On March 11, 2009, the Massachusetts Department of Public Health (DPH) adopted final regulations implementing the Pharmaceutical and Medical Device Manufacturer Conduct requirements as enacted under Chapter 305 of the Acts of 2008, An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Healthcare. With the approval of these final regulations, Massachusetts now dominates as the state with the most comprehensive and stringent disclosure law.
As approved, the final regulations take the following action:
Establish a state code of conduct for pharmaceutical and medical device manufacturers that restricts the scope of permissible marketing activities
Establish restrictions on pharmaceutical manufacturer use of non-patient identified prescriber data
Mandate annual reporting of compliance with the state code of conduct
Require annual disclosure of certain payments or other economic benefits provided to health care practitioners and other covered persons or entities, such as pharmacists, hospitals and nursing homes
The final regulations make significant changes to the proposed regulations, which were published in December 2008 (for more information, click here). Some of the more significant changes include revisions to the definition of “sales and marketing activities,” changes to the provision governing the use of non-patient identified prescriber data and the addition of an enforcement provision that sets forth a specific procedure to levy fines for violations.
Massachusetts is the only state to require that pharmaceutical and medical device manufacturers adopt and comply with a state-authored code of conduct. It is also the only state to require disclosure of gifts and other financial benefits by both pharmaceutical and medical device companies. The final regulations take effect on July 1, 2009, and the first financial disclosure is due on July 1, 2010. The financial information reported to DPH will be posted on the DPH website and will be searchable by company and by health care provider.
Pharmaceutical and medical device manufacturers must act quickly to prepare to comply with this very broad-reaching set of conduct and reporting requirements. It is of particular importance to train and prepare all employees to comply, especially those responsible for direct interactions with covered health care practitioners or other entities.
A more detailed analysis of the final regulations and their impact on pharmaceutical and medical device activity in the commonwealth will be published in the near future. For more information on the adoption of the final regulations, visit the DPH website.