Advisory Opinion of the Code of Ethics

Issues Raised
When and how must an ophthalmologist disclose professionally related commercial relationships and interests to patients and other relevant parties?

Applicable Rules
Rule 2. Informed Consent
Rule 11. Commercial Relationships
Rule 15. Conflict of Interest

Definitions (exclusively for the purposes of this Advisory Opinion)

• Commercial healthcare entity - a proprietary health-related business having separate and distinct objectives with regard to profit, such as  pharmaceutical, devices, and medical equipment industries and related entities or business partners.
  
  
• Commercial relationship – a formal business relationship between a commercial healthcare entity and a physician.
  
  
• Conflict of interest – a discrepancy between the ophthalmologist’s professional responsibilities to serve the patient’s best interests and his o her own personal interests or incentives.
  
  
• Commercial interest - an ownership interest in a medical or other health care facility or service.
  
  
• Threshold financial interest/ownership  - one hundredth of one percent (.01%).
  
  
• Ownership – an interest held by an individual or an individual’s family member.

The AMA’s definitions of family members are used in this document and are noted here:

• “Immediate family member” - spouse, domestic partner, parent or child.
  
  
• “Extended family member” - spouse, domestic partner, parent, mother-in-law, father-in-law, child, spouse of child, grandchild, brother, sister, or spouse or child of a brother or sister.

Background
Although the holding of commercial interests or the receipt of personal gifts in itself is not necessarily unethical, the ophthalmologist must respect the importance of the patient's interest above his or her own when these interests differ.

Patients have a right to trust that a service or product is recommended to them because it is an appropriate balance of safety, efficacy, and cost based on sound professional judgment and unbiased by extraneous factors or inducements.

A conflict of interest is a discrepancy between the ophthalmologist’s professional responsibilities and his or her personal interests or incentives. When a practicing ophthalmologist has professionally related commercial interests, the potential exists for a conflict of interest in patient care. It is essential that conflicting commercial interests be disclosed to the patient and to colleagues who may be affected by them. Not all commercial interests necessarily raise conflicts, however; of equal importance in this discussion is the distinction between, and the physician’s understanding of, those arrangements or relationships that raise conflicts of interest and those that do not.  Examples of arrangements or relationships with commercial healthcare entities that do not raise conflicts include hospital-sponsored golf tournaments for its clinical staff or an industry-sponsored “Steak & Ale” dinner honoring a retiring Chair.  A general guideline (embraced by the British Medical Association and the American College of Physicians) as to the appropriateness or inappropriateness of a commercial relationship or other such arrangement is for the ophthalmologist to assume the position of the patient and ask himself or herself the following: Would you be willing to have these arrangements or inducements generally known?. This Advisory Opinion is provided using this criterion of accountability, with the recommendation to err on the side of disclosure when in doubt.

Arrangements that may Require Disclosure
The following are examples of potentially problematic arrangements between commercial healthcare entities and ophthalmologists.  The ophthalmologist should scrutinize such arrangements for the potential to bias patient care and then adequately disclose them to the patient and other relevant parties.

1. Holding a controllable, negotiable interest in an ophthalmic-related business  (e.g., financial investment, stock holdings, options, or warrants) either directly or  through an immediate family member that creates a conflict between the financial  interests of the ophthalmologist and the medical interests of the patient.
   
   
2. Board membership or a paid consultant relationship with an ophthalmic-related business.
   
   
3. Receiving commercial support of educational and scientific meetings and  research where the sponsor controls or influences the content of the meeting or  research.
   
   
4. Contractual relationships with commercial healthcare entities where economic  incentives or penalties may influence patient care.
   
   
5. Any real or implied obligation to promote a company's products in exchange for money, gifts, favors, entertainment, travel, or accommodation.
   
   
6. Accepting gifts from commercial healthcare entities. It is important to realize  that the acceptance of a gift establishes a relationship between the donor and the  recipient with expectations of reciprocity.
   
   
7. Participating in non-educational or non-business related activities (e.g., social  functions, meals, travel and entertainment) where there is no genuine professional  benefit to the physician and no apparent benefit to or advancement of patient  care.

Disclosure Methodology

• Disclosure to Patients
Disclosure of conflicts of interest to patients should be either oral or written. In the case of an oral communication, the disclosure of the ophthalmologist's commercial interests shall be made as part of a communication containing a recommendation for treatment or a referral, and it shall reasonably apprise the patient of the commercial interest in question if that commercial interest has a reasonable chance of biasing decisions about patient care. The patient should be informed of alternative avenues of obtaining care from other physicians with whom the ophthalmologist has no disclosable professionally related commercial interests if the patient expresses concern about the apparent conflict of interest.

In lieu of an oral communication to a patient, the ophthalmologist may make the required disclosure in a written communication using one or more of the following forms, or by using a similar methodology:

(a) posting a conspicuous sign in an area that is likely to be seen by patients and  patients' guardians,

(b) incorporating a conspicuous written notice in the ophthalmologist's existing  office documents, such as prescription sheets, office information or policy  booklets, referral forms, and any similar regularly distributed information handout,  or

(c) providing a written disclosure document for a patient or a patient's guardian.

