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SPRING/SUMMER 2018 FLCANCER.COM Private First Class Lara Stachow Marketing Promotes the Best of FCS Operational Excellence Awards THE MAGAZINE FCS

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Page 1: THE MAGAZINE€¦ · management. He received his MBA from the University of Tennessee, School ... safety and efficacy of Etirinotecan Pegol (EP) in women with recurrent platinum-resistant

SPRING/SUMMER 2018

FLCANCER.COM

Private First Class Lara Stachow

Marketing Promotes the Best of FCS

Operational Excellence Awards

T H E M A G A Z I N EFCS

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TAMPA

SEBRING

WEST PALMBEACH

ORLANDO

TALLAHASSEE

GAINESVILLE

ST. PETERSBURG

SARASOTA

FORT MYERS

NAPLES

OCALADAYTONA BEACH• OUR LOCATIONS

Altamonte SpringsApopkaAtlantisBonita SpringsBradenton (2)BrandonBrooksville (2)Cape Coral (2)Clearwater (3) Clermont Crystal River DavenportDaytona BeachDeland Englewood Fleming Island Fort Myers (2)Gainesville Hudson (2)InvernessJacksonvilleLady Lake (3)Lake Mary Lake WalesLakewood RanchLand O' Lakes Largo (3)Lecanto Leesburg (3) Naples (4)New Port Richey (2)

Corporate Headquarters

FCS Foundation

Palatka

North PortOcala (3) Orange City Orlando (3)Ormond BeachOviedo

Palm Beach Gardens Palm Coast (2)PoincianaPort Charlotte Port Orange Sarasota (3)Sebastian (2) Sebring Spring HillSt. Petersburg (3)Stuart Sun City Tallahassee (2)Tampa (3)Tavares The Villages (3)Venice (2)Vero Beach (2) Wellington West Palm BeachWinter ParkZephyrhills

For more information on a specific location, please visit FLCancer.com

World-Class Medicine. Hometown Care.

3_fall_2017_FCSMagazine final-dv.indd 24 10/19/17 10:32 AM

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Spring/Summer 2018 3

Spring/Summer 2018Contents

In This Issue

DEPARTMENTS 6 FCS News26 Patient Letters

SPOTLIGHTS11 Operational Excellence Awards32 Doctor Spotlight: Dr. Sachin Kamath 34 Nurse Spotlight: Esther McKay, R.N.,

BSN, OCN36 Department Spotlight: Revenue Cycle Team38 Senior Management Team Spotlight: Michael Essik

FEATURES18 The Fighter’s Spirit20 Marketing Promotes the Best of FCS

FCS Vice President of Finance, Michael Essik and his wife, Julie

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TAMPA

SEBRING

WEST PALMBEACH

ORLANDO

TALLAHASSEE

GAINESVILLE

ST. PETERSBURG

SARASOTA

FORT MYERS

NAPLES

OCALADAYTONA BEACH• OUR LOCATIONS

Altamonte SpringsApopkaAtlantisBonita SpringsBradenton (2)BrandonBrooksville (2)Cape Coral (2)Clearwater (3) Clermont Crystal River DavenportDaytona BeachDeland Englewood Fleming Island Fort Myers (2)Gainesville Hudson (2)InvernessJacksonvilleLady Lake (3)Lake Mary Lake WalesLakewood RanchLand O' Lakes Largo (3)Lecanto Leesburg (3) Naples (4)New Port Richey (2)

Corporate Headquarters

FCS Foundation

Palatka

North PortOcala (3) Orange City Orlando (3)Ormond BeachOviedo

Palm Beach Gardens Palm Coast (2)PoincianaPort Charlotte Port Orange Sarasota (3)Sebastian (2) Sebring Spring HillSt. Petersburg (3)Stuart Sun City Tallahassee (2)Tampa (3)Tavares The Villages (3)Venice (2)Vero Beach (2) Wellington West Palm BeachWinter ParkZephyrhills

For more information on a specific location, please visit FLCancer.com

World-Class Medicine. Hometown Care.

3_fall_2017_FCSMagazine final-dv.indd 24 10/19/17 10:32 AM

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4 FCS The Magazine

DR. HARWIN: In January 2018, a district court upheld the Hospital Outpatient Prospective Payment System (OPPS), which institutes a reduction in payment to certain hospitals for drugs acquired through the 340B Drug Discount Program. Launched in 1997, the 340B program was originally intended to boost resources for hospitals that treat many low-income patients; however, studies from Harvard Medical School and

others have demonstrated that the program has not delivered on its promise to improve care for the needy. In some cases, hospitals are accused of using the program to increase revenues.

This is a step in the right direction in support of community oncology. As the Community Oncology Alliance (COA) pointed out, “In recent years, several Medicare policies have had the unintended consequence of threatening the stability and survival of the community cancer care system.” In conjunction with Xcenda, our own Dr. Lucio Gordan conducted a national study demonstrating that chemotherapy was 71% more expensive and physician visits averaged a 333% increase in cost if patients were treated in the hospital setting.

BRAD PRECHTL: Our FCS physicians have provided tremendous leadership within COA, Florida Society of Clinical Oncology (FLASCO) and other organizations at the local, state and national levels to ensure the strength and survival of community oncology. Specifically, Drs. Michael Diaz (St. Petersburg) and Lucio Gordan (Gainesville), who both serve on the COA and FLASCO boards of directors, as well

as the FCS Executive Board, are leading initiatives to support community practices, such as Florida Cancer Specialists, and educate patients, referring physicians and the public about the advantages provided by community oncology.

The majority of cancer patients in the United States are being treated in a community setting; and, in practices such as FCS, these patients receive the highest quality care, in a cost-efficient manner close to where they live. In 2018, we look forward to furthering community oncology and providing treatment for our patients that is at the pinnacle of cancer care.

A LOOK AHEAD… COMMUNITY ONCOLOGY 2018BY DR. WILLIAM HARWIN, FOUNDER & MANAGING PARTNER, AND BRAD PRECHTL, CEO

PHYSICIAN LEADERSHIPPRESIDENT

WILLIAM N. HARWIN, M.D.

ASSISTANT MANAGING PARTNER, DIRECTOR, EXECUTIVE BOARD

STEPHEN V. ORMAN, M.D.

DIRECTOR OF PATIENT ADVOCACY, DIRECTOR, EXECUTIVE BOARD

MICHAEL DIAZ, M.D.

DIRECTOR OF QUALITY AND MEDICAL INFORMATICSLUCIO GORDAN, M.D.

SCIENTIFIC DIRECTOR OF CLINICAL RESEARCH, DIRECTOR, DRUG DEVELOPMENT PROGRAM

LOWELL L. HART, M.D.

DIRECTOR OF RESEARCH OPERATIONS JAMES A. REEVES, JR., M.D.

EXECUTIVE MANAGEMENTCHIEF EXECUTIVE OFFICER

BRAD PRECHTL

CHIEF OPERATING OFFICERTODD SCHONHERZ

GENERAL COUNSELTOM CLARK

CHIEF MARKETING & SALES OFFICER SHELLY GLENN

CHIEF REVENUE CYCLE OFFICER SARAH CEVALLOS

SENIOR MANAGEMENTRAY BAILEY

CHRISTY BANACH LOIS BROWN

DON CHAMPLAIN MELISA CHANDLER MELODY CHANG

DIANE COPE DAVID CURRY RICH DYSON JEFF ESHAM

MICHAEL ESSIK CLAUDIA FRENCH INGA GONZALEZ KATIE GOODMAN

KATHERINE HOGAN LEVESTER JONES

SUE KEARNEY JODI LOHNES

ROSE ANN MEYERS MARK MOCH

FRANK NUNZIATO NICOLE PICAZIO

ANNIE PIGUE ANNE RONCO JEFFREY RUBIN

TARA RUSKA LYNN SAWYER LAURA SPERRY

SIERRA TOMLINSON DENICE VEATCH

SAMANTHA WATKINS

PUBLISHED BYIN PARTNERSHIP WITH

THE M

AG

AZIN

EFCS

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Spring/Summer 2018 5

FOR MORE INFORMATION, PLEASE CONTACT: Shelly Glenn at [email protected] or Lynn Clemens at [email protected]

10.26-28 2018 2018 FCS Clinical SummitRitz-Carlton Grande Lakes 4012 Central Florida Parkway Orlando, FL 32837

World-Class Medicine. Hometown Care.

SAV E T H E DAT E

FLCancer.com

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6 FCS The Magazine

✚ FCS Joins Tampa Bay Buccaneers To Honor Wounded WarriorsFCS joined the Tampa Bay Buccaneers in honoring

military veterans, especially wounded warriors and their families, at the Bucs game on Nov. 12, with guest speaker Brian Ford, Chief Operating Officer for the Buccaneers. Before kickoff, a celebratory Tailgate Party was held at the Tampa Cancer Center for FCS patients and staff, veterans and Bucs fans. All gathered for great food, games and giveaways as they got ready to cheer on their favorite NFL team.

FCS is a Tampa Bay Buccaneers sponsor and is proud to support the Wounded Warriors Project and honor the men and women who have bravely sacrificed for our nation.

✚ FCS Spreads Holiday Cheer To Families In NeedThe FCS Senior Management Team and Corporate Office Staff sponsored two families with one of the children who

is currently under active cancer treatment. The families provided wish lists through the Candlelighters of Southwest Florida Foundation. Presents, cookies, and milk were enjoyed by all!

Pictured in Photo | COO Todd Schonherz and one of the sponsored families from Candlelighters of Southwest Florida

FCSNews

✚ Hope Health & Sunshine Foundation Feeds FCS Patients for ThanksgivingOn November 20 and 21, thanks to the Hope Health

and Sunshine Foundation, nearly 200 patients at St. Anthony’s and Bardmoor were treated to Thanksgiving dinner boxes and a turkey. The Hope, Health and Sunshine Foundation is a non-profit foundation dedicated to helping cancer patients in the Tampa Bay area with support from community partners and sponsors.

✚ Pinellas Offices Host Patient Appreciation EventThe FCS Pinellas County offices joined together on Nov. 17 to serve a Thanksgiving dinner to more than 400

patients and their family members. Thank you for all your help this holiday season!

✚ Medical Oncologist Gamini Soori, MD, Joins FCS In Southwest FloridaMedical Oncologist Gamini Soori, MD, joined FCS on

Jan. 2 and will be practicing at three locations: the Colonial and Gladiolus offices in Fort Myers, Florida, and Cape Coral Cay West in Cape Coral, Florida.

Dr. Soori is board-certified in internal medicine, geriatric medicine, medical oncology, hematology and medical management. He received his MBA from the University of Tennessee, School of Business PEMBA program and is a Certified Physician Executive. Dr. Soori graduated with honors among the top ten in his class at the Faculty of Medicine, University of Ceylon, Colombo, Sri Lanka, and completed his Residency in the United Kingdom. He is actively engaged in clinical research in affiliation with several national co-operative clinical trial groups, including his role as principal investigator of the National Cancer Institute-funded Missouri Valley Cancer Consortium.

Gamini Soori, MD

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Spring/Summer 2018 7

FCSNews

✚ Dr. Dan Spitz Co-Authors Expanded Phase 2 StudyDr. Daniel Spitz, who practices at FCS’s West Palm Beach location,

was co-author of a new study evaluating the safety and efficacy of Etirinotecan Pegol (EP) in women with recurrent platinum-resistant or refractory ovarian cancer (PROC).

Published in the November 2017 issue of Gynecologic Oncology, the Phase 2 Study sought to demonstrate improved tolerability of EP, with a trend toward progression free survival (PFS) and the convenience of less frequent dosing administered in 21-day intervals.

The primary purpose of the study was to further define the activity of EP when it was administered as a fourth-line regimen in patients with PROC. The study demonstrated an overall response rate of 15 percent, with clinical benefit achieved in over half of the patients and a median progression free survival and overall survival of 4.4 months and 10.2 months, respectively. Compared to other single agents used in advanced PROC, these results were encouraging. The study concluded that “further evaluation earlier in the disease course and in combination is warranted.”

Read the full article online at ncbi.nlm.nih.gov.

✚ Burris Named New President Of American Society Of Clinical OncologyDr. Howard A. “Skip” Burris III was

elected President of the American Society of Clinical Oncology (ASCO) for 2019-20. Dr. Burris serves as Chief Medical Officer and President of Clinical Operations for Sarah Cannon, HCA Healthcare’s global cancer institute. In his roles, he leads clinical strategy and drug development initiatives for Sarah Cannon, and he practices medical oncology as a partner with Tennessee Oncology, headquartered in Nashville, Tennessee.

FCS is a strategic research partner with Sarah Cannon, offering clinical trials in over 30 strategic locations across Florida, as well as a community-based Phase 1 Drug Development Unit (DDU) in Sarasota, Florida.

FCS Chief Executive Officer Brad Prechtl said, “Dr. Burris is an excellent choice as President of ASCO. He is an icon in cancer research, having authored more than 300 publications and over 450 abstracts that have helped advance cancer care tremendously. We look forward to his leadership in the coming years.”

Dr. William Harwin, Founder and Managing Partner of FCS, added, “Dr. Burris established the very first community-based Phase 1 drug development program in the nation in 1997, which later became Sarah Cannon. Through the FCS Clinical Trials Program, we have been privileged to work with Dr. Burris and Sarah Cannon for many years and help bring many new drugs to hundreds of thousands of cancer patients throughout the United States.”

✚ Dr. Michael Diaz Attends Emergency Hill Day In WashingtonFCS Physician Dr. Michael Diaz, who also serves as

the FCS Director of Patient Advocacy and as Vice President of the Community Oncology Alliance (COA), was one of several national community oncology leaders to attend the Emergency Hill Day event in Washington, D.C., on Nov. 30. Dr. Diaz met with Congressional and Administration representatives to discuss the devastating impact of the Medicare sequester payment cut on community oncology and on cancer patients undergoing treatment.

