According to a recent article from Medical Meetings, the Alliance for Continuing Medical Education “is moving ahead with its plans to design and implement a national system that would standardize the conflict-of-interest disclosure process for faculty” involved in continuing medical education (CME).
The article noted that the Alliance “is nearing the end of the initial phase of developing a national disclosure system (NDS).” The system would “provide a uniform online collection tool, and develop a searchable national data repository.”
According to Alliance Executive Director Paul D. Weber, MA, the whole NDS system is scheduled to be up and operating by the second quarter of 2012. Faculty disclosure of potential conflicts of interest is required by many continuing education accrediting organizations, including the Accreditation Council for CME (ACCME).
The creation of an NDS is a logical step considering the regulatory and legal environment involving conflict of interest, transparency and disclosure in the health care industry. With payments to doctors being posted starting next year under the Physician Payment Sunshine Act, it will be important for all CME providers to ensure that their faculty disclosures match what will be published through the Sunshine Act.
Creating a standardized format, while initially burdensome and expensive, will eventually lead to better coordination for CME providers to ensure they are compliant with ACCME Standards for Commercial Support and that their programs are free from bias or conflicts of interest.
Nevertheless, it will be important that whatever format or system the Alliance creates, an emphasis on detail and description is critical. Although such disclosures will not be made public, To only disclose payments and general categories is problematic, as we have seen with what ProPublica has done. The Alliance needs to make sure that the system collects sufficient data on disclosure forms to ensure that the information is not used or taken out of context.
The idea to develop the National Disclosure System, which has been percolating at the Alliance for at least a year, was sparked by the 2009 Institute of Medicine Report, “Conflict of Interest in Medical Research, Education, and Practice.”
Among the report’s recommendations that the Alliance took to heart was a call to revamp the current disclosure system. As the article pointed out, part of the problem is that every CME organization “develops its own rules about what needs to be reported, the reporting mechanism faculty must use, and how to attest to the veracity of the information they report.” Some in the CME community believe this makes disclosure “redundant, cumbersome, burdensome, and confusing to faculty who have to fill out different disclosure forms for every organization they work with over the course of the year.”
The IOM recommended that major stakeholders in the community should develop a consensus process to decide what the standard disclosure data elements should be. It also recommended that stakeholders come up with a uniform reporting format so the disclosure data can be collected in a standardized manner, then come up with a standardized process so everyone takes the same approach.
The IOM has convened an informal committee of key stakeholders to begin the consensus process to develop the data elements, or “field definitions,” and to look at the data repository and retrieval process, which is the central repository where this data would be collected and maintained. However, while the IOM is often the impetus for change in healthcare, its expertise is in pulling together stakeholders to build a broad-based consensus process—not necessarily in implementation.
Committing to the Project
Before jumping in, the Alliance surveyed the approximately 5,000 faculty members who have subscribed to its National Faculty Education Initiative, along with a “sizeable number” of CME providers. According to Weber, the survey found that:
– 96% of faculty said they would welcome a standardized format and central repository
– 92% of CE said they want a standardized format and 85% supported a central repository
– Three-quarters of the faculty were interested in having their information made available through a faculty directory, and 73 percent of the providers said they wanted to use that information; and
– Close to 60 percent expressed that they’d be willing to pay for this service
Consequently, the Alliance decided to jump in and put the funding in place to take the next step toward developing and implementing an NDS system that builds on what IOM has started. This does not mean it will be supplanting the IOM’s efforts, says Weber. “We will be working closely with IOM, and we plan to take advantage of synergies with what the IOM is doing.”
Step 1: Building Consensus
According to Weber, the first phase of the Alliance’s NDS implementation project began in earnest with a meeting in August to bring together stakeholder organizations that will be critical to getting the project into play. These included the major national healthcare organizations; the Alliance’s counterparts in the other health professions such as nursing, physician assistants, and pharmacy; and the accrediting organizations such as the ACCME, the American Academy of Family Physicians, the American Osteopathic Association, the American Nurses Credentialing Center, and the Accreditation Council for Pharmacy Education.
At the meeting, the Alliance provided an overview of the current accreditation standards for CE across all the health professions. The Alliance also provided a representative listing of the COI disclosure data elements shared across those fields, and a first draft of what the Alliance thought would be the minimum data elements required to provide full disclosure. They also had put together a collection tool so people could see a sample template, and they shared a set of attestation rules describing the process.
The Alliance has already revised the data elements and collection tool based on the comments it received from the stakeholders. After sending it out for another round of stakeholder comments and suggestions, the Alliance will gather a provider advisory group composed of all the CME provider types, as well as providers from within its sister and brother physician assistant, osteopathic physician, nursing, and pharmacist organizations.
According to Weber, the plan is to reach consensus on the common COI disclosure data elements and agree on a uniform collection tool and the attestation rules that will govern the collection and updating of the information by the end of 2011.
Step 2: Build the Platform
The Alliance will build its NDS on the same platform as its National Faculty Education Initiative. This platform, which is powered by Scitent, includes a robust learning management system and a database backbone that Weber says can be used as a foundation for the NDS as well.
The plan is to work with Scitent to build the collection repository that will allow programs that offer CE to enroll on a subscription/fee basis and use it as their password-protected and encrypted remote server to collect and manage their COI disclosures 24/7. While the Alliance is funding it and will manage the NDS, the data will be owned and managed by the CE program subscribers.
In addition to the disclosures piece, the NDS also will include a national faculty directory. Faculty can choose to put their bios the directory, which CE programs can access to search for faculty by specialty area, by disease, by geography, etc. “If we reach critical mass in terms of the number of providers who participate, it’s foreseeable that a faculty member who worked for one program or a couple of programs multiple times throughout the year would have to submit their disclosure information only once,” says Weber. “But they’d gain an additional benefit if someone else tapped them to be faculty for their programs. They wouldn’t have to submit additional disclosure information; they’d just have to grant authorization for the other provider to access their information.”
Finally, the Alliance is seeking two to four national organizations with which to partner to help capitalize the initial development of the database and to provide their imprimatur. The plan is to roll it out to CE providers and faculty across the healthcare spectrum by spring 2012.