Editor's Note: This article is an edited transcript of the course presented live on AudiologyOnline on September 25, 2009. While this article preserves the original transcript whenever possible, some editorial license was taken to insert information from the presenters' slides, provide full references, and to otherwise account for the different formats (presented v. written) on behalf of the reader. Those interested in viewing the original presentation, can register here.
Disclaimer: The opinions and assertions presented here are the private views of the presenter and are not to be construed as official or as necessarily reflecting the views of the American Academy of Audiology or the Ethical Practices Committee.
We're living in an unprecedented time in healthcare. Many changes are happening on a lot of different fronts. Let's look outside the box of audiology and see what's happening elsewhere that may potentially impact us as healthcare providers.
To begin, think about your own life as a professional. Think about your own relationship with your doctor and healthcare providers, and what you expect from them in terms of professional behavior. Most likely, you expect clinical expertise coupled with impeccable integrity.
Next, determine what matters most when evaluating your professional goals. Ask yourself this question: What is my highest aspiration as an audiologist? Before answering this, first take a step back and look at what is motivating or driving a particular clinical decision-making behavior. This might include financial success; prestige and recognition; knowledge; popularity; job security; pleasing others; and/or personal integrity.
If personal integrity ranked second, or was behind any of those on the list, then it is subject to possible compromise and sacrifice. Remember, as a professional, you will have to make choices.
Why Study Ethics?
Whatever the setting you work in - whether it is a teaching hospital, clinic, private practice, or other setting - expect to encounter ethical dilemmas. While there is nothing wrong with encountering ethical dilemmas, you will need a framework for resolving them. As an audiologist, you should look toward a code of ethics for guidance.
Ultimately, ethics are very personal in that only you have control over your behavior. Socrates said, "The unexamined life is not worth living." Take some time to do just that and examine your professional life.
Here are some questions to reflect on:
What kind of audiologist do I want to be?
- Do I want to have independent judgment unbiased by commercial interests?
- Do I want to be able to do what I think is best for my patients or do I want someone else to decide for me?
- Who owns me?
- Have I lost control of my professional destiny?
- Do I use current scientific evidence-based practice techniques to guide my clinical decision-making?
If you don't like who you are at the end of your soul searching, think about how you can change your behavior to become what you aspire to be.
No matter what has happened in the past, you can always begin anew. Consider this quote from Maya Angelou, "You did then what you knew how to do and when you knew better, you did better." You can make a better decision for the future.
What is a Professional?
A quote from Edmund Pelligrino, M.D., a renowned professor of medical ethics at Georgetown University, provides a great definition of what it is to be a professional. "To be a professional is to make a promise to help, to keep that promise, and to do so in the best interests of the patient. It is to accept the trust the patient must place in us as a moral imperative. The nature of the relations we have described are grounded in the human condition. They impose moral obligations that must transcend standards of moral behavior in society at large. A true professional is, in sum, an ordinary person called to extraordinary duties by the nature of the activities in which he or she has chosen to engage (Pelligrino, 1983)."
Although the terms "morals" and "ethics" are often used interchangeably, they are not the same. Ethical behavior is governed by following the agreed upon professional behavior standards as stated in the code of ethics of your professional association. Ethics is the science that explains the whole valuing process.
On the other hand, morals relate to the individual and vary greatly. They are shaped by a number of different things, such as a person's family values, religion, and individual character development.
Therefore, morals cannot form the basis of a code of ethics. A different benchmark is required, and that benchmark is a code of ethics.
The Importance of a Code of Ethics
Most likely, when you joined a professional organization such as the American Academy of Audiology (AAA), the Canadian Academy of Audiology (CAA), the American Speech-Language-Hearing Association (ASHA), Academy of Doctors of Audiology (ADA), or others, you were asked to sign a code of ethics as a membership requirement. For some of you, that may be the first and last time that you will encounter a code of ethics. In signing, you are consciously and voluntarily agreeing to uphold the standards written in the code of ethics and agree to hold your colleagues to the same standards.
