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12th Clinical Trial Billing & Research Compliance Conference (EXL)


Feb 25, 2018 – 12:30 PM

1850 Hotel Plaza Boulevard
Orlando, FL 32830 Map

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12th Clinical Trial Billing & Research Compliance Conference With the key areas of coverage analysis, reimbursement, coding, and billing focused upon this year in the 12th Annual Clinical Trial Billing and Research Compliance Conference, how can you afford to miss it? Start your plans now to not only attend the only event on clinical trial billing but have the luxury of being in Orlando with access to Disney and Universal Studios! Plan to increase your revenue and monitor billing integrity as you send your entire team to a full four-day conference featuring 25+ educational sessions, 40+ expert speakers, and 200+ attendees. Our goal is that you learn from expert speakers who have information to share with YOU and your billing compliance team! We hope to see you in the MAGIC of billing compliance! CCB Continuing Education Credits & AAPC CEUs The Compliance Certification Board (CCB)® has approved this event for up to 24.9 CCB CEUs. Continuing Education Units are awarded based on individual attendance records. Granting of prior approval in no way constitutes endorsement by CCB of this event content or of the event sponsor. This program also has the prior approval of AAPC for 29 continuing education hours (CEUs). Granting of prior approval in no way constitutes endorsement by AAPC of the program content or the program sponsor. Please contact Joel Nunez at for further information. Key Topic Areas for 2018 Revenue Cycle Management Billing Compliance Audits Coverage Analysis Government Payers Commercial Payers Financial Management Budgeting Contracting Who Should Attend The 12th Clinical Trial Billing & Research Compliance Conference is designed for professionals from sites, payers, CROs and sponsors with roles and responsibilities involving: Clinical Research Billing Clinical Trial Management Compliance Operations Consulting Contracts and Budgeting Coverage Analysis Grants Management Healthcare Provider Relationships Site Management Investigator Sites IRBs Managed Care, Medicaid and Commercial Health Plans Quality Assurance Research Administration Research Compliance Research Finance Regulatory and Quality Assurance Services Nurse Auditing Internal Audits This event is also of interest to: Advocacy Groups Agency and Capitol Hill Staff Brokers and Agents Health Services Researchers Legal Counsel Private Exchanges Software and Technology Providers Healthcare Providers Managed Care Organizations, Medicaid and Commercial Health Plans Medicaid Officers IRBs SMO Sponsors EHR and Hospital Billing Systems AGENDA Pre-Conference Workshop Day  SUNDAY, FEBRUARY 25 12:30PM – 1:00PM Registration for Workshop Attendees   WORKSHOP A 1:00PM – 5:00PM Advanced Coverage Analysis and the Budget Process – What’s the Secret? Kathleen Hurtado, R.Ph., Consultant, KELLY WILLENBERG & ASSOCIATES Chris Longspaugh, Pharm.D., Consultant, KELLY WILLENBERG & ASSOCIATES WORKSHOP B 1:00PM – 5:00PM Advanced Billing Audits — What You Need to Know Wendy Portier, MSN, RN, CHC, CHRC, CPHQ, Consultant, KELLY WILLENBERG & ASSOCIATES Cynthie Lawson, BSBM, CHRC, CPC, Consultant, KELLY WILLENBERG & ASSOCIATES   5:00PM – Workshop Day Concludes Day One  MONDAY, FEBRUARY 26 7:30AM – 8:00AM Registration and Continental Breakfast 8:00AM – 8:15AM Welcome by Conference Chair and Opening Plenary Remarks: Current Issues in Clinical Trial Billing Compliance Kelly Willenberg, DBA, RN, CCRP, CHRC, CHC, President, KELLY WILLENBERG & ASSOCIATES 8:15AM – 9:15AM The Payer Issues Panel Moderator: Kelly Willenberg, DBA, RN, CCRP, CHRC, CHC, President, KELLY WILLENBERG & ASSOCIATES Panelists: Thom R. Mitchell, M.D., FACEP, FACP, Senior Contractor Medical Director, CAHABA GBA, LLC Sunil V. Lalla, M.D., FACS, Medical Director, JURISDICTIONS H & L, NOVITAS SOLUTIONS, INC. Olatokunbo Awodele, M.D., Contractor Medical Director, NATIONAL GOVERNMENT SERVICES, INC., J6 9:15AM – 10:00AM CMS Update — Where Are We Today After 17 Years With the Clinical Trial Policy Kimberly Brandt, Principal Deputy Administrator for Operations, CENTERS FOR MEDICARE AND MEDICAID SERVICES Ryan Meade, J.D., CHRC, Senior Fellow, Center for Compliance Studies,  LOYOLA UNIVERSITY OF CHICAGO SCHOOL OF LAW 10:00AM – 10:30AM Networking Break 10:30AM – 11:15AM Provider Relations From the Medicare Jurisdictions — Who Do You Call When You Have a Question? Moderator: Kelly Willenberg, DBA, RN, CCRP, CHRC, CHC, President, KELLY WILLENBERG & ASSOCIATESThom R. Mitchell, M.D., FACEP, FACP, Senior Contractor Medical Director, CAHABA GBA, LLCSunil V. Lalla, M.D., FACS 11:15AM – 12:00PM Revenue Optimization! J. Christian Weydert, MBA, Coverage Analysis Specialist, GUIDESTAR Tracy Popp, Director of Research Financial Operations, NORTON HEALTHCARE RESEARCH OFFICE 12:00PM – 1:00PM Luncheon 1:00PM – 1:45PM A Comparison of Institutional Processes and Experiences of Research Revenue Cycle Management With and Without CTMS and/or EMR Lila Dalton, B.S., RN, Director, Clinical Trial Center, LOMA LINDA UNIVERSITY HEALTH Kristi Davis, A.A., Research Administrator, UNIVERSITY OF ARIZONA HEALTH SCIENCES CENTER 1:45PM – 2:30PM How to Build a Dynamic Education Program: An Overview of GEAR Rhonda Hoffman, System Director, Research, NORTON HEALTHCARE RESEARCH OFFICE 2:30PM – 3:15PM Investigational Device Exemption Clinical Trials — Reimbursement Challenges and Best PracticesRebecca Ohta, R.N., Manager, RRO, THE QUEENS MEDICAL