Criticized by the U.S. Senate Committee on Finance and the CME community for its inadequate oversight system, the Accreditation Council for CME has announced a three-year plan designed to toughen its enforcement process and strengthen the boundaries between commercial supporters and providers.
Historically, thefocused on setting standards and offering guidance, says Murray Kopelow, MD, ACCME chief executive. Now, the organization is expanding its function. “We didn't and never had a strong emphasis on policing and enforcement. The CME enterprise has changed what they wanted us to do — and we are responding.”
One of the weaknesses in the ACCME system, flagged by the Senate Finance Committee in its April 2007 report on CME, is the length of time — sometimes years — that it can take for providers that are found in noncompliance to redress their problems. To close that gap, during the past year the ACCME has sped up the process whereby providers found in noncompliance must submit improvement plans and verify their progress. It has also imposed tougher sanctions — the percentage of providers put on probation has increased from 1 percent to 10 percent.
In addition, the ACCME is ramping up its scrutiny of providers it identifies as high-risk, beginning with the providers that are the most dependent on commercial support — those receiving 80 or 90 percent of their income from the pharmaceutical industry.
Another high-risk area is joint sponsorship. The ACCME is looking closely at those providers that primarily focus on jointly sponsoring activities with nonaccredited organizations, to make sure that the provider is adequately supervising the process so that the activities are conducted in compliance with ACCME guidelines.
“If an organization jointly sponsors 1,000 activities a year with only three staff people, that provider will have to outsource [part of the process] to the nonaccredited organization,” Kopelow says. “We need to make sure it's all being done right under those circumstances.”
Among the projects in the works is a Web portal that would enable providers to upload their data on each activity to a central ACCME database. Instead of gathering information from providers every four years, during the reaccreditation process, “We're making it more real-time, so that we have an up-to-date, accurate database that we can use for [activity] sampling and surveillance,” says Kopelow.
When Kopelow announced plans for this database at the Alliance for CME annual conference in January, providers expressed concerns that translating information from their databases to the ACCME's would create all sorts of difficulties. “Those people are absolutely correct — that's why we are not rushing in to this. We are not going to create a system that is onerous,” Kopelow says. Providers won't be required to upload data until 2009 at the earliest, he says.
He adds that the ACCME is discussing plans for creating one combined database system with other organizations responsible for accrediting healthcare professional education.
Measuring for Bias
While CME has been under government and media attack for being atool of the pharmaceutical industry, CME leaders have pointed out that there is no data to justify or refute that perception. In the near future, ACCME plans to begin gathering that data by mandating that providers measure activities for commercial bias and content validity. The ACCME is cooperating with the MedBiquitous Consortium, an organization that develops technology standards in the healthcare education field, to ensure that ACCME's data format is as consistent as possible with the industry standards that are being developed. Standardized data will allow providers and the ACCME to compare results across activities and organizations, Kopelow says. In addition, the ACCME's upcoming initiatives include developing a system for monitoring activities on site.
Can We Talk?
During the past year, the ACCME has taken several steps to curtail interactions between accredited providers and commercial supporters. Now, it has issued a call for comment on a proposal that would restrict contact even further. The new rules would stipulate that accredited providers could not “receive communications” from commercial interests announcing specific content/therapeutic areas that are available for CME funding or “receive communications” regarding companies' internal criteria for providing grants. Does this preclude providers from reviewing companies' requests for proposal? RFPs can be construed as a means for companies to offer guidance on content, which is prohibited by the ACCME, Kopelow says. He acknowledges that grantors and providers need some means of communicating about companies' therapeutic interests, otherwise providers and supporters will be expending unnecessary energy writing and reviewing grants that are not likely to be funded.
Industry has to be allowed to say that it funds continuing medical education that is related directly or indirectly to its business interests, but cannot be allowed to control the content or the topics, he says. “There's got to be a recognition that there is a form of the interaction that generates what we call ‘topic bias.’ That's unacceptable.”
The ACCME wants to hear providers' and supporters' views about appropriate communication mechanisms. In fact, he says, it was representatives of industry who suggested stricter guidelines in this area. He has contacted industry trade groups — the Biotechnology Industry Organization, the Pharmaceutical Research and Manufacturers of America, and the Advanced Medical Technology Association — to elicit input from their members.
The ACCME has also issued a call for comment on a proposal for a new model of commercial support. Under the recommended paradigm, educational needs would have to be identified and verified by organizations that do not receive commercial support and are free from financial relationships with industry, such as government agencies; CME activities would have to address professional practice gaps that are corroborated by “bona fide” performance measurements such as those done by the National Quality Forum; content would have to align with curricula specified by “bona fide organizations” such as the American Medical Association and the American Board of Medical Specialties; and activities would have to be verified as free from commercial bias. The ACCME is accepting comments on these proposals through August 11.
For more information, visit www.ACCME.org.