PhRMA, AdvaMed codes: changing business interactions

Adopted in 2003, the Pharmaceutical Research and Manufacturers of America (PhRMA) Code and the AdvaMed Code of Ethics have brought about changes in the ways pharmaceutical and medical device companies do business in optometry and ophthalmology.

In addition to changes in business practices, these guidelines have altered the protocols for ophthalmic and optometric meetings and education.

Details of PhRMA guidelines

The PhRMA guidelines focus on six main areas: informational presentations, educational or professional meetings, consultants, speaker training meetings, scholarship and educational funds, and educational and health care practice-related items.

Concerning informational presentations or discussions, the code states that occasional meals (but no entertainment or recreational events) may be offered as long as they are modest and occur in an environment conducive to informational communication.

Regarding continuing medical education, the guidelines state that financial support from companies is permissible, but there are limitations on this support. The code states that “because the giving of any subsidy directly to a health care professional by a company may be viewed as an inappropriate cash gift, any financial support should be given to the conference’s sponsor, which, in turn, can use the money to reduce the overall conference registration fee for all attendees.”

The role of consultants is also clarified in the PhRMA Code, which specifies that “legitimate consulting or advisory arrangements are appropriate, but token consulting arrangements should not be used to justify payments to health care professionals.”

Interpretations, confusion

Paul C. Ajamian

According to Paul C. Ajamian, OD, FAAO, center director of Omni Eye Services of Atlanta and continuing education chairman of SECO, the PhRMA guidelines have affected him in his capacity as an educational speaker. “The guidelines have been interpreted more strictly by some companies than others. In some cases they have altered what I can or cannot do as a lecturer and CE chair of SECO,” Dr. Ajamian told Primary Care Optometry News in an interview.

He said differing interpretations of the PhRMA guidelines have led to some confusion among speakers and meeting planners alike. “The guidelines are just that – guidelines, not law,” he said. “Depending on the drug company and its legal advisors, the way speakers are sponsored and meetings are supported can vary.

“I am hopeful that we are heading in the direction of unrestricted educational grants that will allow speakers to present a balanced program without it being an ‘infomercial’ for their products,” Dr. Ajamian continued. “If a company does want to introduce or promote a product, such as at a dinner meeting, it needs to be advertised that way so attendees know what to expect.”

Kirk L. Smick

Kirk L. Smick, OD, FAAO, a lecturer, practitioner at Clayton Eye Center in Morrow, Ga., and chairman of the Conference Advisory Board for International Vision Expo, agreed that the interpretation and implementation of the guidelines has not been a smooth process.

“As a practitioner, I have found that many companies spend a lot of time explaining what they can’t do anymore, which has a negative bent to it,” he said in an interview. “Also, after having read the guidelines cover to cover, I find that many companies interpret them differently from each other and differently from what the guidelines actually say.”

Dr. Ajamian did, however, emphasize the need to limit the power of companies in sponsored lectures.

“We do need to get away from ‘infomercials’ where a company sponsors a program and either dictates the program or has a speaker that is a ‘talking head’ that does an advertisement for their products.”

The AdvaMed Code of Ethics

Similar to the PhRMA guidelines, the AdvaMed Code of Ethics specifically addresses proper conduct for medical device companies, according to Bill Fitzgerald, compliance officer for Alcon Labs.

“The PhRMA guidelines and the AdvaMed code are very similar, except that the AdvaMed code addresses the different interaction that has to occur when a device or diagnostic product manufacturer is educating and training a customer,” he told PCON. “This training and education is required by the Food and Drug Administration. Both [PhRMA and AdvaMed] have had similar restrictions on what can be provided to customers in the form of meals, hospitality, gifts and support.”

Bill Fitzgerald

Mr. Fitzgerald said Alcon is a member of AdvaMed and has adopted the AdvaMed code as its standard for how the company interacts with its customers, across all divisions, in the United States.

“We apply the same standards across all divisions because you see an increasing number of optometrists who are prescribing drugs to treat eye conditions, which in turn are reimbursed through Medicaid, and now Part D of Medicare,” he said.

According to Steve Chesterman, manager of corporate communications for AMO, his company has also adopted the AdvaMed Code.

“The code is based upon principles similar to those set forth in the anti-kickback regulations that govern products reimbursed by Medicare and Medicaid,” he told PCON in an interview. “The code is designed to establish industry standards for ethical interactions and collaborations with health care professionals.”

Implementation by companies

Mr. Fitzgerald said implementing the AdvaMed code has been a learning experience for Alcon. “The codes both have different standards that are contrary to what might be considered typical business interactions,” he said.

Mr. Fitzgerald said these departures from typical business practices may lead to confusion. For example, he said, sales personnel wonder why they cannot play golf with a customer, or take a customer and his or her spouse to dinner.

“In any other industry, that is perfectly acceptable,” he said. “What sets us apart is that a significant portion of the products consumed in our industry are reimbursed through some form of government health care system or by third-party insurers.”

He said these payers want to be certain that the decision to use a company’s products is based entirely on the quality of those products. “Those payers want to be sure that decision is based on what is best for the patient, not what wine was served at dinner,” he said.

Mr. Fitzgerald said Alcon’s sales force has been relatively easy to train and monitor for compliance with the AdvaMed code. It has been more difficult to communicate the guidelines to health care providers, he said.

