Adams School of Dentistry: Vendor Relations Policy

Title

Adams School of Dentistry: Vendor Relations Policy

I. Introduction

A. Purpose

The UNC Adams School of Dentistry ("ASOD") works to advance the goals of providing quality health care, first class dental education, and transformational research consistent with the highest principles of integrity. Interaction with Vendors can support the ASOD's mission of education, research, service and patient care, but should not compromise patient confidentiality, interfere with patient care, bias research results, or bias the education of residents, or students.

This Policy is designed to enable ASOD faculty, staff and students to engage with Vendors in ways that protect personal and institutional integrity and foster compliance with applicable laws and regulations. When conducted ethically and transparently, interactions with Vendors can result in benefits to our patients and trainees. It is appropriate and oftentimes necessary, for example, for faculty members to become involved at various stages of drug and device development so that they can assist with the development of products and services that will benefit their patients and society. Appropriate contacts with industry sales representatives also provide learning opportunities about new therapeutic options, research products and other services or supplies. In all these activities, the safety and well-being of our patients and the integrity of our institution must be our foremost concern.

B. Scope of Applicability

This Policy applies to all ASOD employees, faculty, students and residents, regardless of the location at which they work or are assigned ("Covered Personnel").

Financial relationships of family members of Covered Personnel are considered to be the same as the relationships of the Covered Personnel. These relationships are also subject to disclosure and regulation as provided under this and related policies. "Family Members" includes one's spouse and dependent children. For the purposes of this Policy, "spouse" includes a person with whom one lives together in the same residence and with whom one shares responsibility for each other's welfare and shares financial obligations.

Definitions

  1. Covered Personnel: all ASOD employees, faculty, students and residents, regardless of the location at which they work or are assigned.
  2. Donation: anything offered free of charge or consideration to the ASOD as an organization or to a ASOD department/unit (unlike "Gifts," which are offered to Covered Personnel individually). Donations may include the provisioning of financial assistance to the ASOD, such as for research grants, publication grants, critical needs, capital improvements, or capital campaigns.
  3. Educational Seminars: any conference, meeting, or training session – including continuing dental education events – convened by or at the ASOD for the purpose of disseminating scientific or professional knowledge (any similar activities convened or promoted by a Vendor are considered “Work-Related Travel Opportunities” under this Policy). Educational Seminars relevant to this Policy are classified as either “Vendor-Led” or “Vendor-Supported.”
    1. Vendor-Led: Any educational seminar where the content is delivered by a Vendor representative.
    2. Vendor-Supported: Any educational seminar where the content is delivered by someone other than a Vendor representative, but has been convened with the financial assistance of a Vendor.
  4. External Professional Activities: activities that are not included within the Covered Personnel employment responsibilities, if performed for any entity, public or private, other than the Covered Personnel's employer, that are undertaken for compensation, monetary or in-kind, and are based upon the professional knowledge, experience, and abilities of the employee. External Professional Activities and Work-Related Travel Opportunities are mutually exclusive activities.
  5. Family Member: includes Covered Personnel's spouse and dependent children. For the purpose of this Policy, "spouse" includes the person with whom one lives in the same residence and with whom one shares responsibility for each other's welfare and financial obligations.
  6. Financial Relationship: refers to the possession or receipt by Covered Personnel or a Family Member of:
    • Income, in any form and in any amount and for any purpose, received from a Vendor.
    • Ownership, in any form (including stock options or warrants) other than through a mutual fund in a Vendor.
    • In-kind compensation from a Vendor such as the provision of goods, travel, or lodging.
    • Royalties, including royalties received through the University, originating from a Vendor.
    • Gifts made for the benefit of a Covered Personnel by a Vendor to the University, or any affiliated foundation.
  7. Gifts: anything offered free of charge or consideration to Covered Personnel that may be used by Covered Personnel or their Family Members for non-educational or non-patient-related purposes. Examples of gifts may include tote bags, electronic appliances (e.g., iPods), food, wine, flowers, chocolates, gift baskets or holiday gifts, cash or cash-equivalents (e.g., gift certificates). The term "Gifts" excludes the following terms also defined under this Policy: Donations, Samples, and Vendor-Authored Materials.
  8. Ghostwriting: the practice of allowing someone other than the named author to write a paper or presentation delivered or reported to be written by the named author.
  9. Promotional Events: any activity convened by or at the ASOD where one purpose is to showcase a Vendor’s product or services to Covered Personnel. Promotional Events include Vendor Day exhibits and vendor-led product demonstration or training (e.g., loupes). For the purpose of this Policy, the term excludes product demonstrations that are solicited at the request of ASOD employees for the purpose of evaluating the Vendor’s product for fitness in legitimate ASOD business use.
  10. Samples: products distributed to Covered Personnel for the sole purpose of evaluating their effectiveness and fitness for use in legitimate ASOD educational or business activities. Samples are nominal in cost, limited in quantity, and of de minimis commercial value outside of professional responsibility and use.
  11. Speakers' Bureau: panel of experts who deliver talks or papers for compensation in any form for the promotion of a product, service, or device manufactured or marketed by the entity directly or indirectly providing such compensation.
  12. Vendor: any business that manufactures, provides or has potential to provide products or services to the ASOD.
  13. Vendor-Authored Materials: any type of printed or handwritten brochures, advertisements, signs, or other materials promoting a Vendor's product or services.
  14. Vendor Day: annual event organized by the ASOD to acclimate students to vendor products and services in a controlled setting.
  15. Work-Related Travel Opportunities: invitations extended to Covered Personnel by a Vendor to participate in off-site activities that are hosted, promoted, or otherwise sponsored – in whole or in part – by a Vendor. These activities may include attendance at educational seminars or conferences, presentations, training sessions, product evaluations, or meetings to discuss potential research collaborations. External Professional Activities and Work-Related Travel Opportunities are mutually exclusive activities.

