January 2018 brought a new era of increased transparency and vetted ethics and compliance into the medical meetings industry. That’s not to suggest there was a lack of transparency or ethics prior to that. There wasn’t.
But the revamped 2018 MedTech Europe Code of Ethical Business Practice, which affect not just European-based medical meetings but meetings everywhere, usher in a newly stringent set of guidelines aimed at ensuring that interactions remain untainted and unbiased between the companies that make and sell medical devices and technology and the health care professionals who use them.
The biggest change is that medical device companies can no longer directly support individual health care providers. In the past, they could underwrite a physician’s attendance at a medical meeting by helping with travel costs, for example. As of January, that is no longer permitted, and the repercussions could be far-reaching.
Then, there’s the General Data Protection Regulation (GDPR), which went into effect in May. That regulation impacts how meeting planners and others use and protect attendee data, including registration information, for example. While GDPR is currently a European law, it’s impacting how other organizations are working with data and currently affects any U.S. company or meeting with international clients or attendees.
And finally, there’s Open Science, which can potentially have a major effect on continuing medical education, primarily in terms of whether it will continue to be a viable revenue source for medical meetings.
The fact is, planners of medical and pharma meetings have always had challenges related to stringent compliance rules, but the challenges today have even more far-reaching impact.
Pat Schaumann, CMP, CSEP, DMCP, HMCC, senior director, health care compliance for Martiz Travel, whose work has included the American Medical Device Summit, Pharma Forum, Global Pharmaceutical and Medical Meetings Summit and ExL Events, notes that there is a lot happening and about to happen that medical meeting planners must stay on top of.
“Planners need to be aware of changing state and country compliance laws and regulations, particularly with New Jersey, Nevada and Chicago, as well as Japan and South Korea,” she says.
Additionally, they need to be aware of how the new codes and regulations can affect accreditation for continuing medical education. “With the launch of MedTech Europe’s new Code of Ethical Business Practice earlier this year, and GDPR going into effect in May, there have been new challenges regarding the processes of health care organizations (HCOs) in terms of gaining sponsorship dollars from medical device companies and how that can affect their accreditation for continuing medical education (CME).”
Planner knowledge, she says, “is key to mitigating any health care challenges.”
The Accreditation Council for Continuing Medical Education (ACCME) is a good source for medical meeting planners on the issue of GDPR. It’s important for planners to understand that GDPR and ACCME compliance are not at odds.
“We understand the concern of accredited CME providers regarding their potential obligations under the newly implemented GDPR,” says Graham McMahon, M.D., MMSc, president and CEO of ACCME. “However, compliance with the new EU-mandated regulation would not put an accredited CME provider at odds with the ACCME’s accreditation requirements.”
ACCME requirements state that CME providers “must have mechanisms in place to record and, when authorized by the participating physician, verify participation for six years from the date of the CME activity.”
Thus, McMahon notes, “If a learner requests that their participation record not be retained or erased, that would be acceptable to the ACCME. With respect to the annual report data submitted by accredited providers, learner data is submitted in aggregate — aggregate counts of physician and other learners per activity. The accredited provider would still be able to provide that aggregate count even if the identifiable participation record of the learner was erased at the learner’s request.”
He also points out that the ACCME itself protects individual patient information by mandating all CME providers must attest that any accreditation materials they submit “will not include individually identifiable health information, in accordance with the Health Insurance Portability and Accountability Act (HIPAA), as amended.”
Moreover, McMahon says, “Accredited providers that offer CME activities that count for Maintenance of Certification (MOC) are required to meet certifying board requirements for collecting and using learner data. As part of this process, accredited providers must obtain permission from learners to share data about their activity completion with the ACCME and certifying board.”
When in doubt about GDPR, he adds, seek input from legal counsel.
Christina J. Wurster, chief revenue officer at HRS in Washington, D.C., who has presented webinars and education session at industry events and conventions, including PCMA Convening Leaders, is an expert on this topic. Through HRS, an international education and advocacy organization for cardiac arrhythmia professionals and patients, she has been part of many medical meetings and understands how these new regulations can impact meeting budgets and traditional revenue models.
Commenting on the MedTech Europe Code of Ethical Business Practice, she says, “These new regulations, which were focused initially in Europe, have been adopted by multinational medical-device manufacturers globally. As of January, manufacturers can no longer provide funding support directly to physicians to offset their costs to attend medical education conferences. In the past, commercial support provided much-needed funds to cover costs including travel, housing and registration.
