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 lynda.hilliard@ucop.edu

C.J. Wolf 512-579-5017 cjwolf@utsystem.edu