Massachusetts Makes Significant Changes to Gift Ban Law The commonwealth of Massachusetts has been

Massachusetts Makes Significant Changes to Gift Ban Law
The commonwealth of Massachusetts has been battling with the Pharmaceutical and Medical Device Manufacturer Conduct Law that bans gifts from drug and device makers to physicians, as these could ostensibly be viewed as bribes. As part of its annual budget process, the Massachusetts legislature has whittled down provisions in the existing law, also known as the “physician gift ban” or Mass. Gen. L. c. 111N.

One of the more significant amendments allows for restaurant meals to be provided to physicians. The revision reads: “The provision of or payment for modest meals and refreshments in connection with non-CME educational presentations for the purpose of educating and informing healthcare practitioners about the benefits, risks and appropriate uses of prescription drugs or medical devices, disease states or other scientific information, provided that such presentations occur in a venue and matter conducive to information communication.”

The change is qualified by two conditions: First, the “gift” of a meal and drinks must be “modest,” and the Department of Public Health can determine what “modest” means in any given context. Second, companies providing such meals to physicians are required to report them to state regulators on a quarterly basis. Companies already are required to disclose other types of industry/provider interactions, so this will not be a significant added burden.

Another important change is that companies now are permitted to provide training to physicians for a certain technology without having a signed sales agreement in hand. Previously, this was not allowed because “training” could tend toward excessive trips to exotic locales with a physician’s family along for the ride. These trips could be seen as a way to elicit a sales agreement rather than real training.
Tom Sommer, president of the Massachusetts Medical Device Industry Council (MassMEDIC), praised the enactment of corrections to the law:

“MassMEDIC is pleased that the state legislature, particularly Senate President Therese Murray and House Speaker Robert DeLeo, and Governor [Deval] Patrick have addressed some of the most onerous portions of the state’s ‘gift ban’ law. Medtech companies now can train doctors, nurses and technicians on new and innovative medical devices before a sales agreement is in place. This will enable healthcare providers to make informed purchasing decisions that have a positive impact on their patients”.

The House also voted to repeal a disclosure rule that requires all financial arrangements between drug and device makers with prescribers to be posted on a website maintained by the state Department of Public Health.

The federal “Sunshine Act” (42 U.S.C. 1320a-7h), so called because of its function in “shining light” on potentially clandestine activities, pre-empts any state law requiring manufacturers to report to a state any marketing expense information that also must be reported to the U.S. Department of Health and Human Services.

Not everyone is pleased with the decision, however. Doctors and medical students alike have had their factions speaking out against relaxing the ban, claiming that gifts, meals, and training trips can only lead to newer more expensive devices and drugs that may not necessarily be better.

A petition of protest signed by 100 medical students and doctors was delivered to Governor Patrick on June 18, 10 days before the vote took place.

A letter from Harvard University medical student David Tian and Brown University medical student Reshma Ramachandran included with the petition read: “The trust at the heart of the doctor-patient relationship is being eroded by the perception that doctors are ‘on the take’ from industry.”

This was the third time state lawmakers have attempted to vote down the gift ban. The ban was not lifted, but there were certainly enough amendments added to ameliorate some of the more strict aspects of the law.

At the federal level, industry has been urging the Centers for Medicare & Medicaid Services to publish its final rule implementing the Physician Payments Sunshine Act, a provision of the Patient Protection and Affordable Care Act that would require pharmaceutical, medical device, biological and medical supply manufacturers to report payments made to providers and teaching hospitals to the Department of Health and Human Services. There was still no final rule as of late-August.