In 2013, the Centers for Medicare & Medicaid Services (CMS) enacted a 2 percent sequester payment cut to Medicare. The sequester cut for cancer drugs has increased costs to seniors, Medicare and taxpayers. Many community oncology practices have not survived or are struggling to survive because Medicare drug reimbursements are often below costs due to the sequester cut.

Community oncology practices are where the majority of Americans with cancer are treated. Closing community practices limits access to care — particularly for rural patients — and shifts the site of cancer treatment into hospitals.

According to Dr. Diaz: “Congress needs to understand that extending the sequester cut will force more community practices to close or consolidate, further increasing costs to cancer patients who have no other option than to be treated in a more expensive, less convenient hospital setting.”

To learn more, read the full article on the Community Oncology Alliance website at CommunityOncology.org.

✚ New Radiologist | Dr. Subha RamanWe are proud to announce the

addition of our new Radiologist, Dr. Subha Raman. Dr. Raman graduated medical school and completed her Radiology residency at Grant Medical College in Mumbai, India. She also was a resident at the University of Pittsburgh Medical Center and at William Beaumont Hospital in Royal Oak, Michigan. She is board certified by the American Board of Nuclear Medicine and the American Board of Radiology and has a professional membership with the American Roentgen Ray Society.

Dan Spitz, MD

Howard Burris, MD

Subha Raman, MD

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8 FCS The Magazine

✚ FCS Partnered With UnitedHealthcare Implement Innovative Cancer Care ModelFCS is partnering with UnitedHealthcare to implement a

cancer care model focused on quality patient care, best treatment practices and health outcomes. The episode payment model shifts reimbursement away from the current “fee-for-service” approach that emphasizes volume of care delivered. Similar payment models have shown to enhance care coordination and improve health outcomes for patients while reducing overall costs.

Sarah Cevallos, FCS’s Chief Revenue Cycle Officer, said, “Our collaboration with UnitedHealthcare to expand enhanced oncology services provides the growing population of Florida’s oncology patients access to additional services to support their health care needs.”

In a study published in the Journal of Oncology Practice, UnitedHealthcare’s episode of cancer care payment initiative (EOC) reduced overall cancer expenses by more than a third while improving quality outcomes. The program rewards participating medical oncologists if they demonstrate superior clinical results and reduce the total cost of care.

✚ Promotion | Senior ManagementOn January 2, 2018, Sierra Tomlinson was promoted to

Director of Value-Based Care. Sierra is responsible for overseeing the success of the value-based care initiatives, as well as implementation of new strategies to meet the needs of the demanding value-based programs. Prior to being named Director of Value-Based Care in 2018, she was the Senior Project Manager in Operational Excellence. While continuing to work on value-based care changes, Sierra assisted in collaborative efforts with Clinical and Operations teams to enhance processes throughout FCS. Sierra enjoys spending time with her family, volunteering, boating and cheering for the Gators.

✚ Diane Cope, PhD, ARNP,BC, AOCNP | Director of Nursing Diane has been an oncology nurse for over thirty years,

with a doctorate in nursing from the University of Miami and an ARNP from the University of South Carolina. She brings a solid background of clinical, management, and educational experience to her position, having worked as an oncology nurse practitioner at Florida Cancer Specialists and as a faculty member at Florida Atlantic University and the University of North Carolina.

As Director of Nursing, Diane’s responsibilities will include overseeing and supporting the daily functions of the nursing role in the provision of safe, quality oncology patient care, including the execution of the Standard Operating Procedures and national oncology nurse standards of care. Diane will continue to assume the role of chair of the Clinical Directions Team and work closely with the Medical Directors and staff to address clinical issues and policies. Diane currently resides in Fort Myers with her husband, son, and two canine sons.

To learn more about Diane visit https://flcancer.com/en/leader/diane-g-cope-phd-arnp-bc-aocnp/.

FCSNews

✚ Happy Hat Project | Sarasota Cattlemen LocationOn Monday, January 15, 2018, daughters of Drs. Janice Eakle and Richard Buck presented hand knitted hats for

patients at the Sarasota Cattlemen location. Abigail Eakle and Margaret Buck started the Happy Hat Project to provide hats for patients that have lost their hair due to chemotherapy.

Pictured in photo left to right | FCS Physician Dr. Eakle’s daughter Abigail Eakle, FCS Physician Dr. Buck’s daughter Margaret Buck and Physician Liaison Mary Ellen Woska

✚ FCS Foundation DonationOn December 1, 2017, the Hernando County Sheriff’s Office presented a check for $2,250 to the FCS

Foundation. Donations were generated from their Pink Patch program. The collectible Pink Patches were sold to sheriff’s office employees in a tri-county area, as well as the local community. Funds are designated for cancer patients in Hernando, Pasco and Citrus Counties.

Pictured left to right | Sheriff Al Nienhuis; Lynn Rasys, Executive Director, Florida Cancer Specialists Foundation; Sergeant Darryl Smith

Sierra Tomlinson

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✚ Party Under the Stars | Lakewood RanchThe FCS Foundation is proud to announce another successful Party Under the Stars event that raised more

than $200,000, with all proceeds going to the Foundation. This year, the fundraiser honored FCS Foundation Board Chair Brad Prechtl, who also serves as FCS CEO, and his wife Terri Prechtl, who is the FCS Foundation Lead Patient Support Volunteer at the Lakewood Ranch location of Florida Cancer Specialists. Three FCS physicians, Drs. Richard Brown, Anjan Patel and Miguel Pelayo, served as honorary chairs of the event along with co-chairs, Celgene representative Kim Wyar and Genentech representative Dwight Henry.

Pictured left to right | FCS Foundation Board Member Cory J. Person, Esq., FCS COO Todd Schonherz, FCS Foundation Lead Patient Support Volunteer Terri Prechtl, FCS Foundation Board Chair and FCS CEO Brad Prechtl, FCS Foundation Board Member and CMSO Shelly Glenn and FCS Foundation Executive Director Lynn Rasys

✚ Be the Match | Rx To GoOn Tuesday, November 28, Rx To Go hosted a rally and bake sale for Be The Match, a bone marrow donation

organization. We raised over $200 in funds for the organization, but more importantly, had 19 members of our team volunteer as potential bone marrow donors. Thank you to everyone who participated in such a great cause!

To learn more about Be The Match and see how you can help patients in need, check out: https://bethematch.org/

✚ Blanket Warmer Donation | PasadenaPassing along the gift of warmth to our patients, Dave and Bobbi Norris of the Make a Difference Foundation

donated a new blanket warmer to our St Pete Pasadena location.

Pictured left to right | Physician Liaison Manager, Maria Ramos-Person, VP of Practice Operations Jeff Rubin, Dave and Bobbi Norris, FCS Physician Dr. Vu Tran Ho, CMSO Shelly Glenn, Physician Liaison Sandy Brooks

✚ Milk and Cookie Pajama DayThe Corporate 2 Team was invited to wear pajamas and bring in cookies to share during the holidays.

Pictured left to right | Brigida Araujo, Rawanis Edison, Nikita Delgadillo, Julie Martinez, Myranda Ayala - Utlization Managment

FCSNews

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10 FCS The Magazine

✚ Centralized Scheduling Ugly Sweater DayThe Corporate Office staff wore ugly sweaters to the office to celebrate the holiday season!

Pictured left to right | Karen Monos, Deidre Jenkins, Prisma Aguilar, Virginia Davis, Elaine Olson, Laura Williams

✚ MESTRONG 5k Race | February 3, 2018

In February, we sponsored MeStrong’s Deland 5K,

which raised money for cancer research and support for patients and families. Photo From Left to right | Kim Martin, Kim Winters, Dr. Melgen, Linda Ryan, Kathy Guyer. Not in photo but another cofounder is Barbara Underhill

✚ Relay for Life | Tallahassee We were proud

to participate in Tallahassee’s Relay for Life, where we raised money and awareness for the American Cancer Society. Pictured left to right | FCS Physician Dr. Paresh Patel, Senior Physician Liaison Monica Tyler, Haley Barber, Vickie Barber, Renee Ferriby, Patty Wright and Alexis Simpson

✚ Holiday ProjectDuring the holidays, items were donated to the Military Support Foundation, Inc. for gift boxes for troops.

There was a great response and the donations were welcomed.

Melanie Ciavarella – Utilization Management

✚ New Hospitalist | Port Charlotte We are proud to welcome our newest Hospitalist, Dr. Arsh

Singh. Dr. Singh attended medical school at the University of Szeged in Hungary and completed his residency at Brookdale University Hospital Medical Centre in Brooklyn, N.Y., where he also served as Chief Fellow.

He is board certified in Internal Medicine, Medical Oncology and Hematology. He also has memberships with the American Society of Clinical Oncology, the American Society of Hematology, the Florida Medical Association, the Florida Association of Indian Physicians and the Oncolytics Stewardship Committee at Sarasota Memorial Hospital.

FCSNews

Arsh Singh, MD

For all photos, article suggestions, and information to be included, content must be provided to [email protected] by the following due dates:

Winter Issue 2018 - Aug 1 for articles; Sep 15 for photosSpring Issue 2019 - Nov 1 for articles; Dec 15 for photos

Summer Issue 2019 - Feb 1 for articles; Mar 15 for photos Fall Issue 2019 - May 1 for articles; Jun 15 for photos

**Please include full names for all photos, in order from left to right. Photos must be high resolution or they will not be included.

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Operational Excellence Awards

CONGRATULATIONS TO THE SARASOTA CATTLEMAN OFFICE FOR WINNING THE GROUP/OFFICE AWARD

On behalf of our Executive Board, Physicians and Executive Management Team, please join us in recognizing our 2017 Operational Excellence Award winners. Each year we receive hundreds of nominations from patients, staff and physicians who share remarkable stories of our team members who go above and beyond in demonstrating our C.A.R.E. Values. We truly appreciate the hard work, effort and unyielding compassion that each of you exhibit every day on behalf of our patients.

Todd Schonherz, Chief Operating Officer

Award Winner Job Title Home Office Adriana Caro-Vargas Patient Service Specialist Naples-Goodlette Nicole Steinke Lead Medical Assistant Cape Coral Cancer Center Julia Papagianis Lead Medical Assistant Sarasota Cattlemen Kim Baker Patient Service Specialist Bardmoor Skyshane Mustian Licensed Practical Nurse St. Petersburg Monica Posada Patient Service Specialist Lead Tampa Cancer Center Jennifer Wheeler Licensed Practical Nurse Brandon Cancer Center Lisa Bickhardt Patient Service Specialist Brooksville East Lorraine Collins Registered Nurse Brooksville Shanedra Gordon Patient Service Specialist Gainesville Cancer Center Christine White Registered Nurse Ocala Eva Ayala-Hernandez Patient Service Specialist Wellington April Arredondo Registered Pharmacy Technician Trainer Vero Beach Office Jennifer Wagner Patient Service Specialist Lead Clermont South Amanda Cioffi Lead Medical Assistant Orange City Tara Burrows Patient Service Specialist Leesburg Noth Rachael Carvajal Medical Assistant Villages Cancer Center Sabrina Maldonado Patient Service Specialist Daytona Cancer Center Kaya Gonsalves Medical Assistant Port Orange Katelyn Gaylord Patient Service Specialist Winter Park Melissa Clough Registered Nurse Orlando Orange

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Operational Excellence Awards

ORLANDO ORANGE Pictured left to right | Jenean Fletcher, Office Manager, Kathy Kelley, Head Nurse, Zulma Katz, Office Manager, Melissa Clough, Registered Nurse, Todd Schonherz, COO, Dr. Sonalee Shroff, and Lynn Sawyer, Regional Director

BROOKSVILLE EAST Pictured left to right | Wesley Zubritsky, Regional Lab Monitor, Jeff Rubin, VP of Operations, Lisa Bickhardt, Patient Services Specialist, Cheryl Pederson, Office Manager, Lynette Rausch, Head Nurse and Dr. Raju Rao

DAYTONA Pictured left to right | Dr. Khan, Pamela Venneri, Office Manager, Sabrina Maldonado, Patient Services Specialist Lead, Inga Gonzalez, VP of Operations, Dr. Harris, Teresa Warner, Registered Nurse and Todd Schonherz, COO

LEESBURG NORTH Pictured left to right | Annie Pigue, Associate Director of Operations, Dr. Tummala, Inga Gonzalez, VP of Operations, Tara Burrows, Patient Services Specialist, Kelli Mendoza, Office Manager and Susan Dowling, ARNP

ST. PETERSBURG Front Row | Janette Melendez, Medical Assistant, Jeff Rubin, VP of Operations, Skyshane Mustian, Licensed Practice Nurse, Veronika Beard, Office Manager, Koren Nichols, Medical Assistant, Lan Pham, Financial Counselor, Kelli Hughes, Registered NurseBack Row | Angie Mount, Patient Service Specialist, Pat Drogon, Danielle Lewandowski, Patient Service Specialist and Dr. Iyer

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Spring/Summer 2018 13

Operational Excellence Awards

NAPLES GOODLETTE Pictured left to right | Crystal Briscoe, Licensing Specialist, Dr. Daniel Morris, Adriana Caro-Vargas, Financial Counselor and Dr. Joel Grossman

WINTER PARK Pictured left to right | Todd Schonherz, COO, Lynn Sawyer, Regional Director, Dr. Lee Zehngebot, Katelyn Gaylord, Patient Service Specialist, Tonjua Jones, Registered Nurse, Dr. Stefani Capone, Terri Gross, Office Manager, Rebecca Flower, Registered Nurse and Dr. Yaman Suleiman

BROOKSVILLE Pictured left to right | Lissa Hildebrand, Radiation Therapist, Shelby Adkins, Radiation Therapist, Yinny Claro, Radiation Therapist, Laura Gould-Geering, Dosimetrist, Alison Murty, Senior Office Manager, Jeff Esham, VP Radiation & Radiology, Lorraine Collins, Registered Nurse, Kelvin Rodriguez, Lead Radiation Therapist, Dr. Sawson Bishay, Julie Briggs, Manager Radiation Services, George Hervieux, Medical Assistant II Radiation Oncology, and Joe McMahon, Physicist

