Clinical Research Billing Compliance Summit 2025: Full Schedule

1:00pm PST

PRE-CONFERENCE WORKSHOP A: Your House is on Fire: Navigating the Fallout

Monday February 24, 2025 1:00pm - 4:30pm PST

This workshop will guide you through the essential steps to take when significant clinical research billing (CRB) compliance issues are uncovered during an internal or external audit. Whether your institution needs to establish a CRB program from the ground up or revamp its existing model, this session offers a detailed roadmap from pre-award to revenue cycle and post-award. We will delve into critical topics such as engaging external counsel, determining the need for self-disclosure, identifying and collaborating with key stakeholders, and implementing effective compliance strategies. Participants will gain actionable insights into managing billing charges, securing stakeholder buy-in, and fostering a culture of compliance. This workshop is designed for clinical research professionals, compliance officers, and institutional leaders committed to maintaining the highest standards of research billing integrity.

OBJECTIVES

Engage External Expertise and Assess Disclosure Requirements:
- Determine the appropriate circumstances for involving external counsel with specialized expertise in research billing litigation.
- Establish criteria for assessing the necessity of self-disclosure following audit findings.

Identify and Collaborate with Key Stakeholders:
- Pinpoint essential internal and external stakeholders critical to CRB compliance.
- Develop effective strategies for securing stakeholder buy-in and facilitating regular collaborative meetings during the change process.

Implement and Manage a Comprehensive CRB Compliance Program:
- Formulate strategies for managing current billing charges, including the potential implementation of a bill hold.
- Conduct a thorough needs assessment to build a dedicated CRB compliance team (from pre-award to revenue cycle and post-award).
- Establish/restructure robust processes for pre-award activities.
- Cultivate a culture of compliance through targeted training programs tailored to relevant employees.

Speakers

Mikki O’Neal, MBA, CHRC, CCRC, CCRP

Associate Vice President Research Operations & Infrastructure (ROI), University of Miami

Dawn Pittinger, DBA, MBA-HA, CHRC, CCP, CHC

Research Financial Compliance Officer, Moffitt Cancer Center

Dr. Dawn Pittinger is the Research Financial Compliance Officer at Moffitt Cancer Center. She is responsible for developing and overseeing the clinical research revenue cycle and grants management auditing programs under Corporate Compliance while ensuring financial integrity in research... Read More →

Scott Streibich, MBA, MHS, CHC, CHRC, CPB

Director, Clinical Research Revenue Cycle, The Johns Hopkins University School of Medicine

Scott Streibich, MBA, MHS, CHC, CHRC, CPB is Director, Clinical Research Revenue Cycle for the Johns Hopkins University School of Medicine. Mr. Streibich previously administered Research Compliance and Clinical Research Revenue Cycle activity in several organizations, including Moffitt... Read More →

Monday February 24, 2025 1:00pm - 4:30pm PST

6:00pm PST

🎉 Opening Night Kick-Off Party 🥳

Monday February 24, 2025 6:00pm - 8:30pm PST

Please join us for a kick off party with cocktails and food as we celebrate our annual gathering of the research billing compliance community.

Monday February 24, 2025 6:00pm - 8:30pm PST

Networking Break

7:15am PST

MAIN CONFERENCE DAY ONE: Registration & Breakfast

Tuesday February 25, 2025 7:15am - 8:00am PST

Networking Break

8:00am PST

Opening Remarks

Tuesday February 25, 2025 8:00am - 8:15am PST

Speakers

Kelly Willenberg, DBA, RN, BSN, CHRC, CHC

CEO, Kelly Willenberg & Associates

Dr. Kelly Willenberg has owned Kelly Willenberg & Associates for fifteen years. As a registered nurse with 40 years of experience, her company works in clinical research and healthcare compliance. Dr. Willenberg serves as a faculty member, as well as, serving on the Board of Directors... Read More →

Tuesday February 25, 2025 8:00am - 8:15am PST

9:00am PST

📚 Breaking the Bank - Denials

Tuesday February 25, 2025 9:00am - 9:45am PST

TBA

According to the American Hospital Association claim denials have surged by an average of 20.2% for commercial plans and 55.7% for Medicare Advantage plans. Are you struggling with denials in your clinical trial billing program? Join Joe and Richard to hear how to work through the denials and not break your bank!

