CAHABA, WPS, AETNA, NATIONAL GOVERNMENT SERVICES, NOVITAS AND CMS Main Conference Sessions Include: ➜ Follow the Money: Effective and Compliant Management of Physician Compensation ➜ Cloudy with a Chance of Sunshine: NIH Conflicts of Interest Management in the Era of the Physician Payments Sunshine Act ➜ Improve Your Cost Reimbursement with Expanded Coverage Analysis ➜ Translate How to Assess and Manage Staff Workload Shares Where the Industry Stands with the Clinical Trial Policy and When Changes Are Expected Ryan Meade, J.D. Director Regulatory Compliance Studies Discuss Real Issues with Medicare, Medicare Advantage Plans and Commercial Payers Thom R. Mitchell, M.D., FACEP, FACP Senior Contractor Medical Director Olatokunbo Awodele, M.D. Contractor Medical Director Carolyn Cunningham, M.D. Contractor Medical Director Rosemarie Hakim, Ph.D., CMS Senior Research Technical Advisor, Coverage and Analysis Group SPONSORS LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW CLINICAL TRIAL BILLING & RESEARCH COMPLIANCE February 28-March 2, 2016 New Orleans Downtown Marriott at the Convention Center // New Orleans, LA 10 TH ANNIVERSARY Bringing Together Sites, Payers and Sponsors to Address and Discuss Clinical Billing Challenges and Best Practices to Achieve Compliance Assurance CONFERENCE Register Today 866-207-6528 www.exlevents.com/CBRC “I could not have grown in billing compliance at this pace had I not attended ExL Pharma’s annual billing compliance conferences. The people you meet and networking are invaluable.” —RESEARCH FINANCE COMPLIANCE ANALYST, ST. VINCENT HOSPITAL AND HEALTHCARE, INC. CCB APPROVED FOR CCB CREDIT(s) Comp l iance Ce r t i fica t ion Board 36.3 A Pre-Conference Workshop Day: Payers and Clinical Trial Coverage: Providers and Payers Working Together, including speakers from UConn Health, Health Disparities Institute, AmeriHealth Caritas, Blue Cross Northeastern Pennsylvania and Summit Reinsurance Services Two Interactive Master Classes: Beyond the Clinical Trial Policy — Pitfalls, Danger Zones and Other Hazards, Including NCDs and LCDs Beyond Coverage Analysis and Medicare Rules — Developing (or Improving Upon) Your Comprehensive Research Billing and Compliance Assurance Process with CTMS and Billing Systems
Transcript
CAHABA, WPS, AETNA, NATIONAL GOVERNMENT SERVICES, NOVITAS AND CMS
Main Conference Sessions Include: ➜ Follow the Money: Effective and Compliant
Management of Physician Compensation
➜ Cloudy with a Chance of Sunshine: NIH Conflicts of Interest Management in the Era of the Physician Payments Sunshine Act
➜ Improve Your Cost Reimbursement with Expanded Coverage Analysis
➜ Translate How to Assess and Manage Staff Workload
Shares Where the Industry Stands with the Clinical Trial Policy and When Changes Are Expected
Ryan Meade, J.D. Director Regulatory Compliance Studies
Discuss Real Issues with Medicare, Medicare Advantage Plans and Commercial Payers
Thom R. Mitchell, M.D., FACEP, FACP Senior Contractor Medical Director
Olatokunbo Awodele, M.D. Contractor Medical Director
Carolyn Cunningham, M.D. Contractor Medical Director
Rosemarie Hakim, Ph.D., CMS Senior Research Technical Advisor, Coverage and Analysis Group
SPONSORS
LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW
CLINICAL TRIAL BILLING & RESEARCH COMPLIANCE
February 28-March 2, 2016 New Orleans Downtown Marriott at the Convention Center // New Orleans, LA
10TH ANNIVERSARY
Bringing Together Sites, Payers and Sponsors to Address and Discuss Clinical Billing Challenges and Best Practices to Achieve Compliance Assurance
“I could not have grown in billing compliance at this pace had I not attended ExL Pharma’s annual billing compliance conferences. The people you meet and networking are invaluable.” —RESEARCH FINANCE COMPLIANCE ANALYST, ST. VINCENT HOSPITAL AND HEALTHCARE, INC.
