05/30/2014 – 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.
Friendly URL: http://www.mass.gov/dph/pharmamed
Use the link above to return directly to this page in the future.
This page provides information relating to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) regulation.
Manufacturers of pharmaceuticals and medical devices are required to disclose certain transactions (any fee, payment, subsidy or other economic benefit with a value of at least $50) with anyone who prescribes, dispenses or purchases prescription drugs or medical devices in the Commonwealth. This does not include consumers who purchase prescription drugs or medical devices. The Department, as required by legislation, has created a database to provide the disclosed information to the public.
In this section you will find information about the statute, regulation and frequently asked questions (FAQs) relating to the Massachusetts Marketing Code of Conduct.
In this section you will find:
- Descriptions of the basic terms and general information about the regulation and the database that was created from the information reported by the pharmaceutical and medical device manufacturing companies.
- Reports based on the information disclosed by the manufacturing companies for the period July 1, 2009 through December 31, 2009, as well as all of calendar year 2010.
Information for Covered Recipients
Covered recipients are the people and entities that are in a position to decide which pharmaceuticals and medical devices are used.
If you are a covered recipient and believe the data reported about you is incorrect, you should contact the pharmaceutical or medical device manufacturer that reported the information. Please refer to this list of contacts for registered manufacturers .
If you have questions about the regulation or the database, email: email@example.com.
If you are a manufacturer and have questions regarding the processing of the compliance form, annual fee, or the annual disclosure report, please email: firstname.lastname@example.org.
This information is provided by the Division of Health Care Facility Licensure and Certification within the Department of Public Health.