The American Medical Association's National Task Force on CME Provider/Industry Collaboration conference, held October 17 to 18 in Baltimore, set the stage for a new era in continuing medical education, as heralded by the new accreditation criteria released by the Chicago-based Accreditation Council for CME in September. Perhaps the most eagerly awaited speaker was ACCME's chief executive, Murray Kopelow, MD, who took to the podium to provide an update on the implementation of the Standards for Commercial Support and to address the new criteria.
He started off by saying that CME is about helping doctors give the best care all the time, all over the world. “We are a strategic asset to physicians on their journey,” he said.
He then walked through all the toolkits, phone support, and workshops ACCME has provided to help CME providers come to grips with the new Standards. “It's been two years since we introduced the new Standards for Commercial Support, and nothing bad has happened at reaccreditation. We've seen no surprising patterns, nothing we haven't seen before.” He also stressed that the Standards are key to ensuring the validity of CME, and that providers now have the tools and mechanisms to resolve conflicts of interest. “As CME becomes safer for pharma, it will continue to place its money in CME,” he added. Perhaps as a hint on what the implementation process will be like for the new criteria for accreditation, he said, “Remember the lessons of the past as we move forward.”
While the new accreditation criteria have not provoked the firestorm that the new Standards did, CME providers have voiced some objections. Among them are that the changes seemed to come out of the blue for many, and that the CME community was not allowed to comment before the criteria were issued in final form. Kopelow explained that the development process included the creation of the Competency and Continuum Task Force, whose work was summarized and published on the ACCME's Web site in 2003 and has been available for three years for CME community comment.
Kopelow explained that the goal of the new criteria is to make CME a valuable tool in support of physicians' maintenance of certification and maintenance of licensure requirements. “CME has always been one of the mechanisms [for verifying physician competence], but it can only stay so as long as it demonstrably improves patient care,” Kopelow said. “We expect there will be a curve. We expect complete compliance to be a multiyear process,” he reassured the audience.
Some requirements will be easier to meet than others, he acknowledged, pointing out that providers who are in compliance with the new Standards are already meeting the criteria related to commercial support. “By 2012, we expect you will have the system in place to make the changes” needed for compliance, he said.
“We are willing to have you set the pace because how fast you move depends on the resources you have.” It's all about closing the gap in [healthcare] quality and the gap in the systems, he said. “Mind the gap.”
Among the questions the audience had for Kopelow was if he expected any providers to be able to reach Level 3 accreditation, accreditation with commendation, when the first round of surveys under the new criteria begins in November 2008. To achieve a Level 3 accreditation, an organization must be able to integrate CME into practice improvement, use non-educational strategies, identify factors that affect patient outcomes, address barriers to physician change, and participate in quality improvement. Kopelow said, “We think some providers already meet these requirements. There are CME providers who already are linked into their larger environment. I think the only barrier to achieving Level 3 is the strategic decision to do it.”
When asked what areas providers need to concentrate on, Kopelow said one focus should be outcomes measurement. The next goal, which he called “almost a political, organizational one,” is to get a seat at the quality improvement table. “If you're not invited to a meeting, hold a meeting of your own” and invite the quality improvement people to join you.
For more coverage of the new criteria, see “Aiming High,” page 22.
The conference's other keynote and general session speakers addressed the broader healthcare system and regulatory environment. Capt. David Rutstein, MD, chief medical officer, Office of Public Health and Science, U.S. Department of Health and Human Services, kicked off the meeting by explaining how physicians must commit to patients, science, and integrity, and have an underlying commitment to serving humanity. “These same principles are important to CME,” he said. “It's not just about passing exams: CME shapes the future of medicine.” He also introduced what he called “the mantra of the Office of Surgeon General: Content must be based on the best science and evidence. It must underpin every CME course as well. Otherwise, what's being delivered isn't CME.” He added that straying from this mantra results in a gradual decline in the quality of medical education, and eventually a decline in patient health. “A commitment to formal CME is a commitment to quality, and therefore to the health and well-being of the diverse population that lives in this country. On behalf of the Office of the Surgeon General of the United States, I thank you for what you do.”
Thomas Abrams, director, drug marketing, with the Food and Drug Administration, gave the FDA's perspective on enforcing drug promotion regulations. “[Drug] risk information — and the lack of including risk information in promotion — is of great interest,” he said. Inadequate information on risk is the biggest focus of the Office of Medical Policy Division of Drug Marketing, Advertising, and Communications, he added. It is the subject of the majority of letters DDMAC sends, and it is critical to public health. Abrams said that drug companies put a lot of effort into promoting beneficial claims about drugs; the same effort needs to go into explaining the risks.
He said that DDMAC sent 13 warning letters from July 2005 to June 2006, a 250 percent increase over the average of previous years. “The positive aspect is that the warning letters were effective in stopping illegal promotion. The negative is that we had to take these actions,” he said. The most common violations are promotions that inadequately communicate the risks associated with a drug, and include misleading effectiveness claims and misleading comparative claims.
Another panelist, James Sheehan, assistant U.S. attorney based in Philadelphia, explained that the Department of Justice uncovers fraud and false statements made during the FDA approval process: “If [pharma companies] hadn't cheated the FDA to get approval, we wouldn't be paying for these drugs” through payee programs such as Medicaid and Medicare, he said. The other focus is on fraud and false statements related to off-label promotion: “But for false or misleading off-label promotion, docs would not have used these drugs,” he added.