III. Policy

A. Reporting of Financial Relationships

Covered Personnel are required to report Financial Relationships at the time of any proposed activity covered under the terms of this Policy using the University’s online reporting structure. Such arrangements can be subject to scrutiny under health care fraud and abuse regulations. A Financial Relationship may exist whether the Covered Personnel is paid directly or whether compensation is routed through another legal entity, such as a limited liability company or non-profit organization. Failure to disclose financial relationships as required under this Policy may result in disciplinary action up to and including dismissal.

The reporting requirements of this Policy are supplemental to and are required in addition to any reports required under the University's Policy on Individual Conflicts of Interest and Commitment, Policy on Institutional Conflicts of Interest, and/or External Professional Activities for Pay ("EPAP"). Financial information reported under this Policy is protected as confidential personnel information. Access to information disclosed under this Policy will be limited to those who need to know for business purposes, which includes the supervisors of Covered Personnel who must review proposed activities prior to initiation.

There is separate disclosure process for organizers and presenters of Continuing Education (CE) events. For more information, contact the ASOD's CE office (see "Contact Information" section).

B. Purchasing Contracts with Vendors

Contracting with Vendors on behalf of the ASOD must be accomplished through the appropriate Purchasing Department and not directly by Covered Personnel. Covered Personnel are generally prohibited from participating in the ASOD's or UNC-Chapel Hill's negotiations with any Vendor with whom such Covered Personnel have a personal interest, a financial interest, or personal or family relationship. Covered Personnel may, however, provide professional advice to the ASOD or UNC-Chapel Hill persons reviewing specific goods and services, provided that they disclose any potential conflict of interest to those whom they are advising.

C. Accepting Technology from Vendors

No new information technology system, application, or device shall be accepted - whether by purchase, loan, donation or otherwise (including those intended for product evaluation or demos) - unless the following conditions have been met:

  1. The sponsoring department has notified ASOD Information Systems to evaluate compatibility and supportability of the proposed acquisition, including the level of support required by ASOD Information Systems staff.
  2. The proposed acquisition has been evaluated for potential implications under relevant institutional privacy and security requirements, which may necessitate the execution of a Business Associate Agreement (BAA) and/or security risk assessment if applicable.
  3. The sponsoring department has considered the costs and liabilities associated with the proposed acquisition in consultation with the ASOD Finance.

D. Educational Seminars

All information presented at Educational Seminars must be consistent with the School’s mission of research, education and quality patient care and may not be used as a platform for the delivery of a "sales pitch." The Chair of the sponsoring department (or, in the absence of a specific sponsoring department, the Dean's Office or Academic Affairs) is responsible for ensuring that a proposed Educational Seminar meets this standard and that any references to a Vendor's product or service are incidental in nature and subordinate to the educational subject matter being presented.

