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Massachusetts Softens the Gift Ban Law

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.

©1994-2023 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume II, Number 195
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About this Author

Brian P. Dunphy, Pharmaceutical Attorney, Mintz Levin, Anti-Kickback Lawyer,Health Care Enforcement & Investigations Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Complex Commercial Litigation
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Brian has handled a wide range of health care litigation matters, government investigations, and voluntary disclosures for an array of health care providers, life sciences companies, and private equity funds and their portfolio companies. He defends clients against allegations of false claims for payment to the government, in SEC investigations and enforcement proceedings, and represents clients in complex business disputes. Brian also counsels clients on health care regulatory issues, including telemedicine laws, compliance with the federal Physician Payments Sunshine Act and analogous...

617-348-1810
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