Sept. 28,

2012 – Pharmaceutical and medical device companies may be allowed to provide “modest meals and refreshments” at non-continuing medical education (CME) events in Massachusetts if proposed “emergency amendments” to the state’s law covering codes of conduct for these industries are adopted. An Oct. 19 hearing is planned to discuss the amendments.

In July, state legislators passed revisions to the 2008 Pharmaceutical and Device Manufacturer Code of Conduct (PCOC) as part of the 2013 state budget.

The Massachusetts Public Health Council last week set forth an exception to the 2008 gift ban that would allow meals to be offered at non-CME presentations for healthcare professionals outside of the office or hospital setting.

The amendments set forth the following definition: “Modest Meals and Refreshments, 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.”

The amendments also include the following provisions:

• Pharmaceutical or medical device manufacturing companies and agents may provide or provide payment for modest meals and refreshments to health care practitioners outside of the health care practitioner’s office or hospital setting 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, provided that such presentations occur in a venue and manner conducive to informational communication. For the purposes of 105 CMR 970.006(3), “appropriate uses” may not include the promotion of off-label uses of prescription drugs or medical devices.
• No pharmaceutical or medical device manufacturing company may provide or provide payment for such meals and refreshments permitted under 105 CMR 970.006(3) unless such pharmaceutical or medical device manufacturing company files quarterly reports detailing all non-CME educational presentations at which such meals or refreshments are provided. Reports shall include:
  • the location of the non-CME presentation;
  • a description of any pharmaceutical products, medical devices or other products discussed at such presentation;
  • the total amount expended on such presentation; and
  • an estimate of the amount expended per participant, factoring any meals, refreshments or other items of economic value provided at such presentation.

The amendments, which the Council has asked to be adopted on an emergency basis, also allow “for transparency through federal disclosures published in a searchable database by the DPH allowing monitoring of manufacturer conduct.”

The proposed amendments do not change the code of conduct regarding meals related to CME. The current provision stipulates that pharmaceutical or medical device manufacturing companies may not provide “payment for meals directly to a health care practitioner at any CME event, third-party scientific or educational conferences, or professional meetings, although a CME provider or conference or meeting organizer may, at its own discretion, apply any financial support provided by a pharmaceutical or medical device manufacturing company for the event to provide meals for all participants.”

According to the Massachusetts Public Health Council, the proposed amendments for non-CME events:

• Are consistent with nationally recognized standards included in industry codes of conduct;
• Promote educational and training opportunities;
• Implement legislative intent to balance consumer protection, the legitimate interests of pharmaceutical and medical device manufacturers, and promoting the education of health professionals; and
• Include a definition of modest meals and refreshments that does not include a specific dollar limit.

In addition to holding the Oct. 19 hearing, the Massachusetts Department of Public Health will be accepting written comments on the proposal. The regulation will be voted on by the Council at its Nov. 14 meeting and will be filed with the Secretary of the Commonwealth. The final regulation will be effective as published on Dec. 7.

“We are working with PhRMA and other allies on how best to participate in the upcoming Oct. 19 hearing,” said Coalition for Healthcare Communication Executive Director John Kamp. “Indeed, we are looking for input from members in comment form and would particularly like to hear from our members in Massachusetts.”