A code of ethics proclaims to the public what professional behaviors they can expect from us: that we've collectively agreed to maintain the very highest standards of professionalism in patient care; that we're going to treat people with honesty; that we will use integrity in our research; that we will use independent professional judgments when making decisions; and that we will be collegial with one another.
Heinz Luegenbiehl, Ph.D., professor of philosophy and technology studies at Rose-Hulman Institute of Technology in Indiana, clearly states why a code of ethics is needed for a profession. He states, "The adoption of a code is significant for the professionalization of an occupational group because it is one of the external hallmarks testifying to the claim that the group recognizes an obligation to society that transcends mere economic self-interest (Luegenbiehl, 1983)."
Now let's dig a little bit deeper and determine the impact and implication of a code of ethics and how it can be useful in practice.
In audiology, as with other healthcare practices, patients place a high degree of trust in practitioners. Protecting the profession's integrity is a priority. Ultimately, it is always best for to us to govern ourselves rather than to be governed by others.
It is important for professionals to support a code of ethics, which serves as a collective recognition by a profession's members of its responsibilities. It creates a whole culture and environment in which ethical behavior is the norm. It proclaims that the profession is seriously concerned about having responsible and professional conduct. A code of ethics can also be used as an educational tool.
Gift Giving Poses a Problem
Sometimes professional associations with a code of ethics will work on ways to further delineate or explain concepts from their codes of ethics. In 2002, the pharmaceutical industry created The Pharmaceutical Research and Manufacturers of America (PhRMA) codes, which delineated what the relationship should be between physicians and the pharmaceutical representatives who worked with them.
Things had gotten a bit out of hand. Doctors were receiving lavish trips, golf outings and expensive meals from the pharmaceutical industry. It became very close to becoming a Department of Justice issue. As a result, the PhRMA group (which regulates pharmaceutical manufacturers) decided that it would write a code that would provide guidance on what appropriate conduct should be for pharmaceutical people working with physicians and physicians' offices.
ADA & AAA: Ethical Practices Guidelines on Financial Incentives from Hearing Instrument Manufacturers
Some parallels to the audiology profession are noteworthy. In 2003, AAA and the ADA jointly wrote Ethical Practices Guidelines on Financial Incentives from Hearing Instrument Manufacturers (ADA & AAA, 2003). This is currently used today.
It contains four guiding principles for interactions by members with manufacturers.
- When the potential for conflict of interests exists, the interests of the patient must come before those of an audiologist. A conflict of interest is when your professional judgment could be impaired by an outside financial interest or some other outside entity.
- A commercial interest in any product or service recommended must be disclosed to the patient.
- Travel expenses, registration fees, or compensation for time to attend meetings, conferences, or seminars should not be accepted directly or indirectly from a manufacturer.
- Free equipment or discounts for equipment, institutional support, or any form of remuneration from a vendor for research purposes should be fully disclosed and the results of research must be accurately reported.
In summary, the key point regarding ethics and the law is that audiologists are legally bound to follow the licensure laws of their states and they are ethically bound to follow the code of ethics of their professional association.
Federal Laws
There are three federal laws that audiologists should be aware of: The Physician Self-Referral Prohibition Statute, commonly referred to as the "Stark Law"; False Claims Act and related laws; and the Anti-Kickback Statute.
The Stark Self Referral Prohibition is a federal law that guards against self-referral. The False Claims Act states that it is a violation of the law to bill for services not provided. For example, billing for a complete audiologic diagnostic evaluation when you only obtained pure tone air conduction thresholds would be a false claim.
The Federal Anti-Kickback Statute prohibits any person from receiving any remuneration for purchasing any item or service reimbursable under a federal healthcare program. The federal government broadly defines remuneration as anything of value.
Violations of the Anti-Kickback Statute are punishable by up to five years in prison, criminal fines up to $25,000, administrative civil money penalties up to $50,000, and exclusion from participation in federal healthcare programs.
