SOCRA New York Chapter Presents:
Wendy Portier MSN, RN, CHRC, CHC, CPC and Cynthie Lawson CHRC, CPC
Research Compliance Consultants
Oct 15, 2024, 12:00 – 1:00 p.m. EST
Register in advance for this meeting:
https://upstate.zoom.us/meeting/register/tJUud--gqTsuH9MEgbIBXrmNj0ZCUsPb5SGJ
After registering, you will receive a confirmation email containing information about joining the meeting.
Summary: Clinical research billing compliance is one of the most complex healthcare compliance areas to understand and
operationalize. In 2000, the Centers for Medicare and Medicaid (CMS) issued the National Coverage Determination (NCD) 310.1 –
the Clinical Trials Policy (CTP) – that addresses which items and services (I/S) provided as part of a clinical trial may be covered and
not covered by Medicare. This session will review the basics of clinical research billing compliance including: the regulatory
background, how to determine if a clinical trial qualifies for coverage, and real-world experience of operationalizing clinical research
billing with various organizational stakeholders.
Objectives:
Speaker Bios: Wendy Portier has over 30 years of experience in healthcare including: Clinical Research Compliance, Clinical
Research, Corporate Health Care Compliance, Managed Care, Care Management, Quality, and Critical Care
Nursing. Having worked on the provider, researcher, payer and sponsor sides, Wendy has a unique perspective,
extensive knowledge and real-world experience regarding clinical research compliance and operations, including:
assessing sites including due diligence assessments; implementing process improvements; leading government
inspections & responses; auditing and monitoring; implementing compliance programs; and improving the research
billing revenue cycle – from coverage analysis, budgets, contracts, authorizations, claims review to denials &
appeals management. Wendy also has a special interest in training, improving processes with best practices and
assisting organizations with writing policies and procedures in a simplified manner. Wendy is currently an
independent consultant in research compliance and operations. Previously, Wendy was the Medical Management Director at a health
insurance cooperative start-up and served as a consultant with a major consulting firm and contract research organization. Prior to that,
Wendy served as a Corporate Compliance Officer, Chief Research Compliance Officer and Clinical Research Coordinator 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 operations and compliance; health care auditing; research billing; and health care compliance.
Cynthie has over 20 years of experience in financial and revenue cycle operations including clinical research billing
compliance. 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.
Cynthie has worked in the provider and payer arena. Her experience includes: Systems build and integration,
process improvements, conducting and managing internal and external monitoring and auditing, clinical trial
budget forecasting and negotiations, Coverage Analysis, coding and claims processing, claim denial reviews and
appeals, accounts payable and receivable, and reconciliation. Cynthie holds a Bachelor’s degree in Business
Management. She is also a certified Healthcare Research Compliance Professional (CHRC) and a Certified
Professional Coder (CPC).
CE: The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education
programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program will provide 1 hours of continuing education hours. *When registering, note Certificate of Attendance Need (General or SOCRA).