Transcript Office of Institutional Compliance

Office of Institutional
Compliance
Presentation to the Provost’s Department Chairs
Leadership Program
February 19, 2009
Lynn Zentner, Director
Office of Institutional Compliance
Compliance Office – Four Components
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The Core Compliance Program
Conflict of Interest Program
University Administrative Policies
Delegations Management
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The University’s Core Compliance
Program
• Modeled in large part after the Federal
Sentencing Guidelines
• Approximately 30 different risk areas
• Partnership with OGC and the University’s
Office of Internal Audit
• Ensures a coordinated approach:
– Identification and management of risk
– Setting compliance-related priorities
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The University’s Core Compliance
Program – Subject Matter Areas
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Athletics
Boynton Health Service
Community University Health Care Center
Conflict of Interest
Copyright
Data Security/Privacy/HIPAA
Dining Services
Disability Services
Environmental Health & Safety
Equal Opportunity and Affirmative Action
Facilities Management
Fiscal Operations
Grants Management
HIPAA Compliance
Housing and Residential Life
Human Resources
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The University’s Core Compliance
Program – Subject Matter Areas
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Information Technology
Internal Audit
International Programs
Occupational Health & Safety
Privacy
Public Safety
Research – Animal Subjects
Research – Human Subjects
Research – BioSafety
Research- Controlled Substances
Technology Commercialization
School of Dentistry (billing compliance)
Student Finance
Tax Management
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The University’s Core Compliance
Program – Subject Matter Areas
• Examples:
– Research
• Animal and human subjects safety and welfare
• Protocol approval and adherence
– Human Resources
• FMLA
• FLSA
• New vacation policy
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The University’s Core Compliance
Program – Subject Matter Areas
Examples Continued:
• Data Security/Privacy/HIPAA
– Security of private data – employee, student,
patient
– Encryption
• Occupational Health & Safety
– Personal Protective Equipment (PPE)
– Chemical storage and protection from flammables
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The University Core Compliance
Program
• Compliance Partners are identified for each
compliance area.
• Reporting process occurs twice annually.
• Compliance Partners submit written summary of
identified risks, related risk management
approaches, and the identification of trends.
• In person meetings/conference calls are held.
• Significant risks/areas of emphasis are identified
through this process and other information
gathering for focus during next reporting period.
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The University’s Core Compliance
Program – Current Emphasis
• Occupational Health & Safety
• AAALAC
• Conflict of Interest Program
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The University Core Compliance
Program
• Occupational Health & Safety (OHS)
– A few years ago, President Bruininks asked VPs
Carol Carrier, Tim Mulcahy and Kathy O’Brien to
form a Working Group charged with evaluating
the then current status of the University’s OHS
Programs.
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The University’s Core Compliance
Program – Current Emphasis - OHS
• Goals:
• Develop an integrated and carefully coordinated
program
• Utilize the expertise that exists within the many
departments within the scope of OHS
• Close gaps that exist in services and training
• Reduce redundancies regarding the same
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The University’s Core Compliance
Program – Current Emphasis - OHS
• External assessments are currently focusing
on how to most effectively:
– Integrate the operations of our current programs;
– Identify, evaluate and manage all related risks;
– Develop comprehensive standards, policies, and
procedures; and
– Establish a leadership model.
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The University Core Compliance
Program –Emphasis – Animal Research
• The Association for Assessment &
Accreditation of Laboratory Animal Care
(AAALAC) conducted accreditation site visits in
early 2007 and again in February 2008.
• AAALAC identified the following issues:
– Strengthening the oversight, leadership and
expertise of the membership of the IACUC
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The University’s Core Compliance Program
– Emphasis – Animal Research
– Developing greater consistency in the use of
Personal Protective Equipment; and
– Ensuring that certain biohazard containment
practices are sufficient to properly contain the
hazard and minimize risk to personnel.
– The results of an external assessment are
assisting the University in determining the most
effective approaches to addressing the issues
identified by AAALAC.
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The University’s Core Compliance Program
– Emphasis – Conflict of Interest Program
• The Conflict of Interest Program was transitioned
to OIC effective September 1, 2008.
• A time of transition often provides an
opportunity to evaluate a current infrastructure,
policies and procedures.
