PQRS/

http://www.ama-assn.org/ama/pub/physician-resources/clinical-practice-improvement/clinical-quality/physician-quality-reporting-system-2013.page




















https://www.cms.gov/PhysicianFeedbackProgram/

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/ValueBasedPaymentModifier.html













myCGS Resources

CGS offers myCGS, a web portal used to perform online

functions securely over the Internet!

Special functions will include

Submit Part B Claims

Patient eligibility inquiries

Provider financial inquiries, including the amount approved-to-pay

and the last three checks paid

View/print copies of remittance advices

Submit Redetermination requests!

From Part B homepage

http://www.cgsmedicare.com/partb/myCGS/index.html


27

myCGS Resources

You can participate in myCGS if you have a signed

Electronic Data Interchange (EDI) Enrollment Agreement on

file with CGS.

Electronic submitters already have an agreement on file with us.

• You do NOT have to be an electronic submitter to register.

The EDI Enrollment Agreement is located in the EDI Enrollment

Packet

• http://www.cgsmedicare.com/pdf/EDI_Enroll_Packet.pdf

The turnaround time for a new EDI application to process is

approximately 20 days.


28



http://www.cgsmedicare.com/pdf/EDI_Enroll_Packet.pdf

http://www.cgsmedicare.com/pdf/EDI_Enroll_Packet.pdf



myCGS Resources


29

•CLAIMS Tab: NEW! Medicare claims can now be submitted through myCGS! You can also check the status of claims.

•REMITTANCE Tab: View and print remittance advices (RAs)

•ELIGIBILITY Tab: With validated patient information you can check: o Current/previous year’s deductible o Therapy cap information o Date next eligible for the Medicare-

covered preventive services o Medicare Advantage (MA) plan

enrollment o Determining primary payer (MSP) o Details on home health episodes o Hospice benefit periods o Hospital and skilled nursing facility

stays

•FINANCIAL TOOLS Tab: Inquire about claims approved-to-pay and the last three checks issued.

•MESSAGES Tab: Read secure messages and alerts regarding system access and functions performed in the portal

•FORMS Tab: Submit certain forms directly to CGS. Currently available: o Submit Redeterminations (NEW File

Size!) o Requests for eOffset (immediate offset) o Reopening requests o Respond to Medical Review (MR)

Additional Documentation Requests (ADRs)

•ADMIN Tab: Used by Provider Administrator to grant access to other users

Resources

The myCGS Video Library

• The Benefits of myCGS

• Introducing myCGS Three-Part Video Tutorials

myCGS Web Portal Registration Checklist

• Step-by-step instructions to help you register

myCGS Frequently Asked Questions (FAQs)

User Manual

EDI Helpdesk: 1.866.276.9558

Watch for EXCITING myCGS enhancements!!!


30

http://www.cgsmedicare.com/pdf/mycgs/chapter2_partb.pdf

http://www.cgsmedicare.com/pdf/mycgs/chapter3.pdf




http://www.cgsmedicare.com/pdf/mycgs/chapter7_partb.pdf





Questions?

Thank you for joining us!

10/13/15

1

Chris, Pepe, Policy and Program Development Bureau of Managed Care Ohio Department of Medicaid October 16, 2015

MyCare Ohio: Serving Ohio’s Dual Eligibles

M a k i n g O h i o B e t t e r

O H I O D E PA R T M E N T O F M E D I C A I D

Statutory Authority

• Demonstra,on -‐ Using innova,ve service delivery system that improves care, increases efficiency, and reduces costs.

• A three year demonstra,on project that integrates Medicare and Medicaid services into one program, operated by an MMP-‐ Medicare Medicaid Plan). Ohio submiLed request to CMS in Aug. 2015 to extend the demonstra,on.

• Concurrent 1915(b) and 1915(c)waivers effec,ve 4/1/2014 – 3/31/2019 – implement two types of waivers for integra,on of Medicare and Medicaid service to elderly and disabled individuals.

10/13/15 2

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2



Combined 1915(b)/(c)

•  1915(b) -‐ Allows states to provide Medicaid benefits through a managed care delivery system to manage cost, u,liza,on, and quality of care.