“Physicians outside the U.S. do not have the same resources available to them to support attendance to global medical education conferences, so the new regulations severely disrupt their ability to attend. Under the new regulations, there are pathways for the support, but they require an independent third party, e.g., a hospital or foundation, to facilitate a grant and scholarship process. While this is led by the medical device industry, pharmaceutical manufacturers independently are also introducing new regulations to tighten commercial support.”
That, she says, impacts registration and all that registration dollars support. “The biggest challenge,” Wurster continues, “is planning for declines in attendance due to the travel restrictions, which directly affect registration revenue. Planners are having to plan on reductions in revenue while maintaining a quality program and high-value experience for attendees. In addition to the reduction in commercial support, international attendees are also faced with increased barriers to obtaining travel visas.”
But the repercussions are even more complex than that. “The organization, Ethical MedTech in Europe, which designed these travel regulations did not account for geographic regulations impacting medical meetings within the U.S.,” she says. “That resulted in the regulations stipulated by the U.S.-based ACCME being in direct contrast to the suggested new pathways provided by Ethical MedTech to support attendees.”
Clearly that has been a nightmare for planners and other organizers in the medical meeting arena. “Medical meetings that provide CME have had to recalibrate and look for new ways and new partners to help support attendees getting to their meetings,” Wurster says.
Unfortunately, the alternative pathways to support for attendees are not easy. While the intent is to separate doctors and products so that manufacturers don’t have any undue influence over doctors or anyone providing education at medical conferences, it’s not just a matter of finding hospitals and foundations that can take money from medical device companies and use it to fund grants that help prospective attendees. There are also restrictions on what kind of organizations qualify as a permitted third party.
“Ethical MedTech does allow nonprofit organizations and professional conference organizers (PCOs) to become approved MedTech Partners via its vetting system,” Wurster says. “The medical society hosting the meeting cannot be involved and must rely on other organizations to facilitate the grant funding and scholarship process independently for delegates.”
Compliance is a critical issue for planners and medical conferences in general, but following the ever-changing rules and regulations is a daunting task. “There are constant changes on the horizon,” says Schaumann. “That’s what makes compliance and transfer of value reporting so complex. Every company does it differently and every country — 89 current countries — does it differently. There is no standardization, consistency or predictability.”
And to make things more challenging, she notes, “Politics play a huge role in health care policy.”
The issue of Open Science may not be a huge factor in the U.S. yet, but Kristi Casey Sanders, CMP, CMM, DES, HMCC, director of thought leadership for MPI, says it’s coming, and planners should start adjusting now.
“There’s something just over the horizon that could have severe implications for the medical meetings community,” Sanders cautions. “The National Academy of Sciences is advocating for Open Science, which means any federally funded research needs to be made available to the public free of charge. This extends to publications and education created from the research. The feeling is that if research was funded with taxpayer money, the public owns the content.”
The implications of this are substantial. “It means the whole revenue model for continuing medical education, and even certifications, may be forced to go to an open-education policy, where it must be offered free of charge to the public,” Sanders says. “That will hit medical meetings first and then ripple outward. It’s already in effect in Europe. We have maybe three to five years to prepare for it here, so planners need to start thinking about how to develop new revenue streams once this one dries up.”
Of course, on the face of it, Open Science is a positive that can benefit us all. “First, and foremost, it is important for planners to understand what Open Science means,” Schaumann says.
‘It’s a global movement to make scientific research, results and data available and accessible to everyone. According to authors Elizabeth Gilbert and Katie Corker, ‘Open Science can help speed scientific discovery. When scientists share their materials and data, others can use and analyze them in new ways, potentially leading to new discoveries.’”
But if research is free and available to physicians, would they still need research-based CME at meetings? McMahon believes so.
“There will always be a need for face-to-face accredited CME meetings to support the advancement of science. At meetings, health care professionals have the opportunity to engage directly with experts who provide context and insight about research data, answer questions and facilitate discussion about how research can be applied to practice. Effective CME conferences do much more than deliver information about research,” he says.
“CME providers are education experts who design learning experiences that inspire curiosity and encourage dialogue and collaboration among peers by incorporating a variety of educational strategies, such as case studies, simulation, small-group problem-solving and reflective exercises. CME providers build longitudinal relationships with health care professionals, offering opportunities for feedback and deliberate practice to reinforce learning long after the conference is over,” McMahon says.
How that plays out in the future will be something planners must stay on top of — along with every other challenge in this field.
Not all challenges are so monumental and global in nature. Some also relate to the details of planning a medical meeting, not unlike planning other kinds of meetings. But the details in the case of medical meetings often fall under a litany of domestic and international regulations.