The Department of Health and Human Services, Office of Inspector General, offers these guidelines under The Federal Anti-Kickback Statute for determining a violation:
- Does the arrangement have a potential to interfere with or skew clinical decision-making?
- Does the arrangement have a potential to increase costs?
- Does the arrangement have a potential to increase the risk of overutilization?
- Does the arrangement raise patient safety or quality of care concerns?
- Do gifts from industry diminish or appear to diminish the objectivity of professional judgment?
Noticeably, there's some crossover in the code of ethics when talking about conflict of interest and anti-kickback laws.
In audiology, examples of kickbacks include gifts, points, vacations, equipment, entertainment, gift cards, and other incentives tied into purchasing patterns with manufacturers.
For example, if you enter into an arrangement with a particular manufacturer that states that if you sell 10 of their hearing aids, you will get an American Express gift card valued at $100, then that is both a conflict of interest and a kickback. Remember, the federal government defines remuneration as anything of value.
Influence of Gifts - Gift and Giver Characteristics
For quite some time, a culture of gift giving existed in our profession. Hearing aid manufacturers would offer cruises, trips, and all kinds of things. Many audiologists innocently accepted the gifts, not knowing that they were a conflict of interest.
Research literature shows that gifts of any value create a sense of indebtedness and an obligation to repay (Gouldner, 1960; Mauss, 1954; Cialdini, 1993). It is human nature to want to reciprocate. Feelings of obligation are not related to the size of the gift (Cialdini, 1993). Social science literature also reveals that gifts influence behavior even when the giver is disliked (Cialdini, 1993).
If you are interested in this topic, more information can be found at www.nofreelunch.org/aboutus.htm. There are a number of interesting studies at that website about gift giving, particularly in the pharmaceutical industry, and the influence that gifts have on the prescribing behavior of physicians.
The Changing Landscape of Ethics
Today's consumers are demanding more transparency, openness, and accountability in every sector including government, commerce, healthcare, and education, to name a few. Consumers want more information. They want to understand more about transactions, how their money is being spent, and where their insurance dollars are going.
Currently, there's a Direct Access bill - H.R. 3024, the Medicare Hearing Health Care Enhancement Act of 2009 - under consideration that would allow patients to directly go to an audiologist for a hearing evaluation or other audiological testing instead of having to first see a physician to get an order.
As audiology gains recognition as a doctoring profession and with direct access, we will likely see a much greater demand for transparency, openness, and accountability by patients.
Literature from a number of different sectors shows a convergence is taking place in society with regards to ethics across all of these different sectors. As a profession, ideally we will respond proactively, not reactively, to some of these changes.
Physicians Payments Sunshine Act of 2009
One bill that will likely have implications for the audiology profession is the Physicians Payments Sunshine Act of 2009. This bipartisan bill was sponsored by Senator Chuck Grassley, a Republican from Iowa, and Senator Herb Kohl, a Democrat from Wisconsin. It was co-sponsored by Senator Amy Klobuchar, a Democrat from Minnesota.
This bill would require that manufacturers of drugs, biologic and medical supplies report their gifts, payments, and transfers of value to physicians. They would be required to provide transparency in the relationship between physicians and the manufacturers of drugs, devices, biological or other medical supplies which are paid for under Medicare, Medicaid, or the State Children's Health Insurance Program (SCHIP). Ultimately, there would be quite a long laundry list of disclosures that manufacturers would be required to make.
All covered recipients would be required to provide information about payments made in terms of compensation, food, entertainment, gifts, travel, consulting fees, honoraria, funding for research, funding for education, stocks, or stock options that they might hold, ownership or investment interest, and any other kind of economic benefit.
Basically, anyone who produces, markets, or distributes drugs, devices, or medical supplies under Medicare, Medicaid, or SCHIP will have to report those payments.
Excluded items include patient educational materials, DVDs, literature, rebates/discounts, and prescription or device samples.
