Fellowship to consider two proposed SOPs
Editor’s Note: Under the AAOS Professional Compliance Program, adopted in April 2005, the fellowship votes on all Standards of Professionalism (SOP). An SOP establishes the minimum standard of acceptable conduct for orthopaedic surgeons in a particular area. SOPs are mandatory and apply to all fellows and members of the AAOS.
At the 2007 Annual Meeting, two proposed SOPs (on Advertising by Orthopaedic Surgeons and on Orthopaedist-Industry Conflicts of Interest) will be considered by the Bylaws Committee in its role as the SOPs Oversight Committee. These SOPs have been reviewed by the Ethics Committee, the Committee on Professionalism, the Board of Councilors, the Board of Specialty Societies (BOS/COMSS) and the AAOS Board of Directors.
A vote on the proposed SOPs will be conducted after the 2007 Annual Meeting. To be adopted by the fellowship, SOPs require a vote of at least 20 percent of the active, inactive and emeritus fellows, and an affirmative vote of two-thirds of those fellows casting ballots.
The Committee on Professionalism recommended, and the AAOS Board of Directors concurred, that the SOPs on Orthopaedist-Industry Conflicts of Interest will take effect immediately upon adoption by the fellowship, but will not be enforced for one year. Enforcement of the SOPs on Orthopaedist-Industry Conflicts of Interest will begin with acts occurring on or after January 1, 2008 to enable the AAOS to conduct an educational program for the Fellowship regarding these SOPs prior to their enforcement.
The complete text of the proposed SOPs is presented here for your consideration.
Standard of Professionalism #1:
Advertising by Orthopaedic Surgeons
At the core of the patient-physician relationship is a sense of trust. A patient trusts that the physician is knowledgeable and provides appropriate representations of his or her abilities. An orthopaedic surgeon who misrepresents his or her abilities or advertises musculoskeletal services in a false or misleading fashion damages the patient-physician relationship of trust. In addition, the orthopaedic surgeon who misleads through advertising may prevent a patient from making informed decisions about important health care matters.
For purposes of these Standards of Professionalism, advertising to the public includes, but is not limited to, information appearing on behalf of an orthopaedic surgeon and/or his or her professional entity (e.g., partnership, limited liability partnership or corporation) on the Internet or e-mails and in phonebooks, magazines, newspapers, direct mail, flyers, billboards, video presentations, and directories available to the public. In addition, advertising includes printed material typically used in the practice setting: letterhead, mailing envelopes, business cards, referral forms, office forms, appointment cards, brochures, pamphlets, office mailings, and signage inside or outside of the office. Advertising includes radio and television advertisements, including interviews, and telephone voice messages. Advertising includes any activity in which an orthopaedic surgeon pays in any way, including providing services in exchange for advertising, to communicate with the public.
Advertising of services, as well as competition between and among orthopaedic surgeons and other health care practitioners, is ethical and acceptable. It is the obligation of the orthopaedic surgeon to present a fair and honest representation of services and the goals, alternatives, expectations and risks associated with these services. In advertising as in all communications with patients and the public, orthopaedic surgeons have an ethical obligation to present themselves and the services they provide to patients in a clear and accurate manner. This principle of ethical conduct, when it is applied to advertising, is buttressed by its enforcement in law.
The U.S. Federal Trade Commission also has rules governing physician advertising. It is the responsibility of AAOS Fellows and Members to be familiar with and comply with these regulations as well as applicable State and local laws. Regulations make advertisements that are false or misleading illegal and subject to prosecution. Parties are encouraged that before filing a complaint with AAOS they attempt to resolve their disputes through other alternatives including state or federal resources.
The Standards of Professionalism draw from the aspirational Code of Medical Ethics and Professionalism for Orthopaedic Surgeons that appears in bold italics. The statements that follow the aspirational Code establish the baseline standard of acceptable conduct for orthopaedic surgeons who advertise their services. Violations of these mandatory standards may serve as grounds for a formal complaint to and action by the AAOS as outlined in the AAOS Bylaws Article VIII.
These Standards of Professionalism apply to all AAOS Fellows and Members and all forms of advertising. Only an AAOS Fellow or Member may file a complaint of an alleged violation of these Standards of Professionalism regarding another AAOS Fellow or Member.
Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, I. D.:
When obtaining informed consent for treatment, the orthopaedic surgeon is obligated to present to the patient or to the person responsible for the patient, in understandable terms, pertinent medical facts and recommendations consistent with good medical practice. Such information should include alternative modes of treatment, the objectives, risks and possible complications of such treatment, and the complications and consequences of no treatment.
