MM: What should CME providers and medical meeting professionals do to make sure their concerns are heard by legislators?

Riordan: I don't see that an all-out onslaught on state legislatures is necessary at this time. I would suggest a more reasoned approach may be in order. For example, as states begin considering legislation that could adversely affect bona fide medical meetings, advocates could meet with their legislators to ensure that they understand why medical meetings are critical to understanding advances in medicine and treatment, and ultimately to patients. It's important to remember that state legislative sessions are short — some last only months. Therefore, the bills are going to move fast, if they move at all. So now is the time for organizations that are affected by medical meetings to get talking points prepared and have them ready for the 2010 legislative sessions.

Powell: Both PhRMA and, in a number of states, individual sales representatives have talked with legislators. And company compliance officers may also reach out to legislators and explain the PhRMA code program to them. Also, once legislators realize that more than 70 percent of all scrips are filled with generic drugs because states have generic substitution laws, they realize that patients are largely getting generics unless there is not a generic available. And once they realize the cost-saving argument is not accurate, many legislators are not all that sure that this kind of legislation actually makes sense.

Most state legislators are receptive to the argument that marketing-cost-reporting legislation does not improve healthcare for anybody in the state, it adds an administrative burden to the state, and it won't reduce the state's costs. So I expect to see continuing legislation in states, but I don't expect that there will be an increase from the one or two states that have been enacting legislation each year.

Mandell: I think medical conference planners should keep an eye on what's happening on the federal level, but accept the reality that the genie is already out of the bottle on regulating this at the state level, and more and more states are going to consider laws. They can join forces with organizations at the state level that promote economic activity at events to help educate legislators and regulators who may, with all the best intentions, want to jump on the regulatory bandwagon, but may not really understand the realities of how CME events and other scientific conferences work.

Once a state proposes a law or regulation, there's a public comment period. And that's an opportunity for event organizers to make sure that states that are contemplating getting into regulation do it in a fair and balanced way.

The Experts

William M. Mandell
Leader of Health
Law Practice
Pierce & Mandell P.C.
Boston

Michael Manthei
Partner
Holland & Knight LLP
Boston

Marjorie E. Powell
Senior Assistant
General Council
PhRMA
Washington

Retta M. Riordan
President
Riordan Consulting LLC
Westfield, N.J.

Mass FAQs

The Massachusetts Department of Public Health has posted a list of frequently asked questions about its regulation of pharmaceutical or medical device manufacturing company (PMDMC) conduct. Here are a few that apply specifically to CME and medical meetings (see the full FAQ list at www.mass.gov):

Q: Are restaurants in hotels considered by DPH to be appropriate facilities for meals in conjunction with CME or other third-party scientific, educational or professional meetings or conferences?

A: Yes, such meals may be provided in hotel restaurants.

Q: Does a CME program have to be ACCME-accredited?

A: No. The program itself need not be accredited by ACCME, but if it receives support from a pharmaceutical or medical device manufacturing company, the commercial support must comply with the ACCME Standards for Commercial Support.

Q: Is a conference or event organizer free to request and dispense funds as they feel appropriate for implementation of their own conference?

A: Yes, other than compliance with ACCME Standards for Commercial Support, the regulations do not regulate the manner in which event organizers use their funds.

Q: Is DPH going to expect a report on payments to third-party scientific or educational conference or meeting organizers?

A: No. PMDMCs need not report payments to third-party scientific, educational or professional meeting organizers unless the meeting organizer is a covered recipient.