Vendor products or sales materials may not be distributed, used, or otherwise disseminated to attendees - any program that includes this content will be governed by the “Promotional Events” section of this Policy, regardless of the amount of unbiased scientific content included in the program.

In addition, Covered Personnel must adhere to any American Dental Association Continuing Education Recognition Program (ADA-CERP) Standards and Procedures when organizing, holding, or presenting an Educational Seminar for which CE credit is awarded.

1. Vendor-Led (e.g."Lunch-and-Learns")

Vendor Representatives may lead Educational Seminars under the following conditions:

  1. The proposed content of the Educational Seminar is reviewed at least ten (10) calendar days in advance of the session by the sponsoring unit or department
  2. Program content is grounded in scientific/academic integrity
  3. The inviting unit or department notifies the Dean's Office in writing at least seven (7) calendar days in advance of the session that:
    1. it intends to invite a Vendor representative to speak at an Educational Seminar; and
    2. it certifies that the foregoing requirements regarding acceptable content have been met and can provide the materials for further review upon request
  4. No samples or gifts are provided to attendees
  5. No meals or refreshments are provided to attendees, except at "Lunch-and-Learns" for students as provided below

Vendors may provide modest meals or refreshments to ASOD's DDS or Dental Hygiene candidates at Educational Seminars that have been organized solely for their benefit (i.e., "Lunch-and-Learns"), provided that:

  1. Attendance at the event is voluntary
  2. All attendees register in advance with the sponsoring unit or department

2. Vendor-Supported

Vendors may provide a donation or educational grant to the ASOD, consistent with the "Donations" section of this Policy, which the relevant department or unit may choose to use in support of an educational presentation (including those offered for CE credit). Financial support provided by the Vendor to the ASOD cannot be related to the past, present, or anticipated volume or value of purchases made by the ASOD. No quid pro quo should exist or be expected by the Vendor for future interactions with the ASOD. The supporting Vendor must execute a written agreement with ASOD and/or the Dental Foundation of North Carolina, as applicable, as a means of creating appropriate documentation of the parties' intent and expectations.

Speakers or other instructors must disclose any associations that they may have with a Vendor, consistent with the Sunshine Act and institutional policy, that could create any actual or perceived conflict of interest with respect to the topic being presented. Speakers must include such disclosures in printed materials distributed at the Educational Seminar and at the beginning of any presentation. There is separate disclosure process for organizers and presenters of CE events. For more information, contact the ASOD's CE office (see "Contact Information" section).

E. Promotional Events

While expanding Covered Personnel’s knowledge and proficiency with new products and technologies is encouraged to improve the delivery of oral health care, any Promotional Events organized by or at the ASOD must be consistent with the School’s mission of research, education and quality patient care. Vendor Day activities shall be governed by the Procedure for Vendor Day Activities. For Promotional Events where no specific Procedure has been issued, the Dean’s Office most review and approve the proposed activity at least ten (10) business days in advance of the Promotional Event.

Vendors may not provide meals or refreshments at Promotional Events. Vendors may not distribute gifts at Promotional Events, except as provided by the “Gifts” section of this Policy. Vendors may distribute product samples at Promotional Events, provided this is done in accordance with the "Samples" section of this Policy.

Vendors must enter into an agreement approved by the ASOD Dean's Office and the Office of University Counsel before leaving behind any capital equipment or other multiple use product brought on-site for evaluation, training, or other educational purposes. Covered Personnel attendees must have a confirmed and appropriate level of training to operate any medical devices or products featured during the session before any hands-on training with the devices occurs.

F. Vendor-Authored Materials

Vendors are not permitted to distribute, post, or otherwise leave their literature anywhere at the ASOD unless specifically requested by faculty or staff or in connection with an approved Promotional Event, such as ASOD Vendor Day. Vendors may leave educational materials regarding their products or services that may be useful to patients or students with the applicable department administration. Under no circumstances may Vendors distribute materials directly to patients.

No promotional material or product information from the Vendor may be attached to any such item. Vendors may not provide any items that can be used for non-educational purposes (e.g. iPods, DVD players), even if such items may also have an educational purpose.

G. Samples

Covered Personnel may solicit and/or accept complimentary drug, device, or other product samples from Vendors for evaluation in legitimate ASOD educational or business use, provided that no actual or implied quid pro quo exists. Vendors may provide only the quantity of samples - at no charge - that is reasonably necessary for the adequate evaluation of the product(s). Covered Personnel may not sell product samples that were given free of charge.