CCB APPROVED FOR
CCB CREDIT(s)Compliance Certi�cation Board
36.3
A Pre-Conference Workshop Day: Payers and Clinical Trial Coverage: Providers and Payers Working Together, including speakers from UConn Health, Health Disparities Institute, AmeriHealth Caritas, Blue Cross Northeastern Pennsylvania and Summit Reinsurance Services Two Interactive Master Classes:Beyond the Clinical Trial Policy — Pitfalls, Danger Zones and Other Hazards, Including NCDs and LCDs
Beyond Coverage Analysis and Medicare Rules — Developing (or Improving Upon) Your Comprehensive Research Billing and Compliance Assurance Process with CTMS and Billing Systems
Dear C o l league,This year’s 10th Anniversary Clinical Trial Billing and Research
Compliance Conference is a special one. We are celebrating 10
years as the only conference specifically dedicated to clinical
research billing with a consistent track record of growth and
satisfied attendees. In an effort to bring together sites, sponsors
and payers over the past few years, we have advanced the
strategies of our field. This will be our best conference yet, with
an anticipated 250 attendees expected in New Orleans at the
Marriott Convention Center. Along with our sponsors — Complion,
Bio-Optronics, BRANY, The CITI Program, and Kelly Willenberg &
Associates — we intend to take this conference to the next level.
Our goal is to bring awareness to the challenges we in billing
face, and our hope is that, by working together, we can prevent
incorrect billing and non-existent reimbursement.
The conference will address many topics, including the coverage
analysis process, workload and budgeting, reimbursement, the
Open Payments Sunshine Act, physician billing, CTMS, NCD/
LCD, appeals and denials, and much, much more. With sponsors,
commercial payers, and Medicare and the Medicare contractors at
the table, we can extend the collaboration between us.
2016 is a leap year, so plan to “Leap into Billing Compliance” with us
in February in one of my favorite cities to visit, New Orleans. There
will be some jazz, jambalaya, beignets and beads in the Big Easy! I
hope you will make plans to join us!
Sincerely,
Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC
KELLY WILLENBERG & ASSOCIATES
» Clinical Research Billing
» Coding
» HIM
» Clinical Trials Management
» Research Finance
» Contracts and Budgeting
» Research Compliance
» Quality Assurance
» Coverage Analysis
» Grants Accounting
» Research Administration
» Compliance Operations
» Site Relations
» Legal and Regulatory
» Claims Processing
» Patient Financial Services
» Denials and Appeals
WHO SHOULD ATTEND This conference is designed for professionals from sites, payers and sponsors with roles and responsibilities in the following areas:
SPONSORSHIP & EXHIBITING OPPORTUNITIESDo you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event or distribute promotional items to attendees. ExL Events will work
closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, please contact Andrew Sinetar at 212-400-6237 or [email protected].
This conference is also of interest to investigator sites, SMOs, CROs, consulting agencies, state Medicaid plans and commercial payers.
CCB Continuing Education Credits
This conference program has been approved for 36.3 Compliance Certification Board (CCB) Continuing Education credits in compliance training, education, and auditing and monitoring for compliance. Granting of prior approval in no way constitutes endorsement by CCB of the program's content or sponsors. A one-hour session translates into 1.2 CCB CEUs for CHC, CHRC, CHPC and CCEP.
Please visit www.exlevents.com/CBRC for more information.
NEW ORLEANS DOWNTOWN MARRIOTT AT THE CONVENTION CENTER 859 Convention Center Blvd New Orleans, LA 70130 USA
Experience the excitement of the Crescent City at New Orleans Downtown Marriott at the Convention Center. Our riverfront hotel in Downtown New Orleans is housed in a renovated 19th century cotton mill and offers more than 300 spacious rooms and suites. Our hotel also benefits from an excellent location in the vibrant Arts District, near top New Orleans attractions such as the French Quarter, Harrah’s Casino, the Cruise Port and more.
The New Orleans Downtown Marriott at the Convention Center is sold out! Not to worry we have more rooms available across the street at the Hyatt Place at the Convention Center.To make reservations please call 1-888-233-1234 and request the group rate for ExL’s 10th Clinical Billing Meeting or click here.
ExL Events, Inc. is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus, or travel and events companies. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at [email protected].