VILLAGES CANCER CENTER Pictured left to right | Amber Bell, Assistant Office Manager, Dr. Veliz, Dr. Acevedo, Rachael Carvajal, Medical Assistant, Dr. Kamath, Andy Gerrard, Office Manager, Annie Pigue, Associate Director of Operations, Inga Gonzalez, VP of Operations, and Allen Bergemann, Head Nurse

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Operational Excellence Awards

SARASOTA CATTLEMEN Front Row | Dr. Richard Buck, Jessica Buccigrossi, Medical Assistant, Heather Schwenk, Physician Assistant, Dr. Janice Eakle, Sandra Sanabria-Elliott, Patient Services Team Leader, Stormie Hendrix, Patient Services SpecialistBack Row | Kathy Miller, ARNP, Renata Leimig, Registered Nurse, Karli Cole, Patient Service Specialist, Kari Hopkins, Medical Assistant, Samantha Johnston, Licensed Practical Nurse, Julia Papigianis, Lead Medical Assistant, Patty Hall, Registered Nurse, Dr. Fadi Kayali, Caroline Peacock, Registered Nurse, Julie Brown, Head Nurse, Tina Glanden, Senior Office Manager, Pilar Banclhon, Registered Nurse, Jennifer Sine, ARNP, Megan Register, Medical Assistant and Leighton Bryant, Patient Service Specialist

VERO BEACH Picture left to right | Dr. Raul Storey, April Arredondo, Regional Pharmacy Trainer, Lois Brown, Director of Operations and Katrina Thompson, Senior Office Manager

CLERMONT SOUTH Pictured left to right | Donna Milam, Head Nurse, Annie Pigue, Associate Director of Operations, Jennifer Wagner, Inga Gonzalez, VP of Operations, Donna Swearingen, Senior Office Manager, Dr. Meera Iyengar and Cynthia Bologna, ARNP

SARASOTA CATTLEMEN Pictured left to right | Dr. Fadi Kayali, Samantha Johnston, Licensed Practical Nurse, Keri Hopkins, Medical Assistant, Dr. Richard Buck, Julia Papagianis, Lead Medical Assistant, Tina Glanden, Senior Office Manager, Allison Harlan, Medical Assistant, Denise Torres, Medical Assistant, Megan Register, Medical Assistant and Jessica Buccigrossi, Medical Assistant

WELLINGTON NORTH Front Row | Dr. Marilyn Raymond, Eve Hernandez, Patient Service Specialist, Dr. Daniel Spitz, Lois Brown, Director of Operations Back row | Todd Schonherz, COO, and Kim Delgado, Office Manager

ORANGE CITY Pictured left to right | Michelle Cook, Patient Services Team Leader, Lauren Rivera, Physician Assistant, Amanda Cioffi, Medical Assistant Team Lead, Inga Gonzalez, VP of Operations, Dannette Ball, Office Manager, and Lisa Sosa, ARNP

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Operational Excellence Awards

SARASOTA CATTLEMEN Pictured left to right | Dr. Eakle, Julie Papagianis, Lead Medical Assistant, and Tina Glanden, Senior Office Manager

OCALA Left to Right: Betty Kimball, Financial Counselor, Dr. Shilpa Oberoi, Kim Fiscus, ARNP, Cindy Woods-High, Licensed Practical Nurse, Jeff Rubin, VP of Practice Operations, Christina White, Nurse Specialist, Theresa Jones, Office Manager, Rashana Wilson, Charge Nurse, Shatoya Pierre, Registered Nurse, Ashley Gandy, Registered Nurse, Kristeen Foster, Registered Nurse, Kathy Bruce, Medical Assistant Team Lead, Mirna Cortes, Financial Counselor

PORT ORANGE Pictured left to right | Todd Schonherz, COO, Susan Price, Senior Office Manager, Kaya Gonsalves, Medical Assistant, Inga Gonzalez, VP of Operations, and Marie Hobbs, Charge Nurse

SARASOTA CATTLEMEN Pictured left to right | Dr. Fadi Kayali, Dr. Richard Buck, Tina Glanden, Senior Office Manager, Julia Papagianis, Lead Medical Assistant, and Jeff Rubin, VP of Operations

LARGO/BARDMOOR Pictured left to right | Jeff Rubin, VP of Operations, Dr. Ziegler, Kim Baker, Patient Service Specialist, Dr. Luong, Michelle Reinhard, Head Nurse, Shawnie Albritton, Office Manager, Sam Watkins, Director of Operations, and Crystal Knight Medical Assistant

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16 FCS The Magazine

As true leaders in industry, true innovators in care

and true partners in service, ION Solutions has

been dedicated to fighting for community oncology for 20 years.

One of the ways we demonstrate our

commitment to independent community

oncology is through our advocacy efforts on

Capitol Hill.

Since 2015, Community Counts has raised

awareness on the impact of sequestration,

the Part B Demo Project, and other issues

paramount to the viability of the community

setting. Just last year, more than 500

individuals contacted 280 legislators through

this outreach program.

True leaders.

True innovators.

True partners.

YEARS

ION SOLUTIONS

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As true leaders in industry, true innovators in care

and true partners in service, ION Solutions has

been dedicated to fighting for community oncology for 20 years.

One of the ways we demonstrate our

commitment to independent community

oncology is through our advocacy efforts on

Capitol Hill.

Since 2015, Community Counts has raised

awareness on the impact of sequestration,

the Part B Demo Project, and other issues

paramount to the viability of the community

setting. Just last year, more than 500

individuals contacted 280 legislators through

this outreach program.

True leaders.

True innovators.

True partners.

YEARS

ION SOLUTIONS

to pay their everyday living expenses. Imagine cancer patients who can’t make car

The Foundation pays for non-medical expenses such as mortgage, rent, utilities and car payments, so that patients can concentrate on recovering from cancer.

What Separates the FCS Foundation from Other Charities?Florida Cancer Specialists pays the overhead, which means that 100% of all donations

go directly to help cancer patients in need! The FCS Foundation provides help for the entire family, as well, by relieving some of the stress cancer patients and their family members face on a daily basis. In 2017, the FCS Foundation provided aid to 843 patients.

The Florida Cancer Specialists Foundation is seeking volunteers to provide non-medical support and comfort to patients undergoing treatment for cancer at Florida Cancer Specialists clinics. Duties include offering a pillow, warm blanket, snack or beverage to the patient, sharing a magazine and providing companionship.

Applications are available at Foundation.FLCancer.com/Volunteer or send email inquiries to: [email protected]

5204 Paylor Lane, Sarasota, FL 34240

of the FCS Foundation!

For more info or to donate, call (941) 677.7181 or visit Foundation.FLCancer.com

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18 FCS The Magazine

COVER STORY

Private First Class, Lara Stachow

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The Fighter’s SpiritService and Toughness Steeled Lara Stachow’s Fight Against CancerBY KIM HARRIS THACKER

On April 26, 1986, the Chernobyl Nuclear Power Plant light water reactor exploded. A month later, Private First Class Lara Stachow arrived in Hanau, Germany. The soldiers she served as

an Army cook said that radioactive fallout had drifted like pollen over Hanau for two weeks after the reactor exploded. Twenty-three years later, in Tampa, Florida, Lara Stachow was diagnosed with breast cancer.

“The government denies that I or anyone else who was stationed over there was exposed to the fallout,” says Stachow. “But I believe that’s why I ended up with breast cancer.”

She was in “top form,” she says, when she was diagnosed in 2009. “I was running marathons, working out, I’d been on the construction battalion in the Navy and had been in charge of their logistics, I was working a demanding manual labor job with UPS, and then I felt a lump.”

She immediately contacted a friend, Dr. Ian Matheson, for whom her mother had worked for many years. He quickly fit her into his busy schedule. He sent Stachow to his daughter, a radiologist at St. Joseph’s Hospital. Suspecting that the lump was cancerous, the radiologist performed a biopsy.

“On April 7, I had a lumpectomy,” Stachow says. “The tumor was the size of a golf ball. I wanted to keep it and make it into a paperweight. Hunters mount whatever they kill; why couldn’t I have my tumor? But it was given to Moffitt for research purposes. I guess my cancer was something special. I’m not quite sure. I was too busy surviving to find out the details.”

The surgeon who removed Stachow’s tumor was Dr. James Christensen, whom Stachow describes as a tall, formidable-looking man. Since Stachow viewed her battle with cancer as a team effort, the fact that her surgeon had the stature of a linebacker seemed appropriate.

“Dr. Christensen’s not the kind of guy who sits at your bedside,” she says. “But I didn’t want him to be emotional. This is war. This is survival. You can’t be easygoing with something where a month makes a difference in whether you live or not. You have to fight like a warrior.”

A Desert Storm Veteran, Stachow certainly knows how to fight. “I think my experiences in the Army and Navy honed my attitude toward battle,” she says. “But my strength doesn’t come from the military; it comes from my heritage.”

Stachow’s family is Lithuanian, and her grandparents and mother survived World War II in a labor camp in Germany.

“My mom’s last memory of her country was running through the fields while the tanks were coming over the hill,” Stachow says. “She was a little kid: six years old.”

After American soldiers liberated the camp, Stachow’s family emigrated to the U.S. Born in 1967 in Chicago, Stachow grew up as feminism was on the rise, and Helen

Reddy was singing, “I am woman.” But female strength was made most obvious to Stachow through the example of her own mother.

“You have to have strength and resolve if you come from a background like my mother’s,” says Stachow. “In the Lithuanian community, everybody from her time was some kind of veteran. You learned to tough it out. You learned that you take responsibility for your life. Going to church, going to confession. That’s not going to absolve you from your responsibilities to your community and to yourself. My mom was a single mom. She fought to get a job. I heard the way people talked down to her. She taught me that life’s going to hit you hard, but you have to persevere.”

Stachow’s mother was often heard to quoting Eleanor Roosevelt to her daughter: “A woman is like a tea bag: You can’t tell how strong she is until you put her in hot water.”

For Stachow, the water reached a boiling point post-surgery, when she began chemotherapy treatments with Florida Cancer Specialists.

“My oncologist, Dr. David Wright, was so caring and so sympathetic. I wish he could treat everyone,” Stachow says. “He did all he could to help me to be ready for chemotherapy treatments. That stuff tears apart your body. I felt like it shocked my body, like you shock a pool with chemicals. I couldn’t do my UPS job while I was going through chemo, because I was weakened and my immune system was shot.”

Stachow was the Leading Petty Officer of the supply shop as a reserve at Jacksonville’s Naval Mobile Construction Battalion 14 when she was diagnosed. “I didn’t miss a single day working with the Navy,” says Stachow, who also filled in for an active duty petty officer during her treatments. “I did go home after lunch one day because I was really tired — but not until I had finished my work.”

Now nine years after her diagnosis, Stachow is right back at UPS, driving a 24-foot truck and delivering packages day in and day out. But she believes her real calling is helping cancer patients and cancer survivors.

“Once, when I was meditating, I had this calm just come over me, and I distinctly heard, ‘You’re going to go through this, but you’re going to be fine. It’s not just for you. This is for other people,’” Stachow says.

She dreams of one day hosting a support group, where cancer survivors and their loved ones get together for a drink and a chat. Until then, Stachow will continue to deliver packages and share her story of surviving cancer with anyone who will listen.

“If my story helps just one person, that’s fantastic,” she says. “Maybe that one person will tell another person, and it will just keep on going.”

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20 FCS The Magazine

Sharing the FCS Story -- Communicating Value and QualityBY ROB RUSHIN

M arketing can conjure varied and inaccurate connotations for people outside the profession. That’s one reason the American Marketing Association rewrote the definition of marketing in 2013 to read: “Marketing is the activity, set of institutions, and processes for creating, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large.”

When you get down to it, the services offered by FCS are not your typical consumer product or service. People turn to Florida Cancer Specialists (FCS) for high quality care in the face of serious medical conditions, not to fulfill consumer cravings.

That might be one reason the FCS marketing team prefers to talk about their mission in a different way.Shelly Glenn, Chief Marketing and Sales Officer for FCS, says, “We use the word ‘communications’ instead of ‘marketing’, as that

more accurately describes what we do.”The stakeholder audiences (yes, there are many) go beyond current or prospective patients. The FCS Marketing team is charged

with making sure that these constituents stay abreast of trends and news, all in service to the larger FCS mission: to deliver expert and compassionate cancer care.

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Glenn, who joined FCS in 2012 as Vice-President of Marketing, has witnessed tremendous growth in the FCS network and built an outstanding team that includes employee members, such as Physician Liaisons, internal marketing personnel and foundation staff, as well as dedicated vendors and two external advertising agencies — Ganick Communications and ChappellRoberts. Both agencies support the many facets of marketing and communications services needed to promote the statewide practice in addition to increasing local awareness. Ganick Communications has worked with FCS since 2009 and specializes in developing focused content, radio advertising, video production and other creative strategies; ChappellRoberts came on board in August 2016 to assist with graphic design, print and broadcast advertising, as well as digital strategies, including the development of a new FCS website in 2017.

Led by Glenn, the FCS Marketing Team is dedicated to evaluating and identifying the needs of the practice, along with the opportunities for growth, and is highly skilled at blending the expansive array of strategic and creative elements necessary for success. An examination of the four major initiatives under Shelly’s leadership brings their differences from the typical consumer-marketing model into sharper focus.

