What you need to know:

Massachusetts regulators have approved recent amendments to the Massachusetts Gift Ban Law that lift prohibitions on providing meals to healthcare providers outside of the hospital or physician office setting.

What you need to do:

Pharmaceutical and medical device companies that are subject to the law will need to file quarterly reports detailing all non-CME educational presentations where such meals and refreshments are provided, and they should watch for further guidance from Massachusetts to ensure they remain in compliance with reporting guidelines.

On November 21, Massachusetts regulators approved final regulations allowing pharmaceutical and medical device companies that are subject to the law to provide “modest” meals and refreshments to Massachusetts healthcare providers outside of the hospital setting in connection with non-CME educational presentations.

Earlier this year, as described in a prior Choate Alert, Massachusetts made substantial changes to the Massachusetts Gift Ban Law that loosened its restrictions on providing meals. While the former version of the Gift Ban Law forbade almost all meals outside of the hospital or physician office setting, companies may now provide “modest” meals and refreshments to healthcare providers, so long as those meals and refreshments are offered in conjunction with educational presentations and are conducted “in a venue and manner conducive to informational communication.”

Modest Meals Are Loosely Defined and Do Not Prohibit Alcohol

The final Gift Ban regulations broadly define a “modest” meal as one that “as judged by local standards [is] similar to what a healthcare practitioner might purchase when dining at his or her own expense.” Importantly, Massachusetts regulators did not impose specific requirements defining the setting where these meals may take place (although the regulations require that the setting must be “conducive to informational communication”), nor do the regulations ban the provision of alcohol during informational sessions.

Companies Must Comply with Strict Reporting Guidelines

Pharmaceutical and medical device companies that that are subject to the law and provide meals and refreshments to healthcare providers are subject to strict reporting guidelines— guidelines that Massachusetts regulators have signaled could become more onerous in the future. Pharmaceutical and medical device companies must file quarterly reports detailing all non-CME educational presentations where such meals and refreshments are provided. The Massachusetts Public Health Council voted to add language to the final Gift Ban regulations that allows the Commissioner of Public Health to demand that companies provide additional information as the Commissioner deems necessary. Choate will continue to keep you updated on further developments in this evolving area of law.