Tuesday, October 21
9:00 am – 10:15 am
General Session: Practical Strategies for Dealing with Scientific Misconduct
Handout 1 Evaluation
Lisa Murtha, JD, CHC
Managing Director
Huron Consulting Group, LLC
- This session will provide a description of the laws and regulations that address scientific misconduct
- The session will outline recent cases that define the standards for inquiry and investigation of allegations of scientific misconduct
- The session will also provide an overview of practical strategies for CCOs and others to deal with these sensitive and sometime politically charged matters
- Finally, the session will outline compliance monitoring steps to be employed by CCOs to ensure that scientific misconduct is mitigated or eliminated in their organizations
10:30 – 11:45 am
General Session: Research Compliance Oversight in the
Department of Veterans Affairs
Handout 1 Evaluation
Karen M. Smith, PhD
Director, Midwestern Region
VA Office of Research Oversight
- VA Office of Research Oversight mission
- Compliance oversight methodology for a nationwide health system
- Coordinating compliance with the VA’s university affiliates
- Challenges of ensuring privacy, information security and human research protection with multiple research relationships and national databases
12:30 – 1:30 pm
Lunch Speaker: FDA Compliance Update
Handout 1 Evaluation
Doreen Kezer
Branch Chief/Manager
U.S. Food & Drug Administration
- U.S. Food and Drug Administration (FDA)
- Centers for Devices and Radiological Health (CDRH)
- An Organizational Overview FDA
- FDA/CDRH Bioresearch Monitoring Program
- CDRH Warning Letters
- Responses to FDA Warning Letters
1:45 – 3:00 pm
Concurrent Breakout Sessions
101 Handling Challenges in Biospecimen Research
Handout 1 Evaluation
Kristen B. Rosati, JD
Partner
Coppersmith Gordon Schermer & Brockelman PLC
John R. Mills, JD
Legal Counsel
Mayo Clinic
- Ownership versus control or custodianship of biospecimens
- Compliance with the HIPAA Privacy Rule
- Compliance with the OHRP and FDA regulations requiring IRB review of human subject research and the informed consent requirements for participation in tissue research
- Risk management issues
102 Building a Compliant Clinical Research Budget
Handout 1, Workbook.xls Evaluation
Rich Haldeman
CFO
Kimmel Cancer Center
Thomas Jefferson University
- Optimizing your process and players to arrive at a compliant
budget
- Working with physicians routine costs
- Integrating the sponsor negotiation with the compliant budget
- Building easy to audit budget templates
- Integrating the compliant budget with closeout procedures
103 Research Enforcement Initiatives and Updates
Handout 1 Evaluation
Gary Eiland
Partner
King & Spalding LLP
- Overview of enforcement risks in research, including CMS’ National Coverage Determination policy, cost transfers, allocation of charges to award costs, effort reporting, indirect cost rates, research billing coordination, management of training grants, reporting of support from non-grant sources, subrecipient award monitoring, scientific misconduct, financial conflicts of interest, and informed consent improprieties
- Discussion of current enforcement efforts
- Recent judicial interpretations of the False Claims Act (with respect to original source and presentment provisions and public disclosure bar)
- Practical strategies for assessing internal compliance and minimizing False Claims Act risks, including self-disclosure and obtaining OIG or CMS advisory opinions.
104 Billing for Clinical Trials: The Long and Winding Road—Research Compliance Leads to Your Door
Handout 1 Evaluation
Rachel Nosowsky, Esq., CHRC
Attorney & Counselor at Law
Miller Canfield Paddock & Stone PLC
Kelly Willenberg
Director
Spartanburg Regional
- Regulatory framework for billing for clinical trials
- Developing a study specific billing plan
- Key issues in the billing process
- Improve communication and transparency in research compliance
- Maximize reimbursement in clinical trials by identifying hidden costs, billing accuracy and knowing the research rules and regs
- Identify research misconduct issues and know how to deal with them
- How to work on the revenue cycle management to coordinate with the clinical trials team at your hospital
3:15 – 4:40 pm
Concurrent Breakout Sessions
201 Tips and Tools to Develop a Research Compliance Program at Your Organization
Handout 1, Handout 2, Handout 3, Handout 4 Evaluation
Gene DeLaddy, CIA
Senior Vice President, Corporate Compliance
Carolinas HealthCare System
Kathryn Thibodeau
Manager, Corporate Compliance
Carolinas HealthCare System
Jane Green
President
Walter B. Morley Research Foundation
- Create a research compliance program with defined expectations and goals
- Develop a plan to incorporate research into the established compliance program
- Identify and recruit key stakeholders to help develop and implement the research compliance program
- Create a plan for monitoring and auditing for research compliance
- Develop a physician education component for compliance to research
202 Medicare Coverage Analyses: The Nuts and Bolts of Building and Conducting a Coverage Review
Handout 1, Handout 2 Evaluation
Chrissie Davis
Manager
Huron Consulting Group
Ronnie Landis
Research Management Coordinator
NYU Medical Center
- Conducting an MCA, what are the guidance regulations?
