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/policies/administrative/uwmf/uwmf-wide/administrationlegal/100002.policy

201606166

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UWMF,

Policies,Administrative,UWMF,UWMF-wide,Administration/Legal

Interactions with Industry (100.002)

Interactions with Industry (100.002) - Policies, Administrative, UWMF, UWMF-wide, Administration/Legal

100.002



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Policy on Interactions with Industry

January 1, 2012








University of Wisconsin Medical Foundation, Inc.




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Purpose of Policy:
This policy establishes guidelines for interactions between Industry and faculty physicians employed by
the University of Wisconsin-Madison (“UW”), as well as other UW- or UWMF-employed health care
professionals. The UW School of Medicine and Public Health (“SMPH”) has entered into a Memorandum
of Understanding with UWMF, whereby UWMF is charged with implementation of this Policy on behalf of
the UW and SMPH with respect to UW Faculty Physicians and other UW-employed health care
professionals.

We encourage interactions and partnerships with Industry which serve the public good and promote our
missions. These interactions must be appropriately conducted and monitored in order to avoid or
manage conflicts of interest that can adversely affect our patients or the institution. The purpose of this
policy is well summarized by the Association of American Medical Colleges: “the overarching goal for
both academic medicine and Industry must be to maintain productive relationships in research, education,
and patient care that contribute to the health of the public and sustain the public’s trust.”

Statement of Policy:
Interactions with Industry should be conducted so as to avoid conflicts of interest when possible, and to
minimize and effectively manage these when conflicts do exist.

Basis for Policy:
Professionalism is a core value of UWMF and the SMPH, and forms the basis for the provision of health
care. Because health care providers occupy esteemed and privileged positions in our society, we must
maintain a strong relationship of confidence and trust between clinicians and their patients. Promoting the
values and behaviors associated with professionalism for both current and future generations of
healthcare providers is a primary responsibility of an academic health center. All health care providers
must ensure that the process by which they make clinical decisions is transparent, ethical, free of undue
economic influence, and reflects the highest professional standards. Patients deserve and expect well-
informed, objective health care decision-making based on their best interests.

An individual conflict of interest occurs when a person with entrusted responsibility has another interest
that may conflict with the proper exercise of that responsibility.

UWMF was chartered by the University of Wisconsin Board of Regents in 1996 to support the educational
and research missions of the SMPH through the coordination and delivery of clinical care by the faculty of
the school. The authority bestowed in the charter carries with it the responsibility to exercise our clinical
mission with the highest standards possible. While the UW has policies that speak to conflicts of interest,
such policies do not fully reflect the special covenant that exists between clinicians and patients, and do
not respond to the urgency felt by academic health centers to formulate specific policy in this area. As a
result, UW and the SMPH have delegated the responsibility to implement this Policy on behalf of the UW
and SMPH with respect to UW Faculty Physicians and other UW-employed health care professionals

Scope of Policy:
This policy addresses a specific set of interactions with Industry, and purposefully excludes others. In
particular, it does not address activities certified for CME credit by an ACCME-accredited organization,
nor does it generally address faculty research activities, the former being addressed by the Office of
Continuing Professional Development and the latter through the University of Wisconsin-Madison
policies. This Policy addresses the following areas:

I. Gifts to Individuals
II. Gifts to UWMF
III. Attendance at Non-CME certified events / outside activities funded by Industry
IV. Speaking at Non-CME certified events Sponsored by Industry
V. [Intentionally Omitted]



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VI. Consultation with Industry
VII. Ownership and Corporate Board Membership
VIII. Royalties
IX. Oversight of Outside Relationships with Industry: The Industrial Interactions Review Committee
(IIRC)
X. Internal Disclosure
XI. Disclosure to Patients
XII. Site Access by Industry Representatives
XIII. Industry Sponsored Scholarships and Other Educational Funds for Trainees
XIV. Pharmaceutical Samples
XV. “Ghostwriting” and Responsible Communications Practices
XVI. Individual Involvement with Industry in Purchasing Decisions for UW Healthcare Entities

Application of Policy:
This policy applies to all UW Faculty Physicians and UW- or UWMF-employed health care professionals
(defined collectively as “UW/UWMF Providers,” below).

Definitions:

A. Industry or Industry Representatives: Manufacturers, services, and other vendors of
pharmaceutical, medical device, medical supply, and medical testing companies, and their
employees, representatives, agents, and vendors.