•  Sec,ons waived: » 1902(a)(1) – Statewideness » 1902(a)(10)(B) – Comparability of Services » 1902(a)(23) – Freedom of Choice

•  1915(c) – Allows states to provide tradi,onal long-‐term care benefits, as well as home and community-‐based services (HCBS). The (c) running concurrently with (b) provides the services through a managed care delivery system.

10/13/15 3



Agreements

•  3-‐Way Agreement between CMS, ODM, and the managed care plans provides coordina,on of Ohio’s regula,ons with Medicare regula,ons and benefits from both packages of services. Incorporates the provider agreement by reference. The agreement also outlines responsibili,es, monitoring ac,vi,es, and expected outcomes for CMS, ODM, and the Medicare-‐Medicaid plans.

• Ohio also maintains a separate provider agreement with MCPs for enrollees, that also sustains the process for Medicaid-‐only recipients. Addi,onal services and requirements not listed in the 3-‐Way.

10/13/15 4

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3



Rules

• MyCare Ohio Rules – 5160-‐58 for MyCare Ohio program specific regula,ons and references back to 5160-‐26 for all managed care requirements.

10/13/15 5



Who is eligible for MyCare Ohio? » Full Medicaid and Medicare Parts A, B, and D;

» Age 18 or over; and

» Reside in one of the 29 demonstra,on coun,es.

» This includes individuals who are: ─ Residing in nursing facili,es ─ Receiving PASSPORT, Choices, Ohio Home Care, Transi,ons Carve Out, or Assisted Living home care waiver services ─ Receiving behavioral health services in community sedngs

10/13/15 6

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4



Who is not eligible for MyCare Ohio?

•  Individuals with an ICF-‐IID level of care served in an ICF-‐IID facility or on a DODD waiver.

•  Individuals enrolled in the Program of All Inclusive Care for the Elderly (PACE).

•  Individuals who have third party insurance. •  Individuals who have re,ree medical benefits. •  Individuals who have a delayed spenddown.

10/13/15 7



Enrollment Process

•  Enrollment occurs monthly •  Individuals are enrolled to a MyCare Ohio plan with an effec,ve date about 60 days in the future.

•  Individuals have at least 60 days to voluntarily select a plan, or the MyCare plan selected for them goes into effect.

10/13/15 8

10/13/15

5



Dual Benefits or Medicaid Only

•  Enrollment in the Medicaid benefit for MyCare Ohio is mandatory. •  Individuals have the choice of having the MyCare Ohio plan administer both their Medicaid and Medicare benefits (Dual Benefits) or their Medicaid benefits only (Medicaid Only).

•  Individuals have choice of switching between Dual Benefits and Medicaid Only monthly.

• All passive enrollments default to Dual Benefits.

10/13/15 9



Enrollment statistics

•  94,056 individuals enrolled for October 2015. •  66.4% are full Dual Benefits enrollment •  25.8% receive MyCare Ohio waiver benefits.

•  19.6% reside in a nursing facility.

10/13/15 10

10/13/15

6



Benefits

•  Benefit package includes all benefits available through the tradi,onal Medicare & Medicaid programs, including long term services and supports (LTSS), and behavioral health

•  MyCare Ohio Plans may elect to include addi,onal “value-‐added” benefits in their health care packages

10/13/15 11

LTSS, and behavioral health services are new to managed care



MyCare Ohio Benefits

10/13/15 12

Medicare/Medicaid Benefits Benefit Type

Inpatient Hospital Medicare, unless days exhausted then Hybrid

Inpatient Mental Health (including Freestanding and State Operated Hospitals) Medicare unless days exhausted, then Hybrid

Skilled Nursing Facility Hybrid

Home Health Hybrid

Hospice Medicaid (for NF room and board only)

Physician Services Medicare

Out-Patient Hospital or Ambulatory Surgery Center Services --outpatient clinic/surgery Medicare

Laboratory, X-Ray and Imagining Medicare

Chiropractic Medicare

Podiatry Medicare

Ambulance Hybrid

Ambulette Medicaid

Outpatient Rehabilitation Services (OT,PT,ST) Hybrid (Medicaid pays after Medicare visit limits)