- Where to find supporting information for coverage analysis
- What to do when coverage information cannot be found in an NCD or LCD
- How to document the MCA
- What to do with an MCA after it has been finished
203 Clinical Trial Billing Compliance: Current Processes and Future IT Automation
Handout 1 Evaluation
James A. Moran
Assistant Dean Clinical Trials
Washington University
Carlos Brown
Director Compliance
Barnes Jewish Hospital
- Clinical Trial Billing Compliance Process
- Clinical Trial Financial Management
- Clinical Trial Management IT Solutions
204 Federal Grants Compliance: Cost Reimbursement and Administrative Issues
Handout 1 Evaluation
Robert Kenney
Partner
Hogan & Hartson, LLP
- Salary reimbursement and effort reporting
- Effort commitments
- Cost transfer problems
- Avoiding False Claims Act exposure
|
 |
Wednesday, October 22
9:00 – 10:15 am
General Session: Anti-Kickback Stark and
Related Fraud & Abuse Issues in Research:
What Every Compliance Officer Needs to Know!
Handout 1 Evaluation
Gadi Weinreich
Partner
Sonnenschein, Nath & Rosenthal
10:30 – 11:45 am
General Session: Medicare Contractor’s Perspective on Coverage
Handout 1 Evaluation
Ryan Meade
Partner
Meade & Roach, LLP
Richard K. Baer, MD
Medical Director, Medicare Part A
National Government Services, Inc.
Medical Policy Unit
12:30 – 1:15 pm
Lunch: Hot Topics In Research Compliance
Handout 1 Evaluation
Moderator:
Kelly Willenberg
Director
Spartanburg Regional
Carole Klove, RN, JD
Chief Compliance and Privacy Officer
UCLA
Angelique Dorsey, JD
Research Compliance Director
MedStar Health
1:15 – 2:30 pm
Concurrent Breakout Sessions
301 IRB Compliance
Handout 1 Evaluation
Kristin H. West, JD
Assoc. VP & Director Office of Research Compliance
Emory University
Marjorie A. Speers, PhD
President and CEO
Association for the Accreditation of Human
Research Protection Programs, Inc® (AAHRPP®)
- Frequent findings on IRB compliance reviews
- Policy and procedure check-up
- Assessing your IRB meetings
302 Quality Improvement or Human Subjects Research?
A Glimpse at the Gray Areas
Handout 1 Evaluation
William Kitchens
Partner
Arnall Golden Gregory, LLP
- What is QA/88 QI? What is research?
- When conducting a project, who determines whether it is QA/QI or research?
- What if this is unclear?
- What about CME review projects and the development of evidence-based medicine?
- Making a determination and subsequent steps.
- If a quality improvement initiative is really research, what steps must be taken by physician/investigator/institution/IRB/QA personnel?
- How can that process be expedited?
- Latest developments/recent cases involving conflicts in determination—what is the
- OHRP saying?
- What are institutions doing?
303 IN Ds, IDEs, and Medical Devices...
Who Are You Going to Call?
Handout 1 Evaluation
Dorothy C. Sellers
Director of Operations
Medical Billing Specialists, Ltd.
- Review FDA evaluation and approval processes related to drugs, devices and biologics
- Discuss the special requirements for sponsor-investigators
- Learn how the drug and device regulations differ in terms of“emergency use” and other “expanded access” protocols
304 The Institutional Conflict of Interest Dilemma:
Approaches and Challenges
Handout 1 Evaluation
Kendra Dimond
Director
Daylight Forensic & Advisory
Lori Collins
Chief Compliance Officer
Morehouse School of Medicine
Jim Ward
AVP for Compliance and Ethics
Georgetown University
- What is different about “Institutional” Conflicts of Interest?
- What are the implications of the AAMC/AAU recent Report?
- What are the challenges to developing and implementing an Institutional policy?
2:45 – 4:00 pm
Concurrent Breakout Sessions
401 Clinical Research Trial Process Improvement in AMC’s: The Importance of Buy-In
Handout 1 Evaluation
John Steiner, Esq.
Chief Compliance Officer
UK HealthCare
University of Kentucky
Rebecca Scott
Clinical Research Compliance Manager
University of Kentucky
- Getting approval from the top
- Committee membership
- Committee charge
Subcommittee structure
- Committee work-flow
- Getting approval of committee’s recommendations
402 Effort Reporting Compliance
Handout 1 Evaluation
Terry Reeves
Chief Compliance Officer
University of Texas Medical Branch at Galveston
403 Case Studies in Medicare Coverage and Research Billing
Handout 1 Evaluation
Ryan Meade
Partner
Meade & Roach, LLP
- Review coverage rules for multiple hypothetical schedules of events
- Discuss a collection of the most common Medicare billing rules affecting coverage of clinical research services
- Learn how to identify information in protocol and informed consent relevant for coverage analyses
- Examine examples of clinical trial agreement and informed consent language that can impact billing
|