• A process involving an internal self-assessment
and an external evaluation are identifying ways in
which we might modify our current
infrastructure, policies and procedures.
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The University’s Core Compliance
Program - UReport
• UReport is a web-based and call center
reporting service which:
– Can be used to report violations or suspected
violations of local, state, and federal laws and
University polices; and
– Provides for anonymous reporting
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The University’s Core Compliance
Program - UReport
2008 metrics:
• 161 reports submitted
• 139 were submitted on-line; 19 were received
via the call center, 2 were received via the mail
and 1 was received “in person”
• 29% were anonymous
• 20% were deemed to be credible reports of a
violation of law or policy
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The Conflict of Interest Program
Program Purpose:
• To ensure that the integrity of the work that we
do here - our research, teaching and community
outreach - is not called into question because of
external relationships . To the extent that a
business or financial relationship with an external
entity might call into question the objectivity
which we carry out our teaching, research and
community outreach activities, the integrity of
the University may be called into question.
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The Conflict of Interest Program
• The University’s Conflict of Interest Program
evaluates both individual and institutional
COIs.
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The Conflict of Interest Program
• An individual business or financial COI:
– A situation that compromises a covered
individual’s professional judgment in carrying out
University teaching, research, outreach, or public
service activities because of an external
relationship that directly or indirectly affects a
business or significant financial interest of the
covered individual, an immediate family member,
or an associated entity as defined in related
administrative policy.
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The Conflict of Interest Program
• An institutional COI:
– A situation in which the research, teaching,
outreach, or other activities of the University may
be compromised because of an external financial
or business relationship held at the institutional
level that may bring financial gain to the
institution, any of its units, or the individuals
covered by this policy.
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Conflict of Interest – the University’s
Internal Disclosure & Review Process
Policies and procedures:
• Three administrative Policies – one to address
individual conflicts and two to address
institutional conflicts, and
• Several procedures to address conflicts of
interest arising out of gifts, licensing &
technology transfer, purchasing, investments
and conflicts that arise in the context of
human subjects research.
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Conflict of Interest – the University’s
Internal Disclosure & Review Processes
Three Committees:
• An Institutional COI Review Committee
• Two Individual COI Committees:
– AHC
– Provost
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Conflict of Interest – the University's
Internal Disclosure & Review Process
The Disclosure Process:
• REPAs
• Annual financial disclosures by “University
officials”
• Proposal Routing Forms
• ROCs
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Conflict of Interest – the University’s
Internal Disclosure & Review Process
Other avenues for disclosure:
• When submitting new or continuing
applications to the IRB, the IACUC or the IBC;
• When receiving a contribution or gift which
has the appearance of creating a conflict; and
• When involved with technology transfer.
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Conflict of Interest – the University’s
Internal Disclosure & Review Process
Review and resolution:
• Review by departments and colleges
• COI program review and management
– Executive Committee review
– Full Committee review
– Development of a Management Plan
– Management Plan follow-up
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Conflict of Interest – Recent and
Current Activities
• Internal self-assessment and external
evaluation conducted fall of ’08.
• May result in the revision of current policies
and procedures and modification of the
current infrastructure.
• Efforts underway to create a COI database.
• A more comprehensive approach for
management plan follow-up is being
developed.
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Conflict of Interest – Recent and
Current Activities
• Development of standards to govern
relationships with industry/external entities
– The current landscape
• Disclosure of failures in higher education
• Senator Grassley’s “Sunshine” legislation
– The Medical School Recommendations on the
Oversight of External Relationships
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Conflict of Interest – Industry Relationships
The Enforcement Landscape
Scrutiny by the Federal Government:
• The Pharmaceutical Industry
– Serono - $567 million in part for kickbacks paid to physicians
– TAP Pharmaceutical - $559 million in part for kickbacks paid to
physicians
– Bristol Myers Squib- $515 million in part for kickbacks to
physicians
– Smith Kline Beecham- $325 million in part for kickbacks to
physicians
– AstraZeneca Pharmaceuticals- $266 million in part for kickbacks
to physicians
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Conflict of Interest – Industry Relationships
The Enforcement Landscape
The Device Industry:
• Settlement of claims against 5 orthopedic
companies in September 2007 for $311 (Stryker,
DePuy, Zimmer, Smith & Nephew and Bionet)
– Scrutinized consulting agreements for legitimacy and
$$ paid
– Deferred prosecution agreements
– On-site monitors
• Fall 2005 Department of Justice subpoenas
served on Medtronic, St. Jude and Guidant (now
Boston Scientific).