Cardiac and Pulmonary Rehab Services Medicare

DME and Supplies including Diabetic Supplies Hybrid

Prosthetics Medicare

Diabetes Self-Management/Training Medicare

Vision Care Hybrid (post-cataract glasses are Medicare)

Preventive Services Medicare

Medical Nutritional Therapy Hybrid

Renal Dialysis Services Medicare

Part B Prescription Drugs Medicare

Family Planning Services and Supplies Hybrid

10/13/15

7



MyCare Ohio Benefits

10/13/15 13

Medicare/Medicaid Benefits Benefit Type

Dental Medicaid

Prescription Drugs Medicare or Medicaid by drug type

Private Duty Nursing Medicaid

Pharmacological Management Hybrid (during BH transition only, then Medicare

after) Behavioral Health Assessment (Physician and Non-Physician for MH Only) Hybrid Behavioral Health Counseling and Therapy (Individual and Group) including Independent Psychologist Hybrid

Crisis Intervention (24-hour availability) Hybrid

Partial Hospitalization Hybrid Outpatient Substance Abuse Services

Hybrid Community Psychiatric Support Treatment (Individual and Group) Medicaid

Ambulatory Detox Medicaid

Intensive Outpatient Medicaid

Laboratory Urinalysis for AOD Medicaid

Med-Somatic Medicaid

Methadone Administration Medicaid

Waiver Services- all types Medicaid



Eligibility for MyCare Ohio HCBS Waiver

•  In order to be eligible for the MyCare Ohio HCBS Waiver an individual must be:

•  Enrolled in the MyCare Ohio demonstra,on at ,me of applica,on

•  Determined to have NF-‐based Level of Care (Intermediate or Skilled)

•  Determined to require at least 1 waiver service monthly •  In the absence of the waiver, require hospitaliza,on or NF to meet

his/her needs

10/13/15 14

10/13/15

8



The MyCare Ohio Waiver

• Services provided in the following Waivers are included in the MyCare Ohio Waiver:

•  PASSPORT •  Assisted Living •  Ohio Home Care

10/13/15 15

The MyCare Ohio Waiver has taken all of the above waivers and combined them into one



Waiver Services •  Adult Day Health Services •  Alterna,ve Meals Service •  Assisted Living Services •  Choices Home Care ALendant •  Chore Services •  Community Transi,on •  Emergency Response Services •  Enhanced Community Living Services •  Home Care ALendant •  Home Delivered Meals •  Homemaker Services

•  Home Medical Equipment & Supplemental Adap,ve and Assis,ve Devices

•  Home Modifica,on Maintenance & Repair

•  Independent Living Assistance •  Out of Home Respite Services •  Personal Care Services •  Pest Control •  Nutri,onal Consulta,on •  Social Work Counseling •  Waiver Nursing Services •  Waiver Transporta,on

10/13/15 16

10/13/15

9



Waiver Self-Direction There are two kinds of authori,es members may have to direct their services:

1.   Employer Authority means the member assumes responsibili,es of being the worker’s employer. The member will recruit, hire, train, direct, and terminate their worker from providing care to if necessary.

Must use the State-‐contracted Financial Management Service (FMS). The FMS pays provider claims as authorized by the Plans, and takes care of payroll responsibili,es (e.g., reports to IRS, take out taxes, etc.)

2.   Budget Authority means the member assumes responsibility to establish a rate of pay with the service provider(s) within certain guidelines, and schedule when and how services are to be provided within the budgeted amount established by the member and his/her Care Manager/Waiver Service Coordinator.



Waiver Service Providers

•  In order to contract with the Plan to serve MyCare Ohio waiver members, providers must be either an ODA-‐cer,fied or ODM-‐approved Medicaid waiver provider.

•  Providers apply for cer,fica,on/approval through the same HCBS Waiver en,ty to which they always have applied.

•  Waiver service claims are submiLed directly to the MyCare Ohio Plan.

10/13/15 18

10/13/15

10



Care Management: The Cornerstone Of The MyCare Program

•  Comprehensively coordinate the full set of Medicare and Medicaid benefits across the con,nuum of care including medical, behavioral and long term services and supports needs.

