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Notice regarding federal preemption: In accordance with the 2012 amendments to chapter 111N of the General Laws, the Department of Public Health may not require a pharmaceutical or medical device manufacturing company to disclose information that has been disclosed to a federal agency pursuant to federal law and that may be obtained by the department from such federal agency.
Therefore, any payments disclosed to the Centers for Medicaid and Medicare Services pursuant to the Physician Payments Sunshine Act of 2009, 42 U.S.C. 1128G, need not be disclosed to the Department.
However, payments to practitioners that fall outside the federal mandate must continue to be disclosed to the Department in accordance with chapter 111N and associated regulation, 105 CMR 970.000.
All other requirements of the Department’s regulation remain in effect. Continuing regulatory elements beyond the federal rule include the annual registration requirement and associated fee submitted to the Department, as well as the annual self-audit.
Furthermore, the “gift ban” that prohibits specific types of payments and interactions between pharmaceutical and medical device companies and Massachusetts health care practitioners remains in effect and will not be altered by federal preemption.
Consistent with the regulation, the Department expects companies to continue to report all instances of non-compliance or be subject to a penalty (970.010) or enforcement action (970.011).
A guidance document regarding the new quarterly meal reports is being worked on, and will be released in the near future. Until that time, manufacturers should not take any action regarding the quarterly meal reports. Once guidance is released, it will be available in this location.