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Conflict of Interest – Industry Relationships
The Enforcement Landscape
By Whistleblowers:
• September 2008 whistleblower suit reported
in the local media regarding alleged receipt of
kickbacks by local physicians for prescribing
the off-label use of a biologic marketed and
sold by Medtronic.
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Conflict of Interest – Industry Relationships
The Enforcement Landscape
By Congress:
Re Alleged Inadequate Disclosures in Higher Education:
• Harvard: Senator Charles Grassley (IA) alleged that two Harvard
faculty/physicians failed to report $1.6 million in consulting fees to their
institution.
• Stanford: Senator Grassley alleged that the Chair of the Department of
Psychiatry failed to report $6 million in ownership interest in stock in a
company involved in a government-funded study that the physician
oversees.
• Emory: One of the nation’s most influential psychiatrists is alleged to have
earned more than $2.8 million in consulting arrangements with drug
makers from 2000 to 2007, failed to report at least $1.2 million of that
income to his university and violated federal research rules.
• University of WI: An orthopedic surgeon is alleged to have received more
than $19 million in royalty payments from Medtronic over a 4-year period.
UW did not share in the payments. Researcher says that UW facilities
were not used for the patent-related work.
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Conflict of Interest – Industry Relationships
The Enforcement Landscape
• In early August of 2008, the media
reported that Senator Grassley sent
letters to several institutions of high
education seeking information about
the quality of the reporting system by
which academic researchers report
their outside income to their
institutions.
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Conflict of Interest – Industry Relationships
The Enforcement Landscape
Senator Grassley’s concerns:
– That colleges and universities often do not
monitor or audit the information the researchers
report so the only person who knows if the
reported income is accurate is the person who is
receiving the money.
– Although he is not saying that there is something
inherently wrong with accepting money from
industry, for the sake of transparency and
accountability, it is his view the American public
should know who the physician is taking money
from.
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Conflict of Interest – Industry Relationships
The Enforcement Landscape
Legislation
• Federal: September 2007, Senators Grassley and Herb Kohl
(WI) introduced legislation requiring manufacturers of
pharmaceutical drugs, devices and biologics to disclose the
amount of money they give to physicians through payments,
gifts, honoraria, travel and other means.
– Senator Amy Klobuchar is a co-sponsor.
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Conflict of Interest – Industry Relationships
The Enforcement Landscape
– Senator Amy Klobuchar’s comments on the proposed
legislation: “This is a common sense legislation that helps
ensure the integrity of our health care system. It is
important to shed light on the millions of dollars these
companies spend on marketing – money that could be put
into research or lowering the cost of prescriptions.”
– Letters of endorsement from the AMA, the Association of
American Medical Colleges, AdvaMed, Pharma, Medtronic,
and Merck.
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Conflict of Interest – Industry Relationships
The Enforcement Landscape
By States:
• Several states and the District of Columbia have “sunshine
laws” - some that provide public disclosure and others that
do not; some that require disclosure by only the
pharmaceutical industry and some that require disclosure
by both the pharmaceutical and device industries:
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Minnesota (the first)
Vermont
Maine
District of Columbia
West Virginia
Massachusetts
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The University Policy Office
• Merged with OIC in 2007
• Michele Gross manages the process of policy
development, revision, maintenance and
retirement.
• The Policy Advisory Committee (PAC) ensures
that policies are needed and aligned with
institutional mission, goals, and priorities.
• The President’s Policy Committee (PPC) provides
final institutional review and approval.
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The University Delegations Management
Program
BOR policy:
• Reserved several authorities to itself.
• Delegated general executive management and
administrative authority to the President and
to further delegate that authority to other
executive officers and employees.
• Formerly managed by OGC.
• Currently reviewing the existing electronic
tracking system for possible modifications.
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Questions?
Lynn Zentner, Director
Office of Institutional Compliance
612/626-7852
[email protected]
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