Inside the Build: A Crash Course in Coverage Analysis

If you have ever wondered how a coverage analysis is built, this seminar walks you through the essential components step by step. You get a high-level overview of the process, learn the core elements that drive accurate billing and compliance, and pick up practical tools and tips you can use right away. By the end you will understand the foundational workflow, the documents involved, and how each piece fits together to support compliant clinical trial operations.

Who this is for: coordinators, research finance and billing staff, compliance analysts, and anyone new to coverage analysis or who has never built one. If you have sat in a summit session wondering how the coverage analysis actually gets made, start here.

The X Factor: What Every Research Team Member Should Know About Compliance

The X Factor is this: every team member, regardless of role, directly influences the integrity, safety, and credibility of the research enterprise. Compliance is a behavioral expectation woven into daily decisions, documentation, communication, and culture, and this seminar looks beyond billing to show that compliance is operational. Topics include human subject protection, consent conundrums, research misconduct, research security, research privacy, and how communication can shift culture. Even where billing is the high-risk area, you must recognize and escalate many other red flags when appropriate.

Who this is for: research compliance professionals, and healthcare compliance, privacy and legal officers who have research under their purview. Built for the whole research team, billing office included.

CAR-T, Cancer Diagnostics, Molecular and Clinical Genetics, Disease Assessment in Assays and Biomarkers and Other Complex Billing Compliance: Where Risk, Regulation, and Revenue Collide

Curious about CAR-T and other advanced cell therapies but tired of jargon-filled presentations that leave you with more questions than answers? Do assays and biomarkers give you grief? This crash course breaks down the entire journey. We start at the cellular level, exploring how these living drugs are developed and why they are transforming treatment. From there we look at key considerations in clinical care, including patient workflows, treatment protocols, and operational planning. Finally we tackle coding, billing, and reimbursement, so you can translate innovative science into sustainable practice. Expect clear explanations, candid discussion of real-world challenges, and practical strategies to stay compliant and get paid accurately.

Compliance by Design: Leveraging CTMS, EMR, and AI for Accurate Research Billing

Accurate research billing has never been more complex, or more essential to organizational integrity. As clinical care and clinical research increasingly intersect, leaders must ensure that billing workflows are efficient and inherently compliant. This workshop explores how a Compliance by Design approach transforms research billing by embedding governance, automation, and auditability directly into CTMS and EMR integration and AI-enabled workflows. Participants will learn how modern CTMS and EMR systems can be architected to work in concert, creating a unified data backbone that supports protocol-driven charge segregation, real-time documentation validation, and transparent billing pathways, and how AI enhances this ecosystem by interpreting protocols, flagging billing risk, identifying mismatches between documentation and charges, and strengthening revenue integrity without adding administrative burden.

The Compliance Career Journey: Finding Mentors, Building Influence, and Shaping the Future

What does career growth look like in research compliance, and how can we better support the next generation of professionals? This interactive panel brings together research compliance professionals at different stages of their careers to share their experiences, challenges, and lessons learned along the way. Panelists will discuss the role mentorship has played in their careers, how they have navigated new opportunities and change, and what it takes to grow into leadership roles. Through open discussion and audience participation, attendees will gain practical advice for their own career development while exploring how we can better support and prepare future leaders in research compliance.

The Coverage Analysis Document Concordance: Your Single Source of Alignment Truth

This workshop introduces the Coverage Analysis Concordance, a structured method for validating alignment across the protocol, budget, informed consent, and Medicare billing rules. Participants will learn how concordance reviews reduce downstream billing risk, strengthen documentation integrity, and eliminate discrepancies before they become audit findings. You leave with a practical, repeatable framework for ensuring every study document tells the same operational and compliance story, and hear how one site uses a matrix with templates to ensure document concordance.

Chairperson's Opening Remarks and Official Welcome

Medicare Update 2027

Stay ahead of the curve on the Medicare coverage landscape with a Medicare Contractor Medical Director. Gain a comprehensive understanding of the latest trends and developments affecting clinical trial billing, the new hurdles with CMS, and a front-line view of what contractors expect from research sites.

The Inpatient Billing Trap: Untangling Clinical Research Chaos

When research participants are admitted, billing becomes a maze of bundled payments, unclear documentation, and competing coverage rules. This session explores real-world inpatient dilemmas and the operational breakdowns that drive errors. Attendees will gain actionable tools to improve coordination, charge capture, and compliance.

