Industry Organizations Unite to Define Massachusetts Gift Ban 4818

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. MassMedic opposed the legislation from the beginning, first lobbying to prevent the inclusion of gift-ban and credentialing requirements, and later urging Massachusetts Governor Deval Patrick to veto the legislation.

In a letter sent to MassMedic members after passage of the legislation, the association commented that “the bill, as presented to the Governor, represents a real threat to healthcare product innovation, by restricting access to healthcare professionals.” The letter urged MassMedic members to “tell the Governor that the bill, as passed, would impose a significant burden on Massachusetts medical device companies and drive medical product development and training programs to other states.”

In signing the legislation over industry objections, Governor Patrick still offered some hope that the concerns expressed by manufacturers would be addressed. “I am confident that the Department of Public Health will develop regulations that, consistent with the intent of the legislation, enhance transparency without requiring the disclosure of trade secrets and proprietary information, or impeding medical research or the education of healthcare providers,” Patrick noted in his transmittal letter to the state Legislature. “All interested parties will have a full opportunity to participate in and comment on the development of those regulations.”

Taking the governor at his word, 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 recommendations were delivered with a letter to Department of Public Health Commissioner John Auerbach, whose office is now reviewing the law and developing the implementing regulations.

“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.”

The letter was also sent to Massachusetts Secretary of Housing and Economic Development Dan O'Connell, who has expressed a particular interest in seeing that industry's implementation issues are addressed.

“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.”

The letter was signed by AdvaMed president and CEO Stephen J. Ubl, MassMedic president Tom Sommer, MDMA executive director Mark B. Leahey, and MITA director of health policy Theresa Gorenc. Key recommendations listed in the organizations' comments included the following.

To read the entire letter and recommendations, visit the version of the documents available from the MassMedic Web site at www.massmedic.com/docs/macom08.pdf.

According to MassMedic, the Massachusetts Department of Public Health is expected to take the next several weeks to draft emergency regulations that will go into effect on January 1, 2009. The rules 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.

© 2008 Canon Communications LLC

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