Restaurants that cater toin Massachusetts may be losing some of their business.
For years, pharmaceutical companies have invited doctors to dinner meetings—informational presentations held at restaurants. But now, dinner meetings for healthcare practitioners licensed in Massachusetts are off-limits, explained healthcare attorney William M. Mandel, Pierce & Mandell PC, Boston, during an April 15 webinar sponsored by the New England Chapter of the Professional Convention Management Association.
As we reported in "Massachusetts Finalizes Drug and Device Marketing Code," Medical Meetings Extra, March 20, 2008, the new state law imposes restrictions on meeting venues, gifts, meals, and entertainment and has far-reaching ramifications for healthcare meetings.
Under the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, which goes into effect July 1, 2009, informational presentations accompanied by a meal that are sponsored by medical device or drug companies must be held in a medical office, hospital, or a device training facility, not offsite in a restaurant.
“There are a lot of differing interpretations of the code," Mandell said. "The wording is not 100 percent clear. It's possible that a medical device training program accompanied by a meal could be held in a hotel room that simulates an operating room, but that would be a broad interpretation." The Department of Public Health, which created the code, has been asked for clarification about appropriate settings for device trainings, he said.
CME providers, medical education companies, and other third parties are allowed to use unrestricted grants from pharma companies to offer participants meals at events that meet the code's criteria for scientific conferences. The Department of Public Health will be asked for further clarification about whether third parties can use drug/device company funding to hold dinner meetings at restaurants, Mandell said. He cautioned that the pharma company would have to provide an unrestricted grant to the third party, and that the third party would have to initiate and coordinate the meeting. “Companies cannot use third parties to do an end run around the rules,” he said.
The Massachusetts code also prohibits companies from providing entertainment or recreation to healthcare practitioners--another area open to interpretation. Speaking during the webinar, Patrick B. Moscaritolo, President and CEO, Greater Boston Convention & Visitors Bureau, explained that when a medical device company planned to take doctors from a convention center meeting to a special event at the Museum Of Science via a duck tour boat, the company’s compliance officer nixed the idea, saying the duck boat sounded like too much fun and they should use more a traditional vehicle. Joking that duck boats are a traditional mode of transport in Boston, Moscaritolo said that the example made him realize that “the GBCVB needs to develop relationships with compliance officers to understand their perspective,” since they are responsible for interpreting the new PhRMA and AdvaMed codes, as well as the Massachusetts law, and establishing internal company guidelines.
Many meeting professionals continue to have questions about the law’s jurisdiction, Mandell said. He clarified that the law applies to company interactions with healthcare practitioners who are licensed in Massachusetts, regardless of where the interaction takes place. For instance, at a meeting in D.C. with physicians from Massachusetts, drug and medical device companies would be under the same obligation to adhere to the code that they would be if the meeting were held in Boston, Mandell said.
One webinar participant asked whether the law applied to international attendees. Pharma companies often underwrite travel, registration, and other expenses for physicians from other countries attending U.S. medical conferences.
Mandell said that the DPH has released supplemental materials that explicitly state that the code imposes no restrictions on doctors licensed in other states or other countries. “Massachusetts law does not regulate financial transactions between drug and device companies and healthcare practitioners who are not licensed in Massachusetts,” Mandell said.
However, Moscaritolo pointed out that European countries are now questioning whether such payments are appropriate, and predicts that in the next few years, European countries will restrict or completely prohibit companies from subsidizing healthcare providers' attendance at international events.
Mandell reiterated the good news for meeting professionals about the law, as he has in previous presentations. 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 Greater Boston Convention & Visitors Bureau is continually updating its online Frequently Asked Questions document about the code, speakers said, and is planning to produce a downloadable handbook summarizing the new regulations and compliance strategies, which will be available at its Web site in about three weeks.