Massachusetts Adopts Revisions To Health Care Practitioner 'Gift Ban' Law

Amendments permit pharmaceutical and medical device companies to pay reasonable expenses for medical device training, and for modest meals and refreshments for educational interactions.

On July 8, Massachusetts Governor Deval Patrick signed the commonwealth's FY 2013 budget, which included legislation that amended the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct. In essence, the amendments to the Code of Conduct struck down part of the so-called "Gift Ban" Law (Gift Ban), codified at Mass. Gen. Laws Ch. 111N (2008). Before it was amended, the Gift Ban imposed certain restrictions on the provision of meals, gifts, and other transfers of value by pharmaceutical and medical device manufacturers to health care practitioners. The law also required drug and device manufacturers to annually report allowable gifts and other transfers of value provided to health care practitioners. The implementation regulation issued by the Massachusetts Department of Public Health (Department) is codified at 105 C.M.R. 970.000 (2009).

Changes to the Gift Ban

The amended Gift Ban now does the following:

Permits the payment of reasonable expenses necessary for technical training on the use of medical devices.This amendment will allow medical device manufacturers to provide essential training on new and innovative medical devices without a written sales agreement in place between the device manufacturer and the health care practitioner. Permits pharmaceutical and medical device companies to pay for "modest meals and refreshments" for health care practitioners, in connection with non-CME educational presentations made for the purpose of educating and informing health care practitioners about the benefits, risks, and appropriate uses of prescription drugs or medical devices, disease states, or other scientific information, provided that the following requirements are met: Such meals and refreshments "occur in a venue and manner conducive to informational communication." Pharmaceutical or medical device manufacturers comply with the new quarterly reporting requirement described below. This significantly eases the Gift Ban's previous meal and refreshment provision restriction (i.e., only allowing meals within a health care practitioner's office or in a hospital setting), and now permits meals and refreshments in other venues, such as restaurants. Requires pharmaceutical and medical device manufacturers to submit quarterly reports related...