CENTER 3:15PM – 3:45PM Networking Break 3:45PM – 4:30PM Discussion on the Use of a CTMS and an EHR — Your Questions Answered! Suzanne Nicholl, Ph.D., CCRA, Senior Account Manager, BIO-OPTRONICSRick Leesmann, Lead Solution Strategist, CERNER CORPORATIONBishoy Anastasi, Director, UCLA Office of Clinical Research, Financial Coverage & Activation, UCLA 4:30PM – 5:00PM Benefits to Using CTMS Enhancement in Billing Compliance Suzanne Nicholl, Ph.D., CCRA, Senior Account Manager, BIO-OPTRONICSMichelle Smith, CCRC, Research Project Coordinator, SETON 5:00PM – 5:30PM Improving Site Efficiency and Compliance Through Centralized Document Management Rick Arlow, Founder and CEO, COMPLION 5:30PM – 6:30PM Networking Reception Day Two TUESDAY, FEBRUARY 27 7:30AM – 8:00AM Registration and Continental Breakfast 8:00AM – 8:15AM Chairperson’s Recap of Day One Kelly Willenberg, DBA, RN, CCRP, CHRC, CHC, President, KELLY WILLENBERG & ASSOCIATES 8:15AM – 9:00AM Clinical Trial Billing and Financial ManagementKelly Willenberg, DBA, RN, CCRP, CHRC, CHC, President, KELLY WILLENBERG & ASSOCIATES 9:00AM – 9:45AM The 60-Day Overpayment Requirement Sonya Castro-Quirino, AVP, , TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER 9:45AM – 10:15AM Networking Break 10:15AM – 11:00AM The Sunshine Act and Compliance in Research Jeanna Julo, B.A., B.A., CCRP, Assistant Director, Clinical Data Management and Quality Controls, Auditing and Training, KANSAS UNIVERSITY MEDICAL CENTER RESEARCH INSTITUTE 11:00AM – 11:45AM We’re All in This Together: Including All Stakeholders in Hospital-Based Research Alicia Drew, MSN, RN, CNL, RADIOLOGY IMAGING ASSOCIATES, P.C. 11:45AM – 12:45PM Luncheon 12:45PM – 1:30PM A Practical Approach to Clinical Trial Capacity PlanningPhilip J. Butera, MBA, Administrative Director, Clinical Trials, LEVINE CANCER INSTITUTE, ATRIUM HEALTH 1:30PM – 2:15PM Coverage With Evidence Development: Navigating the Maze Shanna Ford, BSHCA, CPC, CHRC, Clinical Research Compliance Officer, UNIVERSITY OF UTAH  2:15PM – 3:00PM Weaving Research Compliance Into Corporate Compliance Donetta Horseman, Chief Compliance Officer, MOFFITT CANCER CENTER 3:00PM – 3:30PM Networking Break 3:30PM – 4:15PM Maintaining Regulatory Obligations of an IND/IDE Denise A. Roe, MSM, RAC, CHRC, CCRP, CIP, Vice President, Clinical Research Regulatory and Quality Management, ST. JUDE CHILDREN’S RESEARCH HOSPITAL 4:15PM – 5:15PM Molecular Diagnostic Testing: Alphabet Salad With a Side of Codes Wendy Schroeder, RN, BSN, CCRC, CRCP, Director of Research and Regulatory Programs, VISIONGATE, INC. 5:15PM – Wrap-up by Conference Chair Kelly Willenberg, DBA, RN, CCRP, CHRC, CHC, President, KELLY WILLENBERG & ASSOCIATES Master Class Day WEDNESDAY, FEBRUARY 28 8:00AM – 8:30AM Registration and Continental Breakfast   MASTER CLASS A 8:30AM – 12:00PM Barrel of Monkeys: CTMS or No CTMS (or Two) and Billing Compliance Sally Shipley, Manager, Research Finance and Regulatory Affairs, CARLE FOUNDATION HOSPITALJoe Fugitt, Manager, Research Finance, SPECTRUM HEALTHAnya Dang, CPC, Research Revenue Integrity (RRI), UNIVERSITY OF CALIFORNIA IRVINE HEALTH MASTER CLASS B 8:30AM – 12:00PM The Preauthorization and Financial Review Process From Having Done It Dawn N. Pittinger, MBA, CHRC, CRCP, Manager, Clinical Research Billing, SUMMA HEALTHLinda Iovanni, MBA, BSN, RN, CCRP, Chief Operating Officer/ Director of Research, MARYLAND ONCOLOGY HEMATOLOGYKathleen Hurtado, R.Ph., Consultant, KELLY WILLENBERG & ASSOCIATES MASTER CLASS C 8:30AM – 12:00PM Building Processes: The Trek Toward the 21st Century Heather Davis, B.A., CHCP, Director, Center for the Advancement of Research and Education, STEWARD HEALTH CARE SYSTEM — WEST DIVISIONChristina Jackson, MJ, BSN, RN, CCRC, CHRC, Compliance and Education Manager — Responsible Study Conduct Conflicts of Interest Official for Research Services, FH OFFICE OF RESEARCH INTEGRITY   12:00PM – 1:00PM Working Lunch 1:00PM – Master Class Concludes, End of Conference ----------Faculty---------- Bishoy AnastasiDirector, UCLA Office of Clinical Research, Financial Coverage & Activation, UCLA Rick ArlowFounder and CEO, COMPLION   Complion founder Rick Arlow was immersed in clinical research during an NIH-funded M.D./Ph.D. medical scientist training program at Case Western Reserve University, which resulted in publications with several leading journals, including Neuroscience. Although he loved the work, he was shocked at how cumbersome operations and regulatory compliance were for the research sites and how much time was wasted on manual tasks and paper binders. Inspired by his experience and drawing on his engineering background, Rick put together a world-class team experienced in clinical research and enterprise content management to build Complion, a document management and workflow platform. Built specifically around the needs of clinical research sites, Complion helps reduce regulatory burden, improve compliance and streamline operations. Since its founding, Complion has grown to be the industry-leading solution used by physicians, hospitals, academic medical centers, health systems and cancer centers around the country. Rick is a frequent lecturer for several professional research organizations, including ACRP, MAGI and SCRS. He was involved with a biotech business resulting in several patents and was recognized in Business Week’s “Top 25 Under 25 Entrepreneurs.” Rick takes great pride in Complion’s contributions to the research community and their mission to improve patient outcomes and expand medical knowledge. Olatokunbo Awodele, M.D. Contractor Medical Director, NATIONAL GOVERNMENT