In the age of technology, many organizations struggle with incorporating federal and billing regulations with electronic systems.
This seminar will take you through the clinical research financial life cycle. It will focus on the financial feasibility of considering a clinical research study to be performed at an organization by incorporating it into the integrated systems and managing patient and sponsor billing. You will learn about:
- The various types of funding sources and their power to influence a robust budget to support a clinical research study
- The requirements of the Centers for Medicare and Medicaid Services’ (CMS) for obtaining coverage for clinical trials and how to create a Medicare Coverage Analysis (MCA)
- The difference between National Coverage Determinations and Local Coverage Determinations
- How to incorporate the MCA in the budgeting process, and effectively negotiate this budget with pharmaceutical sponsors
- How to streamline the contract language process and improve study activation times
- How to effectively leverage technology solutions to manage the study and the overall portfolio
- The applicable regulations, operational efficiencies, and risk mitigation through a compliant clinical research billing (CRB) program
- The best practice approaches and how leverage reports to manage a clinical research portfolio
- How to create a clinical research dashboard to house key performance indicators
- How to create staff models to aid with ensuring appropriate resources to manage the studies in the clinical research portfolio.
Learning Objectives:
- Discuss federal and billing regulations while building compliant clinical research billing program.
- Describe the financial feasibility process and deciding to perform/participate in clinical research study.
- Best practice approaches for reducing study activation times.
- Reducing the financial review timelines to improve activation times.
- Creation of fee structures to support study team salary and infrastructure.
- Describe the creation of the Medicare Coverage Analysis (MCA), determining coverage of items and services.
- Incorporating MCA into clinical trial budget.
- Discuss integrating MCA into an electronic health record.
- Compliant management of patient billing.
- Discuss sponsor billing leveraging system integrations.
- Discuss study close out processes.
- Discuss reports for effective portfolio management.
- Develop effective and meaningful metrics.
- Leverage data analytics to drive decision making.
- Understanding how to build key performance indicator dashboards.
- Creating staffing models for various structures.
- Discuss managing organizational risk.
- Identifying risk and creating risk mitigation strategies.
Areas Covered:
- Federal regulations
- Financial activities supporting clinical research studies.
- Working with the Institutional Review Boards.
- Creating a compliant clinical research billing program.
Who will Benefit:
- Clinical Research Coordinators
- Clinical Trial Managers
- Clinical Research Associates
- Clinical Research Managers/Directors
- Administrative Directors
- Financial Analysts
- 08.30 AM - 08.59 AM – Registration, Meet & Greet
- 09.00 AM - Session Start Time
- 9:00 AM - 10:00 AM
- Seminar objectives review, expectations and scope.
- Developing fee structures
- 10:00 AM - 11:00 AM
- Study Feasibility
- 11:00 AM - 12:00 Noon
- Medicare Coverage Analysis
- 12:00 Noon - 1:00 PM Lunch
- 1:00 PM - 2:00 PM
- Medicare Coverage Analysis (continued)
- 2:00 PM - 3:00 PM
- Case Studies
- 3:00 PM - 4:00 PM
- Developing clinical research budgets
- 4:00 PM - 4:30 PM
- Budget negotiations
- 08.30 AM - 08.59 AM – Registration, Meet & Greet
- 09.00 AM - Session Start Time
- 9:00 AM - 10:00 AM
- Overview of Day 1
- Case studies
- 10:00 AM - 11:00 AM
- Study activations
- System integration discussions
- 11:00 AM - 12:00 Noon
- Financial consenting process
- Case study
- 12:00 Noon - 1:00 PM Lunch
- 1:00 PM - 2:00 PM
- Patient billing
- Sponsor billing
- Case study
- 2:00 PM - 3:00 PM
- Study close out
- Metrics
- Data analytics
- Key performance indicators
- 3:00 PM - 4:00 PM
- Staffing models
- 4:00 PM - 4:30 PM
- Wrap up
Mary Veazie
Executive Director, MD Anderson Cancer Center
Mary Veazie is a Certified Public Accountant with over 15 years of experience in clinical research finance. Collectively, she has over 25 years of financial and auditing experience. She developed and directed a clinical research finance office for a large academic medical center. She is certified in Healthcare Research Compliance and Healthcare Compliance. Ms. Veazie’s skill set includes full comprehension of the clinical research billing process and its impact on an organization’s clinic operations and revenue cycle.
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