By a vote of 10 to 0, the Massachusetts Public Health Council adopted The Pharmaceutical and Medical Device Manufacturer Code of Conduct on March 11. The regulations, which are the toughest pharmaceutical rules in the country, have far-reaching ramifications for healthcare meetings.
The code, which will take effect on July 1, 2009, regulates interactions between drug and device companies and healthcare practitioners, placing restrictions on meeting venues, gifts, meals, and entertainment. It also requires companies to disclose any gifts or payments to healthcare practitioners worth $50 or more; this data will be made publicly available on a state Web site.
The controversial marketing code was mandated as part of an ambitious healthcare cost-containment bill, which was signed into law by Massachusetts Gov. Deval Patrick in August 2008. The restrictions have generated tremendous concern in the hospitality andindustry, although there is some good news in the final version.
During public hearings held by state officials, and in other communications with lawmakers, medical meeting and hospitality professionals argued that the code would have a chilling effect on the healthcare conventions and meetings business in Massachusetts, which brings in hundreds of millions of dollars in revenue annually. In fact, as reported in "Massachusetts Law Hits Medical Conventions," MeetingsNetExtra, February 3, 2009, the American Academy of Allergy, Asthma, and Immunology canceled its 2015 annual meeting in Boston because of concerns about the regulations.
In early drafts of the code, it was unclear what types of venues would be allowable. Due to advocacy efforts by the Greater Boston Convention & Visitors Bureau, the final version clarifies that nothing in the code prohibits companies from using hotels, convention centers, or other special-event venues for continuing medical education or other third-party medical meetings. The code does say that conference venues need to be "appropriate and conducive" to education.
The GBCVB is pleased with the new language and commends the Patrick administration for responding to the hospitality industry's concerns. "This is the law of unintended consequences. They didn't set out to destroy our meetings business,” said Patrick B. Moscaritolo, president and CEO, GBCVB, speaking during a Professional Convention Management Association New England Chapter meeting held in Cambridge, Mass. last week. “They are dealing with the larger issue of healthcare cost containment, which is now a national issue. Do I wish this never happened? Absolutely. But I learned to never underestimate the power of people's voices to get their message across."
Other restrictions in the Massachusetts code are similar to those in the newly updated codes issued by PhRMA and AdvaMed. Pharmaceutical and medical device manufacturers are prohibited from paying directly for meals at continuing medical education events or other medical conferences, although CME providers or meeting organizers may use corporate financial support to pay for meals.
The Massachusetts code bans companies from providing entertainment or recreational items of any value, such as theater or concert tickets, to healthcare practitioners. It also forbids any giveaways, including pens, coffee mugs, and gift cards. Unlike the updated PhRMA and AdvaMed codes, which allow companies to give educational items such as anatomical models, the Massachusetts code does not make any exceptions to the gift ban.
The regulations do allow companies to offer commercial support of CME as long as continuing medical education providers adhere to the standards of the relevant accreditation body, for example, the Accreditation Council for CME.
Moving forward, the GBCVB is taking action to address the ongoing concerns and questions of medical meetings and hospitality professionals. It has retained the services of healthcare attorney William M. Mandel, Pierce & Mandell PC, Boston, to help develop a frequently-asked-questions document, which should be available on its Web site next week. The GBCVB is producing a downloadable handbook summarizing the new regulations and compliance strategies, and plans to host seminars for meetings professionals.
In addition, the GBCVB will meet with the Massachusetts Speaker of the House Robert DeLeo next week to begin the process of legislative redress, although that is a slow and tenuous process, said Mandell.
"The message is: The sky is not falling," said Jeffrey D. Melin, MEd, CMP, director of education for the American Epilepsy Society, West Hartford, Conn., speaking at the PCMA/NE meeting. "Medical society annual meetings will go on." The AES is meeting in Boston in December, Melin said, underscoring that societies like the AES that follow theguidelines should not have any concerns. Mandell added it is an overreaction for societies to take their meetings out of Massachusetts.
Unlike the PhRMA and AdvaMed codes, which are voluntary, the Massachusetts code has teeth rule breakers will be fined up to $5,000 for each violation. But those penalties apply only to drug and device companies, Mandell assured worried attendees at the PCMA/NE meeting. "No one in this room is going to jail because of this law," he said. In a follow-up interview, he suggested that medical meetings professionals should educate themselves about the law and come up with reasonable approaches for the different types of events they handle.
Another area of ambiguity is the law’s jurisdiction. Can a company exhibiting at a medical society annual meeting in Chicago, for example, provide entertainment or gifts for a physician from Massachusetts? "The most conservative approach would be to follow the Massachusetts code for all interactions with healthcare practitioners licensed in Massachusetts, whether those interactions are inside or outside of the state," said Mandell.