• Disclosure to the Public and Other Relevant Parties
Disclosure to the public and other relevant parties shall also be either oral or written. The communication shall prominently disclose the ophthalmologist's disclosable professionally related commercial interests at the beginning of the communication.
 
• When to Disclosure
An ophthalmologist’s professionally related commercial interests must be disclosed to patients and other relevant parties when he or she makes a recommendation for, a referral to, offers a description of, or generally discusses:

1) the advantages and disadvantages of the patient seeing another physician with whom the ophthalmologist has professionally related commercial interests and

2) facilities, equipment, devices, procedures or pharmaceutical agents with which the ophthalmologist intends to treat the patient and with which he or she has  professionally related commercial interests.
Ophthalmologists should be careful to observe any additional disclosure requirements that may be mandated by state or federal law.

Financial Relationships Requiring Disclosure
The following are examples of specific financial relationships requiring disclosure to patients and other relevant parties.  These examples identify a disclosable professionally related commercial interest:

1. Fee arrangements: with another physician or practitioner (other than any of the ophthalmologist's partners, co-employees, employees, or employer), (a) if through the direct or indirect payment or reimbursement practices of any third-party payor or payment agency, any portion of the global fee for the ophthalmological service is allocated, divided, or split with the other physician or practitioner, or (b) if the global fee for the service of the other physician or practitioner is allocated, divided, or split with the ophthalmologist; and
   
   
2. Facilities (such as ASCs and laser centers), equipment, devices,  procedures, and pharmaceutical agent: if an interest of one hundredth of one percent (.01%) or more in one of the above is directly or indirectly owned by (a) the ophthalmologist, (b) the ophthalmologist's spouse, parent, child, or grandchild, (c) any other physician or practitioner with respect to whom the ophthalmologist has a commercial relationship described in paragraph (1) above, or (d) any entity of which any person described in clause (a), (b), or (c) above is either an owner, partner, shareholder (otherwise than as a shareholder in a mutual fund), or venturer with a one hundredth of one percent (.01%) or more interest, or a consultant, officer, director, trustee, beneficiary, or employee. For the purposes of this document, stock options shall be considered to be the ownership of an interest in an entity even if they have not been exercised or they are not currently exercisable.

Applicable Rules

Rule 15. Conflict of Interest. "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 provider. Disclosure of a conflict of interest is required in communications to patients, the public and colleagues."

Rule 11. Commercial Relationships. "An ophthalmologist's clinical judgment and practice must not be affected by economic interest in, commitment to, or benefit from professionally related commercial enterprises."

Rule 2. Informed Consent. "The performance of medical or surgical procedures shall be preceded by appropriate informed consent."

Other References

• American Academy of Ophthalmology Advisory Opinions: "Delegation of Services," "Employment and Referral Relationships between Ophthalmologists and Other Health Care Providers," and "Post-Operative Care." (www.aao.org)
  
  
• American Academy of Ophthalmology Policy Statement, “Gifts to Physicians from Industry.” (www.aao.org)
  
  
• American Medical Association, 2001 Code of Medical Ethics, Annotated Current Opinions. Sections 8.032 ("Conflict of Interest: Health Facility Ownership by a Physician"); 8.061 (“Gifts to Physicians from Industry”); 8.08 ("Informed Consent"); 8.09 ("Laboratory Services"); 6.02 ("Fee Splitting"); 6.03 ("Fee Splitting: Referrals to Health Care Facilities"); 6.04 ("Fee Splitting: Drug or Device Prescription Rebates"); 8.05 ("Contractual Relationships"); and 8.132 ("Referral of Patients - Disclosure of Limitations"). (www.ama-assn.org)
  
  
• Editorial, Biomedical research, conflict of interest, and the public trust. Ophthalmology 1989; 96:575-578.
  
  
• Chren, MM: Doctors, drug companies and gifts. JAMA, 1989, 262(24):3448-3451.
  
  
• PhRMA Code on Interactions with Healthcare Professionals.
  
  
• Compliance Program Guidance for Pharmaceutical Manufacturers. Department of Health and Human Services. Office of the Inspector General.
  
  
• Wazana A. Physicians and the pharmaceutical industry. Is a gift ever just a gift? JAMA 2000; 283:373-380.
  
  
• DeAngelis CD. Conflicts of interest and the public trust. JAMA 2000; 284:2237-2238.
  
  
• Coyle SL. Physician-Industry Relations. Part 1: Individual Physicians. Ann Intern Med 2002; 136:396-402.
  
  
• Studdert DM, Mello MM, Brennan TA. Financial conflicts of interest in physicians’ relationships with the pharmaceutical industry: self-regulation in the shadow of federal prosecution. N Engl J Med 2004; 353:1891-1899.
  
  
• Blumenthal D. Doctors and Drug Companies. N Engl J Med 2004; 351:1885-1890.

Approved by: Board of Directors, June 1990
Revised and Approved by: Board of Trustees, May 1994
Reaffirmed by: Board of Trustees, April 1998
Revised and Approved by: Board of Trustees, October 2002
Revised and Approved by: Board of Trustees, September 2005