Muse Creative AwardsThe Muse Creative Awards is a highly prestigious international competition celebrating excellence in the craft and art of communication.• Rose Gold Award

• Stories of Hope web videos - Rose Gold Award

AVA AwardsThe AVA Awards is an international competition that recognizes excellence by creative professionals responsible for the planning, concept, direction, design and production of digital communication. • Gold AVA Award

ADDY AwardsThe ADDY Awards is the world’s largest advertising competition with over 5,000,000 entries annually.• Stories of Hope print campaign – BEST OF BAY• Stories of Hope print campaign – Gold ADDY Award• Stories of Hope web videos – Silver ADDY Award

Healthcare Advertising Awards The Healthcare Advertising Awards is the oldest, largest and most widely respected healthcare advertising awards competition. This year there were over 4,000 entries, all judged based on creativity, quality, message effectiveness, consumer appeal, graphic design, and overall impact.• Bronze: FCS Website • Merit: FCS Stories of Hope Print Campaign • Merit: FCS Stories of Hope Integrated Marketing Campaign-Pamela

Internet Advertising Competition Created by the Web Marketing Association. This competition awards outstanding online advertising. Entries are judged on creativity, innovation, impact, design, copywriting, use of the medium, and memorability.• Best Healthcare Provider Online Video Campaign: FCS Stories of Hope Web

Videos

Stories of Hope and Science campaign has won a Gold Communicator award in the Integrated Campaign (Branding) category.• The Communicator Awards is the leading international awards program

recognizing big ideas in marketing and communications. Founded over two decades ago, The Communicator Awards receives over 6,000 entries from companies and agencies of all sizes, making it one of the largest awards of its kind in the world. They are currently in their 23rd season. For more information on this entry, please visit: https://www.communicatorawards.com/awards/.

Pictured in photo left to right | Physician Liaison Manager Maria Ramos-Person, Physician Liaison

Kay Simpkins, Physician Liaison Mary Ellen Wonska, Physician Liaison Brett Hipsley, Physician

Liaison Rebecca Applebaum, Physician Liaison Brian Cox, JoLynn Wright, Senior Physician Liaison Rhonda Webster, Senior Phyisican Liaison Danielle

Spears, Digital & Creative Marketing Manager Jimmy Khun, Physician Liaison Sandy Brooks,

Communications Specialists & Project Manager Kristina Sparacino, CMSO Shelly Glenn, Marketing

Administrator, Lynn Clemens, Senior Physician Liaison Monica Tyler

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22 FCS The Magazine

Physician Recruitment

Every aspect of the FCS operation is essential to delivering the highest level of patient experience and begins and ends with developing a dream team of the most qualified and expert medical personnel available. That’s easy enough to say and a little harder to pull off in the real world, but this is the mandate for Physician Recruitment, which is handled primarily by Glenn and Marketing Administrator Lynn Clemens.

When an FCS location or physician group specifies a physician opening, the Physician Recruitment team is responsible for identifying and recruiting the most qualified doctors — community oncologists, hospitalists, radiation oncologists, radiologists, pathologists, and psychologists — who meet the requested requirements.

Physician Recruitment can typically present strong candidates within about 90 days, but Lynn says there are exceptions. One physician group recently needed to fill a sudden and unexpected vacancy, and the team scrambled to find several qualified candidates within the first month to fill the gap.

Once a qualified candidate has been identified and contacted for initial screening, Lynn arranges an onsite visit so the physician candidate and the hiring physicians can get to know one another. Physician Recruitment coordinates all travel arrangements, and often works to introduce the candidate to a local real estate agent to help the candidate and their family become part of the community they serve.

After the ideal physician candidate is identified and agreed upon by the hiring physicians and Regional Director, FCS CEO Brad Prechtl presents and negotiates the agreement with the prospective physician.

Physician Liaison/Referral Base Management

One great value offered to support the FCS physicians is found in the outreach to referral physicians, community and education programs that were established and first staffed by Glenn and are now directed by Maria Ramos-Person and her Physician Liaison/Referral Base Management team.

The group partners with Continuing Medical Education organizations to present programs, which help medical professionals stay abreast of current treatment methods and to understand the dynamics of modern cancer care. These programs not only position FCS Physicians as key clinical experts within the community, but they also help raise awareness among non-FCS medical providers about the kinds of services FCS offers. In 2017, the Physician Liaison team facilitated 73 programs, including dinners, Continuing Medical Education, and other educational programs — a 50 percent program increase vs. 2016.

The team of 10 Physician Liaisons, which is double the number of liaisons from 2012, when Glenn established the program with a focus on referral base management, is also responsible for analyzing and reporting referral patterns, insurance dynamics and the non-affiliated healthcare landscape to help FCS leadership create efficient operating strategies. Their research uncovers key data trends on accountable care organizations (ACO’s), insurance and other factors within the market that could affect patient referral trends. Finally, the efforts of the Physician Liaison team have contributed to the overall growth of new patient volume consecutively every year.

Physician Liaison Manager, Maria Ramos-Person

FCS Chief Marketing and Sales Officer, Shelly Glenn

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Internal Marketing, Employee Recruitment & Reputation Management

Digital & Creative Marketing Manager Jimmy Khun heads up the enhanced in-house marketing initiative at FCS. Khun had worked with Shelly previously, and she recruited him for this position in 2016. In less than two years, Jimmy and his team brought all Online Marketing initiatives in-house, varying from Pay Per Click (PPC), search engine optimization, online retargeting, re-marketing and social media in an effort to control expenses and manage these processes internally. In working with the marketing agencies, the internal marketing team revamped FLCancer.com and launched an online reputation management program to track patient reviews of the FCS physicians and clinics within the company.

Digital & Creative’s scope of activity is extensive and includes web development, oversight and maintenance of the FCS Content Management System, which allows authorized FCS staff to update web content as needed. This ensures that each office and their physicians can initiate a rapid response to new developments in their own backyard without going through a cumbersome change request process.

Jimmy and the core internal marketing team includes Communications Specialist/Project Management Coordinator Kristina Sparacino and Graphic Designer/Marketing Specialist Leslie Jaye, who work with the two FCS marketing agencies to oversee development of the creative direction, graphic design and social media strategies at FCS. As you can imagine, maintaining quality and consistency across an organization as large as FCS is a formidable challenge. But delivering consistent and cohesive messaging is critical to effective communications, so Workzone project management software was implemented so that that everyone who uses these tools is thoroughly trained in both the technical aspects and the strategic communications best practices.

Digital & Creative Marketing Manager, Jimmy Khun

Back Row: Marketing Administrator Lynn Clemens, Senior Physician Liaison Danielle Spears, Senior Physician Liaison Rhonda Webster, CMSO Shelly Glenn, JoLynn Wright, Physician Liaison Sandy Brooks, Physician Liaison Mary Ellen Woska, Communications Specialist/Project Manager Kristina Sparacino, Client Services Manager Jessica McIntyre, Physician Liaison Brett Hipsley.First Row: Terri Gagliardi, Physician Liaison Kay Simpkins, Physician Liaison Manager Maria Ramos-Person, Senior Physician Liaison Monica Tyler, Senior Physician Liaison Rebecca Applebaum, and Digital & Creative Marketing Manager Jimmy Khun.

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24 FCS The Magazine

For cancer patients in need, the financial burden of cancer care can impose hardships nearly as damaging as cancer itself. To make matters tougher, some patients at FCS are the primary breadwinner for their family. That’s where the FCS Foundation makes a big difference. Established in 2010, Prechtl chaired the Foundation from its inception until March 2018, when co-chairs Dr. Michael Diaz and Jeffrey Phipps, Sr. were named; Shelly Glenn has served on the board of directors since 2012, lending her expertise to raise money and ensure essential financial support for cancer patients undergoing treatment.

“By giving patients peace of mind in knowing that their everyday bills are being paid while they are undergoing treatment, we allow them to concentrate on what really matters — fighting cancer,” says Lynn Rasys, Executive Director of the FCS Foundation.

The FCS Foundation provides financial support to qualified cancer patients in the state for expenses such as rent, mortgage, car payments or utility bills. Jessica McIntyre, Client Services Manager, processed close to 2,700 patient grant applications in the past year. In 2017, the FCS Foundation awarded over $1.1 million in patient grants.

The FCS Foundation also manages the Patient Support Volunteer Program. These volunteers tirelessly assist patients and their families — whether they are offering snacks and beverages, providing a warm blanket or just engaging in light conversation. The more than 260 volunteers in 41 FCS clinics across the state have one thing in mind: making a difference to people in distress through personal kindness and generosity of spirit.

It seems as if nearly everyone wants to lend a hand. Lynn

notes that because of the “generosity of the Florida Cancer Specialists partner physicians, who continue to pay for all the salaries and administrative overhead of the Foundation, 100 percent of donations received go directly towards paying the essential living expenses of qualifying cancer patients who are going through active treatment.”

For more information on how make a donation, volunteer, or get tickets to an FCS Foundation special event, go to Foundation.FLCancer.com. Everyone can make a difference.

Fun Ways to Support the FCS Foundation In addition to accepting charitable contributions, the FCS Foundation raises money for its programs through a special events series that gives communities a fun way to come together and support the Foundation’s mission. Make your plans now for these events coming up in 2018:

• Lyrics for Life, September 14, Gainesville• Shabby Chic Shades of Pink, October 6,

Tampa• Wine, Women & Shoes, October 19,

Sanibel (New)• Wine, Women & Shoes, November 3,

Lake Mary

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Your insights are always in demand.Participate in potential market research opportunities

to make the biggest impact on patient outcomes.

Innovative treatments require an equally innovative approach to gathering insights.

We respect and value your time as a busy clinician. Which is why we have created a streamlined recruitment site that determines in real time if you are a possible candidate for:

Online surveys | Telephone-based interviews | In-person events

Be a part of the research panel that will help guide the next oncology breakthrough. Join more than 1,400 of your academic and community-based oncology and hematology colleagues bringing innovative therapies to patients around the world.

Maintained by Xcenda, a leading global healthcare consultancy, the Global Provider Insights Network (GPIN) is dedicated to exploring and understanding prescriber behaviors to ultimately optimize patient access to leading therapies.

Compare your treatment decisions to other leading physicians. Discuss how reform and reimbursement affect practice management. And share your insights with your peers to improve patient outcomes.

Visit ExpertsandOpinions.com now to register for current research panel opportunities.

Selected participants are paid honoraria for their participation.

Global Provider Insights NetworkBecome part of the

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26 FCS The Magazine

Dear Dave (Dave Bryan, FCS Volunteer),

Recently, I was the ‘guest’ of the FCS infusion center for two visits, and during those visits, you were the one person who stood out because of your cheerful manner and your willingness to help any and all patients during their procedures.

You were my hero for bringing me a warm blanket both times ... and you will never know how welcome that heat was!

Shortly after my treatments, the Villages Daily Sun printed an article about you and your ‘knicker’ buddies, which my wife and I enjoyed very much. As she also had been a ‘guest’ in the infusion center, she appreciated your attention as much as I did. As she also had worn knickers for several years, she got a huge kick out of your wardrobe.

FCS is lucky to have such a wonderful cadre of volunteers, from an enthusiastic man in pink knickers to accordion players and pianists, each of whom is intended to cheer on the patients and make them feel relaxed in what can sometimes be a very tense situation.

Thank you for all you do. And please accept an imaginary round of applause for being such a great guy.

Patient in The Villages

It is always gratifying to receive

letters from appreciative patients.

Their kind words remind us why we

chose our careers in medicine and

inspire us to do our best work. If you

have a letter from a patient that you

would like to see published, please

submit via email to FCS Marketing

at [email protected]. Please

provide the location and date with

each letter you send.

FCSPatient Letters

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Spring/Summer 2018 27

This is written in appreciation of the staff having touched me along my journey at FCS, and to say in writing that they are appreciated. I know this attitude is part of the trained BayCare culture, but when it is presented day after day without change, it should be recognized.

I especially want to note this about the team in Radiation and specifically Brenda, Mandi and JoGenia, who I saw at least one of during the very long six weeks of visits. They keep a great attitude and interest in the care they are providing. We can all have “off days,” but they did not reflect it in their care. This makes a difference.

My thanks to all for getting me through a challenge and to say I appreciate the entire team who got me there.

Patient in Plant City

I would like to recognize one of your employees for her outstanding work. Sandra Grant, a Financial Counselor at FCS, provided me with excellent and above-and-beyond service.My insurance carrier changed, and so I had provided all my new insurance information at least 30 days in advance to your office. This included my new insurance plan card, my identification and even a new prescription for my medication, Entyvio.

Unfortunately, even though I had provided that information well in advance, I received a call from your office two days before my infusion saying that there was no record of my new insurance and my previous insurance plan had expired. Needless to say, this was both frustrating and upsetting as my husband actually hand carried my new information to your office and sat with the financial counselor as she entered the new data.

Sandra Grant was filling in for this Financial Counselor when the lack of data was discovered, and it was two days before my next infusion when she contacted me. Unfortunately, since I work, I was not able to return the call until the next day. With only one day before my infusion, Sandra stayed on the case, called my new insurance provider, got treatment approval and a treatment plan, and I was good to go for my infusion.

But Sandra’s outstanding service did not stop there. When I met with her the day of my infusion to sign the treatment plan, she told me that she had researched, and I was approved to participate in the Entyvio Connect Co-Pay Assistance Program. Therefore, my out-of-pocket expense went from $3,240 to $50 as I was already approved for this assistance. Sandra really demonstrates great customer service and is a wonderful example of an advocate for both your company and the patient. Please provide her a copy of this letter as well as any recognition you can for a job well done.

Patient in The Villages

FCSPatient Letters

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EXTEND THE POSSIBILITIES.

EXTEND EFFICACY.For patients with multiple myeloma after 1 prior therapy

EXTEND THE POSSIBILITIES.The approval of the NINLARO® (ixazomib) regimen (NINLARO+lenalidomide+dexamethasone) was based on a statistically signifi cant ~6 month improvement in median PFS vs the placebo regimen (placebo+lenalidomide+dexamethasone).*• Median PFS: 20.6 vs 14.7 months (95% CI, 17.0-NE and 95% CI, 12.9-17.6, respectively); HR=0.74 (95% CI, 0.587-0.939); P=0.012

• Lactation: Advise nursing women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.

DRUG INTERACTIONS: Avoid concomitant administrationof NINLARO with strong CYP3A inducers.

