Governmental Regulations

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1 Dilemmas: The AAA Code of Ethics Gloria Garner, Au.D. Chair-Elect, AAA Ethical Practices Committee Jane Kukula, Au.D. Chair, AAA Ethical Practices Committee Governmental Regulations The US Government is the single largest purchaser of healthcare services and products Medicare Medicaid Federal Employee Program Military Programs Vested interest in containing healthcare costs Containing Costs Business world was quick to use computerization to streamline procedures and cut cost, healthcare was not. Paper-based records and billing systems were and still are expensive in cost, accuracy and efficiency While addressing these issues public concern regarding privacy and protection were rising Dilemmas: The AAA Code of Ethics - Part 2 1

2 HIPPA Health Insurance Portability and Accountability Act Initially to protect health insurance coverage when changing jobs (Title 1) Title II Administrative Simplification Electronic transfer Unique identifiers Security Privacy HIPAA Privacy Applies to electronically stored information, paper records, electronically transferred records including fax and telephone Requires patient notification of how their information will be used HIPAA Privacy Adopting and implementing privacy procedures, i.e. determining when records are released to third parties Training employees Establishing Privacy Officer Securing patient records Dilemmas: The AAA Code of Ethics - Part 2 2

3 HIPAA Security Sets standards to assure confidentiality of stored and transmitted information Provides a framework for evaluating security risk and making decisions about system enhancements Regular computer system backups Disaster recovery programs Physical safeguards of computers Federal Anti-Kickback Statute Prohibits any person from knowingly and willfully offering or giving (or soliciting or receiving) remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or kind to refer an individual for any item or service for which payment may be made in whole or in part under a federal health care program. Capturing Reimbursement 2006 AAA Federal Anti-Kickback Statute Violations are a felony with punishment including imprisonment, heavy fines, and or exclusion from federal health care plans. Enforced by the Office of the Inspector General Capturing Reimbursement 2006 AAA Dilemmas: The AAA Code of Ethics - Part 2 3

4 Federal Anti-Kickback Statute Intent Offering, giving, soliciting or receiving remuneration Referral of patients to purchase, lease, order, or arrange for any item or service reimbursable under a federal health plan except for the FEHBP Capturing Reimbursement 2006 AAA Remuneration Broadly defined to include anything of value (Hahn 2006, Risky Business: What you need to Know About HA Commissions) Polling Question A hearing aid company has a professional development plan, for each hearing aid sold, the manufacturer places money into an account which can be used for equipment, CE workshops and other business related items. Dilemmas: The AAA Code of Ethics - Part 2 4

5 Polling Question An audiologist needs a new piece of equipment, instead of going to the bank for a loan, the audiologist arranges with a manufacturer to pay off the equipment by committing to purchase 20 hearing aids over the next year. Polling Question An audiologist goes to a party at convention sponsored by a HA manufacturer. The party is open to all audiologists regardless of whether they dispense that product. Polling Question A sales rep for a manufacturer visits an audiologist over the lunch hour and brings lunch for the staff while discussing the product line. Dilemmas: The AAA Code of Ethics - Part 2 5

6 Stark Law Prohibits physicians and physicians immediate family members from referring patients for designated heath services to an entity in which the physician or his/her immediate family member has a financial relationship, unless a specific exception applies. Stark Civil law not criminal CMS regulations implement the law Limited application to audiologists State Anti-Kickback and Stark Laws Most states also have enacted Anti-Kickback and Stark Laws Often State versions are more strict then the Federal version Know your state laws, seek legal counsel specific to your practice! Dilemmas: The AAA Code of Ethics - Part 2 6

