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Policy for Acceptance and/or Solicitation of Gifts
or Benefits from Vendors
Purpose
The purpose of this policy is to establish appropriate practices regarding
acceptance or solicitation of gifts or benefits from vendors by UTMB
faculty, employees, departments, and other UTMB entities to ensure that
UTMB is in compliance with all applicable federal and state laws and
U.T. System Guidelines.
Audience
This policy and applicable procedures apply to all UTMB faculty members,
employees, students, departments and other UTMB entities.
Policy
University faculty members, employees, departments, or other UTMB
entities may not accept or solicit any gift or benefit that:
might reasonably tend to influence or be perceived as influencing
his/her decision making regarding purchases, contracts, or any other
official duty or that he/she knows or should know is being offered
with the intent to influence/bias his/her decisions, induces his/her
disclosure of confidential information acquired in his/her position,
or induces his/her exercise of official powers or duties in favor
of another.
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General Information
Relationships and transactions between academic medical institutions
and industry are common and sometimes complex. Often, faculty and employees
solicit or are offered "free" goods, gifts, benefits, or grants
for teaching or research programs, honoraria, or travel expenses for
participating in certain activities, actions or projects. Many such
gifts or benefits serve an important and socially beneficial function.
However, some of these gifts or benefits may violate the federal Anti-Kickback
Statute, the federal anti-referral laws, and similar state laws including
felony criminal statutes, and may result in significant fines, possible
imprisonment, and exclusion from federal and state reimbursement programs.
The federal Anti-Kickback Statute prohibits the knowing and willful
solicitation or receipt, offer or payment, overtly or covertly, directly
or indirectly, of any remuneration (anything of value) in cash or in
kind in return for patient, product, or service referrals, or to induce
such referrals. The statute has been interpreted to mean that if even
one purpose of the transaction is to induce referrals it is a violation
of the statute even if it is not the sole purpose of the transaction.
Generally, a gift may be considered improper if it is made to a person
in a position to generate business for the paying party, if the payment
is related to the volume of business generated, if the payment is more
than nominal in value and/or exceeds fair market value of any legitimate
service rendered to the payer, or if the payment is unrelated to any
service at all other than referral of patients.
This policy is intended to provide guidance to faculty, employees,
departments, and other UTMB entities concerning practices that are acceptable
under the laws and practices that are clearly violations of the laws.
Also, this policy provides a process for faculty, employees, departments,
and other UTMB entities to submit proposed gift or benefit transactions
with vendors for review for compliance with all applicable anti-kickback
and anti-referral laws.
This general policy is in addition to various state and federal laws
including , Standards of Conduct and Conflict of Interest, Tex. Government
Code Sec. 572, Offenses Against Public Administration, Tex. Penal Code
Title 8, and the UT System Ethics Policies and Guidelines , and the
AMA Gifts to Physicians from Industry guidelines.
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Definitions
- "Gifts" are benefits which may include,
but are not limited to, the following:
cash, checks, securities, subsidies, real property, personal property,
referrals, offerings, goods, honoria, favors, prizes, services, employment,
business or professional activities.
- "Benefits" means anything reasonably
regarded as monetary gain or monetary advantage, including benefits
to any other person in whose welfare the beneficiary has a direct
and substantial interest.
- "Community-wide Fund Raising Effort"
means an institutional fund raising event sponsored and organized
through the Office of University Advancement. Solicitations must be
made to all vendors in the community not only to vendors currently
service UTMB.
- "Vendor" means any individual or company
that sells goods and/or services to UTMB. For the purposes of this
policy it includes entities that have, are, or may sell good and/or
services to UTMB.
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Acceptance of Gifts or Benefits
Gifts from Industry to Underwrite Costs of Educational Conferences
or Events
Gifts, benefits, or subsidies from industry to underwrite the costs
of educational conferences or professional meetings may be accepted
if the subsidy is accepted by a UTMB Department, Center or Institute,
or the Office of Continuing Education as the conference’s sponsor,
who in turn uses the money to reduce the conference’s cost.
The subsidy should never be paid directly to a UTMB faculty member,
employee, or student either involved with or attending the conference
or meeting. Also, if a vendor subsidizes an educational conference
or lecture the responsibility for and control over the selection of
content, faculty, education methods, and materials must belong to
the organizer of the conference or lectures.
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Gifts from Vendors
Gifts or benefits from vendors into a special educational fund or
scholarship may be accepted, if approved by the Medical Education Program
Director, to support students, residents, and fellows to attend selected
educational conferences or permit them to take time away from training
to do research if the selections of students, residents, or fellows
who receive the funds are made by UTMB personnel. Appropriate educational
conferences are generally defined as the major educational, scientific
or policy making meetings of national, regional, or specialty medical
associations or courses given by visiting professors or faculty recognized
as experts in their field. Inappropriate educational conferences are
conferences that address only a vendor’s product or group of products.
This policy is not intended to discourage attendance at conferences
or meetings that address only a vendor's product or group of products,
only to prohibit accepting gifts or benefits from the vendor to attend
such conferences or meetings.
- Faculty members, employees, departments, and other UTMB entities
may not accept vendor invitations to entertainment events, vacation
resorts, etc. that serve no bona fide academic or educational purpose.
- Gifts, grants or benefits may not be accepted by any faculty member,
employee, department or other UTMB entity for any reason from any
UTMB vendor if the faculty member, employee, department, or other
UTMB entity has or may have a substantive role in the determination
of vendor selection and if such a gift or benefit might be perceived
as influencing the vendor selection.