The personal information of all recipients of product samples should be protected as per local, institutional, and federal laws and policies. In no event may the distribution of samples to patients be accompanied by any of the Vendor's marketing materials or any affirmative messaging that implies endorsement of the product by the ASOD or its faculty, staff, students, and residents.

No service, right, or license may be given to the Vendor in conjunction with the complimentary sample except through a written contract signed by an authorized official of the University or the Dental Foundation of North Carolina.

H. Donations

Vendors may provide unrestricted donations to the ASOD or a ASOD department for charitable or other bona fide philanthropic purposes consistent with ASOD's mission, vision, and values, so long as permitted by applicable laws and other institutional policies. Donations must be fully disclosed and must not be related to the past, present, or anticipated volume or value of purchases made (or to be made) by the ASOD. No quid pro quo should exist for future interactions with a donating Vendor. ASOD must consult with the relevant ASOD or University development officers and/or the Office of University Counsel regarding the proper structuring of Vendor-proffered charitable donations.

Vendors may not have any control over how donated funds are used, including funds donated for trainee scholarships or endowed professorships (i.e., the selection of the trainee or professor must not be influenced by the Vendor). ASOD must consult with the relevant ASOD or University development officers, the Office of Sponsored Research, the Office of Industry Contracting, and/or the Office of University Counsel regarding the proper structuring of Vendor-proffered grants.

In all cases, a written agreement should exist between a donating Vendor and the ASOD to document the grant or donation, including the amount transferred and the intent of the parties. Such grants or donations may also be subject to a conflict of interest review if the support for the benefit of the professional activities of a Covered Personnel or connected to a research project.

Donations must be made to the ASOD by contacting the Dental Foundation of North Carolina (see "Contact Information" section).

I. Gifts

1. In General

Covered Personnel may not receive gifts of any nature or of any value from Vendors. Even items of a relatively trivial value that incorporate a product or company logo (such as pens, notepads, or desk items) may provide an inappropriate opportunity for the company to market to Covered Personnel, to patients, and to other members of the public. This prohibition includes any tangible enticement, whether in cash, extra goods, services, or gifts, which are offered by a Vendor to encourage the use or purchase of the Vendor's product. Under no circumstances may Covered Personnel accept complimentary tickets to sporting or other events from a Vendor.

Covered Personnel may not accept payment, gifts, or other benefits in return for completing evaluations or surveys developed by or for a Vendor.

2. Vendor Day Exhibits

Notwithstanding subsection-1 above, Vendors may distribute small gifts (items that have a relatively trivial or de minimis value) to Covered Personnel if approved to do so at ASOD Vendor Day. Vendors may not distribute cash, gift cards, or other cash equivalents, regardless of value.

Vendor Day registration and approval requirements are found in the ASOD's Procedure for Vendor Day Activities.

3. Use in Prize Drawings

Notwithstanding subsection-1 above, Covered Personnel may accept gifts originating from Vendors if awarded as part of a prize drawing organized by and held on-site at the ASOD. For the purpose of this Policy, such gifts are considered "Donations" and must be donated pursuant to the process outlined in the "Donations" section of this Policy. Vendors may not have any control or direction over how or to whom the donated prize is awarded, and the donation must not be related to the past, present, or anticipated volume or value of purchases made (or to be made) by the ASOD. No quid pro quo should exist for future interactions with a donating Vendor.

All chances to win a prize must be complimentary; under no circumstances may chances be purchased. The Dean's Office is responsible for ensuring donated prizes are awarded in a fair and impartial manner.

4. Professional Conferences

Notwithstanding subsection-1 above, Covered Personnel may accept gifts provided by the organizers of a professional conference or meeting that are available to all attendees at registration, provided the meeting is conducted under national continuing education accreditation body guidelines (e.g., a tote bag provided to conference attendees at check-in).

J. Meals

Covered Personnel may not accept meals or refreshments from Vendors, except in the following circumstances:

  1. Meals that are served as part of a general professional conference or meeting supported in whole or in part by Vendor(s) and included in the event registration (e.g., annual meetings of academic societies where lunch is served to all registered attendees).
  2. Meals provided pursuant to the terms of a University contract.
  3. Meals provided in accordance with the following sections of this Policy:
    1. Educational Seminars (i.e., Vendor-Led "Lunch-and-Learns" for students).
    2. External Professional Activity.