SUNDAY, FEBRUARY 28, 2016 // PRE-CONFERENCE WORKSHOP DAY
7:00 REGISTRATION AND CONTINENTAL BREAKFAST
8:00 WELCOME BY CONFERENCE CHAIR AND OPENING REMARKS: CURRENT ISSUES IN CLINICAL TRIALS BILLING COMPLIANCE
KELLY WILLENBERG, MBA, BSN, CCRP, CHRC, CHC, PRESIDENT, KELLY WILLENBERG & ASSOCIATES CCEED IN AREAS OF REGULATORY
8:15 THE SCARY CHARACTERS OF BILLING COMPLIANCE Who is involved in this process? Where do we find our challenges? Can we confront the obstacles we face daily? What keeps you up at night? At the end of this session, attendees will be able to:
[ Describe the stakeholders they potentially deal with on a daily basis [ Understand conflict management for effective performance [ Explore a humorous look at who is here learning together
DAX KURBEGOV, M.D., PHYSICIAN VICE PRESIDENT, NATIONAL ONCOLOGY SERVICE LINE, CATHOLIC HEALTH INITIATIVES
8:45 WHERE ARE WE AND WHEN WILL WE SEE CHANGES WITH THE CLINICAL TRIAL POLICY? This session will look at the history of the CTP, the changes and the questions that still linger 15 years after its inception. How can this conference help to change the course? What has occurred over the years and what has to happen to make this process easier? Why is this an exciting area to keep your finger on as we move forward into 2016? At the end of the session, attendees will have an appreciation of the future of billing compliance. Ryan will set our morning discussion with payers, including Medicare and Medicare Advantage.
[ Discuss the overall policy [ Differentiate the issues [ Recognize the reasons there are questions today [ Examine potential solutions with payers, Medicare and Medicare Advantage Plans
alike
RYAN MEADE, J.D., DIRECTOR REGULATORY COMPLIANCE STUDIES, LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW
9:45 MORNING NETWORKING AND REFRESHMENT BREAK
10:15 PANEL DISCUSSION: THE REAL ISSUES WITH MEDICARE, MEDICARE ADVANTAGE PLANS AND COMMERCIAL PAYERS This session provides a rare opportunity to hear key perspectives on billing compliance challenges in a unique question-and-answer format.
MODERATOR: KELLY WILLENBERG, MBA, BSN, CCRP, CHRC, CHC, PRESIDENT, KELLY WILLENBERG & ASSOCIATES
THOM R. MITCHELL, M.D., FACEP, FACP, SENIOR CONTRACTOR MEDICAL DIRECTOR, CAHABA GBA, LLC
CAROLYN CUNNINGHAM, M.D., CONTRACTOR MEDICAL DIRECTOR, NATIONAL GOVERNMENT SERVICES, INC.
OLATOKUNBO AWODELE, M.D., CONTRACTOR MEDICAL DIRECTOR, WPS
ROSEMARIE HAKIM, PH.D., CMS, SENIOR RESEARCH TECHNICAL ADVISOR, COVERAGE AND ANALYSIS GROUP, CENTER FOR CLINICAL STANDARDS AND QUALITY, CENTERS FOR MEDICARE & MEDICAID SERVICES
12:00 NETWORKING LUNCHEON
7:30 REGISTRATION AND CONTINENTAL BREAKFAST FOR WORKSHOP AT TENDEES
8:00 PAYERS AND CLINICAL TRIAL COVERAGE: PROVIDERS AND PAYERS WORKING TOGETHER! A PRE-SESSION DOUBLE ESPRESSO IS NOT REQUIRED BUT MAY BE ADVISABLE. FASTEN YOUR SEAT BELT!Payers and providers are challenged to comply with a plethora of complex regulations, and clinical trial compliance only adds to the burden. Health insurance coverage related to clinical trials has evolved over the last 20 years from little to no required coverage to mandated coverage by individual states, Medicare, and — most recently — the Affordable Care Act (ACA). The implementation of health insurance exchanges resulted in 11.2 million Americans enrolling in commercial insurance plans, 37% for the first time, bringing the total insured population to 87%. In doing so, the newly insured also entered into one of the most complex labyrinths of plan choices, rules, exceptions and jargon-laden systems in the world. This session will traverse this labyrinth from the perspectives of consumers, health plan clinical staff, plan administrators, compliance officers, network providers and academic researchers. At the end of this session, attendees will be able to:
[ Discuss regulatory and insurance coverage requirements for clinical trials for various plan types: HMOs, PPOs, Self-Insured, Medicare, Medicaid, Medicaid Managed Care, Duel Eligible and Exchanges
[ Identify health insurance key concepts, terminology, definitions and operations, including covered benefits, medical necessity, utilization and case management, network requirements, medical management, authorization, denials and appeals, and claims submission processes
[ Explain best practices for collaborating with payers to optimize clinical trial participation and patient outcomes, including integrated care coordination and clinical care management
This session will also provide practical tips, examples and case studies from the real world!