SERVICES, INC., J6 Dr. Olatokunbo Olufunmike Awodele is currently one of the Contractor Medical Directors at Wisconsin Physicians Service (WPS) with oversight of Medicare Jurisdictions J5 and J8. She is a graduate of the University of Medicine and Dentistry of New Jersey – Robert Wood Johnson Medical School (now Rutgers Robert Wood Johnson Medical School), and the Rutgers University School of Public Health, where she earned a combined M.D./MPH. She completed her Family Medicine residency at the JFK Medical Center Family Medicine Residency in Edison, New Jersey. She is board certified by the American Board of Family Medicine. Prior to working with WPS, she was a physician reviewer with BCBS of Nebraska for four years and owned her own family medicine practice for nine years. Dr. Ola has been married for more than 22 years and has three children.   Philip J. Butera, MBA Administrative Director, Levine Cancer Institute, CAROLINAS HEALTHCARE SYSTEM   Phil Butera is the Director of Clinical Trials at the Levine Cancer Institute. Phil has primary responsibility for overseeing clinical research operations of adult and pediatric trials regionally. In addition, Phil develops and leads enterprise strategy through programmatic, geographic, technical/operational assessments and planning for continued growth. Phil has 26 years of research and commercial operations experience in the pharmaceutical industry and on the clinical trial site side. His experience ranges from clinical supply chain management, project/vendor management, quality assurance, and developing streamlined processes using lean continuous improvement methodologies. Phil has a bachelor’s degree in Business and a Master’s in Business Administration with a concentration in statistics. Sonya Castro-Quirino, AVP Institutional Compliance Officer, TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER  Sonya Castro-Quirino is the AVP, Institutional Compliance Officer for Texas Tech University Health Sciences Center. Sonya has primary responsibility for overseeing billing and privacy compliance efforts for three academic medical center campuses located throughout West and Northwest Texas. Sonya has over 15 years of compliance experience in government, private and public healthcare. Her experience ranges from monitoring healthcare providers subject to Corporate Integrity Agreements while employed with the Office of Inspector General, developing and implementing an audit and compliance program for Wal-Mart’s 1500+ pharmacies, and serving as a compliance officer for a non-profit healthcare provider and a public academic medical institution. Sonya has a bachelor’s degree in Clinical Laboratory Science and a Master’s in Business Administration with a concentration in Healthcare Organizational Management. Lila Dalton, RN, BSN, CCRPDirector, Clinical Trial Center, LOMA LINDA UNIVERSITY HEALTH Ms. Lila Dalton works under the auspices of institutional leadership of Loma Linda UniversityHealth to produce and implement the strategic plan for the Clinical Trial Center. She overseesadministration in the areas of clinical trial contracting, financial management, site operation andtraining, as well as development and promotion. Furthermore, she collaborates with clinical trialsite personnel and ancillary service providers to ensure good procedural adherence and clinicaltrial progress. Ms. Dalton has been a Registered Nurse since 1992, received her BSN in 2009 and has beencertified as a Clinical Research Professional since 2010. She has over nineteen years ofexperience in clinical research field, with specialized practice in pediatrics, neonatology, andoncology. Her various roles within clinical research have encompassed nursing, coordination,and management. Anya Dang, CPC Research Revenue Integrity (RRI), UC IRVINE HEALTH Anya Dang is currently the Revenue Clinical Trial Analyst of the Research Revenue Integrity under Revenue Integrity at the UC Irvine Health, which is responsible for approval of coverage analysis, securing CMS approval of device trials, management of all hospital and physician research accounts, adverse event sponsor invoicing, research charge master management, and providing OnCore and EPIC support across the enterprise. Anya has 10+ years of extensive clinical research experience as it relates to regulatory affairs, IRB, budgeting, negotiations, coverage analysis, coding, and billing.  Kristi Davis Research Administrator, UNIVERSITY OF ARIZONA HEALTH SCIENCES CENTER Kristi Davis has over 17 years of experience in healthcare administration and compliance. Kristi has a passion for developing efficient, compliant, and streamlined processes-especially for oncology patients who already have an incredible burden placed upon them. During her time working with the University of Arizona stem cell transplant team as a patient financial coordinator, Kristi was able to develop an organized referral process for Medicaid plan members and also worked with Physicians and Hospital administrators to increase the referral base for pediatric and adult patients beyond the extent of the hospitals Transplant Network. She also aided patients and institution with the overturning of payor denials. Kristi’s experience and knowledge led her to her current role as a Research Administrator with the University of Arizona Health Sciences, where she focuses on coverage analysis development and budget negotiation in oncology clinical trials. Kristi has applied her many years of involvement working with the oncology patient population to tirelessly ensure accuracy, compliance, and transparency. She has assisted with the