B. UW Healthcare Entities: Collectively, the University of Wisconsin School of Medicine & Public
Health, the University of Wisconsin Hospitals & Clinics Authority, and the University of Wisconsin
Medical Foundation, Inc.

C. IIRC: Refers to the Industrial Interactions Review Committee. The IIRC is a committee of the
UWMF Board of Directors which is charged with oversight of all UW/UWMF Providers that are
within the purview of this policy.

D. Non-CME Events: Events, including those held in other countries, which are not certified for
continuing medical education credit by an ACCME-accredited organization.

E. UW/UWMF Providers: UW Faculty Physicians and UW- or UWMF-employed physician
assistants, nurse practitioners, nurses, and other health care professionals.


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POLICY
I. Gifts to Individuals
UW/UWMF Providers may not accept from Industry anything of value for their private benefit or the
benefit of their immediate family or an organization with which they are associated, for which payment
or services are not provided in return. This includes, but is not limited to money, property, favor,
service, food, travel, and entertainment. For the purposes of this Policy, there is no minimum value to
a gift; items of little value such as pens, sticky notes, magnets, key chains, and laser pointers, are all
considered gifts.
II. Gifts for Patient Education
By agreement with UWHC, non-branded, non-promotional patient education materials may be
received under the oversight of the UWHC Vendor Liaison Office (VLO). Such gifts for patient
education should first be approved by the VLO staff, who will review the material for inappropriate
promotional messaging. Gifts must be made at the Section, Divisional or Departmental level, with
simultaneous notification of the Chair of the IIRC. Gifts shall not be made to or on behalf of individual
faculty members.
III. Attendance at non-CME Events / Outside Activities Funded by Industry
UW/UWMF Providers may attend Industry-sponsored events, such as educational programs that are
not certified for CME credit, at their own discretion. Dinner programs, “roundtables,” or “educational
conferences” sponsored by Industry are included in this category. In such cases, the UW/UWMF
Providers shall not receive any remuneration or gifts (See Section I, above) in exchange for
attendance. This prohibition includes the cost of meals and reimbursement for any expenses to
attend the program such as food, travel, accommodations, or registration fees. UW/UWMF Providers
who attend non-CME Industry-sponsored events must pay all of their own expenses.
IV. Speaking at Non-CME Events Sponsored by Industry
UW/UWMF Providers may not participate as speakers in outside activities that are promotional and
funded by Industry, such as speaker’s bureaus, speaker’s training programs, and contracted
educational programs.
With prior approval, UW/UWMF Providers may speak at non-CME events sponsored by Industry
which provide unique learning opportunities.
To obtain prior approval to speak at a non-CME event, UW/UWMF Providers must complete the form
located at the following location on uConnect:
https://uconnect.wisc.edu/applications3/emailforms/form.jsp?ef=78
The uConnect form requires answers to the following questions:
A. For events sponsored by pharmaceutical or biologic Industry companies:
1. Why are the events not certified for CME by an ACCME-accredited organization?
2. Will the events comply with the current Code on Interactions with Healthcare Professionals of
the Pharmaceutical Research and Manufacturers of America (PhRMA)?
[Also see all questions enumerated in Section IV.C., below]



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B. For events sponsored by device manufacturer Industry companies:

1. Will the events conform to applicable FDA regulations or guidelines?
2. Will the events comply with the current Code of Ethics on Interactions with Health Care
Professionals of the Advanced Medical Technology Association (AdvaMed)?
[Also see all questions enumerated in Section IV.C., below]

C. For events sponsored by any type(s) of Industry companies:

1. Will the events provide unique teaching/learning opportunities?
2. Do the UW/UWMF Providers involved develop and retain control over the content of
presentations?
3. Are there contracts with clear deliverables?
4. Are the presentations balanced, with consideration of all relevant treatment options?
5. Are the educational materials used non-promotional

Each UW/UWMF Provider who speaks at a non-CME event sponsored by Industry must submit his or
her presentations and an agenda or syllabus for the non-CME event to the IIRC. Materials may be
submitted at any time prior to the non-CME event, but must be submitted no later than one month
after the event. Materials must be submitted electronically to iirc@uwmf.wisc.edu.

