Require disclosure of industry payments to health care practitioners by medical device companies;
Broadest definition of “sales and marketing”;
Disclosure data will be part of the public record. DPH will provide a web database that will be searchable by health care provider name and by company.
Requirements of Medical Device Companies Marketing Codes
Must be in compliance with DPH’s Marketing Code and
Must implement a corporate compliance program, with reporting and certifications to Massachusetts, and
Annual certifications and disclosures of financial relationships to Massachusetts.
DPH Implementation Goals Limit Interactions That Influence Prescribing Patterns Not Restrict Beneficial Industry Interactions (Research and Training) Increase Transparency Of Industry Payments Safeguard Confidentiality of Trade Secrets and Proprietary Information
Applies only to those health care providers licensed in Massachusetts.
However, does apply to Massachusetts licensed health care providers for activities outside of Massachusetts.
Example, if a company sponsored a meal at a restaurant in connection with a conference in New York or conducted product training at an adjacent hotel restaurant, Massachusetts licensed health care providers could not attend.
Coverage Requirements for Policies and Procedures
Consulting services “needs assessment”.
Selecting and retaining health care providers as consultants.
Meetings and ongoing requirements of consultants.
Support of third party conferences and meetings.
Providing of meals to health care providers.
Continued medical education, third-party scientific or education conferences and professional meetings.
Coverage Requirements for Policies and Procedures -Continued
Gifts, entertainment and other items of value.
Scholarships, grants and other financial support.
Investigation of non-compliance.
Corrective action and voluntary reporting.
Capturing and disclosing payments to Massachusetts.
Companies may provide items to HCPs that either benefit patients or serve as a genuine education function.
Other than medical textbooks or anatomical models used for educational purposes, the value of such gifts should have a fair market value of less than $100, and should not be capable of use for non-educational purposes.
Companies may not give HCPs non-educational branded promotional items, even if they are of minimal value and related to the HCPs work or benefit patients.
Research and Educational Grants and Charitable Donations
Provision of research and educational grants and charitable donations by companies are worthwhile undertakings provided they are not offered as an unlawful inducement.
Companies should adopt objective criteria for the provision of grants and charitable donations that do not take into account purchasing criteria and implement appropriate procedures to ensure that grants and charitable donations are not used as an unlawful inducement.
A company’s sales personnel may provide input about the suitability of a grant or charitable donation recipient or program, but they should not control or unduly influence such decisions.
Grants. Companies may provide grants only to conference sponsors to reduce conference costs or to training institutions to allow attendance of HCPs in training. Grants should be paid only to reimburse legitimate expenses for the educational activity, and the conference sponsor is solely responsible for the program content, faculty, educational methods and materials.
Conference meals and refreshments. Companies may provide meals and refreshments to all attendees provided that they are open to all attendees. Meals or refreshments should be modest in value, subordinate in time and focus to the purpose of the conference, and should also be clearly separate from the education portion of the conference.
Acceptance of industry funding for educational programs and fellowships only if provided through a centrally pooled institutional President’s fund at each hospital or approved by a Partners-wide Educational Review Board.
Establishment of a robust, tiered approach to evaluate research related conflicts of interest.
Adoption of a stricter policy holding certain officials to a higher standard because of their influential positions with the organization.
Development of an enhanced infrastructure, including the creation of a new Conflict of Interest Review Committee, responsible for education, oversight and enforcement of Partners policies and practices in regard to industry interactions.
Strengthen oversight of permitted outside activities:
A ban on faculty participation in industry speakers bureaus,
An express prohibition on faculty being listed as authors on papers ghostwritten by others, and
A more rigorous internal review process for certain outside activities.