implementation of a clinical trial management system for financial management and billing compliance while facilitating a streamlined and consistent processes for billing review and charge validation within an electronic medical record management system. Kristi is insightful and astute regarding patient advocacy, compliance, and transparency. She is a natural teacher and her greatest joy is educating about and advocating for better process in clinical trials administration and finance. Heather Davis, B.A., CHCP Director, Center for the Advancement of Research and Education , STEWARD HEALTH CARE SYSTEM - WEST DIVISION  Heather’s healthcare experience began in early 2000 when she started working at a Cardiovascular Surgery practice in The Texas Medical Center. Her career path evolved overtime to a bifurcated focus in CME and Medical Research. Her CME career began in April 2005 as a CME Coordinator for a smaller community hospital. Heather served as a valued member of St Joseph Medical Center’s CME Committee and is an active member of the Texas Alliance for Continuing Medical Education (TACME). In June 2014, she was elected Treasurer of the executive board of TACME. As a CME professional, her goal is to truly impact the healthcare environment and physicians by providing activities to build knowledge and provide the tools needed to deliver the highest quality of patient care. She is proud to have worked closely with a small group to plan, implement, and launch St. Joseph Medical Center’s CME program’s first on-demand enduring material activity. Heather earned her CHCP (Certified Healthcare CPD Professional) credential in 2015. In addition to her CME experience, Heather’s research career started in 2007, when the role of IRB Coordinator merged with the CME Coordinator role. Heather worked closely with the IRB Committee reviewing protocols for IRB oversight to ensure the protection of human subjects. In her current role, she ensures research compliance within the IASIS Healthcare System as well as supports and advocates for IASIS Healthcare’s continuing education programs. Heather recently expanded IASIS’ affiliation with Western IRB to serve as the IASIS Healthcare System’s IRB of record. Research support for our sites includes budgeting, contracting, regulatory, site management, IRB submission, and compliance training of investigators, coordinators, residents, and medical students. As a research professional, her goal is to promote and support research development, investigators, and study team members to ensure compliance and ultimately provide other treatment options for patients who have exhausted traditional medicine. She is an active member of The Society of Clinical Research Associates, SOCRA and an active member of Model Agreements & Guidelines International, MAGI. She is currently working towards her CCRP credential (Certified Clinical Research Professional). Alicia Drew, MSN, RN, CNL Director of Research and Physician Services, RADIOLOGY IMAGING ASSOCIATES, P.C. Alicia Drew, RN is the Director of Research and Physician Services at Radiology ImagingAssociates, a community-based private radiology practice in Denver, Colorado. Comprised ofover 80 physicians, RIA provides professional comprehensive imaging services at 13 InvisionSally Jobe outpatient centers and numerous hospitals in Colorado, Nebraska and Kansas. Alicia’s nursing and administrative experience in a variety of clinical settings has beenadvantageous in building a strong research department structure that can support an expandingportfolio of clinical research in both the private practice and hospital-based settings. Thisbackground gives an important understanding of clinical processes and work flow that is crucialfor the successful integration of research into private practice. Alicia’s clinical focus has been primarily women’s health. Prior to joining Radiology ImagingAssociates, her responsibilities have included administration, nurse navigation, casemanagement, program implementation, grant and non-profit management, quality and work inacademia. Alicia received her Bachelor of Science and Master of Science in Nursing from theUniversity of Oklahoma. Shanna Ford Clinical Research Compliance Officer, UNIVERSITY OF UTAH Shanna Ford is a Clinical Research Compliance Officer at the University of Utah in the Clinical Research Compliance and Education department. Shanna provides coverage analysis for the Internal Medicine departments as well as helps facilitate processes, provides education, and engages in oversight activities to ensure that clinical services are appropriately charged and that claims submitted comply with federal regulations. She has over 20 years’ experience in the healthcare industry and has worked in research billing compliance since 2009. Ms. Ford previously managed a family practice clinic. She has her B.S. in Health Care Administration, is a Certified Professional Coder by the AAPC, and is certified in Health Care Research Compliance by the HCCA.   Joe Fugitt Manager, Research Finance, SPECTRUM HEALTH Joe Fugitt is the Manager of Research Finance at Spectrum Health System in Grand Rapids, MI. He is responsible for oversight of the patient billing compliance process, the Medicare coverage analysis process, new clinical trial pricing, and clinical trial management software (CTMS) usage.  