WORKSHOP CHAIR: WENDY PORTIER, MSN, RN, CCM, CHRC, CHC, CONSULTANT, KELLY WILLENBERG & ASSOCIATES DEBBIE STUBBS, RN, M.S., CCM, VICE PRESIDENT, MANAGED CARE CONSULTANT, SUMMIT REINSURANCE SERVICES, INC. VICTOR G. VILLAGRA, M.D., FACP, ASSOCIATE MEDICAL DIRECTOR, UCONN HEALTH, HEALTH DISPARITIES INSTITUTE CATHY KAUFFMAN-NEARHOOF, BSN, RN, CCM, LNC, DIRECTOR OF INTEGRATED CASE MANAGEMENT, AMERIHEALTH CARITAS JULIE COHEN, B.S., B.A., DIRECTOR OF MEDICAL MANAGEMENT, HIGHMARK BLUE CROSS BLUE SHIELD
10:00 15-MINUTE NETWORKING BREAK
12:00 LUNCHEON FOR WORKSHOP PARTICIPANTS
1:00 WORKSHOP CONTINUES
2:30 15-MINUTE NETWORKING BREAK
5:30 WORKSHOP DAY CONCLUDES
MONDAY, FEBRUARY 29, 2016 // MAIN CONFERENCE, DAY ONE
“It was great seeing everyone in San Antonio. I appreciate all the great information.” —DIRECTOR RESEARCH/REGULATORY COMPLIANCE, METROHEALTH MEDICAL CENTER
1:00 TRANSLATE HOW TO ASSESS AND MANAGE STAFF WORKLOADResearch institutions are facing a higher work burden and operating margins are becoming thinner. Coordinators and study nurses serve a critical role in operational tasks, yet despite demanding workloads, many organizations continually have difficulty effectively quantifying and budgeting for their activities. The goal of this session is to review best practices, operational benchmarks and opportunities for improvement in staff workload, with a particular emphasis on regulatory compliance tasks. This session will go over original data and analysis on operational benchmarks for regulatory compliance tasks obtained in the CenterWatch-Complion Site Survey conducted at more than 160 investigative sites. Opportunities for improvement will be reviewed through a case study on using an eRegulatory platform. This session will provide insights and operational benchmarks to assess and manage staff workloads, thus providing transparency into critical areas affecting financial viability.
At the end of this session, attendees will be able to: [ Identify the current best practices and gaps associated with budgeting staff
activities [ Study new and original metrics on the true cost of compliance in relation to
key regulatory processes and defining site characteristics, as drawn from 160 investigative sites
[ Describe opportunities to improve regulatory compliance and efficiency
RICK ARLOW, FOUNDER, CEO, COMPLION
KATHY HAMMERHOFER, FINANCE DIRECTOR, CENTER FOR CLINICAL RESEARCH AND TECHNOLOGY AT UNIVERSITY HOSPITALS
2:00 IMPROVING STAKEHOLDER COMMUNICATIONS IN CLINICAL RESEARCH BILLING AND COMPLIANCE: CURRENT INDUSTRY PRACTICES This session will examine how to manage current approaches associated with internal and external clinical research within, private practice, community based hospitals, and other research programs. Distinguish tactics for communications to the right stakeholders when clinical research procedures are performed in order to achieve clinical research billing compliance. At the end of this session, attendees will be able to:
[ Improve Communications for Billing Compliance [ Risk to External Partners [ Identify Communication Flow of Stakeholders [ Understand Challenges
DEENA BERNSTEIN, MHS, DIRECTOR OF CLINICAL RESEARCH, SHERIDAN CLINICAL RESEARCH, INC.