The DOJ investigates drug companies for false statements made in clinical trials, failure to report adverse events, and problems with protocol compliance. “My favorite [clinical trial phrase] is ‘lost to follow-up,’” he said. “No one ever dies in a clinical trial — they're just ‘lost to follow-up.’” As to why the DOJ focuses on financial issues rather than patient safety, he explained that fraud statutes are based on the concept of economic harm, and there is extensive case law on fraud and false claims.
Sheehan predicted that the DOJ's focus in the future will be on inappropriate relationships between drug/device companies, thought leaders, and referral sources for Medicare/Medicaid. He also expects to see more whistleblowers come forward. “One thing the ACCME regulations do is help to build that trust between patients and doctors,” he concluded. “Fraud happens when that trust is let down.”
Other speakers outlined Capitol Hill's view of CME. Dan Donovan, senior investigative council, U.S. Senate Committee on Finance, provided an update on the committee's investigation into pharmaceutical grants, including CME funding. The committee had sent letters in 2005 to drug companies asking them to explain their practice of providing educational grants to organizations and state officials that might be in a position to influence Medicare and Medicaid drug-purchasing decisions. Another round of letters was sent in January of this year asking for further information about the role of sales and marketing personnel in awarding grants, and if funding had supported the development or dissemination of treatment guidelines.
Donovan started on a reassuring note: “We're not trying to kill CME,” he said. What the Finance Committee has learned to date from the letters is that most companies are following the Pharmaceutical Research and Manufacturers of America's Code on Interactions with Healthcare Professionals and the Office of Inspector General's pharmaceutical marketing guidance. “The difficult part is teasing out what happens in reality as opposed to what's on paper,” he said. The 23 pharma companies that received the letters spent $1.47 billion in 2004 on educational grants, a 20 percent increase over 2003, he said. “Substantial financing may compromise independence,” he warned.
He added that it is rare for the government to hold hearings based on committee investigation results because of the huge time and expense involved. More often, the Finance Committee deals with request letters, such as the ones they sent out about educational grants. “If we don't get cooperation through letters, we turn to subpoenas and conduct interviews,” he said.
During two sessions, the various “communities of practice” (CME professionals from pharmaceutical companies, medical schools, medical education and communication companies, hospitals, and specialty societies) met with their colleagues and hashed out answers to two questions: What conflicts of interest do you face, and how do you handle them? Peter Vlasses, PharmD, executive director, Accreditation Council for Pharmacy Education, Chicago, took on the unenviable slot following ACCME's Kopelow at the end of the meeting to synthesize the group's thoughts.
He listed the people the groups had said were most likely to have a conflict of interest, and then had participants vote via audience-response system on which are the most difficult to deal with. Pharma employees topped the list, followed by faculty who are also in speakers bureaus, advisory board members/consultants/vendors, inventors/patent holders, clinical trial investigators, and stockholders. The most common ways participants deal with COI are to perform peer review/approval of the content/balance; require evidence-based content/references; inform about and document COI implications/risks; cancel the activity/change speaker/change role when conflict is present; and tell speakers to refrain from making treatment recommendations. When bias is reported, the groups decided, exclude that speaker from future activities.
Another option for COI resolution one participant shared in the specialty society session is to create a legal/compliance staff position and have that person help deal with COI throughout the organization. Everyone seemed to think this was a nifty trick, if you could afford to do it. Several of the specialty society members said they create a database for disclosures for their annual meetings, then ask speakers to update their disclosure forms if necessary if they participate in another activity later in the year.
Another commented that the two biggest challenges are getting honest and complete disclosures, and “watching what happens once they get in that speaker-ready room and start moving slides around.” The answer to the latter would be education: “We have to spend time and energy to educate speakers about the liability and legal issues behind disclosure and COI,” said one audience member. “It's not that they don't want to comply. They just don't know.”
And what about dealing with COI related to CME activity participants who ask questions from the floor? One representative of a specialty society suggested developing a second disclosure-related slide that says that anyone asking a question needs to disclose.
During a special session for members of the North American Association of Medical Education and Communication Companies, the discussion turned to the topic of what to do if a grantor asks to review the content of an activity the company is supporting.
Lawrence Sherman, chief executive officer with the Physicians Academy for Clinical and Management Excellence in New York and moderator of the discussion, asked, “Does any level of [commercial supporter] review co-opt independence?”
Panelist Sondra Moylan, RN, president, American Academy of CME, Skillman, N.J., said, “The ACCME recognizes that commercial supporters can be held accountable, so they may feel compelled to ask for review, and the provider may feel compelled to let them review. However, it's up to the provider to decide to make a change, to control the content.” It also makes a difference who is asking to do the review, she added, and why — for example, to check the science, or to approve the content. It also depends on who receives the comments, and who decides what to do with them.
“I send [the comments] back to faculty members and ask them to check their references. I like to involve the faculty chairperson too, and I like to go to an independent review. I don't tell the faculty members that the comment came from the commercial supporter,” she said. Participants discussed the idea of disclosing that the content was reviewed by pharma for scientific accuracy.
Someone else in the audience asked if the products of six companies were included in the content, does that mean you should let all six review, or just the commercial supporter? Moylan said to have a policy in place and follow it: “Exceptions will get you in trouble.”