UW/UWMF Provider participation in any non-CME event sponsored by Industry is subject to the
following conditions, which are based on provisions of the United States Department of Justice
September, 2007, deferred prosecution agreements with certain device manufacturers
i1
:
1. Fair market value compensation in exchange for time spent in bona fide teaching activities,
but in no event in excess of five hundred ($500.00) dollars per hour.
2. Presence of a management plan for notice to and interaction with patients.
3. Presence of a written contract set in advance, establishing clear and actual deliverables, and
the details of compensation.
4. Reasonable reimbursement for incurred lodging, transportation and dining expenses.

V. [Intentionally Omitted]

VI. Consultation with Industry
A. UW/UWMF Providers may participate in non-promotional outside activities with Industry, such as
providing expert consultation, serving on advisory boards, serving as medical directors or chief
medical officers, serving on research advisory committees or data safety and monitoring boards
for clinical trials, without prior approval but subject to the same requirements outlined in Section
V. B., above, except for the compensation limit included in B.1.

B. UW/UWMF Providers must submit to the IIRC, within one month of completing the engagement,
information about the activity, with details as required by the IIRC.

C. The IIRC will consider the following in its review:
y Is there a need for a management plan for interactions with patients?
y Is there a contract with clear deliverables for services provided at a fair market value?
y Is the content of the work scientific and/or academic rather than promotional or commercial?

D. The IIRC will review the submitted information and, if necessary, meet with the UW/UWMF
Providers. If the IIRC concludes that there are problematic issues with the activity, it may require
a UW/UWMF Provider to obtain pre-approval of any future consulting activities.






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VII. Ownership and Corporate Board Membership
UW/UWMF Providers may own equity interests in or serve in leadership roles (i.e., serving as a
director on a Board of Directors) for Industry companies. These activities must be reported to the
IIRC and must have a management plan for interactions with patients.

Stocks held in mutual funds are exempt from this policy.

VIII. Royalties
UW/UWMF Providers may receive royalties from sales of commercial products sold by Industry;
however, each of the following requirements must be satisfied:

A. Royalty payments for commercial products sold by Industry must not include those sales that take
place at any UW Healthcare Entity. UW/UWMF Providers who receive royalties are responsible
for notifying the source of the royalty payment of this policy and identifying relevant UW
Healthcare Entities in such notification.

B. UW/UWMF Providers who receive royalties for commercial products must disclose this fact, in
writing, to patients who are presented with the option of receiving the commercial product as part
of their medical care.

C. The monetary value of all royalties, including those distributed to UW/UWMF Providers from
WARF, must be reported to the IIRC annually. In accordance with standard WARF reporting
procedures, WARF royalties are reported as single lump sums and not broken down by individual
company payees. SMPH and UWMF will work with WARF to attempt to create accounting
mechanisms that allow categorization of royalties by individual payees.

D. A management plan for interactions with patients is required.

E. UW/UWMF Providers who receive royalties under this section may not participate on any
pharmacy and therapeutics committee, or committee equivalent, when the product for which the
royalty is received is under consideration by such committee.

IX. Oversight of Outside Relations With Industry: The Industrial Interactions Review Committee
(IIRC)

Oversight of all UW/UWMF Providers’ activities in the purview of this policy will be under the auspices
of the IIRC. The IIRC will be established by the UWMF Board of Directors and will be charged with
reviewing and managing all outside interactions between Industry and UW/UWMF Providers that may
affect the clinician-patient interface. The IIRC will be populated by SMPH faculty members and
members of the UWMF Board of Directors, as approved by the UWMF Board of Directors on
recommendation of the UWMF Executive Committee. The Executive Committee will consult with the
UWMF Council of Faculty and UWMF Council of Chairs in developing its recommendations. The
UWMF Board of Directors, on recommendation of the UWMF Executive Committee, will also appoint
a chair of the IIRC. Administrative support to the IIRC will be provided by UWMF.

In its reviews, determinations and actions, the IIRC will carefully consider the overall context and
implication of each interaction with Industry that may create a conflict of interest. Its determinations
will set precedent for the consideration of subsequent situations. Activities of the IIRC will include:

A. Working with UWMF administration and the SMPH Dean’s office to create and maintain a set of
procedures that are complementary to this Policy.

B. Working with UWMF administration and the SMPH Dean’s office to create and maintain a set of
Frequently Asked Questions (FAQ) that address the majority of situations that will fall under this
policy.



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C. Maintaining availability of the IIRC Chair, designated IIRC members, or administrative staff,
through a “Hotline” mechanism, to answer questions about how specific activities might relate to
the Policy.