*TOURMALINE-MM1: a global, phase 3, randomized (1:1), double-blind, placebo-controlled study that evaluated the safety and e� cacy of NINLARO (an oral proteasome inhibitor) vs placebo, both in combination with lenalidomide and dexamethasone, until disease progression or unacceptable toxicity in 722 patients with relapsed and/or refractory multiple myeloma who received 1-3 prior therapies.2

• Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming pregnant, and to use contraception during treatment and for an additional 90 days after the fi nal dose of NINLARO. Women using hormonal contraceptives should also use a barrier method of contraception.

ADVERSE REACTIONSThe most common adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen, respectively, were diarrhea (42%, 36%), constipation (34%, 25%), thrombocytopenia (78%, 54%; pooled from adverse events and laboratory data), peripheral neuropathy (28%, 21%), nausea (26%, 21%), peripheral edema (25%, 18%), vomiting (22%, 11%), and back pain (21%, 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%).

SPECIAL POPULATIONS• Hepatic Impairment: Reduce the NINLARO starting

dose to 3 mg in patients with moderate or severe hepatic impairment.

• Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.

NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONS• Thrombocytopenia has been reported with NINLARO.

During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the fi rst three cycles. Manage thrombocytopenia with dose modifi cations and platelet transfusions as per standard medical guidelines. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and typically recovered to baseline by the start of the next cycle.

• Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for severe symptoms.

• Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in

the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.

• Peripheral Edema was reported with NINLARO. Monitor for fl uid retention. Investigate for underlying causes when appropriate and provide supportive care as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.

• Cutaneous Reactions: Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modifi cation.

• Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly during treatment and adjust dosing as needed.

The NCCN Guidelines are a work in progress that may be refi ned as often as new signifi cant data becomes available. The NCCN Guidelines are a statement of consensus of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

NE=not evaluable; PFS=progression-free survival.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend ixazomib in combination with lenalidomide and dexamethasone as a category 1 treatment option for previously treated multiple myeloma.1

Please see adjacent Brief Summary. USO/IXA/16/0100(3)d

THE FIRST AND ONLY ORAL PROTEASOME INHIBITOR Under contract with your GPO.Get more information at www.NINLAROhcp.com.

EXTEND THE POSSIBILITIES.

EXTEND EFFICACY.For patients with multiple myeloma after 1 prior therapy

EXTEND THE POSSIBILITIES.The approval of the NINLARO® (ixazomib) regimen (NINLARO+lenalidomide+dexamethasone) was based on a statistically signifi cant ~6 month improvement in median PFS vs the placebo regimen (placebo+lenalidomide+dexamethasone).*• Median PFS: 20.6 vs 14.7 months (95% CI, 17.0-NE and 95% CI, 12.9-17.6, respectively); HR=0.74 (95% CI, 0.587-0.939); P=0.012

• Lactation: Advise nursing women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.

DRUG INTERACTIONS: Avoid concomitant administrationof NINLARO with strong CYP3A inducers.

*TOURMALINE-MM1: a global, phase 3, randomized (1:1), double-blind, placebo-controlled study that evaluated the safety and e� cacy of NINLARO (an oral proteasome inhibitor) vs placebo, both in combination with lenalidomide and dexamethasone, until disease progression or unacceptable toxicity in 722 patients with relapsed and/or refractory multiple myeloma who received 1-3 prior therapies.2

• Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming pregnant, and to use contraception during treatment and for an additional 90 days after the fi nal dose of NINLARO. Women using hormonal contraceptives should also use a barrier method of contraception.

ADVERSE REACTIONSThe most common adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen, respectively, were diarrhea (42%, 36%), constipation (34%, 25%), thrombocytopenia (78%, 54%; pooled from adverse events and laboratory data), peripheral neuropathy (28%, 21%), nausea (26%, 21%), peripheral edema (25%, 18%), vomiting (22%, 11%), and back pain (21%, 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%).

SPECIAL POPULATIONS• Hepatic Impairment: Reduce the NINLARO starting

dose to 3 mg in patients with moderate or severe hepatic impairment.

• Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.

NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONS• Thrombocytopenia has been reported with NINLARO.

During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the fi rst three cycles. Manage thrombocytopenia with dose modifi cations and platelet transfusions as per standard medical guidelines. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and typically recovered to baseline by the start of the next cycle.

• Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for severe symptoms.

• Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in

the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.

• Peripheral Edema was reported with NINLARO. Monitor for fl uid retention. Investigate for underlying causes when appropriate and provide supportive care as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.

• Cutaneous Reactions: Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modifi cation.

• Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly during treatment and adjust dosing as needed.

The NCCN Guidelines are a work in progress that may be refi ned as often as new signifi cant data becomes available. The NCCN Guidelines are a statement of consensus of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

NE=not evaluable; PFS=progression-free survival.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend ixazomib in combination with lenalidomide and dexamethasone as a category 1 treatment option for previously treated multiple myeloma.1

Please see adjacent Brief Summary. USO/IXA/16/0100(3)d

THE FIRST AND ONLY ORAL PROTEASOME INHIBITOR Under contract with your GPO.Get more information at www.NINLAROhcp.com.

Page 29: THE MAGAZINE€¦ · management. He received his MBA from the University of Tennessee, School ... safety and efficacy of Etirinotecan Pegol (EP) in women with recurrent platinum-resistant

EXTEND THE POSSIBILITIES.

EXTEND EFFICACY.For patients with multiple myeloma after 1 prior therapy

EXTEND THE POSSIBILITIES.The approval of the NINLARO® (ixazomib) regimen (NINLARO+lenalidomide+dexamethasone) was based on a statistically signifi cant ~6 month improvement in median PFS vs the placebo regimen (placebo+lenalidomide+dexamethasone).*• Median PFS: 20.6 vs 14.7 months (95% CI, 17.0-NE and 95% CI, 12.9-17.6, respectively); HR=0.74 (95% CI, 0.587-0.939); P=0.012

• Lactation: Advise nursing women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.

DRUG INTERACTIONS: Avoid concomitant administrationof NINLARO with strong CYP3A inducers.

*TOURMALINE-MM1: a global, phase 3, randomized (1:1), double-blind, placebo-controlled study that evaluated the safety and e� cacy of NINLARO (an oral proteasome inhibitor) vs placebo, both in combination with lenalidomide and dexamethasone, until disease progression or unacceptable toxicity in 722 patients with relapsed and/or refractory multiple myeloma who received 1-3 prior therapies.2

• Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming pregnant, and to use contraception during treatment and for an additional 90 days after the fi nal dose of NINLARO. Women using hormonal contraceptives should also use a barrier method of contraception.

ADVERSE REACTIONSThe most common adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen, respectively, were diarrhea (42%, 36%), constipation (34%, 25%), thrombocytopenia (78%, 54%; pooled from adverse events and laboratory data), peripheral neuropathy (28%, 21%), nausea (26%, 21%), peripheral edema (25%, 18%), vomiting (22%, 11%), and back pain (21%, 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%).

SPECIAL POPULATIONS• Hepatic Impairment: Reduce the NINLARO starting

dose to 3 mg in patients with moderate or severe hepatic impairment.

• Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.

NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONS• Thrombocytopenia has been reported with NINLARO.

During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the fi rst three cycles. Manage thrombocytopenia with dose modifi cations and platelet transfusions as per standard medical guidelines. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and typically recovered to baseline by the start of the next cycle.

• Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for severe symptoms.

• Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in

the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.

• Peripheral Edema was reported with NINLARO. Monitor for fl uid retention. Investigate for underlying causes when appropriate and provide supportive care as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.

• Cutaneous Reactions: Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modifi cation.

• Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly during treatment and adjust dosing as needed.

The NCCN Guidelines are a work in progress that may be refi ned as often as new signifi cant data becomes available. The NCCN Guidelines are a statement of consensus of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

NE=not evaluable; PFS=progression-free survival.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend ixazomib in combination with lenalidomide and dexamethasone as a category 1 treatment option for previously treated multiple myeloma.1

Please see adjacent Brief Summary. USO/IXA/16/0100(3)d

THE FIRST AND ONLY ORAL PROTEASOME INHIBITOR Under contract with your GPO.Get more information at www.NINLAROhcp.com.

EXTEND THE POSSIBILITIES.

EXTEND EFFICACY.For patients with multiple myeloma after 1 prior therapy

EXTEND THE POSSIBILITIES.The approval of the NINLARO® (ixazomib) regimen (NINLARO+lenalidomide+dexamethasone) was based on a statistically signifi cant ~6 month improvement in median PFS vs the placebo regimen (placebo+lenalidomide+dexamethasone).*• Median PFS: 20.6 vs 14.7 months (95% CI, 17.0-NE and 95% CI, 12.9-17.6, respectively); HR=0.74 (95% CI, 0.587-0.939); P=0.012

• Lactation: Advise nursing women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.

DRUG INTERACTIONS: Avoid concomitant administrationof NINLARO with strong CYP3A inducers.

*TOURMALINE-MM1: a global, phase 3, randomized (1:1), double-blind, placebo-controlled study that evaluated the safety and e� cacy of NINLARO (an oral proteasome inhibitor) vs placebo, both in combination with lenalidomide and dexamethasone, until disease progression or unacceptable toxicity in 722 patients with relapsed and/or refractory multiple myeloma who received 1-3 prior therapies.2

• Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming pregnant, and to use contraception during treatment and for an additional 90 days after the fi nal dose of NINLARO. Women using hormonal contraceptives should also use a barrier method of contraception.

ADVERSE REACTIONSThe most common adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen, respectively, were diarrhea (42%, 36%), constipation (34%, 25%), thrombocytopenia (78%, 54%; pooled from adverse events and laboratory data), peripheral neuropathy (28%, 21%), nausea (26%, 21%), peripheral edema (25%, 18%), vomiting (22%, 11%), and back pain (21%, 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%).

SPECIAL POPULATIONS• Hepatic Impairment: Reduce the NINLARO starting

dose to 3 mg in patients with moderate or severe hepatic impairment.

• Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.

NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONS• Thrombocytopenia has been reported with NINLARO.

During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the fi rst three cycles. Manage thrombocytopenia with dose modifi cations and platelet transfusions as per standard medical guidelines. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and typically recovered to baseline by the start of the next cycle.

• Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for severe symptoms.

• Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in

the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.

• Peripheral Edema was reported with NINLARO. Monitor for fl uid retention. Investigate for underlying causes when appropriate and provide supportive care as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.

• Cutaneous Reactions: Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modifi cation.

• Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly during treatment and adjust dosing as needed.

The NCCN Guidelines are a work in progress that may be refi ned as often as new signifi cant data becomes available. The NCCN Guidelines are a statement of consensus of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

NE=not evaluable; PFS=progression-free survival.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend ixazomib in combination with lenalidomide and dexamethasone as a category 1 treatment option for previously treated multiple myeloma.1

Please see adjacent Brief Summary. USO/IXA/16/0100(3)d

THE FIRST AND ONLY ORAL PROTEASOME INHIBITOR Under contract with your GPO.Get more information at www.NINLAROhcp.com.

Page 30: THE MAGAZINE€¦ · management. He received his MBA from the University of Tennessee, School ... safety and efficacy of Etirinotecan Pegol (EP) in women with recurrent platinum-resistant

BRIEF SUMMARY OF PRESCRIBING INFORMATIONNINLARO (ixazomib) capsules, for oral use

1 INDICATIONNINLARO (ixazomib) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

5 WARNINGS AND PRECAUTIONS5.1 Thrombocytopenia: Thrombocytopenia has been reported with NINLARO with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle. Three percent of patients in the NINLARO regimen and 1% of patients in the placebo regimen had a platelet count ≤ 10,000/mm3 during treatment. Less than 1% of patients in both regimens had a platelet count ≤ 5000/mm3 during treatment. Discontinuations due to thrombocytopenia were similar in both regimens (< 1% of patients in the NINLARO regimen and 2% of patients in the placebo regimen discontinued one or more of the three drugs).The rate of platelet transfusions was 6% in the NINLARO regimen and 5% in the placebo regimen. Monitor platelet counts at least monthly during treatment with NINLARO. Consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per standard medical guidelines.5.2 Gastrointestinal Toxicities: Diarrhea, constipation, nausea, and vomiting, have been reported with NINLARO, occasionally requiring use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea was reported in 42% of patients in the NINLARO regimen and 36% in the placebo regimen, constipation in 34% and 25%, respectively, nausea in 26% and 21%, respectively, and vomiting in 22% and 11%, respectively. Diarrhea resulted in discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for Grade 3 or 4 symptoms.5.3 Peripheral Neuropathy: The majority of peripheral neuropathy adverse reactions were Grade 1 (18% in the NINLARO regimen and 14% in the placebo regimen) and Grade 2 (8% in the NINLARO regimen and 5% in the placebo regimen). Grade 3 adverse reactions of peripheral neuropathy were reported at 2% in both regimens; there were no Grade 4 or serious adverse reactions. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimen, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Patients should be monitored for symptoms of neuropathy. Patients experiencing new or worsening peripheral neuropathy may require dose modification.5.4 Peripheral Edema: Peripheral edema was reported in 25% and 18% of patients in the NINLARO and placebo regimens, respectively. The majority of peripheral edema adverse reactions were Grade 1 (16% in the NINLARO regimen and 13% in the placebo regimen) and Grade 2 (7% in the NINLARO regimen and 4% in the placebo regimen).Grade 3 peripheral edema was reported in 2% and 1% of patients in the NINLARO and placebo regimens, respectively. There was no Grade 4 peripheral edema reported. There were no discontinuations reported due to peripheral edema. Evaluate for underlying causes and provide supportive care, as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.5.5 Cutaneous Reactions: Rash was reported in 19% of patients in the NINLARO regimen and 11% of patients in the placebo regimen. The majority of the rash adverse reactions were Grade 1 (10% in the NINLARO regimen and 7% in the placebo regimen) or Grade 2 (6% in the NINLARO regimen and 3% in the placebo regimen). Grade 3 rash was reported in 3% of patients in the NINLARO regimen and 1% of patients in the placebo regimen. There were no Grade 4 or serious adverse reactions of rash reported. The most common type of rash reported in both regimens included maculo-papular and macular rash. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modification if Grade 2 or higher.5.6 Hepatotoxicity: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms.5.7 Embryo-Fetal Toxicity: NINLARO can cause fetal harm when administered to a pregnant woman based on the mechanism of action and findings in animals. There are no adequate and well-controlled studies in pregnant women using NINLARO. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher than those observed in patients receiving the recommended dose.

