On July 1, 2012, portions of Massachusetts House Bill 4200 (HB 4200) became effective. HB 4200 amended Massachusetts’ Pharmaceutical and Medical Device Manufacturer Conduct Law (Law), which requires the Department of Public Health to “adopt a standard marketing code of conduct for all pharmaceutical or medical device manufacturing companies that employ a person to sell or market prescription drugs or medical devices in the commonwealth.”
HB 4200 amended the Law to allow pharmaceutical and medical device manufacturers to provide “modest meals and refreshments in connection with non-CME educational presentations for the purpose of educating and informing health care practitioners about the benefits, risks and appropriate uses of prescription drugs or medical devices, disease states or other scientific information.” The presentation must occur “in a venue and manner conducive to informational communication.” Additionally, pharmaceutical and medical device manufacturing companies who provide these meals must file quarterly reports detailing all non-CME educational presentations in which they provide such meals or refreshments.
On September 19, 2012, the Massachusetts Department of Public Health (Department) posted emergency regulations to implement the changes in HB 4200. The regulations state that a pharmaceutical or medical device manufacturing company may provide or pay for modest meals that are in the health care practitioner’s office or hospital setting in connection with informational or educational meetings or presentations. Companies may also provide or pay for modest meals outside of the health care practitioner’s office or hospital setting, provided that the meal is “for the purpose of educating and informing health care practitioners about the benefits, risks and appropriate uses of prescription drugs or medical devices, disease states or other scientific information.” Please note that the regulations state that “appropriate uses” may not include the promotion of off-label uses of prescription drugs or medical devices.
The regulations define “modest meals and refreshments” as “food and/or drinks provided by or paid for by a pharmaceutical or medical device manufacturing company or agent to a health care practitioner that, as judged by local standards, are similar to what a health care practitioner might purchase when dining at his or her own expense.”
In addition, echoing the amended law, the emergency regulations also state that the quarterly reports must include:
- The location of the non-CME presentation;
- A description of any pharmaceutical products, medical devices, or other products discussed;
- The total amount spent on the presentation; and
- The estimated cost per participant, including meals, refreshments, and other items of economic value provided.
Further, the regulations explain that companies will no longer be required to submit annual disclosure reports after the 2013 submission for sales and marketing activities occurring in 2012. In addition, the annual disclosure report fee of $2,000 will not be required after July 1, 2012.
The emergency regulations are effective September 19, 2012. There will be a public hearing held on October 19, 2012, to discuss the regulations.