7 State Licensure Consumer protection agency Regulates the practice of audiology within the state Sets entry level requirements Often have COE State Licensure, a look at Ohio Maintain in professional behavior i.e., Prohibits practicing under the influence of illegal substances or alcohol Maintain records and confidentiality Professional behavior in the delivery of services Supervision of aides Performance of research Business practices consistent with state and federal regulations Case I: Is a Donation a Gift? An equipment manufacturer donates a real ear system to the state university audiology program. The system is placed in the university hearing aid dispensary and used by students and the HA Dispensary Coordinator. The donated equipment assists in the university clinic in charging less for their hearing aids thereby undercutting local audiologists Dilemmas: The AAA Code of Ethics - Part 2 7

8 Rules 4c: Individuals shall not participate in activities that constitute a conflict of professional interest. 7a: Individuals shall not use professional or commercial affiliations in any way that would limit services or mislead patients or colleagues. Potential Violations Rule 4c 5 Rule 7a 1 No violation 6 Other Ethical Constructs Biomedical Ethics/Justice:University may not be providing students with a framework for ethical decision making. Rotary International: Is it fair to all concerned? Dilemmas: The AAA Code of Ethics - Part 2 8

9 No Violation Comments Though not a violation the gift should be made known to consumers. There were no strings attached and results in a reduced cost to consumer this is ok. Though not a violation, even if there is a hint of a COI it still should be avoided. Your Comments Raises the question whether the university is encouraging students to purchase mainly or only from those who donate equipment. The donation is a gift (incentive) because it used to dispense hearing aids. If it was used to only train students then it would be donation. Your Comments The donation reduced the cost to the consumer and the reduced cost was passed on the consumer. While the practice of unfair competition within the university s community is unprofessional and unsportsman like, it is not unethical. Dilemmas: The AAA Code of Ethics - Part 2 9

10 Your Comments The gift is to the facility, not the audiologist who does not personally benefit, the gift would benefit patients and also the students as a teaching tool. The use of the equipment could predispose students to be more likely to purchase from this manufacturer in the future. Your Comments If the equipment were being used only to train audiologists, then this would not be violation of Rule 4c. Your Comments It s common to hear private-practice audiologists complain that the not-for-profits such as universities etc, have unfair advantage, because it s often true, but the donated piece of equipment would be a rather minor item. An example of a more serious issue is when NFP advertise their NFP status (and/or suggest to patients directly) to mislead the public into thinking their services are less expensive than the private practitioner when that s not true. Dilemmas: The AAA Code of Ethics - Part 2 10

11 Your Comments If a hearing aid manufacturer made the donation, no conflict exists because there is not a stated expectation of continued use of their brand of hearing aids. The gift reminds audiologists of the manufacturer s name and may influence objectivity in the future. It may not be in violation of the code of ethics but it doesn t create good relationships. Your Comments I do not think that any given practices of pricing hearing aids has an ethical bearing on their professional colleagues. There is nothing in the guidelines to prohibit this and many non profit organizations charge less than private practices for hearing aids. The pricing is an issue completely unrelated to the equipment donation. Your Comments Not a violation, the University should base it s prices on their costs however they should let the public know the equipment was a donation, if not it might be violation of Rule 5a or Principle 7 Dilemmas: The AAA Code of Ethics - Part 2 11

12 EPC Opinion University was not a member and therefore not held to the COE. Donations need to be accepted according the university s ethical guidelines for accepting donations. Development of departmental guidelines to guard against potential COI since the equipment serves two functions, training students and fitting consumers To guard against unfair competition. Questions/Comments To ask a question, please type your question into the chat box in the lower left corner of the screen and click on the Send button located right below the box. Polling Question An audiologist attends an in town, free state approved CE activity sponsored by and HA company covering their newest product. A free lunch is served. Dilemmas: The AAA Code of Ethics - Part 2 12

13 Polling Question A manufacturer offers a free state approved CE activity covering the counseling of families impacted by hearing loss. It is held out of state, the manufacturer pays for the travel, lodging and meals. Case 2: Now That I m a Doctor An AuD audiologist advertises as a doctor without clarifying that the doctorate is in audiology. The audiologist carries a line of herbal products for hair and skin care which the doctor recommends for enhancing hearing and balance. The rationale is with Direct Access audiologists will be on the same level as physicians. Potential Violations Principle 1 2 Rule 2a 3 Rule 2c 2 Rule 2f 1 Principle 4 3 Rule 4a 1 Rule 4c 1 Dilemmas: The AAA Code of Ethics - Part 2 13

