AUGUST 8-10, 2022 | Grand Hyatt, Denver, CO
AGENDA – all times are in mountain time
Workshop One - The Kitchen Sink: Everything You Need to Know about DevicesDevice trials are complex and not for the faint of heart! We’ll review techniques to avoid overpayments and denials. We’ll provide strategies to operationalize your device trials with real-world scenarios and a toolbox for the different types of device trials and how to properly bill for them.
- Category A and B IDEs
- Non-significant Risk Devices
- Humanitarian Use Devices
Diva Miliáns, Associate Director, Clinical Trial Reimbursement, ABBOTT
Workshop Two - First Patient Billing Review – Claim/Data Submission through Payment
Should you be reviewing the first patient on study from the billing compliance side? It is valuable to include the First Patient Review as part of a larger picture. Reconciliation – what does it mean to your site? This session will address a first patient review, reconcile and then go into intermittent confirmations.
- Discover revenue from mis-submitted data, review identified procedures and incidentals
- Analyze denials to warrant some time of contract review and request for payment
- Inspect whether you are siloed and not recognizing where billing is going out incorrectly
Christine Nelson, Director, Office of Clinical Trials at UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL
Workshop Three - So You Want to Build a Research Compliance Program? The Who, What, When, Where and How of Getting StartedCan your research program be successful without a research compliance program? We don’t think so! This session will explore how to build an effective research compliance program from scratch and help you set the stage for partnering with your research team to be an integral part of their success.
- Discuss the importance of a research compliance program and how to get researchers and operations on board.
- Identify the key elements of a compliance program.
- Discuss how to get started, where to prioritize your resources, and setting your program up for longevity and sustainability.
Debra Stavarski, PhD, RN, CHR, System Director, Research Compliance Officer, READING HOSPITAL TOWER HEALTH
Workshop Four - All Things Pediatrics
Pediatrics has its own set of rules when it comes to billing compliance. Here from experienced professionals across the country on tips and tools to make your site successful whether you are a pediatric facility or perform pediatric studies at a larger institution.
- Demonstrate advice from different areas of pediatric research from compliance to managing
- Compare how sites do things differently
- Create an environment of facilitation
Scott Long, VP, Chief Compliance Officer at ST. JUDE CHILDREN’S RESEARCH HOSPITAL
Lorna Lasure, MBA, Manager, Pediatric Academics & Research, PRISMA HEALTH–UPSTATE
- Identify the key indicators for changing established payer coverage analysis documentation.
- Understand how to develop relevant communications that support a compliant acquisition of a research portfolio with active patients.
- Know what relevant drivers are needed to be evaluated to minimize the transaction costs of the clinical research acquisition
- Describe the current workforce sustainability issue for clinical trial sites.
- Explain various strategies to account for increased cost associated with staff shortages, turnover, and inexperienced staff.
- Discuss proactive steps to acquiring additional funding to support ongoing educational needs at the site.
Christina Brennan, MD, Vice President, Clinical Research – NORTHWELL HEALTH
- Understand modifications in their A/R process based on what they have learned
- Review starting from initial budgeting and calendar creation in the CTMS
- Examine new process creation, modifications in budgeting, and streamline billing compliance.
- Identify benefits to implementing a CTMS
- Learn the benefits for patients and staff when using both systems
- Learn ways to increase billing compliance when using both systems
Track A - Building Support for your Clinical Research ProgramYou’ve hired awesome research coordinators, you have exciting studies open with cutting-edge Sponsors, and you have subjects willing to enroll. That’s great, but you need more to build a successful research program – relationships are everything! During this session, we will discuss:
- Engagement of formal and informal leaders throughout the organization
- Strategies to break down silos that can exist between departments and groups
- Understanding needs of key stakeholders
- Finding “win-win” solutions through open and honest communication
Track B - CTMS: More than “Just another system”
This session will focus on how a CTMS helps a site be more successful evaluating process and compliance. Hear why a site needs a CTMS, how to get buy-in from leadership, and how to make it value added once it is implemented!
- Evaluate the basics of calendaring and tracking patients
- Discuss invoicing, project tracking, and reporting.
- Leverage your system for compliance
Amanda B Funson, MBA, Director of Research Finances and Billing, BON SECOURS MERCY HEALTH DEPARTMENT OF RESEARCH
Track A - Budget Development & Coverage Analysis – The BasicsLearn how to determine whether your clinical trial requires a coverage analysis. Obtain the basic tools for developing such an assessment, including the creation of a realistic clinical budget. Discussion will include the benefits of having and utilizing this document, as well as the departmental partnerships necessary to implement a compliant research billing process.
- Understand the Medicare requirements for coverage analysis
- Analyze and articulate the key steps in clinical budget and coverage analysis development
- Describe how “it takes a village” to assure compliant research billing practice
Track B - The Intersection of Policy, Education, and Communications
In the last 15 years, since NCD 310.1 nearly got a significant makeover, research billing compliance (RBC) enthusiasts have honed their expertise and become ever more nuanced. Yet, we still worry about getting out the RBC message to busy research teams. This session looks at the traditional compliance tools of policy and education and how they can be joined to communications to advance compliance assurance and, in particular, RBC, in the coming years.
- Identify the value of considering the links among policy, education, and communications
- Strategize the design of programming that links them
- Apply their intersection to research billing compliance
- Items that sponsors offer to pay for “if not performed per standard of care” and how important it is to take that into account in a coverage analysis.
- Stipends and why the informed consent, budget, and agreement should all match each other.
- The importance of maintaining compliance so no improper billing is performed.
- Concerns with language in the contract that caps sponsor obligations to pay for study costs.
- Challenges related to subject injury payments.
Eli Judge – Senior Clinical Research Contracts and Compliance Analyst, WCG
- Assess financial toxicity and its impact on clinical research participants and the enrolling site.
- Report and discuss findings regarding participant financial understanding regarding clinical research enrollment.
- Recommend and describe the PRoFT Risk Framework©
- Validate coding and identifying missing codes
- Analyze data points reviewed
- Evaluate EPIC charge routing for correctness
- Share the successes and the failures of setting up a central financial compliance review process.
- Explore the impacts of these changes on institutional start-up metrics.
- Explain specific considerations and challenges of rolling out a new Clinical Trial Management System and their impact on financial compliance and institutional metrics.
- The core pillars of Lean as a Lean Management System (Continuous Improvement, Respect for People)
- Definition of A3 Problem Solving (problem solving and continuous improvement approach using a A3 tool)
- Familiarity with how to navigate the A3 Tool
- Discuss areas of knowledge and terminology gaps between clinicians and accountants
- Discover key criteria within the research protocol linking your clinical and accounting teams to strengthen your billing/financial compliance program.
- Differentiate focus areas between the clinical and accounting teams to understand competing priorities within the research protocol.
Candi Barlow, Independent Contractor, KELLY WILLENBERG & ASSOCIATE
- Define standard of care
- Analyze routine care and cost in a qualifying trial
- Evaluate conventional care
Deborah Suarez, Director Research Administration, MIAMI CANCER INSTITUTE
- Formulate a plan for document concordance
- Evaluate discrepancies
- Demonstrate successes in ensuring that good intentions do not miss the mark
Tana Smith, BSN
Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP