The Practical Guide to Clinical Trials Billing

Angela Lynne Simmons, CPA 
Mary Veazie, MBA, CPA, CHC, CHRC 
Linda Yancey, RN, CCRA 

Clinical research trials can help save lives and improve patient care, but conducting these trials can be expensive. While legislation has recently made it easier for healthcare organizations and patients to participate in research programs, organizations still struggle with implementing the processes to make clinical research financially feasible.

The Practical Guide to Clinical Trials Billing provides an array of solutions for every step in the clinical trials billing process, including trial submission and review board approval, charge capture and segregation, and denials management. The book delivers an inside look at the financial life cycle of clinical trials from three revenue integrity experts at university medical centers who manage the complexities of clinical trials billing on a regular basis.

Authors Angela Lynne Simmons, CPA, Mary Veazie, MBA, CPA, CHC, CHRC, and Linda Yancey, RN, CCRA, will help readers unlock the puzzles of clinical research billing compliance, from the initial budgeting and contracting to the final trial closeout procedures. 

Published: October 2018

Page count: 128
Dimensions: 8.5x11 
ISBN: 978-1-68308-846-2

Table of Contents

Chapter 1 – Introduction to Clinical Trials: Terminology and Clinical Research Processes 
Chapter 2 – The Reimbursement Analysis: The Financial Starting Point 
Chapter 3 – Budgeting and Contracting for Clinical Trials 
Chapter 4 – Creating Billing Intention Plans and Study Calendars 
Chapter 5 – Recruitment and Informed Consent Processes 
Chapter 6 – Clinical Services: Patient Access, Service Categorization, and Charge Capture 
Chapter 7 — Standards for Medical Documentation and Charge Segregation 
Chapter 8 – Claims Processing, Insurance Follow-Ups, Denials, and Trial Invoicing 
Chapter 9 – Closing Out a Trial: A Financial Focus 
Chapter 10 – Analytics From Closed Trials to Prepare for New Trials 
Glossary 

About the Authors

Angela Lynne Simmons, CPA, is vice president of revenue and reimbursement at Vanderbilt University Medical Center in Nashville. A Texas Certified Public Accountant, she brings more than 30 years of experience in healthcare operations and finance, and public accounting for healthcare entities. Simmons has expertise in healthcare policy, reimbursement principles from government programs (Medicare and Medicaid), as well as healthcare financial analysis and cost accounting. Much of her focus throughout her career has been on identifying revenue opportunities and pursuing those through improving hospital operations and by Medicare filings and appeals. Prior to Vanderbilt, she was the director of clinical revenue and reimbursement for the University of Texas MD Anderson Cancer Center, where she was responsible for Medicare and Medicaid reimbursement, cost accounting, revenue and rate-setting, financial analysis, and clinical decision support reporting. Simmons is a NAHRI Advisory Board member.

Mary Veazie, MBA, CPA, CHC, CHRC, is a Certified Public Accountant and the executive director of clinical research finance at the University of Texas MD Anderson Cancer Center in Houston. She has more than 15 years of experience in clinical research finance and more than 25 years of financial and auditing experience. Veazie is certified in Healthcare Research Compliance and Healthcare Compliance. Her skill set includes full comprehension of the clinical research billing process and its impact on an organization’s clinic operations and revenue cycle.
 
Linda Yancey, RN, CCRA, is cofounder of Research DefinED, LLC, an educational consulting firm that helps the healthcare and research community develop the skills necessary for clinical research quality and operational efficiencies. She is a clinical research professional with a history of orchestrating successful multi-institutional academic clinical research consortiums and strategic pharmaceutical collaborations designed to decrease clinical trial activation timelines and reduce financial operating costs. Yancey holds Bachelor of Science degrees in both Business and Nursing. She is a Certified Clinical Research Associate and has experience in mass tort legal nurse consulting, auditing/monitoring per GCP/FDA regulations, FDA site inspections, clinical trial management system development, clinical research billing compliance, project management, and pharmaceutical strategic alliances.