The so-called 'gift ban' passed by the Massachusetts legislature at the end of July has kept the medical device industry buzzing for several months. In anticipation of the final shape of the implementing regulations, to be drafted by the Massachusetts Department of Public Health, industry watchers have kept themselves busy with speculation about the effects of the legislation.
But at the beginning of October, four major industry associations took matters into their own hands by compiling a list of recommendations to be addressed as part of the emergency implementation regulations due on December 10.
According to Tom Sommer, president of the Massachusetts Medical Device Industry Council (MassMedic), representatives of the association have met with state public health and economic development officials throughout the past several months to express concerns with the restrictions contained in the new law. In October, Sommer joined with chief executives of industry associations AdvaMed, the Medical Device Manufacturers Association (MDMA), and the Medical Imaging Technology Alliance (MITA), to compile a list of industry-specific issues and recommendations relating to implementation of the gift-ban law.
"The medical technology industry is very concerned with the law's potential to impede critical relationships with providers, restrict education and training, and publicize proprietary information," the associations wrote. "However, we are optimistic that these concerns can be addressed through the department's development of regulation and guidance."
"Our overarching message is that medical devices are different from pharmaceuticals and thus should be regulated appropriately, with a distinct code of conduct," said the association letter.
"We also urge the department to minimize the regulatory impact on businesses, especially small businesses which are responsible for much of the innovation in medical technology," the associations wrote. "Limited resources are best directed to innovation and initiatives that benefit healthcare generally."
According to Mass-Medic, the draft emergency regulations will be released at the monthly meeting of the Massachusetts Public Health Council on December 10. Formal hearings and a review of the emergency regulations will be conducted during the first six months of 2009.