DAWN N. PAMER, BS, CHRC, MANAGER, CLINICAL RESEARCH BILLING, SUMMA HEALTH SYSTEM
2:45 AFTERNOON NETWORKING AND REFRESHMENT BREAK
3:15 DEVICE STUDIES AND THE DEVICE POLICY IN BILLING AND REIMBURSEMENTComplete and accurate IDE clinical trial billing is a point of focus for the Center for Medicare and Medicaid Services as well as for local Medicare Administrative Contractors. In addition, clinical sites contract with many different private insurance companies to provide clinical services for their beneficiaries, and many of these private carriers have distinct requirements for clinical trial billing and coding. This presentation will cover concepts in IDE clinical trial policy and coverage for both government and private payers, as well the key components for a compliant billing process for both the facility and the physician involved in IDE clinical trials.At the end of this session, attendees will be able to:
[ Demonstrate Medicare coverage [ Examine third-party insurance coverage [ Identify coding requirements [ Review billing and payment in IDE trials
CLAY COHORN, SENIOR MANAGER, CLINICAL TRIAL REIMBURSEMENT, ST. JUDE MEDICAL
DIVA MILIANS, SENIOR MANAGER, CLINICAL TRIAL REIMBURSEMENT, ST. JUDE MEDICAL
4:15 AUDITING STRATEGIES FOR REVENUE AND COMPLIANCE INTEGRITYOrganizations performing and billing for clinical trial-related procedures face a myriad of legal and regulatory risk areas. Creating and executing a comprehensive monitoring and auditing strategy is a cost-effective way of facilitating legal and regulatory compliance at your organization. This session will help you create both a review approach as well as associated controls for the following areas:
[ Research billing compliance [ IRB operation and composition [ Conflict of interest identification and management [ Patient and study/trial folder maintenance [ Informed consent process
RICHARD WILLIAMS, MANAGING DIRECTOR, PROTIVITI
5:15 NETWORKING RECEPTION
6:15 MAIN CONFERENCE DAY ONE CONCLUDES
7:30 REGISTRATION AND CONTINENTAL BREAKFAST
8:00 CHAIRPERSON’S RECAP OF DAY ONE KELLY WILLENBERG, MBA, BSN, CCRP, CHRC, CHC, PRESIDENT, KELLY
WILLENBERG & ASSOCIATES CCEED IN AREAS OF REGULATORY UNCERTAINTY
8:15 KEY ELEMENTS OF A SUCCESSFUL BILLING COMPLIANCE STRATEGY Billing compliance isn’t something to be taken lightly, which is why organizations need to have a clearly laid out strategy, paired with supporting technology in order to effectively ensure proper billing compliance and create a culture of awareness and understanding within the organization.
This talk will address the fundamental risks of a poor billing compliance strategy and relay why organizations conducting and managing clinical trials need to have a proper system in place. From there, industry best practices will be discussed related to:
[ Address specific billing compliance needs within his/her organization with a financial CTMS and to effectively compare alternative solutions
[ Develop budgets and billing templates for cost allocation, dealing with protocol amendments and more for both third-party vendors, internal departments and other external vendors
[ Identify and implement tracking activities to ensure compliance across an extended network of sites and service providers
[ Understand proper validation and auditing processes including risk-based and milestone-based strategies for both patient-related and site-related scenarios
Post-presentation, the speakers will take questions on applying these best practices and scenarios with healthcare organizations.
ROSE BOTHNER, PROJECT MANAGER, BIO-OPTRONICS NANCY K. GENTRY, C.P.A., M.B.A., C.R.C.P., FINANCE DIRECTOR FOR
CLINICAL TRIALS, CARILION CLINIC
9:15 CLOUDY WITH A CHANCE OF SUNSHINE: NIH CONFLICTS OF INTEREST MANAGEMENT IN THE ERA OF THE PHYSICIAN PAYMENTS SUNSHINE ACT The Physician Payments Sunshine Act (PPSA) was included as part of the Affordable Care Act. The PPSA requires pharmaceutical companies to report payments made to physicians and teaching hospitals. This information is then released in a public database. Institutions in receipt of federal research funds from the National Institutes of Health must manage potential financial conflicts of interest for researchers and research teams. This session will give an overview of each, highlight key differences and discuss how to practically use the information that is available. At the end of this session, attendees will be able to:
[ State an overview of the PPSA’s and the NIH’s FCOI policies [ Explore contracting issues with sponsors regarding site responsibilities for
reporting [ Utilize published information practically
MONDAY, FEBRUARY 29, 2016 // MAIN CONFERENCE, DAY ONE
