Current federal sunshine provisions that make substantial gifts by vendors to doctors a matter of public record most likely will not cover audiology, but new light is being cast on the profession just the same. And when it comes to accepting gratis gifts and opportunities, even those logo-bearing pens have come under scrutiny, namely, by the American Academy of Audiology.
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AAA has taken the position “through careful research” to eliminate all giveaways on the exhibit floor at conventions, a ban that was inaugurated last year and will be continued, said Therese Walden, AuD, the president of the academy. “It is our ‘new normal,’” said Dr. Walden, a research audiologist for the Army Audiology and Speech Center at Walter Reed Army Medical Center in Washington, D.C.
AAA is not alone in calling for some policy-tweaking to avoid any appearance of conflict of interest. Some state organizations have been looking at how this might be addressed as well. Disability Rights Vermont, part of the National Protection and Advocacy system mandated by Congress, recently wrote a new Hearing Aid Consumer Bill of Rights urging those who need assistive technology to become informed about whether the “instrument is subject to seller incentives.”
In fact, almost as soon as the Patient Protection and Affordable Care Act passed, the regulation on payments and “value transfers” from manufacturers to physicians prompted some soul-searching in audiology. One such examination, “Ethical Equilibrium: The Changing Landscape of Ethics,” forecasted how this would affect the field. Based on an online seminar that now seems eerily prescient, Gloria Garner, AuD, a senior audiologist at the University Health Care System of Augusta, GA, observed that medical centers across the country were adopting a no-gifts and no-free-meal rules for medical staff, although gift-giving seemed part of the professional culture in audiology. She predicted this would become a source of debate and change as time wore on.
Since then, the academy and the Exhibitor Advisory Panel — representatives from industry who work with the convention program committee and meeting-planning staff — gradually lowered the annual meeting giveaway limit from $100 in 2007 to zero as of last spring's convention.
The American Speech-Language-Hearing Association and AAA maintain separate codes of ethics, however, and it remains to be seen whether ASHA will follow suit.
A research team from West Virginia University recently scientifically examined these areas of ethical concern “to provide insight into the ethical perspectives of audiologists across the country.” The intent: to identify ethical dilemmas, to provide a focus for ethics education in audiology programs, and to offer a basis for continuing ethics education in the field. Their online questionnaire delved into these ethical dilemmas, which was completed by 225 audiologists employed in private practices, clinics, hospitals, academic centers, and physician offices.
Nearly half reported ethical conundrums in making clinical decisions that involved payment, such as complying with Medicaid and Medicare and other reimbursement rules that prohibit balance billing or out-of-pocket payment for services. (Contemporary Issues in Communication Science and Disorders 2011;38[Spring]:76.) Financial incentives for hearing devices were prominently mentioned. A near-tie was seen in worker-supervisor interactions such as dishonesty and professional incompetence (35%) and compliance with federal or state regulatory guidelines (34%).
Almost a decade ago, an article in The ASHA Leader said a conflict of interest existed “when an audiologist or immediate family member engages in business practices or relationships that provide the audiologist with financial incentives,” according to Allan Diefendorf, PhD, an associate professor and the director of audiology and speech pathology at Indiana University School of Medicine in Indianapolis. (See FastLinks.)
“This involvement could result in a loss of objectivity, and may affect how services are delivered to a patient who is seeking care and recommendations from the audiologist,” he wrote. “Moreover, although the appearance of a conflict of interest may not actually be a legal or ethical violation, appearances can damage the reputation of an individual, his or her practice, and profession.”
Some audiologists have pointed out that accepting gifts now is even more suspect because of increased public awareness about such promotional activities — cruises trips from companies featuring products or brief seminars held at golf outings. The questions are, when is someone seen as able to be bought, and does it even have to be something expensive?
“The new sunshine provision highlights those issues regarding payments heretofore thought of as business as usual,” Dr. Walden said, adding that this could include manufacturers providing entertainment or food or covering travel costs for the express purpose of branding the manufacturer's product for use in practice or research.
“Years ago, we did not think of this as a bad practice,” Dr. Walden said. “However, there is a large body of evidence which supports the notion that even small gifts provided by one entity to another will influence the decisions or choices of the receiving entity.”
The counter-argument is that gifts of negligible cost do not have an influence or that the individual can make decisions despite marketing strategies.
AAA has been working with the Hearing Industries Association (HIA) on the issue for the past few years, Dr. Walden said, and Andrew Bopp, the director of government relations for HIA, confirmed that the association is looking at it closely, and stressed that HIA members have an appreciation for the intent of the law.
Listing such expenditures on a national database might mean a difference in how medical education sessions are conducted for doctors by many pharmaceutical and medical device manufacturers, but the reporting rule as outlined would not affect hearing health care, except for companies that manufacture only 510k-exempt medical devices. The law is largely aimed at manufacturers of prescription drugs and medical devices that require premarket approval. “It ain't over till it's over,” he said, quoting Yankees catcher Yogi Berra to describe the realm between passage of the initial law and the language written to codify it.
Accepting vendor-financed travel and expenses is an entirely individual decision, stressed Richard Poage, a longtime business coach for audiology practice owners. One way to determine if the gift poses an ethical dilemma, he suggested, is to simply ask yourself: Are you comfortable telling a patient about it? “Where is the line between education and entertainment? It might be this: You aren't heading to [a manufacturer's headquarters to hear how a product is formulated] but being flown to Mexico to hear about it instead,” he posited. “And if that means a trip to Hawaii in December from Chicago, that may be your answer right there.”
It is probably less problematic if such opportunities are accepted from a variety of vendors rather than one consistently. “Over and over, even [accepting] sandwiches can become a big deal,” Mr. Poage said. Conventions and meetings that are underwritten often escape such scrutiny, but “you have to wonder how much” of that is actual promotion versus education, he noted. Or, as Dr.Walden put it: “Obviously, this transparency is the result of the long and recent history of ethics infractions in the health care arena.”
The Centers for Medicare and Medicaid Services in December issued a proposed rule to implement transparency provisions. “As proposed, the rule would not apply to hearing aids since it would cover only medical devices that require FDA premarket approval,” according to an HIA news release.“The proposed regulations stipulate that this would exclude many Class I devices and certain Class II devices which are exempt from premarket notification requirements.”
The HIA statement also noted that “CMS announced that covered device manufacturers will not be required to begin collecting data until after the final rule is published.” CMS is currently soliciting comments.
• Read “Ethical Equilibrium: The Changing Landscape of Ethics” by Gloria Garner, AuD, at http://bit.ly/GloriaGarner.
• ASHA's article, “Professionalism and Conflict of Interest,” is available at http://bit.ly/ASHAcoi.
• Learn more about Disability Rights Vermont at http://www.disabilityrightsvt.org/.
• Click and Connect! Access the links in The Hearing Journal by reading this issue on thehearingjournal.com.
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