The Gray Zone: Sponsor-Funded Routine Care and Its Compliance Implications

One of the most complex and increasingly common dilemmas in clinical research operations: when, whether, and how a study sponsor may pay for routine-care services or conventional medications that participants would ordinarily receive outside the trial. Sitting at the intersection of billing compliance, ethics, contracting, and participant protection, sponsor-funded routine care creates a gray zone that sites must navigate with precision. You leave with a clear framework for evaluating sponsor-funded routine care, drafting compliant contract and consent language, and implementing operational safeguards that protect both participants and the institution.

Clinical Research Billing Review: Operationalizing Compliance

Achieving end-to-end research billing compliance is a top institutional priority, and getting there has been a multi-year operational journey. This session provides a candid review of how UT Southwestern Medical Center built and operationalized its Hospital Research Revenue Cycle function, the structural and technical challenges encountered along the way, and the processes developed to sustain billing compliance at scale.

Strong Starts: Strategies and Systems for Efficient and Effective Study Start-Up

Inefficiencies in study start-up delay activation, increase administrative burden, and introduce compliance risk. This session presents an integrated institutional model designed to streamline study initiation by aligning regulatory review, operational workflows, and stakeholder engagement from the outset. Participants will learn how early coordination of study components reduces rework and accelerates timelines.

Practical AI Use: Risk Assessments to Final Reports

A focused overview of essential audit and compliance operations. Participants will learn how to plan and scope audits, prepare for fieldwork, and incorporate regulatory and internal policy research into their approach. The session covers core risk assessment techniques and demonstrates how to use OIG Work Plan priorities, enforcement trends, and internal referrals to inform audit selection and methodology. Operational skills are emphasized through practical guidance on project management, meeting facilitation, and effective report writing.

Deep Dive into LCDs and NCDs: Try Not to Drown

By the end of this session you will be able to differentiate between NCDs and LCDs and understand their implications for clinical research. Explore regional variations in Medicare coverage policies that affect research billing and trial operations.

AI-Enhanced CMS Audit: How to Prepare for the New Era of Billing Scrutiny in Clinical Research

Future-Proofing Research: Medicaid Compliance and Fraud Prevention as a Strategic Advantage

A foundation in healthcare fraud laws and compliance planning, plus a snapshot of the healthcare fraud fighting landscape. Seeing how much of healthcare cost is lost to fraud and non-compliance makes clear why compliance and fraud prevention are now critical to every healthcare operation, research included.

Charge Review Best Practices

A clear overview of research billing compliance, focusing on accurate patient encounter tracking, proper enrollment and flagging, and the role of a 100% bill hold in ensuring line-by-line charge review. Attendees will learn how to distinguish insurance-billable from study-billable charges using the Medicare Coverage Analysis or CTMS, including correct use of CPT codes, investigational device and drug indicators, and required modifiers. The session also covers the risks of errors such as double billing under the False Claims Act and the steps for correcting and routing inaccurate charges.

Beyond the Audit: Building a Risk-Based, Systems Approach to Research Compliance

Move research compliance beyond the audit checklist. This session applies risk-based and systems-thinking principles, including concepts reflected in ICH E6(R3), to audit planning, shows how to engage Legal, Corporate Compliance, and Research leadership in setting priorities and accountability, and turns audit findings into sustainable improvement in governance, controls, and ongoing monitoring.

Blueprints for Better Trials: How Sponsors and Sites Can Use Playbooks to Drive Consistency and Speed

This session explores how clear, well-structured payment terms and contract playbooks strengthen financial integrity in clinical trials while accelerating study startup and execution. Participants will learn how standardized clauses, milestone-based payment frameworks, and negotiation guardrails reduce ambiguity, protect compliance, and improve site performance. Hear directly from a sponsor on how sites and sponsors can work together for faster, cleaner, and more predictable contracting outcomes.

Afternoon Plenary Block

25 Years In: Lessons Learned, Gaps Remaining and the Road Ahead

A reflection on our progress after two decades and the persistent challenges that remain. Key milestones that shaped billing integrity over 25 years, the gaps still open today, and where automation and payer engagement head next.

Chairperson's Closing Remarks and Adjourn