Frequently Asked Questions
ARBO New Standards for Commercial Support of COPE Approved Continuing Education (March 2008)
ARBO New Standards for Commercial Support of COPE Approved Continuing Education (March 2008)
Why is COPE setting new standards for support?
- COPE is being proactive
The federal government has taken renewed interest in the relationships between industry and healthcare. Since 2000, new regulatory policies aimed at consumer protection and controlling healthcare costs have placed new restrictions on industry interactions with healthcare professionals. Many previously accepted activities are now being questioned. As a result, more industry support has been moved into grants for continuing education activities creating potential conflicts of interest issues for all healthcare professionals. In 2004 the Accreditation Council for Continuing Medical Education (ACCME) addressed these issues by releasing their "Standards for Commercial Support" and in December of 2006 there was federal scrutiny of the effectiveness of these standards. In response, CE accrediting organizations are implementing guidelines implemented guidelines to appropriately manage industry relationships and support of CE activities to ensure transparency, fair balance, content free of commercial bias and an effective system of oversight.
COPE has taken notice of these events and is being proactive.
- To provide a structured environment
Parallel to government inquiry, various Industry groups developed their own voluntary codes on relationships with healthcare professionals. PhRMA and AdvaMed have been in existence since 2003 and have proven to be subject to differences in interpretation. Boundaries need clarification and non-biased interpretation. To operate in a fair and impartial manner, COPE can provide a safe environment for all to operate. Therefore COPE is strengthening the existing guidelines and providing a system of oversight.
- There is a general consensus
In 2006, leaders from the AOA, NBEO, ASCO and ARBO gathered in Chicago Illinois to … "develop a profession-wide consensus-driven approach to the future of continuing education and optometric competence for the benefit of the public" From this meeting, there was agreement that new guidelines were needed for commercial support of optometric continuing education events.
COPE is acting on these recommendations.
- It's the right thing to do
The integrity of our CE system has played an important historical role in the advancement of our profession.
Mandatory continuing education is a requirement of licensure recognized by all fifty state boards. Continued improvement and protection of the integrity of this system is important for our profession and the public welfare to ensure continued competence.
Do these guidelines apply to all commercially supported events?
These guidelines apply only to COPE APPROVED CE events. They do not necessarily apply to state board approved CE events. In addition, industry remains able to organize speaker bureaus and conduct regional and state informational seminars that are not COPE approved.
Are these guideline in effect now?
No, the guidelines recently released are still in draft form. COPE released them in draft form to allow for stakeholder input. While we anticipate that the core principles of the guidelines will remain intact, we encourage discussion and review and will remain receptive to suggestions that may decrease administrative burden or associated costs as well as address logistical concerns while maintaining the objectives of independence, transparency, and educational content free of commercial bias.
Does this mean that a commercial entity can no longer act as a COPE administrator?
In order to ensure that Industry support of CE does not influence content, there must be separation between financial support and the control of all processes that occur in the administration of the CE event. Processes that carry potential for commercial bias include speaker and topic selection, distribution of promotional materials, and the development of presentation materials. Due to this potential conflict of interest, commercial entities will no longer be approved as COPE administrators. Commercial support of a COPE approved CE event can only occur through an unrestricted grant to a COPE-approved administrator. This is a major change from current COPE policy.
Does COPE desire to reduce or eliminate corporate support of CE?
No, the mission of COPE is to assist our member state Boards by providing a standardized method by which optometric CE is approved and administered. Encouraging or discouraging corporate support is not a part of the mission.
COPE recognizes that industry-subsidized continuing education can be effective and free of commercial bias. The requirement that industry support of COPE approved CE events is only secured through unrestricted educational grants reduces the potential for industry to influence content and delivery. This solution can lower costs and increase the availability of CE for Optometrists while ensuring transparency and content that is free of commercial bias. If managed appropriately, it can enable lifelong learning … improve patient care … and benefit the public welfare.
Does COPE anticipate that the increased burden imposed by the new standards will reduce commercial support of optometric CE?
No. This issue of concern is not unique to optometry. Other health care professions that have incorporated similar standards have documented a substantial increase in corporate support. These standards create the safe harbor as defined by the government for industry to provide support without fear of reprisal.
Will these new standards impose any additional limits on off label discussion of product or services?
No. The standards actually create an environment of independence for the lecturer that insulates them from federal guidelines, prohibiting off-label discussion. Although the lecturer is free to discuss off-label use, there are disclosure requirements that will ensure transparency.
How can an onsite COPE reviewer monitor my course presentation and assess the content when he is not an expert in my field?
The On-Site Reviewer does not peer review the presentation content. Their emphasis is on adherence to the guidelines such as proper disclosure and length of presentation. Content is only reviewed to determine that it is consistent with the original submitted outline and free of commercial bias.
What happens to all the courses that are currently COPE-qualified and good for up to 3 more years? Can we no longer use them since we can't hold events?
The new guidelines will be finalized and implemented by 01-01-2009. Although you may still hold these events, the existing guidelines that prohibit promotion of products are still in effect until the implementation date. Speakers are still required to present lectures that are scientifically valid and without commercial bias. As of January 1, 2009, courses that are not constructed in an independent manner will be prohibited therefore existing speaker bureau type courses will be expired.
Will I/we know when an on-site reviewer is in the audience?
In most cases the reviewer will be attending a course that he/she would normally attend for CE credit and will not be announced. Anonymity insulates the reviewer and enhances their objectivity.
Will I/we receive a copy of the report of the On-Site Review (OSR)?
In the event the review finds non-compliance with guidelines the administrator and or lecturer will be notified of those discrepancies.
What if I/we don't agree with the OSR report? Do I/we have any recourse?
Yes this lecturer will have thirty days to appeal in writing. The appeal will then be presented to the entire COPE committee for review.
Many small societies do not have the infrastructure to comply, what shall we do?
COPE is aware that the new guidelines may impose increased administrative burdens on small state societies making it difficult to continue to offer COPE approved courses.
COPE has considered this issue and is looking at numerous alternatives such as empowering the parent state association to act as an administrator. Policy has not been formulated pending the period for comment. We invite your input on potential solutions that may lessen this burden.
We have a concern that funding of our state meeting will decrease if we implement these requirements.
Although this is an acknowledged possibility, the experience of other professions indicates this is unlikely to occur. Industry has indicated they want to continue to support the profession. They have also indicated they want a level playing field and established boundaries. Although it is not the primary intent of COPE, the guidelines will provide a safe environment where industry funding could grow.
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