On November 21, the Massachusetts Public Health Council adopted final regulations governing the definition of “modest meals” provided in connection with an educational presentation by a medical device or pharmaceutical company held outside of a physician’s office or hospital. The regulations finalize emergency amendments adopted in October following changes to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct enacted in July.
Prior to July, device and drug companies were not permitted to provide restaurant meals to Massachusetts physicians. But budgetary amendments passed this summer, in part in response to lobbying by the state’s hospitality industry, eliminated this prohibition by allowing companies to provide modest meals in a venue and manner conducive to informational communication. The statute directed the Council to define “modest meals.”
Under the final regulations, the determination of whether a meal is “modest” is based on whether the cost of the meal is similar to what the physician would pay if dining at his or her own expense. The Council rejected requests to adopt a specific dollar limit for modest meals. It also declined to adopt a recommendation that companies be prohibited from serving alcohol at these meals.
As set forth in the statute and emergency regulations, manufacturers that provide out-of-office meals as part of informational presentations are required to submit quarterly reports detailing the location of the presentation, any products discussed at the presentation, the total amount expended on the presentation, and an estimate of the amount spent per participant. The Council recognized that much of this information is also required to be reported under the Sunshine Act and that the quarterly reporting requirement may therefore be preempted if challenged.
The Council also voted to include in the final regulation a provision allowing the Commissioner of Public Health to require additional data elements to be reported. Potential additional data elements discussed by the Council include the names and qualifications of the presenters and a breakdown of food and alcohol expenses.
The revisions to the Code of Conduct enacted in July and incorporated into the final regulation also broaden the circumstances under which a device manufacturer may pay a physician’s expenses for technical training. Prior law allowed payment of training expenses only when the payment was part of a purchase contract for that device. The amendments allow such payments regardless of whether a purchase contract has been signed.