Earlier this week, the American Medical Association House of Delegates (AMA HOD) passed the Council on Judicial and Ethical Affairs (CEJA) 1-A-11 report entitled, “Financial Relationships with Industry in Continuing Medical Education.”
It came down to a very close vote and worked much like a roller coaster. Initially, the testimony was 2/3rds against the CEJA report. Though the report was conflicted in how it presented commercial support of continuing medical education (CME), the recommendations reinforce current CME practices.
In three of the previous four versions of the CEJA report, the reference committee had recommended approval to the House of Delegates, but the delegates then pulled it out of the consent calendar and voted to refer the document back to CEJA for more revisions.
This time, in a parliamentary move, the reference committee report was pulled out from a list of recommendations scheduled to be voted on by unanimous consent and was quickly debated and then voted on to passed CEJA on a very close vote. This caught many of the opponents off guard and many who spoke the previous day against the measure were not in the room to show their opposition and thus did not speak out.
Overall, those opposed to the measure based their position on the best available evidence that shows that CME is already highly regulated and the data overwhelmingly supports that commercial bias is minimal to nonexistent. Some of the organizations who spoke against the measure included the American Association of Clinical Endocrinologist, American College of Surgeons and several states including Florida and Minnesota.
Those in favor submitted comments that the report was much better than in previous years and other organizations have policies on commercial support and its time we do too. Supporters of the measure included American Association of Family Physicians, American College of Physicians and the Western Mountain Caucus, the organization that this year’s Chairman of CEJA represents.
One supporter noted that, “CEJA was finally largely focusing on individual physician’s interactions with industry and not on interactions between industry and CME providers that comply with ACCME SCS, CMSS Code, etc.
Several organizations submitted detailed comments in advance of the meeting on the report including the Alliance for Continuing Medical Education and the Association of Clinical Researchers and Educators.
Despite what others have suggested, the AMA HOD’s adoption of the CEJA report does not mean an end to commercial support of CME. Rather, it merely reflects an alignment of AMA policies on CME with the ACCME, HHS OIG, and the PhRMA and AdvaMed Code of Ethics. Commercial support of CME will still remain a valuable resource for CME providers to help keep physicians up to date on the latest breakthroughs and treatments.
Background
This is the fifth time that CEJA brought a report on continuing education and its financial relationships with industry, and each of the previous reports has been sent back to CEJA by the AMA House of Delegates and adjusted to reflect recommendations closer to current practices. Several notable players involved in this report include the Regina Benjamin, current U.S. Surgeon General who at the time, was chairman of CEJA for the second iteration of the report. Dr. Benjamin was very gracious in her negotiations with CME providers on the report and hosted a meeting with CME providers in the winter of 2008.
This version recognizes the value of commercial support, and where previous reports focused on the obligations of the CME provider, this report focuses on the obligation of the physician.
Now that the report is approved, the report itself is filed away and the recommendations are added to the AMA ethical handbook. The final recommendations focused on the ethical obligation of presenters to disclose to the learners their financial interests in the topic they are presenting.
Version 5.0
Though the first half of the report goes away, CEJA explicitly recognizes that, “relationships between medicine and industry—such as pharmaceutical, biotechnology, and medical device companies—have driven innovation in patient care, contributed to the economic well-being of the community, and provided significant resources (financial and otherwise) for professional education, to the ultimate benefit of patients and the public.”
This assertion shows CEJA’s recognition of how industry makes life saving and changing treatments, devices, and tools to help improve the health of people each day. It also shows that CEJA is aware that through commercial research, development and discovery, companies are finding ways to diagnose, treat and prevent serious, chronic, and rare diseases at a faster rate than ever before.
Moreover, CEJA recognizes that, “industry support helps to meet the costs of CME activities in the face of uncertain funding from other sources and may help make CME more accessible, especially for physicians in resource-poor communities.” The report also points out that, “industry engagement and support can be especially helpful in ensuring affordable CME when educational activities need high cost, sophisticated, rapidly evolving technology or devices.” In addition to “lower costs, industry support also encourages greater participation than would otherwise be the case by providing amenities.”
