On July 8, 2012, Massachusetts Governor Deval Patrick signed the fiscal 2012 budget, which included significant changes to Chapter 111N, regulating pharmaceutical and medical device manufacturer conduct and reporting. Specifically, the 2012 budget expands the ability for pharmaceutical and medical device companies to provide modest meals and refreshments in conjunction with non-CME educational presentations. Prior to the amendments, modest meals and refreshments could only be provided in conjunction with an educational presentation given by a pharmaceutical marketing agent within the health care provider's office or hospital setting. As a practical matter, this amendment now enables pharmaceutical and medical device manufacturers to provide educational presentations outside of a health care providers office or hospital setting in a venue conducive to informational communication, such as a private room at a restaurant.
If a pharmaceutical or medical device manufacturer provides modest meals or refreshments in conjunction with non-CME educational presentations, the manufacturer must file quarterly reports that detail the following:
- The location of the non-CME presentation.
- A description of any pharmaceutical products, medical devices or other products discussed at the presentation.
- The total amount spent on the presentation and an estimate of the amount spent on each participant, including the cost of food, refreshments and other items of economic value provided at the presentation.
In addition to easing restrictions on meal related expenditures, the revised budget expands the ability for medical device manufacturers to provide training on medical devices. Specifically, the amendments remove the requirement that medical device training occur as part of the vendor’s purchase agreement for a device. Medical device manufacturers will now have the ability to provide training to health care providers prior to a decision to purchase a device.
While the amendments provide pharmaceutical and medical device manufacturers with additional opportunities to provide modest meals and refreshments to health care providers, they do so with enhanced reporting requirements.
See the Chapter 111N Pharmaceutical and Medical Device Manufacturer Conduct to read more.
By Timothy Robinson, General Counsel, MMIS, Inc.