Females of reproductive potential should be advised to avoid becoming pregnant while being treated with NINLARO. If NINLARO is used during pregnancy or if the patient becomes pregnant while taking NINLARO, the patient should be apprised of the potential hazard to the fetus. Advise females of reproductive potential that they must use effective contraception during treatment with NINLARO and for 90 days following the final dose. Women using hormonal contraceptives should also use a barrier method of contraception.

6 ADVERSE REACTIONSThe following adverse reactions are described in detail in other sections of the prescribing information:• Thrombocytopenia [see Warnings and Precautions (5.1)]• Gastrointestinal Toxicities [see Warnings and Precautions (5.2)]• Peripheral Neuropathy [see Warnings and Precautions (5.3)]• Peripheral Edema [see Warnings and Precautions (5.4)]• Cutaneous Reactions [see Warnings and Precautions (5.5)]• Hepatotoxicity [see Warnings and Precautions (5.6)]

6.1 CLINICAL TRIALS EXPERIENCEBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The safety population from the randomized, double-blind, placebo-controlled clinical study included 720 patients with relapsed and/or refractory multiple myeloma, who received NINLARO in combination with lenalidomide and dexamethasone (NINLARO regimen; N=360) or placebo in combination with lenalidomide and dexamethasone (placebo regimen; N=360). The most frequently reported adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). For each adverse reaction, one or more of the three drugs was discontinued in ≤ 1% of patients in the NINLARO regimen.Table 4: Non-Hematologic Adverse Reactions Occurring in ≥ 5% of Patients with a ≥ 5% Difference Between the NINLARO Regimen and the Placebo Regimen (All Grades, Grade 3 and Grade 4)

NINLARO + Lenalidomide and Dexamethasone

N=360

Placebo + Lenalidomide and Dexamethasone

N=360

System Organ Class / Preferred Term N (%) N (%)

All Grade 3

Grade 4 All Grade

3Grade

4

Infections and infestationsUpper respiratory tract infection 69 (19) 1 (< 1) 0 52 (14) 2 (< 1) 0

Nervous system disordersPeripheral neuropathies* 100 (28) 7 (2) 0 77 (21) 7 (2) 0

Gastrointestinal disordersDiarrheaConstipationNauseaVomiting

151 (42)122 (34)92 (26)79 (22)

22 (6)1 (< 1)6 (2)4 (1)

0000

130 (36)90 (25)74 (21)38 (11)

8 (2)1 (< 1)

02 (< 1)

0000

Skin and subcutaneous tissue disorders

Rash* 68 (19) 9 (3) 0 38 (11) 5 (1) 0

Musculoskeletal and connective tissue disorders

Back pain 74 (21) 2 (< 1) 0 57 (16) 9 (3) 0

General disorders and administration site conditions

Edema peripheral 91 (25) 8 (2) 0 66 (18) 4 (1) 0

Note: Adverse reactions included as preferred terms are based on MedDRA version 16.0. *Represents a pooling of preferred terms

(Continued on next page)

T:7”T:10”

IXAZ17CDNY1359_Brief_Summary_Sept_2017_Update_r3.indd 1 9/20/17 4:53 PM

REFERENCES: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.3.2017. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed March 28, 2017. To view the most recent and complete version of the guideline, go online to NCCN.org. 2. Moreau P, Masszi T, Grzasko N, et al; for TOURMALINE-MM1 Study Group. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;374(17):1621-1634. Brief Summary (cont’d)

Table 5: Thrombocytopenia and Neutropenia (pooled adverse event and laboratory data)

NINLARO + Lenalidomide and Dexamethasone

N=360

Placebo + Lenalidomide and Dexamethasone

N=360

N (%) N (%)

Any Grade Grade 3-4 Any Grade Grade 3-4

Thrombocytopenia 281 (78) 93 (26) 196 (54) 39 (11)

Neutropenia 240 (67) 93 (26) 239 (66) 107 (30)

Herpes ZosterHerpes zoster was reported in 4% of patients in the NINLARO regimen and 2% of patients in the placebo regimen. Antiviral prophylaxis was allowed at the physician’s discretion. Patients treated in the NINLARO regimen who received antiviral prophylaxis had a lower incidence (< 1%) of herpes zoster infection compared to patients who did not receive prophylaxis (6%).Eye DisordersEye disorders were reported with many different preferred terms but in aggregate, the frequency was 26% in patients in the NINLARO regimen and 16% of patients in the placebo regimen. The most common adverse reactions were blurred vision (6% in the NINLARO regimen and 3% in the placebo regimen), dry eye (5% in the NINLARO regimen and 1% in the placebo regimen), and conjunctivitis (6% in the NINLARO regimen and 1% in the placebo regimen). Grade 3 adverse reactions were reported in 2% of patients in the NINLARO regimen and 1% in the placebo regimen.The following serious adverse reactions have each been reported at a frequency of < 1%: acute febrile neutrophilic dermatosis (Sweet’s syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumor lysis syndrome, and thrombotic thrombocytopenic purpura. 7 DRUG INTERACTIONS7.1 Strong CYP3A Inducers: Avoid concomitant administration of NINLARO with strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and St. John’s Wort).8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy: Risk Summary: Based on its mechanism of action and data from animal reproduction studies, NINLARO can cause fetal harm when administered to a pregnant woman. There are no human data available regarding the potential effect of NINLARO on pregnancy or development of the embryo or fetus. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher then those observed in patients receiving the recommended dose. Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with NINLARO. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Animal Data: In an embryo-fetal development study in pregnant rabbits there were increases in fetal skeletal variations/abnormalities (caudal vertebrae, number of lumbar vertebrae, and full supernumerary ribs) at doses that were also maternally toxic (≥ 0.3 mg/kg). Exposures in the rabbit at 0.3 mg/kg were 1.9 times the clinical time averaged exposures at the recommended dose of 4 mg. In a rat dose range-finding embryo-fetal development study, at doses that were maternally toxic, there were decreases in fetal weights, a trend towards decreased fetal viability, and increased post-implantation losses at 0.6 mg/kg. Exposures in rats at the dose of 0.6 mg/kg was 2.5 times the clinical time averaged exposures at the recommended dose of 4 mg.8.2 Lactation: No data are available regarding the presence of NINLARO or its metabolites in human milk, the effects of the drug on the breast fed infant, or the effects of the drug on milk production. Because the potential for serious adverse reactions from NINLARO in breastfed infants is unknown, advise nursing women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.8.3 Females and Males of Reproductive Potential: Contraception - Male and female patients of childbearing potential must use effective contraceptive measures during and for 90 days following treatment. Dexamethasone is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters. Because NINLARO is administered with dexamethasone, the risk for reduced efficacy of contraceptives needs to be considered. Advise women using hormonal contraceptives to also use a barrier method of contraception. 8.4 Pediatric Use: Safety and effectiveness have not been established in pediatric patients.8.5 Geriatric Use: Of the total number of subjects in clinical studies of NINLARO, 55% were 65 and over, while 17% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified

differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.8.6 Hepatic Impairment: In patients with moderate or severe hepatic impairment, the mean AUC increased by 20% when compared to patients with normal hepatic function. Reduce the starting dose of NINLARO in patients with moderate or severe hepatic impairment.8.7 Renal Impairment: In patients with severe renal impairment or ESRD requiring dialysis, the mean AUC increased by 39% when compared to patients with normal renal function. Reduce the starting dose of NINLARO in patients with severe renal impairment or ESRD requiring dialysis. NINLARO is not dialyzable and therefore can be administered without regard to the timing of dialysis10 OVERDOSAGE: There is no known specific antidote for NINLARO overdose. In the event of an overdose, monitor the patient for adverse reactions and provide appropriate supportive care.17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information).Dosing Instructions• Instruct patients to take NINLARO exactly as prescribed. • Advise patients to take NINLARO once a week on the same day and at

approximately the same time for the first three weeks of a four week cycle. • Advise patients to take NINLARO at least one hour before or at least two

hours after food. • Advise patients that NINLARO and dexamethasone should not be taken at the

same time, because dexamethasone should be taken with food and NINLARO should not be taken with food.

• Advise patients to swallow the capsule whole with water. The capsule should not be crushed, chewed or opened.

• Advise patients that direct contact with the capsule contents should be avoided. In case of capsule breakage, avoid direct contact of capsule contents with the skin or eyes. If contact occurs with the skin, wash thoroughly with soap and water. If contact occurs with the eyes, flush thoroughly with water.

• If a patient misses a dose, advise them to take the missed dose as long as the next scheduled dose is ≥ 72 hours away. Advise patients not to take a missed dose if it is within 72 hours of their next scheduled dose.

• If a patient vomits after taking a dose, advise them not to repeat the dose but resume dosing at the time of the next scheduled dose.

• Advise patients to store capsules in original packaging, and not to remove the capsule from the packaging until just prior to taking NINLARO.

Thrombocytopenia: Advise patients that they may experience low platelet counts (thrombocytopenia). Signs of thrombocytopenia may include bleeding and easy bruising.Gastrointestinal Toxicities: Advise patients they may experience diarrhea, constipation, nausea and vomiting and to contact their physician if these adverse reactions persist.Peripheral Neuropathy: Advise patients to contact their physicians if they experience new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the arms or legs.Peripheral Edema: Advise patients to contact their physicians if they experience unusual swelling of their extremities or weight gain due to swelling.Cutaneous Reactions: Advise patients to contact their physicians if they experience new or worsening rashHepatotoxicity: Advise patients to contact their physicians if they experience jaundice or right upper quadrant abdominal painOther Adverse Reactions: Advise patients to contact their physicians if they experience signs and symptoms of acute febrile neutrophilic dermatosis (Sweet’s syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumor lysis syndrome, and thrombotic thrombocytopenic purpura Pregnancy: Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with NINLARO and for 90 days following the final dose. Advise women using hormonal contraceptives to also use a barrier method of contraception. Advise patients to contact their physicians immediately if they or their female partner become pregnant during treatment or within 90 days of the final dose.Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking and before starting any new medications.

Please see full Prescribing Information for NINLARO at NINLARO-hcp.com.

All trademarks are the property of their respective owners. ©2017 Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. All rights reserved.

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BRIEF SUMMARY OF PRESCRIBING INFORMATIONNINLARO (ixazomib) capsules, for oral use

1 INDICATIONNINLARO (ixazomib) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

5 WARNINGS AND PRECAUTIONS5.1 Thrombocytopenia: Thrombocytopenia has been reported with NINLARO with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle. Three percent of patients in the NINLARO regimen and 1% of patients in the placebo regimen had a platelet count ≤ 10,000/mm3 during treatment. Less than 1% of patients in both regimens had a platelet count ≤ 5000/mm3 during treatment. Discontinuations due to thrombocytopenia were similar in both regimens (< 1% of patients in the NINLARO regimen and 2% of patients in the placebo regimen discontinued one or more of the three drugs).The rate of platelet transfusions was 6% in the NINLARO regimen and 5% in the placebo regimen. Monitor platelet counts at least monthly during treatment with NINLARO. Consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per standard medical guidelines.5.2 Gastrointestinal Toxicities: Diarrhea, constipation, nausea, and vomiting, have been reported with NINLARO, occasionally requiring use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea was reported in 42% of patients in the NINLARO regimen and 36% in the placebo regimen, constipation in 34% and 25%, respectively, nausea in 26% and 21%, respectively, and vomiting in 22% and 11%, respectively. Diarrhea resulted in discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for Grade 3 or 4 symptoms.5.3 Peripheral Neuropathy: The majority of peripheral neuropathy adverse reactions were Grade 1 (18% in the NINLARO regimen and 14% in the placebo regimen) and Grade 2 (8% in the NINLARO regimen and 5% in the placebo regimen). Grade 3 adverse reactions of peripheral neuropathy were reported at 2% in both regimens; there were no Grade 4 or serious adverse reactions. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimen, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Patients should be monitored for symptoms of neuropathy. Patients experiencing new or worsening peripheral neuropathy may require dose modification.5.4 Peripheral Edema: Peripheral edema was reported in 25% and 18% of patients in the NINLARO and placebo regimens, respectively. The majority of peripheral edema adverse reactions were Grade 1 (16% in the NINLARO regimen and 13% in the placebo regimen) and Grade 2 (7% in the NINLARO regimen and 4% in the placebo regimen).Grade 3 peripheral edema was reported in 2% and 1% of patients in the NINLARO and placebo regimens, respectively. There was no Grade 4 peripheral edema reported. There were no discontinuations reported due to peripheral edema. Evaluate for underlying causes and provide supportive care, as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.5.5 Cutaneous Reactions: Rash was reported in 19% of patients in the NINLARO regimen and 11% of patients in the placebo regimen. The majority of the rash adverse reactions were Grade 1 (10% in the NINLARO regimen and 7% in the placebo regimen) or Grade 2 (6% in the NINLARO regimen and 3% in the placebo regimen). Grade 3 rash was reported in 3% of patients in the NINLARO regimen and 1% of patients in the placebo regimen. There were no Grade 4 or serious adverse reactions of rash reported. The most common type of rash reported in both regimens included maculo-papular and macular rash. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modification if Grade 2 or higher.5.6 Hepatotoxicity: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms.5.7 Embryo-Fetal Toxicity: NINLARO can cause fetal harm when administered to a pregnant woman based on the mechanism of action and findings in animals. There are no adequate and well-controlled studies in pregnant women using NINLARO. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher than those observed in patients receiving the recommended dose.

Females of reproductive potential should be advised to avoid becoming pregnant while being treated with NINLARO. If NINLARO is used during pregnancy or if the patient becomes pregnant while taking NINLARO, the patient should be apprised of the potential hazard to the fetus. Advise females of reproductive potential that they must use effective contraception during treatment with NINLARO and for 90 days following the final dose. Women using hormonal contraceptives should also use a barrier method of contraception.