D. Reviewing UW/UWMF Providers’ participation in non-CME events funded by Industry to the
extent that these activities are permitted by this policy. This may include review of presentation
content or educational materials, creation and monitoring of management plans, or a finding that
participation should not be allowed.

E. Reviewing UW/UWMF Providers’ participation in outside relationships with Industry that are not
promotional. This may include review of contracts, review of levels of remuneration, creation and
monitoring of management plans, or a finding that participation should not be allowed.

F. Reviewing UW/UWMF Providers’ individual stock or stock options, leadership roles on the boards
of Industry entities, and licensing activities; instituting management plans for clinician-patient
interactions which may be influenced by such relationships.

G. Reviewing annual disclosure to IIRC by all UW/UWMF Providers of all outside income that
originates from Industry.

H. Giving final approval or disapproval of outside activities covered by this policy, subject to UW-
Madison and WARF policies governing outside relationships and outside income. If the IIRC
concludes that a UW/UWMF Provider’s participation in an outside activity is incompatible with
provisions of this policy, it will forward its findings and conclusions to the UWMF CEO and SMPH
Dean.

I. Authorizing specific corrective or remedial action on matters subject to this policy. There is an
expectation that activities disapproved by the IIRC will be discontinued on a timeline determined
by the IIRC. Failure or refusal to comply with the IIRC’s determinations will result in referral to the
UWMF Professional Conduct Committee, UWMF HR Department, or SMPH HR Department, as
appropriate, to determine the proper consequences for non-compliance.

For UW Faculty Physicians, recommendations of the UWMF Professional Conduct Committee
will be forwarded to the UWMF Executive Committee for final approval and subsequent action.
Further, the appropriate SMPH Department Chair will be kept informed of all decisions in the
process.

J. The Chair of the IIRC will meet at least annually, and more often as directed, with the UWMF
Board of Directors to provide requested information, to report on the IIRC activity for the
preceding year, and to make recommendations from the IIRC for amendments to the Policy. The
UWMF Board of Directors will act, on a yearly basis, to modify, as needed, and reapprove the
Policy.

K. The IIRC will propose transition plans for UW/UWMF Providers with existing contractual
commitments that are not compatible with this policy.



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X. Disclosure by UW/UWMF Providers

UW/UWMF Providers with outside relationships with Industry, including participation in CME
programs, must file an annual report with the IIRC, the specific content of which will be determined by
the IIRC and approved by the UWMF Board of Directors. Disclosure may only include information
necessary to implement the provisions of this policy. Every effort will be made to collaborate with the
UW and its outside activities reporting mechanisms to avoid duplication. All information collected by
the IIRC will be held confidential to the extent possible, subject to applicable disclosure rules and
laws.

Required disclosure will include:

A. A listing with each Industry company for which a relationship exists, including the name of the
company or organization that provides remuneration.

B. A description of the type of activity (e.g. educational lecture, scientific consulting, etc.), the type of
the remuneration received (i.e. honorarium, stock, stock options, etc.) and whether the event was
certified for CME credit.

C. The dollar amount or monetary value (within $1000) received from each Industry company for
outside activities and the aggregate amount.

XI. Disclosure to Patients
A central database of all relationships between UW/UWMF Providers and Industry will be created and
updated annually. Disclosure to patients will include all of the following:

A. UWMF will post signs in all of its clinics and provide notification on its website to advise patients
that some UW/UWMF Providers have financial relationships with Industry. Patients will be invited
to contact UWMF or SMPH for specific information about their clinicians’ outside financial
arrangements with Industry, including their monetary value. The names of those inquiring will be
kept confidential.

B. Other disclosures about UW/UWMF Providers’ relationships with Industry relationships as may be
required by the IIRC.

XII. Site Access by Industry Representatives
A. Pharmaceutical Representatives
In order to respect patients, patient care areas, and work schedules, UWMF will limit access to its
facilities by pharmaceutical Industry representatives. General access is permitted only to public
areas which are not designated for patient care. Meetings with UW/UWMF Providers should
occur only in non-public areas, such as offices or conference rooms. No promotional activities
shall be permitted to take place in clinic space, waiting rooms, patient lounges, cafeterias, or
other areas where patients may be found.

1. These activities may occur in a manner which is consistent with the guidelines set forth in
UWHC Policy 11.19, as overseen by the UWHC Vendor Liaison Office (VLO).

2. Meetings with pharmaceutical Industry representatives shall be permitted to take place only
by invitation from UW/UWMF Provider or the UWHC Pharmacy Director (or their equivalent
for non-UWHC clinics).