Covered Personnel must pay for their own meals if attending a presentation or journal club organized by a Vendor as an invitation-only event and held at a restaurant or resort.

K. Work-Related Travel Opportunities

For the purposes of this section, “Covered Personnel” shall refer exclusively to employees.

All Work-Related Travel Opportunities must be consistent with the ASOD's mission of education, research and patient care. All Work-Related Travel Opportunity expenses must be paid in the first instance by the ASOD or by Covered Personnel, and not by a Vendor. The Vendor may reimburse the ASOD - which may, in turn, reimburse Covered Personnel as applicable under University policies - for reasonable travel-related expenses subject to the following:

  1. All arrangements related to site visits, including selection of participants, duration of the visit, selection of travel method and accommodations, are made in advance and by the applicable ASOD department.
  2. All expenses will be determined and paid for by the applicable ASOD department with the reimbursement made to the Covered Personnel through the usual process. The Department will send an invoice for appropriate expenses to the Vendor for reimbursement:
    1. Appropriate expenses that may be reimbursed by a Vendor must only include travel, lodging, and food expenses specifically related to business purpose of the Work-Related Travel Opportunity and incurred in accordance with University policies regarding the appropriateness of business expenses and within spending guidelines for expenses, including per diem payments, business class travel, and hotel accommodations.
    2. Appropriate expenses must not include any expenses which are personal in nature or unrelated to the evaluation.

Consistent with the University's Policy on Individual Conflicts of Interest and Commitment, Covered Personnel may not accept compensation from a Vendor for any Work-Related Travel Opportunity except through a University contract or grant. This prohibition includes sponsorship or reimbursement for travel, lodging, event registration costs, meals, or other related expenses. If compensation in any form is to be accepted by Covered Personnel, the activity shall be considered an EPAP and not an institutional Work-Related Travel Opportunity.

Vendors may provide an unrestricted donation to the ASOD (consistent with the "Donations" section of this Policy), which the ASOD may - if it chooses - use in support of a Work-Related Travel Opportunity. Vendors may not have any control over how donated funds are used, including the selection of which Covered Personnel - if any - will attend the event being advertised.

L. External Professional Activity

Through certain external professional activity opportunities, Covered Personnel may apply their specialized knowledge and clinical, teaching, research, and administrative expertise, thereby contributing further to society. These activities are encouraged if they comply with applicable institutional policies and do not create an unmanageable conflict of interest.

This section does not apply to services rendered under an authorized institutional contract between a Vendor and the ASOD/University.

1. Requirements

Whenever any proposed External Professional Activity involves a Vendor and the Covered Personnel, the following conditions apply:

  1. The external activity must not interfere with the employment obligations of the Covered Personnel.
  2. The services must be provided in fulfillment of a legitimate business need on the part of the Vendor and not constitute an unlawful inducement (e.g. reward for recommending the purchase of a Vendor's products disguised as payment for services which are unnecessary).
  3. Compensation for the external activity must be consistent with fair market value in an arm's length transaction for the services provided and cannot not be based on the volume or value of the Covered Personnel's or ASOD's past, present or anticipated business.
  4. Any honoraria, travel reimbursement, meals, or other hospitality associated with the external activity must be reasonable and consistent with the legitimate clinical, educational, administrative, or scientific purpose of the activity. Vendors may not pay for travel, meals, or lodging for Family Members in conjunction with a Covered Personnel's external activity.
  5. Covered Personnel must retain discretion to provide objective commentary or advice based on their professional judgment when delivering the external activity.
  6. Covered Personnel must articulate to Vendor and to any other audience that they are conducting such activities in their individual capacity and their viewed do not necessarily reflect the views of the ASOD or the University.
  7. The external activity may not, in any manner, create an express or implied endorsement by the ASOD or the University of the Vendor's items, supplies, products or services.
  8. Covered Personnel may not use ASOD or University resources for External Professional Activities. Such resources may include facilities, administrative offices, work product, results, materials, property, records, the Institutional Review Board ("IRB"), assignment of work to students, residents or other trainees, the use of institutionally licensed software, or information developed with institutional funding or support, except as otherwise reviewed and permitted under related ASOD or University policies. Covered Personnel should seek guidance from their Department Chair for any clarification.