The goal of this legislation is that all disclosures would be made available on a public searchable website by no later than September 30, 2011. The government relations committee of AAA is monitoring this bill closely because it has implications for non-physician providers of Medicaid services.
In January 2009, an article of interest appeared in the New York Times about Smith & Nephew, a manufacturer of artificial hips and knees (Meirer, 2009). The company was about to send some of its representatives to the American Academy of Orthopedic Surgeons convention. The company had told its representatives that interactions with surgeons during the convention had to be limited to business hours, between 9 a.m. to 5 p.m. This new policy may be due to the fact that Smith & Nephew, along with other hip and knee manufacturers including Zimmer Holdings, DePuy and Biomet are operating under Justice Department oversight as part of a deal to resolve allegations that they illegally induced physicians to use their products.
Meanwhile, Boston Scientific and Edward Lifesciences are being proactive by beginning to disclose physician payments voluntarily on their corporate websites.
And, in the State of Massachusetts, a law was passed in 2008 requiring drug and device companies to report payments to doctors in excess of $50.
Previous versions of the Sunshine Act have been endorsed by PhRMA and Advanced Medical Technology Association (AdvaMed), the association for medical device manufacturers, as well as by the American Medical Association (AMA).
Revised PhRMA Code - July 2008
The PhRMA code, which was passed in 2002, was updated in 2008. It includes more stringent laws and contains clearer language about what is and is not appropriate.
It was decided that distributing branded, non-educational items such as pens, mugs, and other kinds of small reminder objects that typically contain a company logo to a healthcare provider and his/her staff is not inappropriate.
Additionally, the code acknowledges that these items, even though they are of minimal value, are problematic because they may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues.
The more stringent 2008 PhRMA code also prohibits company sales reps from providing restaurant meals to healthcare professionals. It does allow them, however, to bring an occasional meal to the healthcare professional's office in conjunction with an informational presentation. For example, they could do a lunch and learn, but can't wine and dine them in a nice restaurant.
The code also reaffirms and strengthens previous statements that companies shouldn't provide any entertainment or recreational benefits to healthcare professionals. That means no Broadway tickets or golf outings, for example.
Some new provisions in this code require companies to be sure that their representatives fully grasp all of this; and that they've been trained in the applicable state and federal laws, regulatory information, and industry codes of practice (including the revisions in the latest codes governing their interactions with healthcare professionals).
Companies are also being asked to assess, test, and ensure that their representatives understand what to do and to take appropriate action with an employee individually if s/he is not complying with the relevant standards of conduct.
Revised AdvaMed Code of Ethics
AdvaMed, the organization that oversees medical device manufacturers, approved a major update of their Code of Ethics on Interactions with Health Care Professionals. The revised code went into effect on July 1, 2009 (AdvaMed, 2009), and further clarifies between appropriate and inappropriate activity between health care professionals and representatives of AdvaMed member companies.
Michael Mussallem, CEO of Edwards Lifesciences and the chairman of AdvaMed, made this statement in response: "This updated and more rigorous code of ethics reflects the medical technology industry's ongoing commitment to openness, transparency, and high ethical standards. Our industry's primary focus is helping patients and we want to ensure that collaboration between physicians and the industry's scientists and engineers is critical for developing and developing medical solutions."
This statement has implications for audiologists because of the collaborative nature that audiologists and its researchers have with industry.
The major changes to the AdvaMed code include a new code compliance section that will list all of the companies that certify their adoption of the code. It will be available for public review on AdvaMed's website. As with PhRMA, there is also an explicit prohibition on providing entertainment or recreation to healthcare professionals. Additionally, the changes prohibit gifts of any type, including all non-educational branded promotional items regardless of value. There are also some guidelines, however, that will allow companies to enter into royalty arrangements with healthcare providers in exchange for substantial contributions that improve medical technologies. They recognize that some collaboration must occur. Engineers can't operate in silos, and information must be exchanged in order for innovation to move forward.