- An orthopaedic surgeon shall not advertise information in a manner that misleads patients to believe that a diagnosis can be made without consultation or that one method of treatment is suitable for all patients. Advertising shall not be false, misleading, or lead patients to believe that any given procedure is without risk.
- An orthopaedic surgeon shall preserve and maintain the integrity of the profession by not advertising false or misleading statements to a patient or the person responsible for the patient.
Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, II. A.:
The orthopaedic surgeon should maintain a reputation for truth and honesty. In all professional conduct, the orthopaedic surgeon is expected to provide competent and compassionate patient care, exercise appropriate respect for other health care professionals, and maintain the patient’s best interests as paramount.
- An orthopaedic surgeon shall not, when advertising his or her services to the public, make false or misleading representations of his or her ability to provide medical treatment.
- An orthopaedic surgeon shall not use false or misleading photographs or other images in advertising.
- An orthopaedic surgeon shall not use photographs, images, endorsements, and/or statements in a false or misleading manner that communicate a degree of relief, safety, effectiveness, or benefits from orthopaedic care that are not representative of results attained by that orthopaedic surgeon..
- An orthopaedic surgeon shall prevent false or misleading advertising by approving all advertisements regarding his or her practice before dissemination. An orthopaedic surgeon shall be held responsible for any violations of this SOP incurred by a public relations, advertising, or similar firm which he or she retains.
- An orthopaedic surgeon shall make a reasonable effort to ensure that statements made by an academic institution, hospital or private entity on his or her behalf are not false or misleading.
Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, VI.A.:
The orthopaedic surgeon should not publicize himself or herself through any medium or form of public communication in an untruthful, misleading, or deceptive manner. Competition between and among surgeons and other health care practitioners is ethical and acceptable.”
- An orthopaedic surgeon shall abide by all state and federal laws and regulations related to the advertising of degrees and credentials, not advertising them in a false or misleading manner.
- An orthopaedic surgeon, when advertising his or her services to the public, shall not advertise false or misleading certification levels.
- An orthopaedic surgeon, when advertising his or her services to the public, shall not make false or misleading claims or personal representations, including volume of procedures performed and the nature and level of academic appointments and affiliations.
- An orthopaedic surgeon, when advertising, shall not misrepresent or falsely state his or her role in the development or study of a particular surgical procedure.
Standard of Professionalism #2:
Orthopaedist-Industry Conflicts of Interest *
The primary focus of the orthopaedic profession is care of the patient. As part of their lifetime commitment to patients, orthopaedic surgeons must maintain specialized knowledge and skills through participation in continuing medical education programs, seminars, and professional meetings. Often, these professional functions are sponsored by the community of medical device manufacturers, pharmaceutical companies, and other businesses who play an important role supporting continuing medical education (CME) events and the development of new technologies that contribute to the on-going patient-physician relationship. This collaborative effort ensures that patients have the best surgical outcomes through the invention and testing of new technology, research and evaluation of existing technology, and continued education of orthopaedic surgeons.
Cooperative relationships between orthopaedic surgeons and industry benefit patients. Orthopaedic surgeons are best qualified to provide innovative ideas and feedback, conduct research trials, serve on scientific advisory boards, and serve as faculty to teach the use of new technology. Orthopaedic surgeons, in an effort to improve patient care, rely on industry to bring their creative ideas to fruition. A collaborative relationship between orthopaedic surgeons and industry is necessary to improve patient care, but must be carefully scrutinized to avoid pitfalls of improper inducements, whether real or perceived.
Orthopaedic surgeons must be mindful of potential conflicts of interest with patient care in pursuing academic and commercial ventures. A conflict of interest exists when professional judgment concerning the well being of the patient has a reasonable chance of being influenced by other interests of the physician. The self-interest of the physician may be financial in nature. The competing interests may involve fame and notoriety for the physician or time for the physician or the physician’s family. When such conflicts exist, there is concern that care decisions may not be in the best interests of the patient. Disclosure of a conflict of interest is required in communications to patients, the public and colleagues. The benefit to the patient must be the primary goal and must not be compromised. Orthopaedic surgeons, like all physicians, have an ethical obligation to present themselves and the services they provide to patients in a clear and accurate manner.
When faced with a potential conflict of interest that cannot be resolved, an orthopaedic surgeon should consult with colleagues or an institutional ethics committee to determine whether there is an actual or potential conflict of interest and how to address it.