14 Potential Violations Principle 5 1 Rule 5b 1 Principle 6 4 Rule 5a 2 Rule 5b 3 Rule 6a 7 Rule 6b 5 Potential Violations Principle 7 2 Rule 7a 4 Rule 7b 1 Rule 8a 2 Rule 8b 2 COE Principle 1: Members shall provide professional services and conduct research with honesty and compassion, and shall respect the dignity, worth, and rights of those served. Rule 2a: Members shall provide only those professional services for which they are qualified by education and experience. Dilemmas: The AAA Code of Ethics - Part 2 14

15 COE Rule 2c: Individuals shall exercise all reasonable precautions to avoid injury to persons in the delivery of professional services or execution of research. Rule 2f: Individuals shall maintain professional competence, including participation in continuing education. COE Principle 4: Members shall provide only services and products that are in the best interest of those served. Rule 4a: Individuals shall not exploit persons in the delivery of professional services. Rule 4c: Individuals shall not participate in activities that constitute a conflict of professional interest. COE Principle 5: Members shall provide accurate information about the nature and management of communicative disorders and about the services and products offered. Dilemmas: The AAA Code of Ethics - Part 2 15

16 COE Rule 5a: Individuals shall provide persons served with the information a reasonable person would want to know about the nature and possible effects of services rendered, or products provided or research being conducted. COE Rule 5b: Individuals may make a statement of prognosis, but shall not guarantee results, mislead, or misinform persons served or studied. Principle 6: Members shall comply with the ethical standards of the Academy with regard to public statements or publication. COE Rule 6a: Individuals shall not misrepresent their educational degrees, training, credentials, or competence. Only degrees earned from regionally accredited institutions in which training was obtained in audiology, or a directly related discipline, may be used in public statements concerning professional services. Dilemmas: The AAA Code of Ethics - Part 2 16

17 COE Rule 6b: Individuals' public statements about professional services, products, or research results shall not contain representations or claims that are false, misleading, or deceptive. COE Principle 7: Members shall honor their responsibilities to the public and to professional colleagues. Rule 7a: Individuals shall not use professional or commercial affiliations in any way that would limit services to or mislead patients or colleagues. COE Rule 7b: Individuals shall inform colleagues and the public in a manner consistent with the highest professional standards about products and services they have developed or research they have conducted. Dilemmas: The AAA Code of Ethics - Part 2 17

18 COE Rule 8a: Individuals shall not violate these Principles and Rules, nor attempt to circumvent them. Rule 8b: Individuals shall not engage in dishonesty or illegal conduct that adversely reflects on the profession. Other Ethical Constructs Audiologists can only provide services for which we are qualified by education and experience. Audiologists receive no training in hair and skin care products. Virtue Ethics principle of Ethics of Conscience applies Other Ethical Constructs Ethics of Conscience: knowing the difference between right and wrong Biomedical Ethics: Legal issues are raised with regards to implying medical treatment of conditions and fraud with misrepresenting yourself. Dilemmas: The AAA Code of Ethics - Part 2 18

19 Other Ethical Constructs Possible violation of state licensure. The donation allows the university to undercut local audiologists. Utilitarianism is violated because local audiologists could experience financial hardship because of price cutting. Other Ethical Constructs From the biomedical point of view, the patient s autonomy is compromised since a fully informed decision cannot be made. Other Ethical Constructs This crumb is in violation of almost every ethical construct, Virtue Ethics, Duty, Conscience, Utilitarianism and Biomedical Ethics. Biomedical Ethics construct of nonmaleficence may apply. The consumer may believe that the herbal products could cure hearing and balance disorders. Dilemmas: The AAA Code of Ethics - Part 2 19