10:30 FOLLOW THE MONEY: EFFECTIVE AND COMPLIANT MANAGEMENT OF PHYSICIAN COMPENSATIONPhysicians refer patients to hospitals for testing, treatment and procedures. Hospitals and physicians submit claims to governmental and third-party payers. Manufacturers charge hospitals and physicians for drugs and devices; and industry, in turn, sends money to physicians and hospitals for research and marketing activities. Following the money is much easier with recent federal transparency provisions.The first such provision was the Food and Drug Administration (FDA) Modernization Act of 1997 (FDAMA), which required the creation of a registry of clinical trials (www.clinicaltrials.gov). The second was the establishment of billing modifiers associated with the Routine Costs in Clinical Trials National Coverage Determination. The third is the Open Payments website authorized by the Physician Payments Sunshine Act. Among the various models of physician compensation, some create possible fraud and abuse risks. An effective compliance and ethics program that includes a fair market evaluation of compensation can mitigate these risks. When fraud and abuse is identified, lawbreakers face stiff civil and criminal penalties under numerous federal laws. These laws are the Civil War era False Claims Act, the Anti-Kickback Statute and the Physician Self-Referral Law (Stark Law). At the end of this session, attendees will be able to:
[ Describe the pros, cons and risks associated with different models of physician compensation, including billable hours, percent protected time, line-item budgeted compensation and research RVU (rRVU) models
[ Recognize when financial arrangements create Stark, Anti-Kickback, false claims and private inurement risks when compensating physicians for clinical research
[ Critically evaluate the essential elements of an effective compliance program for an organization’s oversight of physician compensation and conflicts of interest in clinical research
REBECCA SCOTT, M.S., B.A., CLINICAL RESEARCH COMPLIANCE AND COI MANAGER, UK HEALTHCARE
BRENT IBATA, PH.D., J.D., MPH, RAC, CCRC, CHRC, DIRECTOR OF OPERATIONS, SENTARA CARDIOVASCULAR RESEARCH INSTITUTE
11:15 A PHARMACEUTICAL SPONSOR’S PERSPECTIVE ON BILLING COMPLIANCE This session will outline Eli Lilly’s perspective on the billing compliance conundrum by sharing lessons learned. Internal controls are set up at Lilly to outline what routine costs are, but what happens when sites do not agree? What are common themes for exceptions by sites? How does one sponsor handle this complicated process? Sites and sponsors must work together to circumvent reimbursement issues from the patients’ perspective. At the end of this session, attendees will be able to:
[ Establish a criteria for defining routine costs [ Develop a monitoring system for when sites have exceptions to the established
guidelines [ Demonstrate how to use communication road maps for various scenarios and
manage expectations
SCOTT P. JENSEN, STRATEGY AND TRANSFORMATION LEADER, GLOBAL CLINICAL BUDGETING AND CONTRACTING, ELI LILLY AND COMPANY
12:00 NETWORKING LUNCHEON
1:00 MEDICARE’S MMSEA SECTION 111 MANDATORY REPORTING FOR CLINICAL TRIALS Many clinical trial sponsors are reporting under Medicare Secondary Payer (MSP) Section 111 (MMSEA). More sponsors are beginning to understand this requirement as awareness grows. Penalties under Title 42 U.S.C. 1395y(b)(8) for not reporting are $1,000 per day per Medicare beneficiary. The cost of non-compliance is much higher than under the Sunshine Act.
Clinical site compliance officers and test coordinators will benefit from understanding the law and how its interpretation allows pharmaceutical companies and reporting agents to collect HIPAA information without violating patient privacy. Clinical trial sites may also benefit by understanding how reporting can help them avoid overpayments and potential fines under the False Claims Act.
At the end of this session, attendees will be able to: [ Analyze MMSEA and its practicality [ Explain and understand what a sponsor needs to do and how sites can help [ Recognize why the law helps clinical trial billing and compliance
DAVID PIATT, CEO, MEDICARE CONSUL SERVICES (MCS)
2:00 ARE YOU RUNNING CLINICAL RESEARCH IN DEFICIT? PART I: IMPROVE YOUR COST REIMBURSEMENT WITH EXPANDED COVERAGE ANALYSISAvoid financial losses from clinical trials at your site. Recovering full cost reimbursement for conducting clinical trials depends on using consistent, transparent, defensible pricing that accounts for cost escalation over the life of the study, applied to a detailed, itemized budget that captures all time and effort costs, item/service costs, and fixed fees over the life of the study. Without this detail, budget negotiations with sponsors are more difficult to support. Funding a deficiency will likely result in study fund deficits and unintended cost sharing of the study expense through write-offs and/or funding support. A coverage analysis is necessary to determine which items/services are not covered by Medicare and other insurers and therefore need to be priced out for payment by the sponsor or other identified funding source. Learn how you can expand your coverage analysis process to secure accurate cost reimbursement budgets and payment schedules. At the end of this session, attendees will be able to:
[ Employ expanded coverage analysis tools and considerations [ Examine true study cost while using the coverage analysis process [ Estimate and secure payment for identified costs [ Appraise next steps and plan for process improvement
SHEILA O’NEAL, RN, CCRC, CHRC, SUPERVISOR, CLINICAL RESEARCH FINANCE, OFFICE FOR CLINICAL RESEARCH, EMORY UNIVERSITY
SHANLEY J. CURRAN, J.D., BSN, RN, CHC, CHRC, CCRP, CONSULTANT, KELLY WILLENBERG & ASSOCIATES
3:00 AFTERNOON NETWORKING AND REFRESMENT BREAK