Understanding common reasons for hospital claim denials
Developing strategies to improve claim approvals for research claims
Analyze complex insurance regulations affecting hospitals

Speakers

Joseph Rivet, Esq, CCS-P, CPC, CHPC, CHC, CAC

Managing Partner, Rivet Health Law, PLC

Joe Rivet is a Managing Partner at Rivet Health Law. He is a licensed attorney in Arizona, Michigan, District of Columbia Federal Court, and is also an arbitrator through AHLA. He practices health law with a focus on transactional matters, compliance, reimbursement, contracts, third-party... Read More →

Richard A Beckner, Esq., CRCP, CIP

Attorney, Rivet Health Law, PLC

Richard Beckner is a healthcare attorney who initially represented payers for the first half of his career until discovering the real challenge (and fun) of obtaining payment for healthcare providers. Richard is licensed in West Virginia and Kentucky for all state and federal courts... Read More →

Tuesday February 25, 2025 9:00am - 9:45am PST
TBA

Presentation

9:45am PST

🤝 Networking Break & Refreshments: Connect, Refresh, and Energize!

Tuesday February 25, 2025 9:45am - 10:15am PST

Networking Break

10:15am PST

🧩 The Connected Technology Ecosystem and Why System Integrations Matter

Tuesday February 25, 2025 10:15am - 11:00am PST

Evaluate your connected technology ecosystem
Understand why system integrations are crucial for financial management
Propose running your research site as a business.

Speakers

Keith Wright, MBA, CCRP

Senior Director, Strategy, Advarra

As Senior Director of Strategy at Advarra, Keith works with research sites to optimize research performance through people, process, and technology. With extensive experience as both a site and sponsor leader, Keith provides a unique perspective to help research sites achieve operational... Read More →

Tuesday February 25, 2025 10:15am - 11:00am PST

Presentation

11:00am PST

💡What I Learned About Billing Compliance Before I Retired

Tuesday February 25, 2025 11:00am - 11:45am PST

With a career spanning 40 years, Dr. Milner has been a great supporter of clinical research and clinical trials, a champion of innovation, and serves as an advocate for long-term strategic business development that supports the best in healthcare. Retired from Yuma Medical Center in September, Dr. Milner reflects on what she learned, and how to harness that with your team daily.

🌐 Navigate your CEO to understand the world of billing compliance
⚖️ Engage in a practical examination of the advantages, limitations, and diverse range of billing compliance issues in a large medical center
🔍 Explore and gain valuable insights to boost productivity and enhance your team's compliance.

Speakers

Trudie Milner, PhD

Retired - Former Senior VP and Chief Operating Officer

Tuesday February 25, 2025 11:00am - 11:45am PST

Presentation

11:45am PST

Luncheon for ALL Attendees

Tuesday February 25, 2025 11:45am - 1:00pm PST

Networking Break

1:45pm PST

📚 Medicare Coverage Analysis in Oncology Trials

Tuesday February 25, 2025 1:45pm - 2:30pm PST

This presentation will cover the overall benefits of performing a Medicare coverage analysis (MCA), including important criteria to consider during MCA with emphasis in ensuring the success and ethical integrity of oncology clinical trials. We'll discuss coverage analysis billing compliance with regulatory requirements and patient access to innovative treatments.
Using real-life examples, participants will learn skills to perform a coverage analysis, how to navigate reimbursement challenges, and the importance of fostering collaboration between stakeholders. If you are involved in oncology clinical research, this session will provide valuable insights for optimizing trial design and execution.

Learn the role of coverage analysis in oncology trials
Examine Medicare's national and local coverage determinations, coding and billing requirements, and more
Discuss best practices for navigating reimbursement challenges in oncology trials
Address billing compliance issues for complex oncology trials

Speakers

Nitya Maddodi

Manager, Business Operations, Advarra

Nitya Maddodi is the Manager of Business Operation Services at Advarra, where he leads his team in the clinical trial startup process. This includes developing Medicare coverage analysis documents in compliance with Medicare guidelines, as well as developing and negotiating study... Read More →

Tuesday February 25, 2025 1:45pm - 2:30pm PST

Presentation

2:30pm PST

🤝 Networking Break & Refreshments: Connect, Refresh, and Energize!

Tuesday February 25, 2025 2:30pm - 3:00pm PST

Networking Break

3:45pm PST

🚀 They Work Hard for Their Money- Paying Physicians for Research

Tuesday February 25, 2025 3:45pm - 4:30pm PST

Proper compensation for physicians involved in clinical research is critical to their engagement and retention.
This session will discuss how to fairly compensate physicians while maintaining ethical and regulatory requirements.