In his over 7 years of research finance and billing compliance experience at Spectrum Health he has negotiated new clinical trial budgets, implemented a CTMS, implemented the Medicare coverage analysis process, managed a portfolio of clinical trials in pediatrics, oncology and cardiovascular health, developed a comprehensive workbook to improve research coding efficiencies and compliance and has reduced insurance payer denials for research participants. Joe has lead process improvements that have resulted in reduced patient bill holds and increased the amount of bills sent to insurance by over $10 million while utilizing two CTMS’s. Most recently he has been an integral part in leading a new electronic health record implementation that impacts research including research billing for facility and ambulatory.     Rhonda A. Hoffman, CCRP System Director, Research, NORTON HEALTHCARE RESEARCH OFFICE Rhonda Hoffman has been working in clinical research for over 20 years as part owner of a Louisville based CRO and at hospitals in the Louisville metro area. For the past 8 years, Rhonda has served as the System Director of Research at Norton Healthcare. She was instrumental in establishing the Gaining Essentials about Research (GEAR) program to promote continuing education for research professionals in the Louisville metro area and this program won the Making a Difference Award at Norton Healthcare. Rhonda has been a member for 12 years and has served for the past 8 years as the chair of the Collaborative Research Group (CRG), a collaboration of research institutions in Louisville, KY.   Kathleen Hurtado, R.Ph. Consultant, KELLY WILLENBERG & ASSOCIATES Kathleen Hurtado was named Chief Executive Officer of Health Research Association, a University of Southern California subsidiary dedicated to providing full-service clinical trial support to USC faculty, in August 2004. An experienced senior executive in the pharmaceutical and biotechnology industries, Ms. Hurtado has spent her career successfully developing, marketing and selling ethical pharmaceuticals. Prior to joining HRA she served as the Director of Operations at the American College of Surgeons Oncology Group at Duke University. Kathleen began her career as a pediatric oncology pharmacist at the MD Anderson Cancer Center in Houston, Texas.  Ms. Hurtado was educated at the University of Houston, where she earned her B.S. in pharmacy.  Ms. Hurtado is affiliated with numerous organizations, including the American College of Healthcare Executives, Board of Councilors the University of Southern California School of Pharmacy, Board of Directors of Priority Healthcare Corporation, Board of Directors for the Westside Family Center and a volunteer at the Downtown Women’s Center.  In her spare time she enjoys hiking, biking, reading, and spending time with her dogs and family.  Linda Iovanni, MBA, BSN, RN, CCRP Chief Operating Officer/ Director of Research, MARYLAND ONCOLOGY HEMATOLOGY Linda Iovanni, MBA, BSN, RN, CCRP is an energetic clinical research professional who works with healthcare organizations to help them refine research operations and navigate the maze of best business practices, regulatory compliance and good clinical practices. With more than 28 years of nursing experience and the majority of her nursing career dedicated to clinical research endeavors, Linda has a true passion for medical treatment options for patients, human subject protection and research compliance and education. She has a breadth of site research regulatory knowledge and a depth of people management skills and healthcare business acumen using lean methodologies that has served her teams well. Linda currently serves as the Chief Operating Officer/ Director of Research at Maryland Oncology Hematology. She provides leadership, compliance oversight and fiscal stewardship to a team of 37 investigators and 24 clinical research staff at 8 research sites of over 150 phase 1 thru 4 oncology studies with a 2.7 million dollar portfolio. Prior to joining Maryland Oncology, Linda lead the development of the Clinical Trials Office at HonorHealth, with a focus on early phase oncology trials under the tutelage of renowned Investigator Daniel Von Hoff, MD. She also was a Practice Administrator/ Research Director of a multi provider cardiology practice and research program, provided research operational consulting services to new investigators, and held many research roles for Banner Health in Arizona. These positions include Facility Research Director, Corporate Director of Research Education and culminated as their Corporate Director of Research Compliance and Regulatory Affairs. Linda also served as the Director of Research Policy and Accreditation Standards for the first national Research Accreditation program developed by the National Commission of Quality Assurance (NCQA) in Washington, DC. Using her extensive research nurse coordinator experience of personally conducting or managing more then 1800 early to late phase multi-disciplinary clinical trials, she is adept at understanding the site clinical research continuum and how it overlays and intersects with overall clinical care. Linda received her Bachelor’s Degree in Nursing from Hartwick College in Oneonta, New York, her MBA from University of Phoenix in Phoenix, Arizona. She is a Certified Clinical Research Professional with Society of Clinical Research Associates (SOCRA) and currently divides her time between Maryland and Phoenix, AZ. Christina Jackson, BSN, RN, CCRC, CHRCCompliance & Education Manager – Responsible Study Conduct Conflicts of Interest Official for Research Services, FH OFFICE OF RESEARCH INTEGRITY Ms. Jackson has over 23 years of clinical research experience with the last 7 years being in researchcompliance. She is a registered nurse and graduated with her BSN in 1990, working in critical carenursing prior to entering clinical research. She