“They spend the bulk of their time providing care for their patients – as they should – and not necessarily following what information is coming from the Office of the Inspector General for Health and Human Services about industry conduct.”

He said health care providers do not always understand the nuances of the anti-kickback statute relative to their interactions with companies. “Things such as practice support beyond that directly related to our products and underwriting the costs of staff to attend conferences are no longer allowed,” he said.

Mr. Fitzgerald said dinners often present the most uncomfortable situations with health care providers. “Health care providers sometimes do not understand why it is not acceptable to bring a spouse,” he said. “In short, the codes do not allow gifts of a personal nature. A meal is to facilitate discussion about products. If that discussion does not occur, then the meal is a gift.”

Mr. Chesterman said AMO has applied the AdvaMed Code of Ethics to all of its business units covering cataract/implants, laser vision correction and eye care.

“These standards help not only to prevent conflicts of interest between the health care provider and the manufacturer, but also to alleviate the perception of improprieties,” he said.

This goal has been achieved through increased documentation and more comprehensive protocols, Mr. Chesterman said. “This is accomplished through more robust documentation of relationships, establishment of processes and various monitoring and compliance efforts to make sure that both our employees and industry health care professionals are educated about the policy.”

Paul Lawrance

According to Paul Lawrance, worldwide vice president of health care compliance for Vistakon, his company has complied with the PhRMA and AdvaMed guidelines through its Vistakon Health Care Compliance program.

“The Vistakon Health Care Compliance program was developed and implemented to ensure that the company meets all of the requirements of the Office of the Inspector General’s (OIG’s) Compliance Program for Pharmaceutical Manufacturers,” Mr. Lawrance said in a statement to PCON. “Additionally, we follow the guidelines established by AdvaMed and with the numerous state and federal laws that affect the health care profession. An Office of Health Care Compliance has been established to train, monitor and audit our employees to ensure compliance with the guidelines.”

Mr. Lawrance said that beginning in 2007, Vistakon will have its communications and marketing materials carry AdvaMed’s Code of Ethics Supporter logo. “This logo is only available to those companies who have committed to establish health care compliance policies and procedures, train all employees on the program, monitor compliance with the company’s program and appropriately respond to deficiencies or violations of these policies,” Mr. Lawrance said.

“Vistakon’s Health Care Compliance policies also cover the sponsorship of professional education by ensuring that we comply with the Accreditation Council for Continuing Medical Education’s (ACCME’s) Standards for Commercial Support, adopted in April 2004,” Mr. Lawrance added. “These standards were developed because it was realized that the success of commercial sponsorship would be measured by how it contributes to improving doctor practice and delivering improved patient care.”

The six major ACCME standard ensure that professional education is free from commercial interest. Mr. Lawrance said Vistakon believes all parties involved in continuing education should consider adopting such standards.

Company-provided CE

Mr. Fitzgerald said a significant challenge for Alcon regarding AdvaMed code implementation has been in the area of continuing education.

“Alcon has gone beyond the code, and we now require that there be no entertainment associated with any education event we sponsor with a grant, even if it is acceptable by the provider’s standards,” he said. “We would prefer that the money be spent enhancing the quality of the education. We want providers to attend an event because of compelling information, not who is performing afterward.”

Mr. Fitzgerald said a reception or dinner is perfectly acceptable as a means to facilitate further discussion of the topics presented.

He said that strict adherence to these guidelines is necessary for industry to maintain the freedoms it now enjoys.

“Everyone – including sales representatives, health care providers and those who service our sector – has to realize that there is intense scrutiny of the manner in which we interact,” Mr. Fitzgerald said. “If we don’t mind our own ship, it is common wisdom that the government may step in and mind it for us. Therefore, it is in everyone’s best interest to adhere to the voluntary standards of the PhRMA or AdvaMed codes.”

For more information:

• Paul C. Ajamian, OD, FAAO, is chair of continuing education for SECO. He can be reached at 5505 Peachtree-Dunwoody Rd., Ste. 300, Atlanta, GA 30342; (404) 257-0814; fax (404) 256-5446; e-mail: ajamian@aol.com.
• Kirk L. Smick, OD, FAAO, practices at Clayton Eye Center in Morrow, Ga. He can be reached at 1000 Corporate Center Dr., Morrow, GA 30260; (770) 968-8888; fax: (770) 960-2465; e-mail: Claytoneye@aol.com.
• Bill Fitzgerald is compliance officer for Alcon. He can be reached at 6201 South Fwy., Fort Worth, TX 76134; (817) 551-8671; fax: (817) 551-4696; e-mail: Bill.Fitzgerald@AlconLabs.com.
• Steve Chesterman is manager of corporate communications for AMO. He can be reached at 1700 E. St. Andrew Place, Santa Ana, CA 92705; (714) 247-8711; e-mail: steve.chesterman@amo-inc.com.
• Paul Lawrance is worldwide vice president of health care compliance for Vistakon. He can be reached at 7500 Centurion Pkwy., Jacksonville, FL 32256; (800) 843-2020; Web site: www.jnjvision.com.

References:

• The PhRMA Code is available at www.phrma.org/code_on_interactions_with_healthcare_professionals/.
• The AdvaMed Code of Ethics is available at www.advamed.org/publicdocs/coe.html.