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).
- 12-30-11 - Circular Letter To Manufacturers Concerning the Pharmaceutical Code of Conduct Regulation in Regard To Federal Regulations
- Instructions On Disclosure Report Submission
- Instructions on Modifying Previously Submitted Disclosure Reports
Instructions for Disclosure Report Creation
- Disclosure Report Electronic Formatting Instructions - January 2011
- Disclosure Report Example
- List of Covered Recipients CY2015 file size 14MB
- Marketing Code of Conduct Covered Recipient ID List Memo
- Guidance for Manufacturers When Not Finding a Covered Recipient
- Payment Disclosure Categories ID List
- Registered Manufacturers Unique ID List - 2/2015
Manufacturer Initial Registration and Annual Registration Renewal
Registered Manufacturer Registration Renewal System
Registered manufacturers are required to renew their registration each calendar year. The 2015 registration period will take place from July 6 through August 31, 2015. Manufacturers that are subject to the regulation for any part of a calendar year are required to renew their registration for that calendar year.
Below is a link to the Online Licensing site for registered manufacturers to renew their registration. Two instruction manuals are available as well: the first is for creating an account for the Online Licensing site, and the second explains the registration renewal process once logged into the Online Licensing site. Please note: this system is only for manufacturers who have previously registered and were assigned a unique ID by the Department. Use of the site will also require an annual renewal ID, which is emailed to manufacturer contacts prior to July 6, 2015.
Please note that the online licensing system will only be available during the annual registration renewal period, which goes from July 6 through August 31, 2015. Manufacturers that need to renew their registration or make other updates will not have access to the system until this time.
- Massachusetts Online Licensing
- Online Licensing Account Creation
- Online Licensing Registration Renewal file size 1MB file size 1MB
- Registration Renewal Form
This registration renewal form is to be used only for manufacturers who are unable to use the above online registration renewal system.
Initial Registration Form
Manufacturers that are registering for the first time should use the below initial registration form. Manufacturers that are newly subject to the regulation should register as soon as they become subject to the regulation.
This information is provided by the Division of Health Care Facility Licensure and Certification within the Department of Public Health.