3:30 ARE YOU RUNNING CLINICAL RESEARCH IN DEFICIT? PART II: WHERE TO START WITH FINANCIAL OPERATIONSThis session will help you to review your accounting for your clinical trials. It will focus on the accounting controls needed to keep your financial viability and other issues to consider before getting started. You will learn about cost, charges, general ledgers, ways to ensure you make money in your clinical trials, and tips for choosing the right CTMS.At the end of this session, attendees will be able to:
[ Identify and illustrate challenges [ Discuss staffing needs and who should be trained [ Understand how reporting and auditing can help with financial return [ Manage finances better with a formula for performing audits [ Differentiate accounts receivable versus financial losses
TRACY POPP, MBA, CCRP, DIRECTOR FINANCIAL OPERATIONS, NORTON HEALTHCARE
MARY VEAZIE, CPA, CHC, CHRC, MBA, EXECUTIVE DIRECTOR, CLINICAL RESEARCH FINANCE, MD ANDERSON
4:15 PANEL DISCUSSION: THE UNINTENDED CONSEQUENCES OF A BILLING COMPLIANCE PROCESS
[ Review lessons learned at the conference [ Delve into action items for the group [ Examine needs for white paper development as an organized billing compliance
action group
MODERATOR: KELLY WILLENBERG, MBA, BSN, CCRP, CHRC, CHC, PRESIDENT, KELLY WILLENBERG & ASSOCIATES
5:15 WRAPUP BY CONFERENCE CHAIR KELLY WILLENBERG, MBA, BSN, CCRP, CHRC, CHC, PRESIDENT,
KELLY WILLENBERG & ASSOCIATES U
5:30 MAIN CONFERENCE DAY TWO CONCLUDES
TUESDAY, MARCH 1, 2016 // MAIN CONFERENCE, DAY TWO
“This conference builds communities. Years later, attendees are still contacting each other about the latest research billing conundrum. If your organization has not sent at least one person, it’s missing out on a lasting resource.” —Research Compliance Officer, Sutter Health
7:30 REGISTRATION AND CONTINENTAL BREAKFAST
8:00 MASTER CLASS A: BEYOND THE CLINICAL TRIAL POLICY — PITFALLS, DANGER ZONES AND OTHER HAZARDS, INCLUDING NCDS AND LCDSCoding and ICD-10 for research is a big task. Defining medical necessity and ensuring that physicians document it in the medical record for coding takes training for the physicians. This workshop will help you to understand National Coverage Determinations, Local Coverage Determinations, ABNs and waivers. Additionally, you will learn how to help your patient financial services collect payments. Join us for an informative session with take-home tools to help you in the “danger zone,” and engage with your peers during group activities and discussions.At the end of this session, attendees will be able to:
[ Understand “medical necessity” and why is it so important [ Review National Coverage Determinations, including Lab NCDs [ Review Local Coverage Decisions, Contractor Articles and Category III codes [ Illustrate how LCDs and NCDs impact claims processing and the coverage analysis process [ Examine the Medicare Advance Beneficiary Notification (ABN) and Waivers [ Associate similar documents from Medicaid and Tricare and commercial insurers [ Explain a presentation of a non-coverage notice to a patient/research subject [ Differentiate needs for process improvement
Tools provided: [ A “cheat sheet” with NCD, LCD and draft language [ A Patient Financial Services “Patient Sheet” [ Consent form cost section language examples [ Service examples of DEXA scans, bundled service/associated services, supplies and radiation oncology [ Examples of commercial waivers
DENISE QUINT, CPC, CHC, CHRC, RESEARCH COMPLIANCE ANALYST, UNIVERSITY OF VERMONT MEDICAL CENTER KATHLEEN HURTADO, RPH, CONSULTANT, KELLY WILLENBERG & ASSOCIATES LAURA ROOME, RESEARCH COMPLIANCE AUDITOR, WAKE FOREST BAPTIST MEDICAL CENTER
10:00 15-MINUTE NETWORKING BREAK
12:00 LUNCHEON FOR MASTER CLASS PARTICIPANTS
1:00 MASTER CLASS B: BEYOND COVERAGE ANALYSIS AND MEDICARE RULES — DEVELOPING (OR IMPROVING UPON) YOUR COMPREHENSIVE RESEARCH BILLING AND COMPLIANCE ASSURANCE PROCESS WITH CTMS AND BILLING SYSTEMS This session will review the system challenges we face in the integration of CTMS and billing, and in the implementation of EMR billing systems. With a vast array of experience, the speakers will outline how to determine the right process to achieve compliance assurance. If you have a process, whether it is manual, electronic or a hybrid of the two, you will analyze essentials for process improvement.At the end of this session, attendees will be able to:
[ Analyze their present process for strengths and weaknesses [ Identify the mix, if any, of manual and electronic means at their disposal [ Consider and recruit the optimal staff, based on context [ Check for a comprehensive system [ Review a feasibility process for replacing a manual or sub-process with electronic solutions [ Translate a billing calendar/coverage analysis into a system such as EPIC, Cerner, MOSAIQ, etc. [ Extrapolate the content and technical challenges with a CTMS integration [ Relate process to electronic invoicing [ Compute a financial return on investment from a CTMS [ Implement electronic EMRs [ Make decisions regarding EMR use and who is to become a “super user” [ Build research records [ Get all of the codes/modifiers built into the system [ Recognize the pros and cons to EMR use for billing compliance
This session will involve small group discussions and small group presentations.