began her research career in 1994 in cardiology researchas a research coordinator. In 1998 she launched a new research department with a cardiology practiceand later established a stand-alone research clinic with a family medicine physician. Ms. Jackson enteredresearch compliance in 2010 at Florida Hospital in Orlando, FL, and graduated from Loyola Law School ofChicago in August, 2017 with her Masters of Jurisprudence in Health Law. Her current responsibilities asa Research Compliance Manager include oversight of compliance with good clinical practice standards,clinical trial billing, responsible conduct in research, and financial conflicts of interest. She teachesclasses on a regular basis and strives to improve processes at the Florida Hospital Research Institutewhich is comprised of 17 research departments across several campuses. Ms. Jackson presented at the2014 Association of Clinical Research Professionals (ACRP) Global Conference & Exhibition, and co-authored a publication in Clinical Investigator in January, 2015. Jeanna Julo, BA, CCRP Assistant Director, Clinical Data Management and Quality Controls, Auditing and Training, KANSAS UNIVERSITY MEDICAL CENTER RESEARCH INSTITUTE Jeanna Julo is the Assistant Director for Clinical Data Management and Quality Controls at the Research Institute of the University of Kansas Medical Center. She is responsible for the auditing, training, and educating of current clinical research administration staff. She also develops and enhances clinical policy, content, and procedures to ensure consistency and quality of studies, documents, and submissions to federal agencies that meet GCP requirements. Jeanna has a Bachelor’s Degree in both Chemistry and Biology from the University of Missouri-Kansas City, and she has been CCRP certified since 2013.   Sunil V. Lalla, M.D., FACS Medical Director, Jurisdictions H & L, NOVITAS SOLUTIONS, INC. Dr. Sunil V. Lalla is a Medical Director with Novitas Solutions, Inc. He serves as the Medicare Administrative Contractor (MAC) Medical Director for Jurisdiction H (Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma and Texas) and Jurisdiction L (Pennsylvania, Maryland, New Jersey, and Delaware and the District of Columbia). Dr. Lalla grew up in Georgia and completed his undergraduate studies at Emory University. He chose to remain in Atlanta and is a 1988 graduate of the Emory University School of Medicine. He completed his residency in General Surgery at the University of Tennessee Health Science, Memphis and served as Chief Resident. After completing his training, Dr. Lalla founded his private practice of General Surgery in South Carolina and remained in private practice for almost two decades. He has served in many leadership roles during that time, including Chief of Surgery and Chair of Quality Improvement Council, in addition to serving on the Board of Trustees of the South Carolina Medical Association. He then was recruited to found and establish a hospital-based surgery group at the South Carolina coast, where he remained until he accepted his present position with Novitas Solutions, Inc. Dr. Lalla has considerable experience with billing and coding and is a Certified Professional Coder (CPC). He is a Diplomate of the American Board of Surgery and a Fellow of the American College of Surgeons. Cynthie Lawson, BSBM, CHRC, CPC Consultant, KELLY WILLENBERG & ASSOCIATES Cynthie Lawson works as an independent contractor with Kelly Willenberg, LLC and has over 15 years of experience in financial and revenue cycle. Cynthie’s expertise is in in research operations including billing compliance and financial management. She has a strong background and expertise encompassing study start-up to final closeout. She has extensive experience with developing and improving process flows for revenue cycle and financial systems. She has experience working with EMR and billing systems including EPIC, Cerner, Meditech and others. Her experience includes: Coverage Analysis, clinical trial budget forecasting and negotiations, claims processing, claim denial reviews and appeals, managing internal and external monitoring and audits, accounts payable and receivable, as well as grant management and SEFA reporting. She is certified as a Healthcare Research Compliance Professional (CHRC) and a Certified Professional Coder (CPC). Most recently, Cynthie was the Research Finance Manager at a large Health System. Cynthie has presented on topics including: Developing a Coverage Analysis, Research Billing Compliance for the Investigator, Research Billing Compliance for the Site, Subject Injury Language, and Front to Back-End Research Billing Processes. Donnetta Lee Horseman, CHC, CHRC, CHPC, CIPP/US, CCE Chief Compliance Officer, H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE Donnetta Horseman is the Chief Compliance Officer at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida where she oversees development, implementation, and management of the day-to-day operations of the Corporate Compliance Program. Prior to joining Moffitt, she was the VP for Business Integrity and Corporate Responsibility Officer for CaroMont Health (Gastonia, NC), with direct responsibility for developing, implementing, and communicating a system-wide corporate responsibility program. Donnetta holds the CHC (Certified in Health Care Compliance, CHRC (Certified In HealthCare Research Compliance), and CHPC (Certified in HealthCare Privacy Compliance) from the HCCA, as well as the CIPP/US (Certified Information Privacy Professional) from the IAPP, and the CCE (Certified Compliance Executive) from the Health Ethics Trust.   