3. Requests for appointments with UW/UWMF Providers by pharmaceutical representatives
shall be made through the VLO.



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4. Alternative processes for implementing the intent of this policy may be adopted for
geographically distant clinics and faculty locations.

B. Medical Device Representatives

Medical device representatives are generally subject to the same rules as pharmaceutical
industry representatives. Medical device Industry representatives may enter patient care areas
only when all three of the following pre-conditions are met:

1. The representative is appropriately credentialed by the organization owning or operating the
clinical entity.

2. The visit is requested by appointment and invitation of a UW/UWMF Provider or designated
SMPH Department personnel, regarding required information on the medical device.

3. The visit to a patient care area is of direct benefit to the patient(s) currently being treated in
the patient care area, or no patients are present.

Whenever possible, meetings should occur in non-patient care areas. These activities should be
scheduled through the UWHC VLO (or equivalent for UWSMPH and UWMF sites). Requests for
the services of device representatives in the operating room or procedure suites do not require
VLO approval.

These requirements do not apply to individuals servicing medical devices which are already in
place. For these individuals, credentialing and an existing service contract are required.

UWMF will require advance notice to, and consent by, the patient if a medical device Industry
representative(s) may be present during any patient care interaction. Adherence to policies for
consent in place by the clinical entity will satisfy this requirement.

Medical device Industry representatives who wish to interact with UWHC, UWMF, or UW clinical
laboratory health care professionals may meet only with the Director of the Clinical Laboratories
or his/her designee and are not permitted to promote their products or to meet directly with
patients, health care providers or non-designated clinical laboratory staff.

XIII. Industry-Sponsored Scholarships and Other Educational Funds for Trainees

All scholarships or other educational funds from Industry, including fellowships, must be donated centrally
to the administration of one of the UW Healthcare Entities or to an SMPH Department. All scholarships
and other educational funds must be freely given and not contain a quid pro quo of any kind.

The evaluation and selection of the individual recipients of such scholarships or educational funds are
solely the responsibility of the receiving entity and are based on criteria determined by that entity, without
involvement of any kind by the Industry donor, except that the Industry donor may direct the scholarship
or other educational funds to a particular specialty area at the time the gift is made.

The existence of a scholarship or other educational funds from an Industry donor must be disclosed to the
IIRC and to the Dean of the SMPH.




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XIV. Pharmaceutical Samples
In response to safety concerns and financial inefficiencies caused by medication samples, as well as
regulatory requirements, all medication samples are prohibited from all UWHC and UWMF clinics.

Specific exceptions may be made for over the counter medications and products approved by the UWHC
Pharmacy and Therapeutics Committee (or equivalent for UWMF clinics and facilities). Such exceptions
will be granted only when sample medications are required for the safe initiation of therapy. The policy will
allow the possibility for the development of centralized sample repositories overseen by the UW
Healthcare Entities.

XV. “Ghostwriting” and Responsible Communications Practices

UW/UWMF Providers shall not allow their written work to be ghostwritten by Industry representatives or
by any other party. Authorship must always be assigned and acknowledged based on standard academic
procedures. When making presentations, UW/UWMF Providers are responsible for the accuracy of the
content of the presentations and slides prepared by others (this does not extend to material taken from
peer reviewed publications).

XVI. Individual Involvement with Industry in Purchasing Decisions for UW Healthcare Entities

All costs related to meals, travel, lodging, etc. for meetings, site visits, or other activities related to a
purchasing decision on behalf of a UW Healthcare Entity must be covered by such UW Healthcare Entity
unit and not the Industry vendor, unless approved in advance by the IIRC.

XVII. Author and Review


Sponsor: UWMF Board of Directors
Author: Jeffrey E. Grossman, MD, CEO
Robert N. Golden, MD, Dean, UWSMPH
Initial Review /
Committee
Approval:
UWMF Board of Directors (October 20, 2009)
Council of Chairs
Council of Faculty

Approval of
Revisions:
UWMF Board of Directors (October 18, 2011)
Council of Chairs (October 11, 2011)
Interactions with Industry Committee (October 6, 2011)


1. See a synopsis of the deferred prosecution agreements at:
http://www.usdoj.gov/opa/pr/2007/November/07_civ_873.html

See all corporate integrity agreements at:
http://oig.hhs.gov/fraud/cia/cia_list.asp