20 Your Comments You have the responsibility of informing your patient what level of education that you have but you must never misrepresent your self as a physician. Members must honor their responsibilities to the public, this includes misleading them as to the difference between an AuD and a physician. Your Comments This looks negatively on all audiologists. Practice is outside the scope of audiology. It is a misrepresentation of credentials and is lying to the public. This is nonsense. EPC Opinion This case came to the EPC in the form of a question. The audiologist did not provide the EPC with a name or with any supporting documentation. The EPC was unable to pursue the case. Dilemmas: The AAA Code of Ethics - Part 2 20

21 Your Comments Administrators, teachers and researchers also face ethical dilemmas daily, but it seems that often too little attention has been given to ethical decision making. Frankly, I wonder whether AAA has missed the boat regarding many important ethical issues. I directed an audiology and speech pathology department in a large university medical center for 26+ years until my retirement recently to join an audiology private practice. The ethical issues that I faced daily as an administrator, teacher, researcher, and clinician were more frequent, complex, and serous than I face today in an audiology private practice.. Polling Question The book, Ethics in Audiology, is nicked named the Green Book Questions/Comments To ask a question, please type your question into the chat box in the lower left corner of the screen and click on the Send button located right below the box. Dilemmas: The AAA Code of Ethics - Part 2 21

22 Polling Question An audiologist employed by a clinic receives a salary plus commission based upon the dollar value of the hearing aids he/she dispenses. Case 3: Deal or No Deal? An audiologist interviews for a position in an ENT practice. He is offered a monthly base salary + commissions on hearing aid sales. The commission is structured so that he would receive twice as much commission for high end aids as he does for entry level aids. He receives a set dollar amount in commission per aid dispensed. Potential Violations Principle 4 (6) Rule 4a (3) Rule 4c (4) Bending Rule 4c (2) Not a potential COE violation: (3) Dilemmas: The AAA Code of Ethics - Part 2 22

23 COE PRINCIPLE 4: Members shall provide only services and products that are in the best interest of those served. Rule 4a: Individuals shall not exploit persons in the delivery of professional services. Rule 4c: Individuals shall not participate in activities that constitute a conflict of professional interest. Ethics of Duty I would think the audiologist would be ethically bound to disclose that they are receiving a greater financial gain by recommending that product Virtue Ethics This case may also be looked at under Virtue Ethics. The consumer may believe the Audiologist has the patient s best interests in mind when prescribing the hearing aids, however in a commission based pay, the Audiologist is likely to have his own bottom line in mind. Dilemmas: The AAA Code of Ethics - Part 2 23

24 Virtue Ethics Virtue Ethics may assume he would, because of his virtuous character, make the right decision for each patient regardless of the financial benefit. Ethics of Conscience The Ethics of Conscience would suggest he would feel guilty if he encouraged someone to buy the higher-end product so he could benefit financially, when that patient might have done well with a lower-end product. Biomedical Principles Biomedical autonomy which allows for the patient to make a decision for them self suggests that if you present all options equally (low end and high end) with pros and cons and the patient decides then you are acting in the patients best interest. Nonmalefecence suggests that we do no harm and if the high end hearing aid is appropriate then it is doing no harm. Dilemmas: The AAA Code of Ethics - Part 2 24

25 Your Comments Salary should not be controlled by any outside agency. The reimbursement, whether by an employer or the patients themselves as in private practice, should be relevant to the amount of service rendered. You would expect to pay more for something that it is more technological in design. The higher priced instruments tend to need more time invested with the patient therefore demanding a higher reimbursement. In our practice, we find that our employees spend more time with the patient per dollar value on high-end instruments that they do with entry-level instruments. No violation of the code of ethics in this case. Your Comments Salary plus commission based on hearing aids sales a common practice in many different industries including our own, whether it is a hearing instrument specialist, a manufacturer s representative, or audiologists. Many places use a percentage of sale so higher end hearing aids would receive a greater commission anyway. Not an ethical issue if patient remains in decision mode biomedical ethics and ethics of duty. Regardless of deal being a percentage of sale or set dollar amount per aid, this ethically is OK as it is NOT tied to a particular manufacturer Your Comments This would violate AAA COE Principle 4, Rule 4C. By accepting a higher commission rate for the high the highend aids, it may influence him to try to sell those hearing aids more which may not always be in the best interest of his patients. This could also be a violation of Rule 4a since he potentially could exploit some of his patients to push the higher end products on them. Dilemmas: The AAA Code of Ethics - Part 2 25

