Research Billing Compliance Summit

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 Devices

Device 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
  • PMAs
  • 510Ks
Denise Quint CPC, CHC, CHRC, Research Compliance Analyst, Office of Compliance and Privacy, UNIVERSITY OF VERMONT MEDICAL CENTER
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
Joe Fugitt, Director, Finance – Research, Office of Research and Education, SPECTRUM HEALTH 
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 Started

Can 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.
Kate Cohen, JD, CHC, CHRC, Chief Compliance Officer, SIU MEDICINE
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
Jiwon Yeo, MHI, ACRP-CP, Research Integration Hub at SEATTLE CHILDREN’S (Invited) 
Scott Long, VP, Chief Compliance Officer at ST. JUDE CHILDREN’S RESEARCH HOSPITAL
Lorna Lasure, MBA, Manager, Pediatric Academics & Research, PRISMA HEALTH–UPSTATE
Kelly Willenberg, CEOKELLY WILLENBERG & ASSOCIATES  
A knowledge of the portfolio is key in knowing your risks. Listen to a seasoned compliance professional speak on how that implicates your revenue transactions:

  • 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
Chad Adams, MPH, AVP, Chief Operational Officer, Vice President, Chief Audit & Compliance Officer, HONORHEALTH (invited)
This session will provide an overview of strategies (including budget increases) to account for workforce shortages at the site-level. Many sites are experiencing significant out-migration of experienced site staff to for-profit organizations.

  • 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.
Lora Black, Executive Director, Clinical Research – SANFORD RESEARCH 
Christina Brennan, MD, Vice President, Clinical Research – NORTHWELL HEALTH
In this session learn how a large Academic Medical Center went live with centralized billing of all non-oncology clinical trials in July 2020, integrating their CTMS with their hospital financial system (Peoplesoft).

  • 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.
Sami Naber, Program Manager, Clinical Trial Billing, CEDARS-SINAI MEDICAL CENTER
There are many moving parts in any given study and implementing a CTMS can assist with tracking patients and study tests and procedures in real time to help ensure proper billing. Interfacing the CTMS with the EHR can provide benefits for patients and staff, increase billing compliance as well as patient safety.

Objectives:
  • 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
Marie Jackson, PhD, MB, Senior Director Research, LE BONHEUR CHILDREN’S HOSPITAL FOUNDATION RESEARCH INSTITUTE

Track A - Building Support for your Clinical Research Program 

You’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
Alicia Drew, Director Clinical Research Services, NATIONAL JEWISH HEALTH

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
Shanna Ford, MHA, CHRC, Associate Director of Finance, HUNTSMAN CANCER INSTITUTE CLINICAL TRIALS OFFICE
Amanda B Funson, MBA, Director of Research Finances and Billing, BON SECOURS MERCY HEALTH DEPARTMENT OF RESEARCH

Track A - Budget Development & Coverage Analysis – The Basics

Learn 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
Katherine Hammerhofer, Finance Director, Clinical Research Center, UNIVERSITY HOSPITALS CLEVELAND MEDICAL CENTER

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
Kaye Mottola, Manager, Research Education, BOSTON MEDICAL CENTER
The clinical trial study start-up process involves many moving parts. Budgets and contracts can be very complicated, and they run the risk of contradicting one another (or other legal obligations) if their drafters do not take care. This presentation will explore some of the common pitfalls in budgets and contracts that those involved in start-up should be wary of, including:
  • 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.
Derek Johnson – Quality Manager, Study Start-up and Administration, WCG
Eli Judge – Senior Clinical Research Contracts and Compliance Analyst, WCG
Baffle the Billing Experts - You’ve got questions, they have answers. Baffle the billing experts while getting your most burning questions answered. If you would like to suggest a question prior to the conference, please submit to kelly@kellywillenberg.com conference Participants
Kelly Willenberg, CEOKELLY WILLENBERG & ASSOCIATES  
Financial Toxicity describes unexpected financial burden and distress commonly associated with cancer patients or those with chronic disease but not directly related to clinical research enrollment. However, clinical research participants are equally at risk. Clinical research sites have an opportunity to prevent and reduce financial toxicity risk by addressing key areas and implementing specific practices. This session will explore new research in this area and present a framework developed around the Prevention and Reduction of Financial Toxicity Risk.

  • 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©
Dawn N. Pittinger, MBA, CHRC, CRCP, Corporate Compliance, Research Billing Compliance Manager, MOFFITT CANCER CENTER
This presentation will evaluate whether elements were followed in a billing plan for the research charges. Did the charge go to the correct payer? Was the billing plan followed? Exploring research coding on claims and validating EPIC and routing of charges will be discussed, as well as sharing numerous tools utilized in the validation process.

  • Validate coding and identifying missing codes
  • Analyze data points reviewed
  • Evaluate EPIC charge routing for correctness
Karen Brautcheck, MS, CPC, CHRC, Compliance Specialist, UF HEALTH SHANDS COMPLIANCE SERVICES
This session will focus on lessons learned from the speaker’s point of view and experience establishing centralized clinical research operations. The goal is to facilitate knowledge and experience sharing during the session that will benefit those in attendance. Compliance, change management, start-up timelines, budgetary impact and other complexities will be explored.

  • 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.
Pavel Kruchek, Director, Clinical Trials Office, UW MEDICINE
This session focuses on specific tactics to move research administrators from reactive to proactive problem solving. We will focus on systematic problem solving and continuous improvement using components of a Lean Management System. Specifically, users will be exposed to A3 problem solving and the A3 problem solving tool, which can be used to improve your local research billing process. This session will include strategies for engaging SMEs (the people doing the work) to drive the process improvement work forward.

  • 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
Amanda Breeden, MA, CRA, AOR, Sr. Director, Sponsored Programs and Research Office (SPARO)/Office of Research, DENVER HEALTH
Join us for a lively discussion on clinical research invoicing and the impact of teamwork in clinical research. Standing in one corner, we have the Clinical team versus the opposing corner, the Accounting team! This session will discuss gaps in knowledge while discovering critical criteria to augment your revenue integrity in clinical research.

  • 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.
Tracy Popp, Independent Contractor, KELLY WILLENBERG & ASSOCIATES
Candi Barlow, Independent Contractor, KELLY WILLENBERG & ASSOCIATE
This session will define the difference between the terms that are widely used in creating study calendars and coverage analysis. Physicians and sponsors refer to the care that patients receive as standard of care. What does that mean? Do you understand what routine care or the routine cost in a clinical trial is? We will explore examples to discern the differences in these terms

  • Define standard of care
  • Analyze routine care and cost in a qualifying trial
  • Evaluate conventional care
Calvin Robinson Jr., Research Financial Analyst – NORTHEAST GEORGIA MEDICAL CENTER
Deborah Suarez, Director Research Administration, MIAMI CANCER INSTITUTE
This session will feature a discussion of case studies where the final document consistency check leads to billing compliance issues. Join the discussion as the panel explores tools that work and suggestions for ensuring a coverage analysis, consent and contract all sync prior to a patient consenting. 

  • Formulate a plan for document concordance 
  • Evaluate discrepancies 
  • Demonstrate successes in ensuring that good intentions do not miss the mark 
Nancy L. Clinton, MBA, RN, BSN, CPB
Tana Smith, BSN
Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP

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