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Approved Jan 14, 2014

What is the definition of a gift when dealing with industry?
For the purpose of this guideline, a gift from industry is defined as anything of value given to an audiologist for personal use and/or personal profit by an industry representative. Examples of gifts include (but are not limited to): cash, material goods, personal entertainment tickets, non-merit based scholarships provided to recipients selected by industry, and personal rebates for large volume purchases. General use business items such as laptops, otoscopes and general continuing education funding would also be considered gifts and should not be accepted by the audiologist.

What is the “gift effect?”
Numerous peer-reviewed published studies have described the impact on human behavior and clinical decision-making on the impact of clinicians receiving gifts. Interestingly, the gift effect can occur even if the clinician feels “immune” to the impact of gifts. The desire to reciprocate on the part of the recipient can occur even if the gifts are of negligible value.

May audiologists accept programming software, cables, and demonstration units from a hearing aid or cochlear implant manufacturer?
Yes. Uniquely compatible items provided for patient care and education, such as proprietary software, wireless interface connections, and cables, needed strictly to dispense a specific product, would not be considered a gift. In addition, product samples, such as demonstration hearing aids, that are not intended to be sold and are used for patient use only, are acceptable.  Educational materials, anatomical models, and posters/charts that directly benefit the patient are not considered gifts.

May manufacturers provide pens, notepads, and other small branded items at large-scale conventions for use by meeting participants?
As long as the pens and notepads and other small branded items are made available to ALL meeting participants and are used to promote the primary educational purpose of the meeting, it is not a gift and is not necessarily a conflict of interest for members to receive these specific items within that context.  Additionally it is not a legal issue for members to use them for taking notes at meeting. The Sunshine Final Rule 2013 states, “Therefore, we will finalize that small incidental items that are under $10 (such as pens and note pads) that are provided at large-scale conferences and similar large-scale events will be exempted from the reporting requirements.” Although the Sunshine Final Rule was written to cover physicians, dentists, optometrists, chiropractors and other state licensed health care professionals, it would likely behoove audiologists to follow suit with its guidance. It should be noted the Sunshine Final Rule 2013 had not been released when these guidelines were originally written in 2011.

It is ethical for audiologists to negotiate a volume discount with individual manufacturers in their practice?
Yes. It is ethical and considered a sound business practice for audiologists to negotiate discounts with manufacturers, assuming the interests of the patient are held paramount to any profit motive. Discounts should not require the audiologist to use any product exclusively, prevent the audiologist from entering into contracts with other manufacturers, and should not require any other commitment from the audiologist.

What is a quid pro quo arrangement?
The term quid pro quo is a Latin term meaning “something for something.” Quid pro quo arrangements between audiologists and industry occur when the audiologist receives a gift or something of personal value in exchange for stipulated purchases with a manufacturer. The quid pro quo arrangements stipulated may occur through a written contract or a verbal agreement.

What are examples of quid pro quo relationships?
Audiologist is provided with a laptop or tablet computer in exchange for purchasing 10 hearing aids.

Audiologist receives a free trip in exchange for purchasing 50 hearing aids.

Audiologist qualifies for and is provided with special business development program resources (i.e., marketing materials, business consultants who train office staff) in exchange for the purchase of 200 hearing aids.

Audiologist is invited to attend continuing education event, sponsored by a manufacturer, as a reward for past/future purchases. Lodging and travel expenses are covered by the manufacturer and the event is at a resort. Other professionals are invited to attend, but will have to pay their own travel and training expenses if they are not customers of the manufacturer.

Can CEU credits be obtained by attending product trainings?
Yes. However, due to changes in the guidelines, industry will be required to adhere to more stringent guidelines before obtaining CEU approval.

What guidance can be offered to industry sponsors planning continuing education events to define “reasonable” and “modest” travel expenses, lodging, and meals?
The American Academy of Audiology recognizes costs of travel, lodging and meals will vary depending on location, season, and type of educational venue. The location and selection of the educational venue should be conducive to the effective transmission of product education and may include commercially available meeting facilities such as hotels and convention halls. Industry sponsors may provide meals and refreshment breaks in conjunction with training events. The meals should be reasonable in value by local standards and should be subordinate to the overall educational focus of the training event. Buffet meals, snacks, soft drinks, or coffee generally available to all participants of large-scale conference or similar large-scale events are acceptable. Per diem guidance by geographic locale for government employees is available online. The U.S. General Services Administration website is regularly updated and the per diem costs of meals and lodging provides a potentially useful and impartial spending guideline for educational event planners.

Can members accept an invitation to an industry sponsored continuing education event and have all travel, lodging, and meals covered by the sponsor?
Yes. Although members are encouraged to pay for their own training-related expenses, there are instances when expenses can be covered by industry. Members should not accept incentives that are beyond reasonable travel expenses, meals, and lodging.  Additionally, members should not receive sponsored education because of past or future business with the company. Sponsored educational opportunities that are reasonable, that provide information that cannot be obtained in other ways, and that are not offered under a quid pro quo arrangement are acceptable.

If my spouse is employed by a manufacturer and I choose to dispense their products in my practice, would this be considered a conflict of interest? If so, does disclosure that my spouse works for the manufacturer adequately manage the perceived conflict of interest?
While this is considered a conflict of interest, written and oral disclosure of the conflict of interest to the patient is sufficient. Although recent research indicates that this disclosure does not eliminate the potential conflict of interest, in some cases this type of conflict is unavoidable.

What are some guiding questions audiologists can ask themselves to clarify the “spirit” of this guideline?

  1. How might my patients feel about my relationship with industry?
  2. How might my patients view my receiving gifts from industry?
  3. How would independent colleagues view my association with industry?
  4. Would I be willing to have the details of my involvement with industry made public?

What is the guiding principle of this guideline?
Regardless of whether an audiologist’s particular situation or industry relationship is described in this guideline, the audiologist’s decisions should be guided by the following principle:

The American Academy of Audiology encourages ethical business practices and a member should not engage in any unlawful inducement.  An“unlawful inducement” means the prohibitions of the federal Anti-Kickback Statute.