🔬 Understand the regulatory risks that arise with physician compensation
💼 Discuss options for structuring compensation for research
🎯 Explore the physician's view of the compensation challenges that arise within research

Speakers

Christina Brennan, MD, MBA, CCRC

Vice President, Clinical Research, Northwell Health

Christina Brennan, MD, MBA has devoted her career to clinical research and currently serves as Northwell Health’s Senior Vice president of clinical research. Committed to the advancement of science and medicine, Dr. Brennan has more than 24 years of extensive clinical research... Read More →

Katherine Cohen, JD, CHC, CHRC

Chief Compliance Officer, Southern Illinois University School of Medicine

Kate Cohen, JD, CHC, CHRC, is the Chief Compliance Officer of Southern Illinois University (SIU) Medicine. In that role, Kate leads the compliance program for the SIU School of Medicine, the affiliated faculty practice plan and the SIU federally qualified health center. Focusing on... Read More →

Tuesday February 25, 2025 3:45pm - 4:30pm PST

Presentation

6:00pm PST

Post Conference Day Cocktail & Dinner Groups Coordination

Tuesday February 25, 2025 6:00pm - 8:00pm PST

8:00am PST

Morning Coffee & Breakfast

Wednesday February 26, 2025 8:00am - 8:30am PST

Networking Break

8:30am PST

🚀 Medicare Discussion 2025

Wednesday February 26, 2025 8:30am - 9:15am PST

This insightful session is designed to ensure you stay ahead of the curve fully equipped to navigate the transitional coverage landscape.

💡 Gain a comprehensive understanding of the latest trends and developments, ensuring you stay up-to-date with recent advancements with a Medicare Contractor

Speakers

Olatokunbo Awodele, MD, MPH

Medicare Contractor Director, National Government Services

Dr Olatokunbo Awodele is a Contractor Medical Director at National Government Services, Indianapolis, Indiana. She received her BA from Rutgers University and her MD, MPH from The University of Medicine and Dentistry of New Jersey – Robert Wood Johnson Medical School (now Rutgers... Read More →

Wednesday February 26, 2025 8:30am - 9:15am PST

Keynote

9:15am PST

Know Your Worth – Negotiating with Sponsors Effectively and Consistently for Clinical Research Sustainability

Wednesday February 26, 2025 9:15am - 10:00am PST

This session will focus negotiate budgets with sites and sponsors with an appreciate for time and effort for administrative activities. Engaging with sponsors so you can get costs covered is important. While the amount per fee requested may appear large, sites should not feel they cannot ask for justifiable budget amounts due to fear of rejection. This presentation should help you to identify some additional fees that you may not have considered asking for, as well as provide a guide to what administrative fees look like at another institution who are actively using an administrative fee schedule provided to all industry sponsors at time of site selection. We hope that you will feel empowered to create a fee schedule “tool” and help educate sponsors on your costs, while creating a sustainable foundation to continue providing or expanding your research offerings at your institution.

Identify the administrative costs your site/institution incurs for all activities.
Build confidence to ask sponsors for the funds your site/institution needs.
Establish an administrative fee schedule at your own site/institution.

Speakers

Candiss Grannis

Consultant, CA Grannis Consulting

Candy brings over 30 years of experience in the healthcare industry, including more than a decade specializing in research budgets and negotiations. She holds a degree in Health Information Management and has obtained coding certifications through AAPC. Additionally, Candy served... Read More →

Amanda B Funson, MBA

Director of Research Finances and Billing, Bon Secours Mercy Health Department of Research

Amanda has 20+ years of experience in the healthcare industry with 8+ years of those in research budgets and negotiations. She has received her master’s degree in business administration from the University of Scranton and traveled abroad to St. Elizabeth University in Slovakia... Read More →

Wednesday February 26, 2025 9:15am - 10:00am PST

10:00am PST

🤝 Networking Break & Refreshments: Connect, Refresh, and Energize!

Wednesday February 26, 2025 10:00am - 10:30am PST

Networking Break

11:15am PST

Roundtables and Discussion

Wednesday February 26, 2025 11:15am - 12:00pm PST

12:00pm PST

Luncheon for All Attendees

Wednesday February 26, 2025 12:00pm - 1:15pm PST

Networking Break

1:15pm PST

Achieving Equality in Research: Navigating Consent and Billing Strategies

Wednesday February 26, 2025 1:15pm - 2:00pm PST

This session explores the importance of equity in research and strategies to address key issues related to participant consent and billing practices. We will discuss practical approaches to make consent processes more inclusive and transparent, and examine how equitable billing practices can reduce financial barriers and support diverse participation in research studies.

Understand the principles of equitable consent practices in research, including key considerations such as the content of the informed consent, methods of obtaining consent, participant autonomy, and cultural sensitivity.
Explore effective strategies for navigating the complexities of billing based on different payers, with a focus on ensuring fairness, transparency, and compliance with ethical guidelines and regulatory requirements.
Identify practical approaches to integrate equity considerations into consent and billing processes, fostering inclusive research environments that prioritize participant welfare and uphold ethical standards.