Rick Leesmann Lead Solution Strategist, CERNER CORPORATION Rick is the Lead Solution Strategist for Cerner’s clinical research EMR solutions and has worked with some of Cerner’s largest academic clients. Prior to his current role, he consulted on both healthcare process and EMR design for several years as a Cerner Millennium Integration Architect. In addition to his current responsibilities, Rick is an undergraduate adjunct instructor teaching courses in subjects that include health IT, regulations, and medical billing/coding. Chris Longspaugh, Pharm.D.Consultant, KELLY WILLENBERG & ASSOCIATES Dr. Chris Longspaugh, a pharmacist with a varied career, has more than 15 years of experience in multiple areas of clinical research, including billing compliance, clinical trial operations, information technology and project coordination. Most recently Chris served as Senior Manager of Medical Operations of a mid-sized biotech company where he was responsible for clinical trial budgeting and forecasting, strategic planning, and key opinion leader endeavors. Chris spent more than eight years at the University of Southern California leading a team conducting prospective clinical trial coverage analyses. As a member of the management team there, he produced operational, budgeting and financial trial reporting tools utilized by the institution. Chris has presented on topics including clinical trial policy/NCD 310.1, investigator-initiated research, clinical trial budgeting and billing processes, routine costs in clinical trials, and research compliance.   Ryan Meade, J.D., CHRC Senior Fellow, Center for Compliance Studies, LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW Ryan Meade is the Director of Regulatory Compliance Studies at Loyola University Chicago School of Law. He focuses his work within the Beazley Institute for Health Law and Policy on courses addressing both long-standing and emerging regulatory challenges for healthcare organizations. He supervises LLM student theses dealing with regulatory compliance and compliance programs, and he assists the Institute in outreach to healthcare associations supporting compliance programs. Professor Meade focuses his legal practice on Medicare and Medicaid compliance, clinical research regulatory law, privacy and security of health information, and the organizational integration of compliance programs. Professor Meade has been active within the healthcare industry promoting the adoption of compliance programs and educating industry leaders. He serves on the faculty of the Health Care Compliance Association’s Compliance (HCCA) Academy, where he teaches “Stark/Anti-kickback, “Auditing & Monitoring,” and various research regulatory topics. He co-chairs HCCA’s annual Research Compliance Conference. He is a member of the advisory boards and an exam writer for the Compliance Certification Board’s Certification in Healthcare Compliance (CHC) and Certification in Research Healthcare Compliance (CHRC). He has served on the advisory board of the CMS Compliance Effectiveness Pilot Project. He has practiced as an associate at Mayer, Brown & Platt and as a partner at Katten Muchin & Zavis, and is one of the founding partners of Meade, Roach & Annulis, LLP and its affiliated consulting firm, Aegis Compliance & Ethics Center, LLP. Since graduating law school he has also studied theology at the University of St. Mary of the Lake and philosophy at Oxford University. Professor Meade’s academic interests focus on the role of the regulatory state in contemporary society, the interaction of ethics and civil law, the history of Anglo-American common law, and the organization of the healthcare system in the United States. He also has interests in legal theory and language. He taught in the Law School as an adjunct for 12 years and also served as an assistant professor at Rush University for more than 10 years. Thomas Mitchell, M.D., FACEP, FACP Senior Contractor Medical Director, CAHABA GBA, LLC Dr. Mitchell grew up in Florida, Texas and Mexico. He attended Cornell University and pursued graduate work in Poultry Science at Cornell. He then attended Cornell University Medical College and subsequently trained in Internal Medicine at Vanderbilt University. Following a Chief Residency in Internal Medicine at the Nashville VA Medical Center he became the Director of Emergency Services at Metropolitan Nashville General Hospital. This was an active inner city ED experiencing around 40,000 visits per year staffed predominantly by house-staff. He has practiced Emergency Medicine for 29 years, most recently in a critical access Emergency Department in rural Tennessee. During that time he also served as the Market Medical Director for Aetna Health Plans of Tennessee and as the Assistant Medical Director for a startup Medicare Advantage plan based in Nashville. He joined Cahaba GBA four years ago as an Associate Medical Director and was promoted to Executive Contractor Medical Director in February of 2015. He continues to practice emergency medicine part time. He is Past President of the Tennessee Chapter of the American College of Emergency Physicians and serves on the reimbursement committee of the American College of Emergency Physicians. Suzanne Nicholl Senior Account Manager, BIO-OPTRONICS Suzanne Nicholl is a Senior Account Manager with Bio-Optronics and has been working in the Clinical Research industry for almost 20 years specializing in clinical research management and helping large site networks and health systems streamline their overall research efficiencies. She has a PhD in Cardiovascular Pharmacology