The main challenges related to medical meetings, according to Schaumann, are planners and sales reps making changes onsite, food and beverage, short lead times and too few trained medical meeting planners.
Last-minute changes are a nightmare for all planners and venues, but in the case of medical meetings, Schaumann says last-minute changes can easily fall outside of compliance without planners being aware of it because they have not been vetted by the necessary departments or governing bodies. In reality, nothing should change once it has been determined that all aspects of the meeting are, in fact, in compliance.
As for F&B, Schaumann says, “All governments, except the U.S. government, set limitations on F&B for medical meetings, and many companies have their own internal guidelines that are typically set by their procurement, compliance or legal departments.”
These caps are similar to those imposed for lodging and food related to government meetings. But the problem arises when U.S. planners are unaware of the specific caps imposed by various countries or international organizations, and meetings are set in places where costs exceed those allowed for F&B for international attendees.
And, it’s not just the cost of food in terms of caps, it’s also the kind of venue and the destination itself.
“There are still many country and company restrictions on destinations and venues,” Schaumann says. “Many regulations state that the destination must be ‘business appropriate.’ Other countries are very specific about not using resorts, gaming destinations, cruise ships and five-star properties, which is very unfortunate, as many of these destinations work hard to overcome the stigma and perception of not being appropriate or too pricey for budgets.”
Wurster sees the same problems, pointing out that many of these issues, from spend caps to the specific type of destination, hinder a physician’s ability to attend a meeting, which is a problem for planners.
“Keeping up with the nuance of each country and region is very challenging. One such new law is related to expenditure caps on lodging, which means a physician’s average hotel rate during their stay cannot exceed a certain amount. In most major U.S. cities that are popular for medical meetings, there are no offerings within the hotel block that are below the expenditure caps. For example, in France, the expenditure cap is equal to approximately $310 USD, and this must include all taxes and fees.”
“Ethical MedTech has been declining meetings that are located at resorts or in resort cities, e.g., Las Vegas,” she adds.
Some organizers are making destination adjustments. “Some medical meetings are moving to Canada and smaller U.S. cities to reduce expenses,” Wurster says. “Plus, in Canada, the visa restrictions are not as strict and are friendlier to international attendees.”
The preferred location options today, says Schaumann, are four-star airport hotels. “They’re easy in and out.”
Also gaining traction are creative venues, such as state-of-the-art facilities that are devoted to practical, clinical and knowledge-based learning.
Schaumann points to the Oquendo Center in Las Vegas, Florida Hospital Nicholson Center in Kissimmee, Florida, CAMLS in Tampa Bay, Florida, Global Center for Health Innovation in Cleveland, Ohio, and notes that Dubai will soon establish a health care innovation center, as well.
Length of meetings is another trend that planners should take into consideration, according to Schaumann. She says the trend today in terms of ideal timing is two-and-a-half days. “If it’s too short, it’s not worth their time, too long, and they won’t attend, as they don’t want to be away from their patients. And the preference is for meetings to be held at the end of the week so doctors have less time away from patients.”
Regardless of meeting destination, venue or timing, the bottom line for many of the issues faced by medical meeting planners is to be certain they are in compliance.
“Regardless of your meeting location,” says Wurster, “if you have exhibitors that are from the medical device industry, you must submit your conference for approval by the Ethical MedTech Conference Vetting System. Without approval, the manufacturers that are members of Ethical MedTech cannot provide any educational grants to your meeting, nor can they provide grants to third-party organizations that support travel scholarships to your attendees.”
The very best way for planners to be up to speed on necessary compliance regulations and protocol is via their own education, which also addresses Schumann’s issue that there are too few trained medical meeting planners available.
Fortunately, there are many ways for planners to ramp up their understanding and knowledge related to medical meetings.
“The Healthcare Meeting Compliance Certificate (HMCC) program is now the most recognized medical meeting certificate program in the world. There are nearly 1,700 HMCCs worldwide, and the classes are offered multiple times of year, as well as being available to companies for private sessions,” Schumann says. “Also, the Events Industry Council offers the CMP-HC certification program to master the knowledge and skills necessary to manage health care-related meetings and events. And, Maritz offers quarterly health care webinars that are accredited through the Events Industry Council and worth CEs.”
To be sure, new regulations and requirements related to compliance for medical meetings are likely to change much about these meetings going forward. This includes necessitating new ways of bringing in revenue and much added work for organizations in terms of procuring financial grants and providing them to health care providers so they can attend the meetings. The best path forward for medical meeting planners may be continuing education specific to these types of meetings, which gives planners something in common with the doctors and other health care professionals who attend the meetings, in large part, to continue their own education. C&IT