For purposes of these Standards of Professionalism, “industry” includes pharmaceutical, biomaterial, and device manufacturers.
For purposes of these Standards of Professionalism, “CME events” refer to educational events that meet the requirements of and have been approved by the Accreditation Council for Continuing Medical Education (ACCME). Further, it is understood that attendance at a CME event shall mean that the orthopaedic surgeon is attending and is not an instructor at that CME event.
For purposes of these Standards of Professionalism, a conflict of interest occurs when an orthopaedic surgeon or an immediate family member has, directly or indirectly, a financial interest or positional interest or other relationship with industry that could be perceived as influencing the orthopaedic surgeon’s obligation to act in the best interest of the patient.
A “financial interest,” “financial arrangement,” “financial inducement” or “financial support” includes, but is not limited to:
- Compensation from employment;
- Paid consultancy, advisory board service, etc.;
- Stock ownership or options;
- Intellectual property rights (patents, copyrights, trademarks, licensing agreements, and royalty arrangements);
- Paid expert testimony;
- Honoraria, speakers’ fees;
- Travel; and
- Meals and hospitality
A “positional interest” occurs when an orthopaedic surgeon or family member is an officer, director, trustee, editorial board member, consultant, or employee of a company with which the orthopaedic surgeon has or is considering a transaction or arrangement.
Some states have enacted legislation regarding relationships between physicians and industry. When the law supersedes these Standards of Professionalism, AAOS Fellows and Members are expected to follow the law.
These Standards of Professionalism draw from the aspirational Code of Medical Ethics and Professionalism for Orthopaedic Surgeons that appears in bold italics. The statements that follow the aspirational Code establish the mandatory minimum standards of acceptable conduct for orthopaedic surgeons when engaged in relationships with industry. Violations of these minimum standards may serve as grounds for a formal complaint to and action by the AAOS as outlined in the AAOS Bylaws Article VIII.
The Standards of Professionalism on Orthopaedist-Industry Conflicts of Interest apply to all AAOS Fellows and Members. Only an AAOS Fellow or Member may file complaints of an alleged violation of these Standards of Professionalism regarding another AAOS Fellow or Member.
Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, I.A.:
The orthopaedic profession exists for the primary purpose of caring for the patient. The physician-patient relationship is the central focus of all ethical concerns.
- An orthopaedic surgeon shall, while caring for and treating a patient, regard his or her responsibility to the patient as paramount.
- An orthopaedic surgeon shall prescribe drugs, devices, and other treatments primarily on the basis of medical considerations and patient needs, regardless of any direct or indirect interests in or benefit from industry.
Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, II. C.:
The orthopaedic surgeon should obey all laws, uphold the dignity and honor of the profession, and accept the profession’s self-imposed discipline. Within legal and other constraints, if the orthopaedic surgeon has a reasonable basis for believing that a physician or other health care provider has been involved in any unethical or illegal activity, he or she should attempt to prevent the continuation of this activity by communicating with that person and/or identifying that person to a duly-constituted peer review authority or the appropriate regulatory agency. In addition, the orthopaedic surgeon should cooperate with peer review and other authorities in their professional and legal efforts to prevent the continuation of unethical or illegal conduct.
- An orthopaedic surgeon convicted of violating federal or state conflict of interest laws or regulations shall be subject to discipline under the AAOS Professional Compliance Program.
Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, III.A.:
The practice of medicine inherently presents potential conflicts of interest. When a conflict of interest arises, it must be resolved in the best interest of the patient. The orthopaedic surgeon should exercise all reasonable alternatives to ensure that the most appropriate care is provided to the patient. If the conflict of interest cannot be resolved, the orthopaedic surgeon should notify the patient of his or her intention to withdraw from the relationship.
- An orthopaedic surgeon shall, when treating a patient, resolve conflicts of interest in accordance with the best interest of the patient, respecting a patient’s autonomy to make health care decisions.
- An orthopaedic surgeon shall notify the patient of his or her intention to withdraw from the patient-physician relationship, in a manner consistent with state law, if a conflict of interest cannot be resolved in the best interest of the patient.
Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, III.C.:
When an orthopaedic surgeon receives anything of significant value from industry, a potential conflict exists which should be disclosed to the patient. When an orthopaedic surgeon receives inventor royalties from industry, the orthopaedic surgeon should disclose this fact to the patient if such royalties relate to the patient’s treatment. It is unethical for an orthopaedic surgeon to receive compensation of any kind from industry for using a particular device or medication. Reimbursement for reasonable administrative costs in conducting or participating in a scientifically sound research clinical trial is acceptable.