and is a certified CRA. Suzanne strives to help deliver best practices that utilize technology to research organizations around the world. More personally, Suzanne enjoys traveling to her home in Ireland, martial arts and spending time with her two children. Rebecca Ohta, R.N. Manager, RRO, THE QUEENS MEDICAL CENTER Rebecca Ohta, BA, BSN, RN has over 20 years experience as Administrator for The Queen’s Medical Center Institutional Review Committee in Honolulu, Hawaii. The last 3 years have also included leading the process of research billing compliance of MCA builds, contracts and budget negotiation, authorizations, hospital and professional billing, system-wide eMR and CTMS implementation. She has experience as a study coordinator, quality management, staff and charge nursing in burns and telemetry, and metabolic analysis in ICU. Dawn N. Pittinger, MBA, CHRC, CRCP Manager, Clinical Research Billing, SUMMA HEALTH Dawn Pittinger is the Clinical Research Billing Manager at Summa Health in Akron, Ohio. Summa Health is a healthcare system consisting of several community hospitals, outpatient centers, free standing EDs and a physician group that functions as teaching facilities without the academic medical center infrastructure. She has 9+ years’ experience in scientific and clinical research with seven of these years focused in clinical research billing for all departments at her institution for both the hospital and professional spectrum. She was instrumental in the initiation and development of a centralized billing office and is currently leading the build and implementation of a CTMS. Dawn recently obtained her MBA in Healthcare Administration, is CHRC and CRCP certified. She is also trying to decide, “What’s next?” Tracy Popp, MBA, CRCP, CCRPDirector of Research Financial Operations, NORTON HEALTHCARE RESEARCH OFFICE Tracy Popp, MBA, CRCP, CCRP, is the Director of Research Financial Operations at Norton Healthcare, Inc. in Louisville, Kentucky. Tracy oversees the wide spectrum of financial operations related to research, including contracting, budgeting, billing, accounting, coverage reviews and finance. She has more than 14 years of experience in healthcare accounting, with the last seven focused on research finance. Tracy received her MBA from Webster University and completed her B.A. in accounting at Valdosta State University. Under her leadership, she has built the dynamic research finance team that exists today at Norton Healthcare. She is a member of various accounting and clinical research groups. Wendy Portier, MSN, RN, CCM, CHRC, CHCConsultant, KELLY WILLENBERG & ASSOCIATES Wendy Portier has more than 25 years of experience in healthcare, including managed care, quality, healthcare compliance, clinical research compliance, clinical research, care management and critical care nursing. Having worked on the provider, researcher, payer and sponsor sides, Wendy has a unique perspective and extensive knowledge regarding clinical research compliance. Her specific research compliance experience includes process improvement, government inspections and responses, auditing, monitoring, the implementation of compliance programs, and research billing revenue cycle improvements — from coverage analysis, authorizations and claims review to denials management. Most recently, Wendy was the Medical Management Director at a health insurance cooperative startup and served as a consultant with a major consulting firm and contract research organization. Prior to that, Wendy served as a Corporate Compliance Officer and Chief Research Compliance Officer at a major academic medical center. Wendy holds a Master of Science in Nursing in clinical research management from Duke University and completed the Health Care Corporate Compliance – Post Graduate Certificate Program at George Washington University. She also holds several healthcare-related certifications and has lectured locally, nationally and internationally on various topics related to clinical research, healthcare auditing, research billing and healthcare compliance. Denise A. Roe, MSM, RAC, CHRC, CCRP, CIPVice President, Clinical Research Regulatory; Quality Management, ST. JUDE CHILDREN'S RESEARCH HOSPITAL Denise (Dee) is the Vice President for Clinical Research Regulatory and Quality Management at St.Jude Children’s Research Hospital, where she oversees the Regulatory Affairs Office, Office of HumanSubject Protections, and Clinical Research Quality Management. Dee has 34+ years’ experience inhealthcare, with the last 20 years dedicated solely to clinical research and regulatory affairs. Sheholds certifications from the Society of Clinical Research Associates (CCRP), the Health CareCompliance Association (CHRC), Regulatory Affairs Professional Society (RAC), and PublicResponsibility in Medicine & Research (CIP). Dee’s passion is creating and nurturing an infrastructurethat engenders a culture where adherence to regulatory and ethical obligations is the path of leastresistance. Please contact the event manager Marilyn (marilyn.b.turner(at) ) below for: - Multiple participant discounts - Price quotations or visa invitation letters - Payment by alternate channels (PayPal, check, Western Union, wire transfers etc) - Event sponsorship NO REFUNDS ALLOWED ON REGISTRATIONS Prices may go up any time. Service fees included in pricing. ----------------------------------------------------------------- This event is brought to you by: ExL Events, Inc. - NewYorkEventsList ----------------------------------------------------------------- CEC180213UPD


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