Recommendations
The first recommendation that CEJA proposes is that, “when possible, CME should be provided without such support or the participation of individuals who have financial interest in the educational subject matter.”
Next, CEJA recognized that in some circumstances, support from industry or participation by individuals who have financial interest in the subject matter may be needed to enable access to appropriate high-quality CME. As a result, they recommend that vigorous efforts be made to maintain the independence and integrity of educational activities. What is problematic about this recommendation is that CEJA recognizes that in many cases, “high-quality CME cannot reasonably be carried out without support from sources that have a direct financial interest in physicians’ clinical recommendations, such as activities that require cadavers or high-cost, or sophisticated equipment to train physicians in new procedures or the use of new technologies.”
CEJA also acknowledges that, “in the earliest stage of adoption of a new medical device, technique, or technology, the only individuals truly qualified to train physicians in its use are often those who developed the innovation.”
In addition, CEJA recommends that physicians who attend CME activities should expect that commercially supported CME:
- Is transparent about financial relationships that could potentially influence educational activities
- Provides the information physician-learners need to make critical judgments about an educational activity, including:
- The source(s) and nature of commercial support for the activity; and/or
- The source(s) and nature of any individual financial relationships with industry related to the subject matter of the activity; and
- What steps have been taken to mitigate the potential influence of financial relationships
- Protects the independence of educational activities by
- Ensuring independent, prospective assessment of educational needs and priorities
- Adhering to a transparent process for prospectively determining when industry support is needed
- Giving preference in selecting faculty or content developers to similarly qualified experts who do not have financial interest in the educational subject matter
- Ensuring a transparent process for making decisions about participation by physicians who may have a financial interest in the educational subject matter
- Permitting individuals who have a substantial financial interest in the educational subject matter to participate in CME only when their participation is central to the success of the educational activity; the activity meets a demonstrated need in the professional community; and the source, nature, and magnitude of the individual’s specific financial interest is disclosed
- Taking steps to mitigate potential influence commensurate with the nature of the financial interest(s) at issue, such as prospective peer review.
Conclusion
These are ethical guidelines for AMA members to follow. These recommendations serve as a guide and principles adopted by a politically motivated body, and should not be interpreted as absolute truth or given the same weight as existing guidelines.
All of these recommendations are covered in existing guidelines, including the 2005 ACCME Standards for Commercial Support, and the FDA Guidance on CME. We do not expect there to be any immediate changes in the system. There will however, be greater emphasis on encouraging other stakeholders in the medical community including the government, insurance and health systems to provide a greater share of the support for CME.
When recommending minimizing industry support when possible, CEJA may not have been aware of the extensive cost associated with maintenance of certification CME (MOC-CME) many of the new modes of CME such as performance improvement (PI) or quality improvement (QI) CME all require significant financial resources to fund collection of data from electronic medical records (EMR) and EMR reminder alert systems.
As CEJA notes in their report, “competing interests are a fact of life for everyone, including but not limited to physicians.”
Though the AMA controls the AMA PRA Category 1 system, it is not likely that this report will change much in the way the credits are awarded. This is because this final version of the CEJA recommendations is currently covered in existing guidelines on commercial support.
In the coming months, commercially supported CME may play a key role in the implementation of health care reform.
In just the area of Accountable Care Organizations (ACO’s), the government will require 64 quality measures for participating facilities. Commercially supported CME provides a unique media to train and educate America’s health care providers on strategies on how to implement and meet those measures.
Now that the report is behind us, rather than focus on amorphous topics such as “perceived bias,” we should focus our efforts on educational programs that improve patient care. In the end, the only thing that should matter to everyone is improving patient care, a goal that CME providers and industry have shared since the beginning. Effective and accurate education is the key, not who financially supports the education.