2. Approval Process

When seeking to engage in a prospective External Professional Activity involving a Vendor, the Covered Personnel's proposed activity must be reviewed for compliance with this Policy, as well as any other applicable employment or conflict of interest policies including the University's Policy on Individual Conflicts of Interest and Commitment:

  1. Covered Personnel (EHRA) must file a "Notice of Intent to Engage in EPAP" through the University's online disclosure system at least ten (10) business days before the proposed activity. Administrative approval/denial for the external activity will be issued through the AIR system.
  2. Covered Personnel (SHRA) must file a "Secondary Employment Notification Form" with their Supervisor at least ten (10) business days before the anticipated activity. Requests will be processed in accordance with the University's Secondary Employment Policy.

Approval is required whether Covered Personnel are paid directly or paid through another legal entity, such as a limited liability company or a non-profit organization. Failure to disclose and/or obtain approval for external activities prior to the engagement as required may result in disciplinary action up to and including dismissal.

It is understood that there may be changes in approved external arrangements during a given academic/fiscal year. Covered Personnel are responsible for submitting amended information to disclose any such changes, including changes in the amount of time or compensation involved. Disclosures must be submitted in writing to the Department Chair (or Dean's Office, as applicable) not later than thirty (30) days after Covered Personnel learn of the changes in the terms of the approved arrangement.

M. Ghostwriting, Speakers' Bureaus, and Speaking Engagements

Covered Personnel are not allowed to engage in Ghostwriting or Speakers' Bureaus under any circumstances.

Covered Personnel may be allowed to participate in speaking engagements compensated by a Vendor, whether as an External Professional Activity or an institutional activity, provided all the following conditions are met:

  1. Covered Personnel are not supporting a Vendor product or service but merely participating as a subject matter expert within their field of expertise.
  2. Covered Personnel retains full editorial control and authority over the content of the presentation. This means that the Covered Personnel creates all content for the presentation and does not incorporate any content that has been developed by the Vendor.
  3. The content of the lecture is educational, free from commercial influence, and is not designed to recommend specific drugs, devices, or other commercial products or services.
  4. The content of the lecture is based on best available evidence and reflects a balanced assessment of the current science and treatment options.
  5. Covered Personnel discloses at the beginning of the presentation all funding and editorial relationships with the Vendor(s), including disclosure of any Vendor sponsorship of the speaking engagement and receipt of honorarium and/or travel reimbursements for providing the presentation to the program attendees.
  6. The slides do not contain any logos or names of the Vendor(s) that sponsored the speaking engagement, except as required for the foregoing disclosures. Under no circumstances may a Vendor logo and a University logo appear on the same slide.
  7. In the judgment of the supervisor authorized to approve such activities, any honorarium and travel expenses paid for the speaker's participation are reasonable.

While prior review of the presentation by a Vendor is acceptable, Covered Personnel may not allow a Vendor to influence the content of the presentation. If the reviewing supervisor, departmental chair, faculty advisor or graduate program director has concerns about possible overreaching by a Vendor in conjunction with a specific presentation, that individual may require that he or she review and approve the slides prior to the presentation.

N. Research, including Sponsored Projects

All research activities, including but not limited to the use of investigational drugs and devices, must be conducted pursuant to University policies and procedures concerning research, including the University's Policy on Individual Conflicts of Interest and Commitment, and may require the involvement of the Office of Sponsored Research, the Office of Clinical Trials, the Office of Industry Contracting, and/or the University's IRB. It is the obligation of the Covered Personnel to learn about the applicable policies and procedures before beginning any research projects. Promotional activities by Vendors may not be performed under the guise of research.

IV. Enforcement

A. Training

Covered Personnel are required to complete training on this Policy within thirty (30) calendar days of initial employment or enrollment. In the event that this Policy is materially revised, Covered Personnel may be required to re-train on this Policy at the discretion of the Dean's Office.

B. Policy Violations

Covered Personnel who are aware of potential violations of this Policy should report those allegations to the ASOD Dean's Office, Conflict of Interest Program, the Office of University Counsel, or to the University's Compliance Hotline ("Carolina Ethics Line") website or by phone (1-866-294-8688).

