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Title: Introduction and Overview
Description:
This session will
illustrate why compliance is important, review compliance issues and
provide an overview of the fiscal compliance program. It will serve as
a foundation appropriate for all individuals who are involved in
clinical trials with billable services.
Learning objectives:
Participants will…
-
Learn the scope and
need for fiscal compliance in reimbursement and billing in clinical
trails.
-
Gain a general
understanding of 3rd party billing and Medicare rules relative to
clinical trial services.
-
Appreciate the
difference between clinical and payment decisions.
-
Learn about the
fiscal training program and requirements.
Title:
:
Fiscal Compliance relative to Clinical Trial Agreements and Human
Subject Protection; Conducting Medicare Coverage Analysis; Coding for
Investigators
Description:
This module will
provide investigators and their staff with knowledge regarding fiscal
language and issues in clinical trial agreements and human subject
protection documents as well as the process for conducting a Medicare
coverage analysis. The session will also cover the unique coding and
documentation requirements for Medicare coverage of a qualifying
clinical trial.
Learning Objectives:
Learn the process of contract review and key issues encountered during
negotiation
-
Learn the process
of contract review and key issues encountered during negotiation
-
Gain an
appreciation for the impact of fiscal compliance on human subject’s
protection and IRB review.
-
Identify areas
requiring consistency between clinical trial agreements (CTA) and
informed consent documents.
-
Learn the
requirements and process for conducting a Medicare Coverage analysis.
-
Learn the
Federal coding and documentation requirements for Medicare coverage
of
items and services provided as part of a Medicare qualifying
clinical trial.
Title:
Preparing Clinical
Trial Budgets and Budget/Grant Management
Description:
This session will
cover general budgeting for clinical trials and use of the research plan
code for promotion of fiscal compliance. In addition, information and
tools will be provided for managing the budget or grant account during
the trial to monitor and correct billing errors or issues. Participants
who are responsible for preparing or managing budgets may also attend
the accompanying workshop designed to give participants “hands on”
experience.
Learning Objectives:
-
Understand and
learn general steps to development of a clinical trial budget
-
Learn about
available tools to assist in budget development
-
Learn about new
standard operating procedures for the University with respect to
budget
development
-
Introduction to
required forms for budget development
-
Review the
process associated with budget/grant management at UK.
-
Identify the
elements of a budgetary file.
-
Recognize the need
to monitor and track clinical trial finances.
-
Review tools
that can be used with budget/Grant management.
-
Gain an
understanding of the importance of communication.
Title:
Research
Patient/Subject Registration
Description:
This section will
provide an overview of the new mechanism to register a patient for
routine care and research charges.
Learning Objectives:
Participants will:
Title:
Putting fiscal compliance into practice.
Description:
This optional workshop will take a sample protocol through the fiscal
process from budgeting to grant management with the opportunity for
hands-on experience with various forms and tools.
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Additional
Web Based Training Resource |
Title: University
of Kentucky: Third-Party Reimbursement for Medical Services related to
Clinical Trials, Mark Barnes, JD
Description:
This web-based module
will serve as a comprehensive review of issues relative to fiscal
compliance in clinical trials. This training is offered to be used
as needed as a resource or to supplement the fiscal training program.
Learning Objectives:
-
Recognize
potential non-compliance issues pertinent in conducting clinical
trials.
-
Understand general
Medicare coverage and billing principles.
-
Be aware of special
coverage principles and practices for medical devices in clinical
trials.
-
Identify the
components of the Medicare National Coverage Decision (NCD) for
clinical
trials.
-
Gain a working
knowledge of how to apply the NCD to clinical trials in order to
designate
and direct costs to the appropriate payor.
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