6 ADVERSE REACTIONSThe following adverse reactions are described in detail in other sections of the prescribing information:• Thrombocytopenia [see Warnings and Precautions (5.1)]• Gastrointestinal Toxicities [see Warnings and Precautions (5.2)]• Peripheral Neuropathy [see Warnings and Precautions (5.3)]• Peripheral Edema [see Warnings and Precautions (5.4)]• Cutaneous Reactions [see Warnings and Precautions (5.5)]• Hepatotoxicity [see Warnings and Precautions (5.6)]

6.1 CLINICAL TRIALS EXPERIENCEBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The safety population from the randomized, double-blind, placebo-controlled clinical study included 720 patients with relapsed and/or refractory multiple myeloma, who received NINLARO in combination with lenalidomide and dexamethasone (NINLARO regimen; N=360) or placebo in combination with lenalidomide and dexamethasone (placebo regimen; N=360). The most frequently reported adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). For each adverse reaction, one or more of the three drugs was discontinued in ≤ 1% of patients in the NINLARO regimen.Table 4: Non-Hematologic Adverse Reactions Occurring in ≥ 5% of Patients with a ≥ 5% Difference Between the NINLARO Regimen and the Placebo Regimen (All Grades, Grade 3 and Grade 4)

NINLARO + Lenalidomide and Dexamethasone

N=360

Placebo + Lenalidomide and Dexamethasone

N=360

System Organ Class / Preferred Term N (%) N (%)

All Grade 3

Grade 4 All Grade

3Grade

4

Infections and infestationsUpper respiratory tract infection 69 (19) 1 (< 1) 0 52 (14) 2 (< 1) 0

Nervous system disordersPeripheral neuropathies* 100 (28) 7 (2) 0 77 (21) 7 (2) 0

Gastrointestinal disordersDiarrheaConstipationNauseaVomiting

151 (42)122 (34)92 (26)79 (22)

22 (6)1 (< 1)6 (2)4 (1)

0000

130 (36)90 (25)74 (21)38 (11)

8 (2)1 (< 1)

02 (< 1)

0000

Skin and subcutaneous tissue disorders

Rash* 68 (19) 9 (3) 0 38 (11) 5 (1) 0

Musculoskeletal and connective tissue disorders

Back pain 74 (21) 2 (< 1) 0 57 (16) 9 (3) 0

General disorders and administration site conditions

Edema peripheral 91 (25) 8 (2) 0 66 (18) 4 (1) 0

Note: Adverse reactions included as preferred terms are based on MedDRA version 16.0. *Represents a pooling of preferred terms

(Continued on next page)

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REFERENCES: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.3.2017. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed March 28, 2017. To view the most recent and complete version of the guideline, go online to NCCN.org. 2. Moreau P, Masszi T, Grzasko N, et al; for TOURMALINE-MM1 Study Group. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;374(17):1621-1634. Brief Summary (cont’d)

Table 5: Thrombocytopenia and Neutropenia (pooled adverse event and laboratory data)

NINLARO + Lenalidomide and Dexamethasone

N=360

Placebo + Lenalidomide and Dexamethasone

N=360

N (%) N (%)

Any Grade Grade 3-4 Any Grade Grade 3-4

Thrombocytopenia 281 (78) 93 (26) 196 (54) 39 (11)

Neutropenia 240 (67) 93 (26) 239 (66) 107 (30)

Herpes ZosterHerpes zoster was reported in 4% of patients in the NINLARO regimen and 2% of patients in the placebo regimen. Antiviral prophylaxis was allowed at the physician’s discretion. Patients treated in the NINLARO regimen who received antiviral prophylaxis had a lower incidence (< 1%) of herpes zoster infection compared to patients who did not receive prophylaxis (6%).Eye DisordersEye disorders were reported with many different preferred terms but in aggregate, the frequency was 26% in patients in the NINLARO regimen and 16% of patients in the placebo regimen. The most common adverse reactions were blurred vision (6% in the NINLARO regimen and 3% in the placebo regimen), dry eye (5% in the NINLARO regimen and 1% in the placebo regimen), and conjunctivitis (6% in the NINLARO regimen and 1% in the placebo regimen). Grade 3 adverse reactions were reported in 2% of patients in the NINLARO regimen and 1% in the placebo regimen.The following serious adverse reactions have each been reported at a frequency of < 1%: acute febrile neutrophilic dermatosis (Sweet’s syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumor lysis syndrome, and thrombotic thrombocytopenic purpura. 7 DRUG INTERACTIONS7.1 Strong CYP3A Inducers: Avoid concomitant administration of NINLARO with strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and St. John’s Wort).8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy: Risk Summary: Based on its mechanism of action and data from animal reproduction studies, NINLARO can cause fetal harm when administered to a pregnant woman. There are no human data available regarding the potential effect of NINLARO on pregnancy or development of the embryo or fetus. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher then those observed in patients receiving the recommended dose. Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with NINLARO. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Animal Data: In an embryo-fetal development study in pregnant rabbits there were increases in fetal skeletal variations/abnormalities (caudal vertebrae, number of lumbar vertebrae, and full supernumerary ribs) at doses that were also maternally toxic (≥ 0.3 mg/kg). Exposures in the rabbit at 0.3 mg/kg were 1.9 times the clinical time averaged exposures at the recommended dose of 4 mg. In a rat dose range-finding embryo-fetal development study, at doses that were maternally toxic, there were decreases in fetal weights, a trend towards decreased fetal viability, and increased post-implantation losses at 0.6 mg/kg. Exposures in rats at the dose of 0.6 mg/kg was 2.5 times the clinical time averaged exposures at the recommended dose of 4 mg.8.2 Lactation: No data are available regarding the presence of NINLARO or its metabolites in human milk, the effects of the drug on the breast fed infant, or the effects of the drug on milk production. Because the potential for serious adverse reactions from NINLARO in breastfed infants is unknown, advise nursing women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.8.3 Females and Males of Reproductive Potential: Contraception - Male and female patients of childbearing potential must use effective contraceptive measures during and for 90 days following treatment. Dexamethasone is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters. Because NINLARO is administered with dexamethasone, the risk for reduced efficacy of contraceptives needs to be considered. Advise women using hormonal contraceptives to also use a barrier method of contraception. 8.4 Pediatric Use: Safety and effectiveness have not been established in pediatric patients.8.5 Geriatric Use: Of the total number of subjects in clinical studies of NINLARO, 55% were 65 and over, while 17% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified

differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.8.6 Hepatic Impairment: In patients with moderate or severe hepatic impairment, the mean AUC increased by 20% when compared to patients with normal hepatic function. Reduce the starting dose of NINLARO in patients with moderate or severe hepatic impairment.8.7 Renal Impairment: In patients with severe renal impairment or ESRD requiring dialysis, the mean AUC increased by 39% when compared to patients with normal renal function. Reduce the starting dose of NINLARO in patients with severe renal impairment or ESRD requiring dialysis. NINLARO is not dialyzable and therefore can be administered without regard to the timing of dialysis10 OVERDOSAGE: There is no known specific antidote for NINLARO overdose. In the event of an overdose, monitor the patient for adverse reactions and provide appropriate supportive care.17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information).Dosing Instructions• Instruct patients to take NINLARO exactly as prescribed. • Advise patients to take NINLARO once a week on the same day and at

approximately the same time for the first three weeks of a four week cycle. • Advise patients to take NINLARO at least one hour before or at least two

hours after food. • Advise patients that NINLARO and dexamethasone should not be taken at the

same time, because dexamethasone should be taken with food and NINLARO should not be taken with food.

• Advise patients to swallow the capsule whole with water. The capsule should not be crushed, chewed or opened.

• Advise patients that direct contact with the capsule contents should be avoided. In case of capsule breakage, avoid direct contact of capsule contents with the skin or eyes. If contact occurs with the skin, wash thoroughly with soap and water. If contact occurs with the eyes, flush thoroughly with water.

• If a patient misses a dose, advise them to take the missed dose as long as the next scheduled dose is ≥ 72 hours away. Advise patients not to take a missed dose if it is within 72 hours of their next scheduled dose.

• If a patient vomits after taking a dose, advise them not to repeat the dose but resume dosing at the time of the next scheduled dose.

• Advise patients to store capsules in original packaging, and not to remove the capsule from the packaging until just prior to taking NINLARO.

Thrombocytopenia: Advise patients that they may experience low platelet counts (thrombocytopenia). Signs of thrombocytopenia may include bleeding and easy bruising.Gastrointestinal Toxicities: Advise patients they may experience diarrhea, constipation, nausea and vomiting and to contact their physician if these adverse reactions persist.Peripheral Neuropathy: Advise patients to contact their physicians if they experience new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the arms or legs.Peripheral Edema: Advise patients to contact their physicians if they experience unusual swelling of their extremities or weight gain due to swelling.Cutaneous Reactions: Advise patients to contact their physicians if they experience new or worsening rashHepatotoxicity: Advise patients to contact their physicians if they experience jaundice or right upper quadrant abdominal painOther Adverse Reactions: Advise patients to contact their physicians if they experience signs and symptoms of acute febrile neutrophilic dermatosis (Sweet’s syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumor lysis syndrome, and thrombotic thrombocytopenic purpura Pregnancy: Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with NINLARO and for 90 days following the final dose. Advise women using hormonal contraceptives to also use a barrier method of contraception. Advise patients to contact their physicians immediately if they or their female partner become pregnant during treatment or within 90 days of the final dose.Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking and before starting any new medications.

Please see full Prescribing Information for NINLARO at NINLARO-hcp.com.

All trademarks are the property of their respective owners. ©2017 Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. All rights reserved.

SEPT 2017 USO/IXA/15/0123(4)

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32 FCS The Magazine

Left to right: Kiran, Shelly, Hailey, Avani (standing in front), Dr. Sachin Kamath, Ethan and Lauren

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Spring/Summer 2018 33

A formative experience with a friend’s cancer diagnosis set Dr. Sachin Kamath on his career path as a radiation oncologist. Kamath, who joined FCS in 2015, was still in elementary school

when his classmate was diagnosed with leukemia. “I learned how sick he was and about his treatments,” said

Kamath, who practices in The Villages. “I was amazed at how this huge team of doctors and nurses came together to not only provide medical treatment, but to provide him and his family emotional support.”

Kamath began volunteering and shadowing physicians at a hospital in his native Sarasota, and, by high school, he had decided on a career in medicine. He attended an accelerated program in which he was accepted early into medical school at the University of Florida. In medical school, his interest in oncology was renewed and Kamath says he was drawn to radiation oncology because it combined his interest in technology with the ability to have close interactions with cancer patients.

When the Moffitt Cancer Center built a radiation oncology satellite facility in The Villages, Kamath was recruited to help lead the program. “Given the demographics of a large retired population in The Villages, cancer is prevalent and the residents demand high quality medical care,” Kamath said. He found that in the past, many patients thought they needed to travel to Gainesville, Tampa, or Jacksonville to receive quality cancer care.

When the Moffitt Cancer Center decided to leave The Villages location in 2015, FCS took over the radiation oncology program and Kamath joined FCS with renewed energy and support to develop a more comprehensive cancer program. “As part of our effort to re-invigorate the cancer program, we quickly purchased a second Varian TrueBeam linear accelerator to expand on our clinical capabilities and also to offer more convenient treatment times for our patients. Under the umbrella of our comprehensive cancer program, we also integrated medical oncology, imaging/lab services, nutritional counseling, in-house pharmacy, and individualized patient navigation/ counseling—all services that help guide cancer patients through their journey. We strive to take care of the whole patient, not just their cancer.”

DOCTOR SPOTLIGHT

Building a partnership with patients is central to Kamath’s strategy of care. He hopes and expects patients to be honest and forthcoming about their symptoms, concerns, and wishes, and, in turn, he serves as a teacher and advisor in developing a personalized treatment plan for their care. “I make sure that when I sit down with patients, I give them the time that they need,” he said. Patients who see Kamath have often already met with other physicians, including medical oncologists. “The first thing I do with each of my patients is to review all of the information that I have about their specific diagnosis and situation. Later, we talk about radiation therapy and any role that it might play in their treatment.” Kamath credits his childhood friend’s journey for the development of his patient-focused approach. Kamath tries to put himself in his patients’ shoes. “I constantly remind myself—this could be me one day.”

Decades ago, radiation therapy was used not to cure cancer, but to shrink tumors and control symptoms of inoperable cancer, Kamath says. That has changed. “We now use radiation therapy more for front-end treatment for cure in addition to palliative care. With combined modality treatment we are achieving better outcomes.” This shift is due, in part, to advances in radiation technology. “We’ve gone from treating large static fields of radiation to pinpointed 3-dimensional radiation delivered with laser-like precision,” Kamath continued.

When not at work, Kamath is busy with his family. He and his wife have five children, including 1-year old twin boys. It’s not unusual for him to work 12 to 14 hour days. “Spending time with my family is important to me, and I try to spend as much time as I can outside of the clinic with them,” he says. In his spare time he enjoys traveling and playing sports.

He credits his parents with instilling in him a strong work ethic. “Growing up, my parents impressed upon my sister and me the importance of choosing a career where you love what you do,” said Kamath, whose sister is also a radiation oncologist practicing in Pennsylvania. “Every day I look forward to coming to work knowing that I am part of a team that works with our patients to help them get through the challenges and struggles that they face each day. I feel so blessed to have this opportunity and am thankful every day.”

The Whole PatientRadiation Oncologist Sachin Kamath, MD Focuses on the Patient BY ERIN HOOVER

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34 FCS The Magazine

Esther Mckay, RN, BSN, OCN and husband David

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Spring/Summer 2018 35

E sther McKay came to love nursing at a young age, captivated by the profession because of her own health struggles. She was born with several congenital defects impacting her heart, spine and

kidney, among other problems. “As a very small child, I was in and out of hospitals as a patient,”

said McKay, who is now a 53-year-old OCN at FCS. “I was taken care of by remarkable nurses, and I felt like it was my calling. I wanted to take care of people, and I never, ever deviated.”