26 EPC Opinion Concerned that HA commissions based on sales establishes a quid pro quo ( something for something ) relationship between employer and audiologist In other words, the audiologist is receiving or accepting remuneration in exchange for a purchase, referral or recommendation. Hearing Aid Commissions Prohibited under some circumstances by the Federal Anti- Kickback Statue. Other forms of incentive compensation are acceptable, ie, pre-determined bonus when a specific productivity benchmark is obtained. Sample Productivity Measures Number of patients seen, length of time spent with patients, total revenue generated and minimum average score on the practice s patient satisfaction survey Predetermined maximum return rate, customer service attitude, total revenue generated and internal customer attitude. Dilemmas: The AAA Code of Ethics - Part 2 26

27 Sample Productivity Measures Team: each staff receives percent of total revenue for being a part of the team Productivity: hours of direct patient care/total each provider generates Staff performance rating patient satisfaction scores. A basic tenet of formulas is that they should not create incentive for unethical behavior. Ethics and Professionalism (Liang) Pharmacy model: Professional-based Established, independent profession, service and products. Strong practice and research-orientation. PharmDs and PhDs are terminal degrees. PharmDs and PhDs on research and teaching faculty. Independent schools of pharmacy (64, not relegated within a department) successful, numerous, grant funded (median $2.3 million annually, range $101K- >$23million), and expanding. ~28 academic journals. Ethics and Professionalism (Liang) Optometry model: Retail-based Dependent profession, providing product fittings. Practice oriented reliant upon corporate branding and location [e.g., Lenscrafters] OD is terminal degree. Generally few ODs on teaching or research faculty; PhDs and MDs dominate research and teaching. Few schools of optometry (17 independent; little extramural grant funding, reliant upon industry, fighting for legitimacy). ~6 academic journals. Dilemmas: The AAA Code of Ethics - Part 2 27

28 Ethics and Professionalism (Liang) What model does audiology wish to adopt? A professional model or a retail model of service delivery? Both are honorable, and make money, but have different reputations, ethics focus, and norms. Polling Question Over the next decade, do you see audiology moving more toward: Questions/Comments To ask a question, please type your question into the chat box in the lower left corner of the screen and click on the Send button located right below the box. Dilemmas: The AAA Code of Ethics - Part 2 28

29 Case 4: Deal or No Deal? An audiologist is planning to set up a private practice. She is weighing the pros and cons of joining a buying group. Can she receive equipment (in exchange for meeting hearing aid sales quotas from a manufacturer through her buying group) and not worry about ethical or legal issues? Does being in a buying group insulate her? Potential Violations Principle 1 (1) Rule 1a (1) Principle 4 (5) Rule 4a (1) Rule 4c (3) Principle 7 (2) Rule 7a (1) COE PRINCIPLE 1: Members shall provide professional services and conduct research with honesty and compassion, and shall respect the dignity, worth, and rights of those served. Rule la: Individuals shall not limit the delivery of professional services on any basis that is unjustifiable or irrelevant to the need for the potential benefit from such services. Dilemmas: The AAA Code of Ethics - Part 2 29

