I think if we're going to tighten the regulations around sales and marketing activities for pharmaceutical and medical device manufacturers, it should be uniform.

MM: The Massachusetts law says that CME providers must follow the Accreditation Council for CME Standards for Commercial Support. But the state provisions are laws, rather than standards for accreditation. Do you think these laws will result in more government scrutiny of accredited CME? What advice do you have for CME providers?

Riordan: To the extent that CME providers are already well-versed in and are following the ACCME standards and continue to do so, they should be fine. I'd advise that they keep solid records with regard to following the standards, particularly in the new and revised areas such as absolute independence.

Any time a voluntary standard is elevated to a law, it certainly raises the bar. ACCME's hammer is that a provider won't be accredited if the standards aren't followed. Now, Massachusetts has a bigger hammer because of the law. Of course, from a practical standpoint, if a prohibition is only in one state, a sponsor can certainly select an alternate venue.

Mandell: If you have good practices for ensuring the independence of the content of your CME events, which you should have been doing all along, and you continue to follow those practices and have a good open dialogue with your commercial supporters about ensuring that they're following those standards, there really don't have to be a lot of dramatic changes, notwithstanding the greater amount of government interest and scrutiny as well as passage of laws and regulations that require things that used to be voluntary.

It's a matter of knowing what the laws say and making sure that you enhance existing good practices. Maybe it makes sense to revisit your more informal policy documents and formalize them, clarify them, and make sure that your commercial supporters understand them. But there really doesn't have to be a great amount of anxiety that somehow the government is going to cut off commercial funding.

MM: What about the jurisdiction of state laws? Must planners consider the state of origin of the participants?

Powell: Massachusetts, in an FAQ document, said the Massachusetts requirements follow the physician. So if you're holding a meeting in another state, you have to ask everybody if they hold a license in Massachusetts — not just where they practice, but where they hold a license. Many physicians are licensed in more than one state.

I think it's going to be important for CME providers to know where their attendees are licensed and to have knowledge of what the restrictions are for the companies from which they're seeking funding for a particular CME program. Now, I don't know whether the state enforcement agencies will start looking at CME providers, but I think the pharmaceutical companies are going to be looking more carefully because they're the ones who face the penalties if they fail to comply with state reporting laws.

Mandell: The Massachusetts Department of Health has said that we need to make sure that the medical convention community and trade associations understand and get the word out to their members that this law applies to interactions that happen outside Massachusetts.

That creates a compliance challenge for the companies. Do they apply the most stringent standards that Massachusetts has come up with to everybody for simplicity's sake? Or do they differentiate between how they interact with the Massachusetts doctors and the other doctors? As more states come up with other variations on regulating this area, it will become challenging and administratively complex if you're trying to follow each state's different rules.

The bottom line is that industry support is not going to be outlawed. The best approach is to follow the AdvaMed and PhRMA codes, be compliant with all applicable laws, and have a firewall between the industry funders and the physician leaders and organizers who decide on CME content and the selection of presenters.

MM: What do you see as the potential unintended consequences of these laws for CME and medical meetings?

Manthei: If we had a situation such as is being proposed in certain quarters, which is to eliminate all manufacturer money from the funding of medical education programs, there would be no money. If you said, well, we're just going to eliminate all manufacturer money from this, then where is the funding going to come from? It's going to come out of the pockets of doctors, who have to pay to go to their own conferences, or the conferences would be much more expensive or much less frequent.”

Also, because the demands are going to be so great on CME providers, they're going to have to get bigger organizationally in order to meet those demands. So you could see a lot of smaller meeting planning organizations getting rolled up into larger organizations. Consolidation may be an unintended consequence — one that hasn't really been talked about in the industry.

This is not a prediction on my part, but I think initially regulation has the potential to choke the flow of scientific information. If you make having CME more complicated, more difficult, more fraught with risk and administrative burden, then I think it could tend to decrease the number and availability of high-quality programs, which over time could mean a contraction in the flow of information.

MM: What do you see as the role of medical conference planners in helping companies deal with aggregate spend disclosure requirements? What can they do to help their companies collect accurate, consistent data?

Powell: Conference planners are going to have to make sure that they have systems in place that appropriately allocate costs and appropriately capture [a list of] who attended the meeting. This could mean distinguishing people who did show up from those who preregistered but didn't show up. Companies may decide to work with a physician's state license number (or numbers, if licensed in more than one state).

Then there may be different ways of calculating spend. For example, if I serve a meal, do I divide the cost of the meal among everybody who is in attendance? What if I've guaranteed 50 people for a meal and only 45 show up? Do I divide the total cost of the meal by 45, or do I allocate to each person the per-person cost excluding the five meals that weren't eaten? This will vary by company, depending on how they've set up their programs. But meeting planners will need to be careful to comply with the company's internal requirements.

Manthei: Companies need to have a documented internal compliance program that addresses all of the issues under the various laws. Just getting the data organized in a meaningful way is difficult and expensive. I think the industry is grappling with two major issues in this regard.

First, how do you collect the information in a way that's going to make the data easily accessible and usable for the ultimate purpose of making these reports and complying with different state and federal statutes that may ultimately be enacted? There are a lot of vendors trying to come up with tools and solutions. But there doesn't yet seem to be any kind of predominating software or process. There's no standardization.

Second, is it better for the manufacturers to do all the monitoring? Or do they want to outsource it to the conference planners or to some third-party organization that's going to track the data and report back? I think it will differ by company. Big manufacturers may want to have control of all of it because the risk to them is very broad and potentially very deep. They're going to make sure that they're contributing money in support of CME in an appropriate way. For the smaller manufacturers, I think it may be a lot more difficult.

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