What stuck in her mind, even as a child, was that most health professionals “took the time to teach me what was happening,” McKay said. “Education took away the fear and empowered me to be able to succeed.”

She takes the same approach with her patients. “I love to teach,” McKay said. “I love to make sure that my patients know what’s happening around them, so that they can advocate for themselves and be an active part of the process.” Understanding the process is especially important for cancer patients, she says. “It’s such a scary word.”

McKay primarily works in Winter Park, Florida, where she focuses on providing care and treatment to patients, which includes, but is not limited to, infusions for chemotherapy, biologic drugs and other supportive medications. While this can be filled with trauma and anxiety, she brings an upbeat attitude and understanding of what it means to be a patient searching for answers. To help ease the tension, McKay and the clinical team aim to add levity during treatment.

“We have fun, believe it or not, in our treatment room,” she said. “We spontaneously break out in song. Certainly we’re very professional and do everything we need to do, but we try really hard to keep it light and focus on living.”

That focus on patient care is one of the reasons McKay said she is proud to be a part of FCS. “I just love the patient care. I love working with my colleagues, from Physicians to Managers and Nurses. It’s a great team approach.”

While her dedication to nursing has never wavered, McKay began her career with a different focus. She was pursuing her Bachelors of Science in Nursing during her last year at the University of South Florida when she took part in a pilot program offering more practical skills as a Labor and Delivery

NURSE SPOTLIGHT

Nurse at Tampa General Hospital. When McKay graduated in 1987, she was hired.

After working 15 years in this field, she took time off in 2001 “to finish raising my son,” who is now 26.

When McKay returned to work in 2006, she was invited to shadow a friend that is a Nurse at Moffitt Cancer Center in Tampa, Florida. After four hours, McKay found the next step in her career.

“I loved it,” says McKay, “and I loved seeing all the love from people in this particular situation — brothers, sisters, mothers, daughters and fathers. I was just captivated by the whole experience and the emotion.”

Witnessing such love and attention made an instant impression, she added. “I thought, ‘I can do this.’”

McKay obtained certification as an Oncology Nurse and worked in the Infusion Department for Moffitt for seven years before her husband was transferred to an engineering job in Orlando, Florida. She then became a nurse with Hematology Oncology Consultants, which merged with FCS in 2015.

The work is intense, personal and also rewarding, McKay said. As one example, she talks about being there for a patient and her family, providing care and hugs and “near the end, more support.”

“It was a privilege and an honor to be a part of someone’s life in a time that’s so important,” said McKay. “I honestly don’t find it depressing. We all are here processing life. Any person can be faced with an obstacle or a challenge. It’s more about how we look at that.”

She is encouraged by the inroads being made in treating cancer and shares that optimism with patients.

“I try to tell patients that there are many things that can be done to battle the disease,” McKay said. “As we sit here, there are people working tirelessly, and there are new treatments and therapies constantly being approved.”

As for McKay, who loves to paddle board, bike and spend time with her rescue dogs, she understands the importance of hope and believing in the future. That hope has guided her since childhood.

“My heart was flipped the wrong way. I was born with one big kidney. I was told I’d never get pregnant. I defeated the medical odds,” McKay said.

“I kept living.”

Guidance Through ExperienceA Childhood of Medical Struggles Steered Esther McKay Into Her CallingBY BY ROCHELLE KOFF

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36 FCS The Magazine

Easing The BurdenFCS’ Revenue Cycle Team Works Behind The Scenes To Give Peace Of Mind To Patients And Their FamiliesBY ROB RUSHIN

The Florida Cancer Specialists’ Business Office in Fort Myers, Florida — “Corporate Two” to people in the know — usually doesn’t see many patients pass through its doors. But the work that goes on

in that building has a significant impact on the quality of care and patient satisfaction throughout the FCS network.

Comprised primarily of the FCS Revenue Cycle team, the staff at Corporate Two is responsible for establishing and managing FCS relationships with insurers and making sure that processes and insurance coverage are clear and efficient. Perhaps more importantly, the Revenue Cycle team is tasked with seeing that patients and their families receive reliable and comprehensive guidance in navigating the financial impacts of their treatment.

Recent years have witnessed growing concern for the negative impacts of “financial toxicity” in health care. This results from patients and families having to cope with extreme stress triggered by the financial burdens associated with sophisticated health care treatments. Because of this, some patients defer treatment, or choose to skip medications because of their concern over the costs involved. This can lead to damaged families and unwanted patient outcomes, but it does not have to be that way.

That is where Sarah Cevallos and her team come in. As Chief Revenue Cycle Officer for FCS, Cevallos oversees a team of around 450 professionals whose mission is to alleviate the financial strain on patients and free up the FCS Physicians, Nurses, and other Clinicians to concentrate on what they do best: win the fight against cancer.

“Our methods of helping cancer patients may look a little different than the ‘traditional’ method,” Cevallos says, “but the passion runs just as deep.”

DEPARTMENT SPOTLIGHT

Cevallos says that when her team is doing its job well, their efforts are “almost invisible” to patients and staff, and “that’s the way we like it.” To remain invisible, Cevallos and her team need to focus on ensuring that the hundreds of revenue cycle functions and processes run seamlessly to keep up with the fast-paced demands that occur within FCS’ clinics every day.

Within the Corporate Two location, a number of back office Revenue Cycle departments are working tirelessly to support this mission. These services include patient insurance registration, obtaining pre-authorizations and referrals, credentialing, contracting, financial aid for under insured patients, insurance billing and collections, payment posting, customer service and refunds. There are approximately 250 team members in this open concept office building that display FCS’ CARE Values, team photos, FCS memorabilia, and even personal photography from the FCS team that makes up these departments. The office was designed to encourage collaboration and promote teamwork amongst the teams.

“Our Financial Counselors are passionate about assisting patients through the difficult financial implications that may come from a cancer diagnosis,”said Christy Banach, Director of Patient Financial Services. “The individual attention and compassion they show to our patients day in and day out is something that is not always seen by others in the office. Their resilient dedication goes a long way to making the patients’ journey just a bit more bearable.”

Not all of their work is invisible. Some team members, the Financial Counselors, meet face-to-face with patients on a daily basis. They help each patient and family navigate paperwork and, more importantly, the options available

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Spring/Summer 2018 37

to alleviate any financial hurdles. Counselors deliver comprehensive knowledge of financial issues alongside a deft ability to relate to patients and put them at ease. Counselors are among the first people patients and families encounter at FCS, but their “invisible” impact leaves patients free to concentrate on a full recovery.

This location also provides a support team for the Financial Counselors located within each FCS clinic. That allows the Financial Counselors to focus on assisting the patients that are coming in each day with questions about their insurance or financial responsibility.

“Our Financial Counselor Support is a team of 20 who assist all FCS locations and nearly 200 Financial Counselors company-wide. Clinic support needs are ‘dispatched’ to the Corporate Two location by our Clinic Financial Managers, and they are assigned to a specialist who works alongside their in-clinic counterparts — ensuring everything is in order for the patient visit in regards to their financials,” explains Shari Duncan, the Financial Counselor Support Supervisor.

“Not only does this Revenue Cycle team ensure that they are providing the FCS network with the best revenue cycle support in the clinic locations and Corporate Two but there is also a team that works offsite to ensure that the physicians are able to see their patients by contracting and credentialing FCS clinicians with all of the major insurance carriers, hospital systems, and other integrated networks throughout the state. Throughout the entire network, this team manages hundreds of insurance payer agreements and maintain relationships with almost 100 hospitals that require ongoing oversite to ensure compliance with privilege requirements. In addition, this team ensures that all physician and lab license requirements are met throughout the network.

While the team juggles the mainstream requirements of insurance contracts, they also manage the value-based care initiatives that FCS has been leading since 2015 when we entered into our first value-based contract with Cigna Healthcare. Since then, FCS now has four value-based agreements which makes up for almost half of our patient population and continues to be looked upon as one of the most advanced community oncology practices in the country due to our never ending strive to be the best in the country.”

Being invisible is hard work. But that hard work, when done well, can go unheralded. It’s not easy to put in that kind of effort without a little acknowledgement. As leader of the team, Cevallos takes care to see that her team gets the recognition they deserve internally. More importantly, she goes to great lengths to ensure that her team understands the importance of their work to FCS’s overall mission.

“As the leader of the Revenue Cycle departments, I host a monthly “all-hands” meeting with our approximately 450 team members company-wide,” Cevallos said. “I take that time to remind our team members that the impact that their positions have on patients runs deep, even if most of them don’t see patients every day.”

It all boils down to their service to the larger mission. Cevallos constantly reminds her team that “even if cancer has or hasn’t been in their family or circle of friends, the work that they do every day is ‘impacted by cancer.’” And that their work has a big impact on the fight against cancer.

The supporting role may not be the most glamorous, but the people at Corporate Two enjoy a satisfying reward: knowing that their work relieves some of the strain on patients and families while making it possible for the FCS clinical teams to deliver the finest cancer treatment available.

“The back office team member’s (which include departments such as billing, collections, refunds, customer service, and payment posting) seat assignment is not based on which department they work in, rather, we set the team’s seating chart to be mixed amongst all departments. We did this to foster open communication and provide transparency to the various opportunities outside of their specific position. When a biller has a question about a claim, instead of trying to find a collector to answer their question, it is likely their neighbor so they can develop that relationship and get the question answered right away.”

–Melisa Chandler, Director of Revenue Cycle (Photo depicts Revenue Cycle team at theFCS Corp 2 Fort Myers Business Office)

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38 FCS The Magazine

FCS Vice President of Finance, Michael Essik

Michael and Julie enjoy spending their weekends at The Vibe Recording. For more information: www.facebook.com/TheVibeRecordingStudio/

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M ichael Essik said he strives for perfection each day.As Vice President of Finance at FCS, Essik

and his team work closely with the Accounting, Revenue Cycle and Operations teams to deliver

the comprehensive financial metrics that allow FCS leadership to effectively govern its business. Essik has held this leadership role since 2014, and he is based in Fort Myers, Florida.

For Essik, every day brings new challenges to go with his normal routine, which includes monthly reporting, financial discussions and financial analysis to support ongoing growth of the organization. He said he usually has a running list of about 10 projects he’s moving forward. Essik also personally handles compensation for Physicians who have joined FCS since 2013. “My mindset is to view the big picture when setting goals, go ‘all in’ every day; and I really mean that. I always look to improve in any way possible everything that I do.”

Essik assists Practices and Physicians with building their FCS affiliation by instituting monthly meetings that discuss financial results, trends and operational activities. Throughout the process, he said, “We maintain transparency and timely reporting, which allows for timely decision-making and keeping our operations on the desired track.”

Within his own department, Essik believes in maintaining autonomy with his team. “Overall, we know what needs to be accomplished. Routines like month-end reporting, getting physicians paid — those are some general goals. But each person has their own approach when it comes to analysis and preparing unique reports,” Essik said.

“It’s important that each associate enjoys their work and can provide their insights and contributions. It makes coming to work a pleasure. It helps you feel part of a team. The dedication of my team and, really, all of our employees, makes me proud to be part of FCS.”

Essik said that much of the financial reporting was done manually when he joined in 2013, when FCS was a smaller company. He has recently helped implement a new automated system to help manage financial information for the approximately 90 locations that make up FCS — a significant achievement as each practice had its own unique operations and arrangements within their groups and specialties.

“The knowledge wasn’t all in one place but throughout many departments. Creating the new system required getting to know everyone, getting to know the whole organization and then applying what I had learned through various other organizations in my career,” Essik said.

An Ohio native, Essik worked briefly for a transportation company, then as a school teacher and volunteer firefighter before beginning his financial career as an accountant for

SENIOR MANAGEMENT SPOTLIGHT

The Business Side is in Good Hands Senior Management Team Member Michael Essik BY ERIN HOOVER

a small Cleveland company. He later gained the bulk of his financial experience after joining the Timken Company, a global manufacturer of bearings in North Canton, Ohio. “Most meaningful, however, was my very first job that I began at age 12, working with my grandfather installing tile, flooring and counter tops,” Essik added. “We did that together through my college years. I have fond memories of those years.”

A subsequent job at Cardinal Health brought Essik to Florida, where he later worked for the drug distributor McKesson and for Charter Schools USA, an education management company. With each new stop came more financial responsibilities for Essik.

“In the financial profession, functions such as accounting and reporting can be performed at any type of business. But, in general, employers tend to be attracted to candidates that have experience specific to their type of business. Even though FCS is not a drug distributor, there was that small connection to my work at Cardinal Health and at McKesson,” he said.

Essik holds Bachelor’s Degrees in Finance, Business and Education from Walsh University and an MBA from Ashland University. At McKesson, he completed the green belt certification for Six Sigma, a set of techniques and tools for process improvement.

Six Sigma concepts revolve around reducing errors and building efficiencies, which has been helpful to Essik in his work for FCS. To him, perfection is another way of saying: “Be as error-free as possible.”

“I strive for perfection each and every day. Not that I always succeed in attaining perfection, but if I aim in that direction, I’m going to get close,” he said.

Because the financial side supports the whole organization, Essik sees a connection between achieving his goals and FCS fulfilling its mission. “The work that we do allows our physicians to focus on their profession, knowing that the business side is in good hands. Ultimately, that’s what is best for our patients — which is what matters most,” he said.

That doesn’t mean that Essik doesn’t try to keep balance between his work and his life. But even when he’s having fun, he’s also learning.

Outside work, Essik plays guitar in a band with his wife, daughter and son. The family band enjoys visiting Fort Myers’ own The Vibe Recording Studio, which offers an on-site recording studio and recording classes, as they hone their sound and try out new songs. “I’m self-taught since lessons were expensive when I was young,” Essik said, noting that kids have an advantage now with YouTube instructional videos. “Over the years, we’ve played for fun and also for small venues, working with other musicians from time to time. It’s kind of my alter ego, where I can express myself differently and just have fun.”

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