30 COE PRINCIPLE 4: Members shall provide only services and products that are in the best interest of those served. Rule 4a: Individuals shall not exploit persons in the delivery of professional services. Rule 4c: Individuals shall not participate in activities that constitute a conflict of professional interest. COE PRINCIPLE 7: Members shall honor their responsibilities to the public and to professional colleagues. Rule 7a: Individuals shall not use professional or commercial affiliations in any way that would limit services to or mislead patients or colleagues Your Comments This scenario is likely a common situation for Audiologists setting up a Private Practice. Buying groups certainly assist in keeping hearing aid prices down for the individual Audiologist. Being in a buying group does not insulate her from other pitfalls of ethics, but does allow her to receive lower prices, that hopefully she will pass along to her patients. I do not believe being in a buying group is a conflict in Ethics. However, receiving equipment in exchange for meeting quotas is a conflict on Principle 4. The Audiologist is in a conflict of interest to meet her quota of a particular manufacturer s hearing aids and may prescribe these when not in the best interest of the patient. Dilemmas: The AAA Code of Ethics - Part 2 30

31 Your Comments By joining a buying group she will be able to enjoy larger discounts on hearing aids, but is still unable to accept gifts from manufacturers through the group due to Principle 4c as it creates a conflict of professional interest. Also, if the buying group has sales quotas with specific hearing aid companies, this could also be considered a conflict of interest as the sales group is dictating types of hearing aids vs. appropriate fitting procedures. EPC Opinion The use of buying groups does not eliminate or absolve the audiologist from the issue of rewards. Despite the "distance" inherent in the buying group, if there is any type of reward attached to the purchase of hearing instruments that will flow back to the audiologist, the facility, the employer, or any designee, there is a hidden cost to the patient that is not evident in the purchase of the hearing instrument. EPC Opinion This conflict is not ameliorated by any such program such as being able to purchase any hearing instrument from any manufacturer, by eliminating any minimum purchasing, or by varying the types of "kickbacks" by any time, level of technology, or manufacturer considerations. The apparent good of the end does not justify the methods used to attain that end. The costs to the patient remain hidden to many, and these rewards or situations would be determined to be a violation of the Code of Ethics of the AAA Dilemmas: The AAA Code of Ethics - Part 2 31

32 Your Comments The audiologist can be viewed as a sales agent due to the fact that he is being compensated for the percentage of the sales. This has the potential to increase costs. Violates the anti-kickback statute. Also potential problem since the audiologist works in an ENT office, creating referrals from the ENTs. There would be a problem if the physician has a financial interest in the hearing aid sales-the audiologist can be implicated as part of Stark violation. The financial gain could impair the audiologist s ability to make an appropriate recommendation, especially since the audiologist will receive increased compensation for high end products. In Summary The Top (and Bottom) Line Financial relationships are HIGHLY regulated in health care. Patients view the relationship with their health care providers as sacred and have the right to expect exemplary standards of professionalism from us. Just because someone makes you an offer doesn t mean it s legal! Just because an arrangement is legal doesn t mean it s ethical! Dilemmas: The AAA Code of Ethics - Part 2 32

33 When Facing an Ethical Dilemma Ask yourself two questions: Would accepting the benefit compromise, or be regarded by others as likely to compromise, the independent exercise of your professional judgment? Would you be willing to have these benefit arrangements generally known by your patients and the public? Don t Forget When in doubt, consult AAA s Code of Ethics as guide to ethical decision-making. The EPC is always willing to provide clarification and education to members who questions to us. Getting the word out.. Ethics is an ongoing professional dialogue New ethical dilemmas emerge as technologies and techniques emerge AAA presents information on ethics at meetings, in journals, and on the web site. The Green Book on Ethics is available from AAA. CEUs are available. Dilemmas: The AAA Code of Ethics - Part 2 33

34 Questions/Comments To ask a question, please type your question into the chat box in the lower left corner of the screen and click on the Send button located right below the box. Thank you! Gloria D. Garner, Au.D. gloriadgarner@aol.com Jane M. Kukula, Au.D. aa1audiology@msn.com Dilemmas: The AAA Code of Ethics - Part 2 34