Sharing in the Compliance Sandbox -
Networking for Success
Higher Education ConferenceHigher Education Conference
Networking for Success
C. J. Wolf, University of Texas
Lynda Hilliard, University of California
Reasons to Share
• It’s what your mother
taught you to do
• It will make you
feel good
Reasons to Share
SCCE Code of Professional Ethics
“communication with professional colleagues
and participation in open professional and participation in open professional
dialogues and exchanges”
Commentary R3.5
Reasons to Share
Program Effectiveness
“modeling its own compliance and ethics program on existing, well-regarded program on existing, well-regarded compliance and ethics programs and best practices of other similar organizations.”
US Sentencing Guidelines
Commentary 2(C)(iii) of Chapter 8 Part B
Benefits of Networking/Sharing
• Avoid “re-inventing the wheel”
• Establish professional communication and feedback channel
• Safe environment to discuss situational and strategic challenges and • Safe environment to discuss situational and strategic challenges and
seek solutions, as well as cheering successes
• Ability to BENCHMARK with an “apples to apples” methodology in
order to dig deeper within organization to affirm effectiveness
• Provides level of credibility when discussing programmatic
needs/changes with Board or Senior Leadership
Case Study: University Consortium
Background:
• UC and UT CCOs both looking for organizations to bounce ideas off of….
– New or revised compliance structures
– Increased focus on a number of compliance risk areas –– Increased focus on a number of compliance risk areas –
– Industry experience/data limited
– Limited compliance resources
• Expanded to include CalTech, UW (School of Medicine), Stanford
University and California State University System
Why? - …Similar Organizations
• Large, public institutions
• Board governance
• Academic, health, and laboratory
components
• Compliance structure within • Compliance structure within
institutions as well as at a system
level
• Subject to state public
information laws
• Influence of public officials and/or
state government
Establishing a Consortium/Network
• Determine Criteria for Network
– Geographic vs Functional
– Size and Scope of Organization and Compliance Structure
– Number of Participating Members (limit to those who share and not just “listen”)
• Network Goals/Objectives
– Shared vision for meeting
• Compliance Risks in Common?
Establishing a Consortium/Network
Do you have all the expertise in-house?
• Export Controls
• Clinical Trial Billing
• Privacy
Information Security• Information Security
• Medical Billing/Coding
• Time and Effort
• Conflict of Interest
• Others??
Give and Take
• Mutual Agreement to be open and share information and/or tools
• Meetings scheduled around presentations on practices to mitigate specific compliance areas of risk, e.g., MedCen clinical trials billing, export risk, e.g., MedCen clinical trials billing, export controls.
– Professional confidentiality a hallmark of the group
– All members must present the challenges and opportunities, within legal constraints if they have that function, for others to learn.
Compliance Risk Areas
Clinical Trial Billing– Educational events
– Regular conference calls
– On-site visits– On-site visits
– Strategies on advancing initiatives (i.e., institutional culture)
– Answering, “Are we the only ones doing this?” or “Why do we have to be so strict?”
– Avoid re-inventing the wheel
– Experience with software and/or vendors
Policy Sharing - UT
• Policy sharing
– UTS 163 Time and Efforthttp://www.utsystem.edu/bor/procedures/policy/policies/uts163.html
– UTS 173 Export Controlshttp://www.utsystem.edu/bor/procedures/policy/policies/uts173.html
– UTS 175 Financial Conflict of Interest in Researchhttp://www.utsystem.edu/bor/procedures/policy/policies/uts175.html
Compliance and the Board--UT
• Feb. 2011 Clinical Trial Billing
http://mediasite.utsystem.edu/mediasite/Viewer/?peid=ab54
5d3dd2d24e2eb18c8612269954011d
scroll the time bar to the 1:09:14 mark (i.e., 1 hour, 9 minutes
and 14 seconds) to view the recordingand 14 seconds) to view the recording
• Aug. 2010 Medical Billing
http://mediasite.utsystem.edu/mediasite/Viewer/?peid=b14c
73a58adc4d5dac151e9d22aa4895
scroll the time bar to the 1:18:30 mark (i.e., 1 hour, 18 minutes
and 30 seconds) to view the recording
Policy Management Project - UC
Clear,
articulated, and
communicated
System wide
policies establish
a foundation for a foundation for
an effective
compliance
program.
Clinical Research Billing Process Review - UC
Five UC Medical
Centers and their
campus research
functions have unique
work environments.
The need to review,
understand and understand and
recommend best
practices to mitigate
potential risks for this
highly visible area was
evident. Compliance
facilitated the
“change process”.
Public Records Act - UCAs a “quasi” California
state agency, UC is
required under state law to
provide public access to
certain UC records per a
prescribed timeframe.
To understand and
determine whether the determine whether the
current processes at the
campuses and the Office of
the President met State
law and were relevant to
the needs of Californians,
ECAS facilitated the
collection of data and
requesting expert advice
on improving the process.
Summary
Questions/Answers
Contact:Lynda Hilliard 510-987-0851 [email protected]
C.J. Wolf 512-579-5017 [email protected]
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