A new section addresses evaluation and demonstration products which sets forth appropriate parameters under which companies may provide products intended to educate both healthcare professionals and patients on newer or improved medical technologies. For example, this means that it is appropriate for a knee or hip surgeon to have a demonstration knee or hip in his/her office, or likewise OK for an otolaryngology surgeon to have a demonstration cochlear implant device in his/her office.
An expanded section addresses the provision of objective reimbursement and coverage in health economics information to healthcare professionals in order to improve patient access to medical technology.
AdvaMed has also revised current Code sections to provide greater clarity and rigor in areas such as consulting agreements, company-conducted training and education for healthcare professionals, as well as research and educational grants.
Academic Medical Centers
Academic medical centers have also made some changes in regard to their policies. They have a heightened awareness of the sensitivity of relationships between their medical students, residents in training, and physicians, with equipment manufacturers, pharmaceutical companies, and other similar types of relationships.
Leaders from several academic medical centers nationwide met to discuss a minimal amount that was appropriate for gifts to medical centers. This was difficult to determine because restricting gifts based on the size of the gift is not feasible. Suppose you decide the gift limit will be $20. Is that $20 wholesale or retail? How often can a company give $20 gifts? Every day, once a week, or once per month? As a result, they decided to set the dollar limit at $0.
Ultimately, rather than restricting gifts based on size, or splitting hairs over defining gifts as modest, educational in nature, or primarily for the benefit of the patient, it just made sense to simply implement an outright ban on gifts.
Therefore, many academic medical centers have adopted a "no gifts" policy, and a "no-food" policy. That means gifts are banned regardless of their nature or value, and industry sponsored meals and snacks are banned within these institutions. Remember, the federal government also views any gift as a gift.
Some academic medical centers that have adopted a policy of no gifts and no meals are the University of Pittsburgh, University of Pennsylvania, Stanford University, Boston University, UMass Memorial Medical Center, and others. Vanderbilt University has a similar policy as does the otolaryngology clinic at the Medical College of Georgia, and I'm sure you are aware of centers in your area with like policies.
Final Thoughts
Financial relationships are highly regulated in healthcare. Patients view the relationships with their healthcare providers as something almost sacred. They truly have the right to expect exemplary standards and professionalism. Remember that just because a representative or someone makes you an offer, it doesn't mean that the offer is necessarily legal or ethical.
Ultimately, the audiology profession needs to remain abreast of the convergence of rapid changes across sectors that potentially may have an impact on us. The public perception of what constitutes an ethical, legal, and appropriate relationship between healthcare providers and manufacturers will continue to evolve.
References
Academy of Doctors of Audiology & American Academy of Audiology, (2003, April). Ethical practice guidelines on financial incentives from hearing instrument manufacturers. Lexington, KY: Author.
AdvaMed, (2009, July). Code of ethics on interactions with health care professionals. Washington, D.C: Author.
Cialdini, R.B. (1993). Influence: The psychology of persuasion. NY: Morrow.
Gouldner, A, W. (1960). The norm of reciprocity: A preliminary statement. American Sociological Review, 25, 161-178.
Levi-Strauss, C. (1969). The elementary structures of kinship (J.H. Bell, J.R. von Sturmer & R. Needham, Trans.). Boston: Beacon Press.
Luegenbiehl, H. C. (1983). Codes of ethics and the moral education of engineers. In D. G. Johnson (Ed.), Ethical issues in engineering (1991; pp. 137 - 154). NJ: Prentice-Hall.
Mauss, M. (1954). The gift: the form and reason for exchange in archaic societies. English translation first published by Cohen & West.
Meirer, B. (2009, January 23). New rules on doctors and medical firms amid ethics concerns. New York Times. Retrieved on December 15, 2009 from www.nytimes.com. Direct URL: www.nytimes.com/2009/01/24/business/24device.html
Pelligrino, E. (1983). What is a profession? Journal of Allied Health, 12 (3),174.