- An orthopaedic surgeon shall decline subsidies or other financial support from industry, except:
An orthopaedic surgeon who has influence in selecting a particular product or service for an entity shall disclose any relationship with industry to colleagues, the institution and other affected entities.
An orthopaedic surgeon shall disclose to the patient any financial arrangements with industry that relate to the patient’s treatment, including the receipt of inventor royalties, stock options or paid consulting arrangements with industry.
An orthopaedic surgeon shall accept no direct financial inducements from industry for utilizing a particular implant or for switching from one manufacturer’s product to another.
An orthopaedic surgeon shall enter into consulting agreements with industry only when such arrangements are established in advance and in writing to include evidence of the following:
- Gifts having a fair market value of less than $100;
- Medical textbooks; or
- Patient educational materialsmay be accepted.
An orthopaedic surgeon shall participate in or consult at only those meetings that are conducted in clinical, educational, or conference settings conducive to the effective exchange of information.
- Documentation of an actual need for the service;
- Proof that the service was provided;
- Evidence that physician reimbursement for consulting services is consistent with fair market value; and
- Not based on the volume or value of business he or she generates.
Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, IV.A.:
The orthopaedic surgeon continually should strive to maintain and improve medical knowledge and skill and should make available to patients and colleagues the benefits of his or her professional attainments. Each orthopaedic surgeon should participate in continuing medical educational activities.
An orthopaedic surgeon shall accept no financial support from industry to attend industry-related social functions where there is no educational element.
An orthopaedic surgeon who is attending a CME event shall accept no industry financial support for attendance at a CME event. Residents and orthopaedists-in-training may accept an industry grant to attend a CME event if they are selected by their training institution or CME sponsor and the payment is made by the training program or CME sponsor. Bona fide faculty members at a CME event may accept industry-supported reasonable honoraria, travel expenses, lodging and meals from the conference sponsors.
An orthopaedic surgeon, when attending an industry-sponsored non-CME educational event, shall accept only travel and modest hospitality, including meals and receptions; the time and focus of the event must be for education or training.
An orthopaedic surgeon, when attending an industry-sponsored non-CME educational event, shall accept no financial support for meals, hospitality, travel, or other expenses for his or her guests or for any other person who does not have a bona fide professional interest in the information being shared at the meeting.
Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, III.D.:
An orthopaedic surgeon reporting on clinical research or experience with a given procedure or device must disclose any financial interest in that procedure or device if the orthopaedic surgeon or any institution with which that orthopaedic surgeon is connected has received anything of value from its inventor or manufacturer.
An orthopaedic surgeon, when reporting on clinical research or experience with a given procedure or device, shall disclose any financial interest in that procedure or device if he or she or any institution with which he or she is connected has received anything of value from its inventor or manufacturer.
An orthopaedic surgeon who is the principal investigator shall make his or her best efforts to ensure at the completion of the study that relevant research results are reported and reported truthfully and honestly with no bias or influence from funding sources, regardless of positive or negative findings.
*We recommend that these Standards of Professionalism (SOPs) take effect immediately upon Fellowship adoption, but that enforcement of these SOPs begin with acts occurring on or after January 1, 2008. This will allow the AAOS to conduct an educational program for the Fellowship prior to their enforcement.
ICL on compliance program scheduled
Are you interested in learning more about the Professional Compliance Program? You will have the opportunity to do just that at the 2007 Annual Meeting in San Diego. Members of the Committee on Professionalism (COP) will conduct a mock grievance hearing as part of an instructional course lecture (ICL).
Professionalism in Orthopaedics: Pearls and Perils (ICL #261), will detail how Standards of Professionalism (SOPs) are developed and adopted. Moderator Peter J. Mandell, MD, chair of the COP, and committee members Murray J. Goodman, MD; William J. Hopkinson, MD; Vincent J. Silvaggio, MD, and Richard E. Strain Jr., MD will then focus on enforcement of the SOPs. You will learn how each side presents its position and how Hearing Panels arrive at recommendations to the Board of Directors. Bring your questions, concerns and comments!
The ICL will be held on Thursday, February 15, 2007, from 4 p.m. to 6 p.m. If you haven’t already registered, you can do so on-site, in Hall D Lobby of the San Diego Convention Center.