•  Each beneficiary in the MyCare program is assigned a Care Manager

»  Is the accountable point of contact for the beneficiary »  Assists beneficiaries with naviga,ng the health care system by linking them with providers, resources, services, informa,on, and supports

»  Coordinates care by involving the beneficiary, caregivers, providers, specialists, and any other individuals the beneficiary elects to have par,cipate on the care team

» Maintains a long-‐term rela,onship with the beneficiary to assess and monitor needs on an ongoing basis

10/13/15 19



Additional Care Management Supports Available for MyCare Beneficiaries

•  Integra,on of waiver service coordina,on into comprehensive care management model

• Home Visits by Care Managers • Centralized enrollee record •  24/7 Care Management Line • Medica,on Management • Aggressive Management of Transi,ons Across Care Sedngs

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MyCare Ohio Appendix M

Quality Measures and Standards Table 1


Quality Measures and Standards Table 1 (conInued)

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Quality Measures and Standards Table 1 (conInued)

MyCare Ohio Proposed Quality Withhold Measures and Standards DemonstraIon Year 1 (SFY 2015 and SFY 2016 )

for Medicaid-‐Only Members (Opt-‐Out) Appendix O

Measure Source Applicable PopulaIon

SFY 2015/CY 2014 Measurement Year

Minimum Perf. Standard

SFY 2016/ CY 2015 Measurement Year

Minimum Perf. Standard

Nursing Facility Diversion Measure

State-‐defined measure

Medicaid-‐Only

Members (Opt-‐Out)

5% decrease from SFY 2014 (CY 2013 measurement year)

Baseline result

5% decrease from SFY 2015 (CY 2014 measurement year)

result

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Reporting • Medicare-‐Medicaid Plans par,cipa,ng in the capitated model:

» are required to regularly report certain informa,on to CMS and par,cipa,ng states – core measures and state specific measures

» are required to demonstrate on an annual basis an adequate contracted provider network sufficient to provide access to covered services in each demonstra,on

» will have a por,on of their rates withheld; payment of these withheld amounts is subject to performance consistent with established quality requirements

» will submit all required quality and performance improvement projects, including Chronic Care Improvement Projects (CCIP), Performance Improvement Projects (PIPs) and Quality Improvement Projects (QIPs)

•  This in in addi,on to HEDIS, HOS, CAHPS, other state specific requirements and waiver repor,ng requirements…

ODM also has quarterly reporIng requirements!

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Still A Work in Progress…

•  Enrollment issues con,nue to be a challenge • Access and understanding of certain benefits (i.e. DME, transporta,on, waiver services)

• Provider claims – ,mely payment, correct submission • Provider’s par,cipa,on in care teams and general understanding and acceptance of MyCare

• Availability of data on progress of program…people are asking for it, and we don’t yet have it…

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MyCare Ohio Ombudsman Role: •  The go-‐to consumer advocate for responding to complaints

•  Inform and educate consumers

•  Inves,gate and help facilitate and resolve complaints

•  Iden,fy systemic issues and opportuni,es for improvement

•  Maintain an independent role

Top 4 most prevalent complaints •  72 Benefits/access

•  23 Enrollment/disenrollment

•  21 Customer service

•  13 Payments/claims

•  Total case ,me (this past quarter): 426 hours -‐ Average of about 3.8 hours a case

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Challenges that the Ombudsman are hearing about: •  Adequacy of provider networks

•  Transporta,on

•  Timely connec,on to waiver services

•  Inability to find home health aides

•  Person-‐centered planning

•  Reducing an,-‐psycho,c medica,ons

•  RCF closures

•  Quarterly mee,ngs with plans



What’s Going On Nationally

10 States have approved Capitated Model demonstra,ons: » MassachuseLs, California, Illinois, Virginia, New York, South Carolina, Michigan, Texas, Rhode Island (new)…and of course, Ohio!

•  2 States are live with a FFS Model Demo » Colorado and Washington

• Addi,onal Informa,on available at: hLps://www.cms.gov/Medicare-‐Medicaid-‐Coordina,on/Medicare-‐and-‐Medicaid-‐Coordina,on/Medicare-‐Medicaid-‐Coordina,on-‐Office/FinancialAlignmentIni,a,ve/ApprovedDemonstra,onsSignedMOUs.html

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Ques,ons?