KAREN MOTTOLA, M.A., CHRC, CPC, CRCC, RESEARCH COMPLIANCE OFFICER, SUTTER HEALTH SYSTEMS OFFICE OF ETHICS AND COMPLIANCE JEANNIE CUNNINGHAM, DIRECTOR OF RESEARCH, GREENVILLE HOSPITAL SYSTEMS BISHOY ANASTASI, ASSOCIATE DIRECTOR, CLINICAL TRIAL AND CONTRACT UNIT, UCLA ROSE BOTHNER, PROJECT MANAGER, BIO-OPTRONICS
2:30 15-MINUTE NETWORKING BREAK
5:30 MASTER CLASS CONCLUDES
MEDIA PARTNERSSPONSORS
WEDNESDAY, MARCH 2, 2016 // POST-CONFERENCE MASTER CLASS DAY
TERMS AND CONDITIONS: By registering for an ExL Events, Inc. (“ExL”) event, you agree to the following set of terms and conditions listed below:
REGISTRATION FEE: The fee includes the conference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments.
PAYMENT: Make checks payable to ExL Events, Inc. and write C762 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options.
**Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.**
CANCELLATION AND REFUND POLICY: If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event:
• Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date.
• Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date.
• Five days or less: A voucher (minus a $395 processing and documentation fee) to another ExL event valid for 12 months from the voucher issue date.
To receive a refund or voucher, please email [email protected] or fax your request to 888-221-6750.
CREDIT VOUCHERS: Credit vouchers are valid for 12 months from date of issue. Credit vouchers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is not applicable now or in the future. Once a credit voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees’ behalf, the credit voucher will no longer be valid.
ExL Events, Inc. does not and is not obligated to provide a credit voucher to registered attendee(s) who do not attend the event they registered for unless written notice of intent to cancel is received and confirmed prior to the commencement of the event.
SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference.
ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare‚ hotel or any other expenses incurred by registrants.
ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date‚ content‚ speakers and/or venue.
*The opinions of ExL’s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events, Inc.
Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL’s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS, INC. EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.
Academic Rate*Early Bird Rate
*Before January 15, 2016 Standard Rate
*After January 15, 2016 Onsite Rate
All-Inclusive Pass $1,695 $1,895 $1,995
Conference + Pre-Conference Workshop Day $1,495 $1,695 $1,795
Conference + Master Class Day $1,495 $1,695 $1,795
Conference Only $1,095 $1,295 $1,395
Corporate Rate
All-Inclusive Pass $2,095 $2,295 $2,395
Conference + Pre-Conference Workshop Day $1,895 $2,095 $2,295
Conference + Master Class Day $1,895 $2,095 $2,295
Conference Only $1,695 $1,895 $1,995
*Must be full time to receive academic rate.
REGISTRATION FEES:
*Offers may not be combined. Early Bird rates do not apply. To find out more on how you can take
advantage of these group discounts, please call 212-400-6240.*
SAVE 25% For every three simultaneous registrations from your company, you will receive a fourth
complimentary registration to the program (must register four). This is a savings of 25% per person.
SAVE 15% Can only send three? You can still save 15% off of every registration.
GROUP DISCOUNT PROGRAMS Questions? Comments? Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please email Conference Production Director Kelly Willenberg at [email protected].
Main Conference Sessions Include: ➜ Follow the Money: Effective and Compliant Management of Physician
Compensation
➜ Cloudy with a Chance of Sunshine: NIH Conflicts of Interest Management in the Era of the Physician Payments Sunshine Act
➜ Improve Your Cost Reimbursement with Expanded Coverage Analysis
➜ Translate How to Assess and Manage Staff Workload
CLINICAL TRIAL BILLING & RESEARCH COMPLIANCE
“I could not have grown in billing compliance at this pace had I not attended ExL Pharma’s annual billing compliance conferences. The people you meet and networking are invaluable.” —RESEARCH FINANCE COMPLIANCE ANALYST, ST. VINCENT HOSPITAL AND HEALTHCARE, INC.