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Monies, Goods or Equipment from Vendors to Specified
Faculty or to
Departments to Fund Research or Education
Gifts from vendors to support research or education may be accepted
only if the donation is accompanied with a letter or other instrument
from the vendor indicating that the specific purpose of the donation
is to support UTMB research or education and is not intended to influence
purchasing decisions or research outcomes. The donation must be approved
by the appropriate Dean of the faculty member and must be accepted by
the Office of University Advancement. This policy does not prohibit
grants and/or contracts from vendors for research or clinical trials
where a formal agreement exists.
Gifts or benefits given to faculty members or employees as a grant
for studies of products when the studies require little or no actual
scientific pursuit should not be accepted. An example is a payment given
as a "research grant" to a faculty member for minimal record
keeping tasks.
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Gifts for Travel, Lodging or Meal Expenses
- Faculty members or employees may accept from vendors reasonable
honoraria and reimbursement for travel, lodging, and meal expenses
to attend conferences or meetings only if the faculty member lectures,
presents posters, presents a paper, participates in a panel discussion,
moderates a panel, or performs in other substantive educational roles
at the conference or meeting. Faculty members who are only attendees
at conferences cannot accept either honoraria or reimbursement for
travel, lodging, and meal expenses.
- Faculty members or employees may accept vendor reimbursement to
attend meetings to act as consultants or to participate in panels
regarding development of new clinical trial protocols, to discuss
clinical trial research results, or to participate in a conference
to understand requirements for future clinical trials.
- No UTMB faculty member, employee, department, or other entity may
accept reimbursement for travel from any vendor if the purpose of
the travel is to view or access a piece of equipment or other product
under consideration for possible purchase by UTMB.
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Gifts in Return for Prescribing or Advocating
Products
Any gift or benefit offered to a faculty member, employee, department,
or other UTMB entity in exchange for, or based on, prescribing or providing
specific services or products is a violation of the Anti-Kickback Statute
and cannot be accepted.
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Gifts Related to Marketing of Products
Faculty members and employees should not accept gifts or benefits
offered in exchange for performing marketing tasks in the course of
practicing medicine or providing research and development services.
An example is accepting money or gifts from a vendor to render an evaluation
of a company's product after using the product by completing evaluation
forms.
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Gifts Valued at $50 or Less
UTMB faculty members and employees may accept gifts or benefits from
vendors if the value of the gift or benefit is not greater than $50,
per person per day; is related to a bona fide academic or educational
purpose; and is not in the form of cash, checks, or negotiable instruments.
This includes food provided by vendors at meetings held within the institution
and to UTMB personnel. A vendor representative must be present at each
meeting, or luncheon when providing gifts of food for that meeting or
luncheon. A department faculty member or appropriate UTMB agent should
also be present at any meeting or luncheon hosted by a vendor if a vendor
representative makes a presentation at the meeting or luncheon.
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Solicitation of Gifts or Benefits
Community Fund Raising Events
Gifts in amounts greater than $50, per person per day may be solicited
from vendors only if such solicitations are for an academic or educational
event sponsored by a UTMB department or UTMB entity and the solicitations
are part of a community-wide funding raising effort. The vendor's
response to the solicitation must be voluntary and not motivated by
an intent to induce referrals or to induce purchase of the vendor's
products or services. Solicitation must not be limited only to those
vendors providing services to UTMB.
Faculty members, employees, departments, and other UTMB entities
should not solicit any gifts of any type greater than $50, per person
per day, for any purpose except a bona fide academic or educational
event.
Review of Vendor Offers or Invitations
A faculty member or employee who receives an invitation or offer
of a gift or benefit from a vendor and is not sure that the offer
is acceptable under this policy should disclose the situation, in
writing, to his/her supervisor. The supervisor make a decision concerning
the acceptance of the gift or benefit. The faculty member or employee
may appeal the supervisor's decision to the Institutional Conflict
of Interest Committee. The Institutional Conflict of Interest Committee
will determine whether the offer is legal and may be accepted and
will provide a written response to the faculty member or employee
expeditiously.
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Violations
Violations of this policy will follow the disciplinary action outlined
in the UTMB Institutional Handbook of Operations and Procedures.
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Bibliography
- Barry, Dennis, Soliciting from vendors; Gifts or rebate Dennis
Barry's Reimbursement Advisor Aspen Publications October 1998 page
12.
- Can I take it? A Guide for ...
- Ganelli, Diane M. Revisiting the ethics of industry gifts. American
Medical News. August 24/31, 1998
- Gifts to Physicians from Industry. JAMA. January 23/30, 1991 -
Vol. 265. No. 4
- Return to Top Guidelines on Giving and Receiving Benefits - Recent
Changes in Texas Ethics Laws.
- Kalb, Paul E. and Bass, I. Scott. Government Investigations in
the Pharmaceutical industry: Off-Label Promotion, Fraud and Abuse,
and False Claims. Issue: 53 Food and Drug Law Journal pp 63-70 (1998).
- Reiss, John B. Commentary on Payment and Reimbursement Issues Affecting
the Marketing of Drugs, Medical Devices, and Biologics, with Emphasis
on the Anti-Kickback Statute and Stark II, Vol. 52 Food and Drug Law
Journal pp. 99-108 (1997).
- Report of the Council on Ethical and Judicial Affairs. "Gifts
to Physicians from Industry." American Medical Association. Report
as Adopted by the House of Delegates on December 4, 1990. Report G
(I-90).
- United States Government. Department of Health and Human Services.
Office of Inspector General. Special Fraud Alert "E" Prescription
Drug Marketing Schemes (Issued August 1994).
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