On July 8, 2012, Massachusetts Governor Deval Patrick signed into law amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, frequently referred to as the “gift ban law.” The amendments softened the strict gift ban law in several ways.
First, pharmaceutical and medical device manufacturers are now permitted to provide “modest meals and refreshments” (to be defined by the Massachusetts Department of Public Health (“DPH”) through regulations) in connection with educational presentations to educate health care practitioners about the benefits, risks, and appropriate uses of their products, or to provide scientific information.
However, manufacturers must file a quarterly report with DPH detailing all of the “non-CME educational presentations at which such meals or refreshments are provided.” The report must include:
- The location of the non-CME presentation;
- A description of any pharmaceutical products, medical devices, or other products discussed during the presentation; and
- The total amount expended on the presentation, along with an estimate of the amount expended per participant (accounting for meals, refreshments, or other items of economic value provided).
Second, medical device manufacturers may pay for a health care practitioner’s “reasonable expenses” necessary for technical training on the use of a medical device. The gift ban law no longer requires the expense to be part of the vendor’s purchase contract for a device; meaning that the training may occur before a sales agreement has been made.
Third, the amendments prohibit DPH from requiring manufacturers to disclose information disclosed under federal law, including the Physician Payment Sunshine Act. DPH is, however, required to make the data that manufacturers will disclose under the Sunshine Act publicly available and searchable on its website.
While these amendments loosen the gift ban law to some degree, most of the restrictions and obligations imposed by the gift ban law remain unchanged. As a result, manufacturers must continue to carefully comply with the gift ban law.