Alleged violations of this Policy by employee Covered Personnel (i.e. faculty and staff) shall be investigated by the ASOD Dean's Office in conjunction with the applicable University offices. On finding of a violation of this Policy by a Covered Personnel who is an employee, the supervisor of the Covered Personnel involved will be notified in writing of the facts and nature of the Policy violation by the ASOD Dean's Office. The ASOD Dean's Office in conjunction with the applicable University Office will work with Human Resources and/or the Provost's Office to recommend disciplinary action or other action provided under this Policy.

Alleged violations of this Policy by Student or Resident Covered Personnel will be referred to the Vice Dean for Education or the Associate Dean for Advanced Dental Education, respectively.

In addition to any sanctions specifically provided herein, Covered Personnel found to have violated this Policy will be subject to disciplinary action up to and including dismissal. All disciplinary action taken hereunder shall follow applicable University and ASOD policies and procedures.

V. Related Requirements

A. External Regulations and Consequences

1. Federal Anti-Kickback Statute

  • The Anti-Kickback Statute is a criminal law that prohibits the knowing and willful payment of "remuneration" (anything of value) to induce or reward patient referrals or the generation of business involving any item or service payable by Federal health care programs (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients).
  • Remuneration can take many forms besides cash, such as free rent, expensive hotel stays and meals, and excessive compensation for medical directorships or consultancies. Taking money or gifts from a drug or device company, or a durable medical equipment ("DME") supplier may implicate the Anti-Kickback Statute.
  • Enforced by the U.S. Department of Health and Human Services Office of Inspector General ("OIG"). Please also see the "Criminal Penalties for Acts Involving Federal Health Care Programs" page on the Social Security Administration website.
  • The OIG has issued a compliance program guidance regarding permissible and suspect interactions between manufacturers of products or services reimbursed by Federal payers (e.g. Medicare/Medicaid) and healthcare professionals: "Compliance Program Guidance for Pharmaceutical Manufacturers" (68 Fed. Reg. 23731; May 5, 2003).

2. Physician Payments Sunshine Act (the "Sunshine Act")

  • In March 2010, the Sunshine Act was passed as part of the Patient Protection and Affordable Care Act (the "ACA"). The stated purpose of the Sunshine Act is to increase transparency of financial relationships between manufacturers of health care products and certain healthcare providers and to allow the public to identify potential conflicts of interests.

3. University Policies, Standards and Procedures:

4. Professional and Trade Association Guidelines

In addition, several professional and trade associations have published guidelines that similarly discuss permissible interactions between industry and clinicians, including:

B. Unit Policies, Standards, and Procedures

Contact Information

Policy Contacts
Subject Title Contact Information
General questions about the Policy Director of Risk & Regulatory Affairs VACANT
Educational Seminars (no credit awarded)
Promotional Events
Director, Student Life and Academic Success Sumitha_Ahmed@unc.edu
Donations from Vendors Associate Dean for Advancement Paul_Gardner@unc.edu
Purchasing Contracts with Vendors Associate Dean for Finance kevin_cain@unc.edu
Accepting New Technology from Vendors Assistant Dean for ASOD Information Systems david_rankin@unc.edu
Educational Seminars for CE credit Director, Continuing Education Deedra_Donley@unc.edu
UNC-CH Conflict of Interest Program Conflict of Interest Officer coi@unc.edu
(919) 843-9953
UNC-CH Compliance Hotline ("Carolina Ethics Line")   (866) 294-8688
https://go.unc.edu/carolina-ethics-line

Details

Article ID: 131319
Created
Thu 4/8/21 9:06 PM
Modified
Mon 4/1/24 4:21 PM
Effective Date
If the date on which this document became/becomes enforceable differs from the Origination or Last Revision, this attribute reflects the date on which it is/was enforcable.
03/02/2022 10:51 AM
Issuing Officer
Name of the document Issuing Officer. This is the individual whose organizational authority covers the policy scope and who is primarily responsible for the policy.
Issuing Officer Title
Title of the person who is primarily responsible for issuing this policy.
Executive Vice Dean for Education
Last Review
Date on which the most recent document review was completed.
04/01/2024 10:51 AM
Last Revised
Date on which the most recent changes to this document were approved.
03/02/2022 10:51 AM
Next Review
Date on which the next document review is due.
03/13/2026 12:00 AM
Origination
Date on which the original version of this document was first made official.
11/18/2015 12:00 AM
Responsible Unit
School, Department, or other organizational unit issuing this document.
Adams School of Dentistry