Massachusetts Issues Final Rule on Drug and Device Manufacturer Marketing Conduct

By Bill Koustas & Alan Kirschenbaum –

In July, we reported that Massachusetts had amended its prescription drug and device marketing law to (among other things) allow pharmaceutical and medical device companies to provide “modest meals and refreshments” as part of an informational presentation to health care practitioners outside of the hospital or medical office setting.  (Note that, in this regard, Massachusetts law is less restrictive than the PhRMA Code on Interactions with Healthcare Professionals, which provides that meals offered in connection with informational presentations made by sales representatives or their immediate managers should be limited to in-office or in-hospital settings.)

On September 19, 2012, the Massachusetts Department of Public Health ("DPH") issued a temporary emergency rule to implement the statutory amendments.  The emergency rule amended DPH regulations in two significant ways.  First, in accordance with the statutory amendment, it removed the prohibition against providing meals to health care practitioners outside of the office or hospital setting, while also requiring pharmaceutical and medical device companies to submit quarterly reports detailing any activities where such meals or refreshments are provided.  Second, in light of the physician payment sunshine provisions of the Affordable Care Act, the emergency rule removed the requirement to annually report other permitted gifts to covered recipients after calendar year 2012.

On November 21, 2012, DPH issued a final rule to replace the earlier emergency rule.  The final rule, which will take effect on December 7, 2012, is similar to the emergency rule, but with a few important modifications.  First, the final rule restores the annual reporting requirement for 2013 and subsequent years to the extent that the required information does not duplicate information that is reported to the federal government under the federal sunshine provisions and that is then reported by the federal government to Massachusetts in annual reports.  Since the federal sunshine provisions cover only remuneration provided to physicians and teaching hospitals, annual reports to Massachusetts will still be required for remuneration provided to other “Covered Recipients” under the Massachusetts law – i.e., hospitals, nursing homes, pharmacists, nurse practitioners, and other practitioners and providers who are authorized to prescribe, dispense, or purchase drugs. 

The final rule retains the quarterly reporting requirement for out-of-office meals and refreshments, but does not specify a reporting deadline.  Presumably, DPH will notify manufacturers about the quarterly report deadline in a future communication.  Interestingly, DPH noted in an explanatory memorandum that much of the information reported in the quarterly reports will likely be covered by the federal sunshine provisions and therefore be preempted, but DPH decided to retain the quarterly reporting requirement regardless.

In issuing the final rule, DPH rejected commenters’ requests to place a monetary cap on what is considered a “modest” meal and to exclude alcoholic beverages.  The definition of “modest meals and refreshments” continues to include both food and drinks without restrictions on alcohol, and the benchmark for “modest” remains what a practitioner “might purchase when dining at his or her own expense,” as judged by local standards.