Speakers

Kendall Perry, MS, CHRC, CPCO

Compliance Analyst, Compliance and Business Ethics, Children's Hospital Colorado

Kendall Perry is a dedicated research compliance analyst at Children's Hospital Colorado, where she brings over a decade of expertise in healthcare compliance to ensure the highest standards of ethical and regulatory adherence. Her career began in Federally Qualified Health Centers... Read More →

Wednesday February 26, 2025 1:15pm - 2:00pm PST

2:00pm PST

Accelerating Study Activation Timelines: Breaking Down Silos for Start-up Success

Wednesday February 26, 2025 2:00pm - 2:45pm PST

In this illuminating session, two WCG experts will delve into actionable strategies for expediting study activation within the NCIs recommended 90-day study start-up timeline. Attendees will gain insights into how operational silos during study activation adversely impact start-up timelines and compliance, slowing progress and potentially
jeopardizing study outcomes. By exploring a more streamlined and integrated approach
to study initiation, we can improve trial efficiency and improve patient care.

 Proven strategies for accelerating study activation within the NCI's recommended
90-day start-up timeline.
 How to fix silos in your study activation before they impact your timelines and
compliance.
 The effects of study activation processes on participants.

Speakers

Derek Johnson

Quality Mgr, Coverage Analysis, WCG Clinical

Derek Johnson is the Quality Manager for WCG. In his current role, Derek maintains a strong and detailed understanding of the clinical trial start-up and coverage analysis process, and is tasked with managing the overall quality of WCG’s coverage analysis deliverables. Derek holds... Read More →

Jamie Harper MHA, CCRP

Vice President, Site Solutions Engagement, WCG Clinical

As Vice President of Site Solutions & Engagement for WCG Clinical, Jamie Harper develops and executes strategic solutions mitigating the challenges experienced at clinical research sites around the globe. Ms. Harper is driven to help sponsors and sites meet critical study endpoints... Read More →

Wednesday February 26, 2025 2:00pm - 2:45pm PST

Presentation

2:45pm PST

🤝 Networking Break & Refreshments: Connect, Refresh, and Energize!

Wednesday February 26, 2025 2:45pm - 3:15pm PST

Networking Break

3:15pm PST

A Look Inside a Community Hospitals Billing Compliance Policies and Procedures

Wednesday February 26, 2025 3:15pm - 4:00pm PST

TBA

This session will provide an overview of billing compliance policies and procedures in place at Parkview Research Center. By the end of the session, you should have an increased insight into which policies and procedures may benefit your institution. You will also learn effective strategies for implementing these practices into your research program.

Analyze what policies and procedures our institution implemented and why we have these practices in place
Understand why implementing policies can keep your institution compliant
Clarify what policies would be good for your institution.

Speakers

Brooke Hoverman, CCRC

Research Contract Specialist, Parkview Research Center

Brooke has over 15 years of experience in clinical research, including oncology study coordinator, protocol writing and development, Medicare Coverage Analysis, research billing compliance, and contract and budget negotiations, and has maintained her ACRP-CCRC since 2013. She developed... Read More →

Kary Ault, MBA, CCRC

Research Clinical Operations Manager, Parkview Research Center

Kary Ault is a Research Clinical Operations Manager with extensive experience in managing and leading cross-functional teams to achieve organizational goals. With a strong background in strategic planning, financial analysis, and stakeholder communication, she has successfully implemented... Read More →

Wednesday February 26, 2025 3:15pm - 4:00pm PST
TBA

Presentation

4:00pm PST

🎯 Proper Coding and Coverage Analysis: The Vital Connection Between Contract and Billing Review

Wednesday February 26, 2025 4:00pm - 4:45pm PST

Accurate coding and claims processing are crucial for compliant research billing. The coverage analyst plays a key role in communicating the coding and billing requirements for specific studies. This session will explore Medicare bundled payment systems and the impact of coding on hospital payments and research billing.

📁 Learn what MS-DRGs are and the Inpatient Prospective Payment System bundling methodology.
💡 Understand APCs and the Outpatient Prospective Payment System bundled payment methodology.
📈 Discuss real-world examples of complex studies and potential overpayment risks.

Speakers

Denise Quint

Owner, Denise Quint, LLC

Denise Quint brings extensive experience in billing related to research, including investigational devices. She is passionate about designing personalized training for any audience. Throughout her career, Denise has sharpened her critical thinking and problem-solving skills in the... Read More →

Wednesday February 26, 2025 4:00pm - 4:45pm PST

Presentation

4:45pm PST

Closing Remarks

Wednesday February 26, 2025 4:45pm - 5:00pm PST