Massachusetts Rules on
Pharmaceutical and Medical Device Company
Code of Conduct
Release Date: March 8, 2013
FACT SHEET ON MASSACHUSETTS GENERAL LAW, CHAPTER 111N,
REGULATING PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURER CONDUCT
Under Massachusetts General Law, Chapter 111N, and implementing agency rules issued by the Massachusetts Department of Public Health (“DPH”), Massachusetts currently has a Pharmaceutical and Medical Device Manufacturer reporting system and code of conduct that applies to certain sales and marketing activities to physicians and other health care practitioners (the “Mass. Law”).
The stated purposes of the Mass. Law are to benefit patients, enhance the practice of medicine, and to ensure that the relationship between pharmaceutical or medical device manufacturers and health care practitioners does not interfere with the independent judgment of health care practitioners or compromise companies’ legitimate confidentiality interests in protecting trade secrets and other intellectual property rights associated with genuine medical research, clinical trials, and the discovery of new treatments and medical devices.
The Mass. Law is intended to follow in large part the voluntary trade association codes of conduct on interactions with health care professionals (the PhRMA Code and AdvaMed Codes established by the pharmaceutical and medical device industries). The Massachusetts law sets these voluntary trade association codes as the minimum standards expected in interactions between pharmaceutical and medical device manufacturing and distribution companies (“PMDMCs”) and Massachusetts licensed physicians and other practitioners who can prescribe medications to patients.
Who is required to follow the Mass. Law?
Only PMDMCs that market their products in Massachusetts are required to follow the Mass. Law. This includes any affiliates of such companies that have offices or branches based in other states or countries if the company has interactions with Massachusetts doctors and licensed health care practitioners.
The Mass. Law code of conduct and reporting requirements apply to such interactions regardless of whether they take place inside or outside of Massachusetts.
What does the Mass. Law require?
Each PMDMC that markets its products to Massachusetts physicians and other prescribers – regardless of where that interaction takes place -- must adopt a marketing code of conduct that complies with the Mass. Law, establish a compliance and training program and submit mandated reports on an annual basis to DPH for posting on a public data base, however Massachusetts tracking and reporting on transactions with physicians and other professionals and teaching hospitals will in large part be replaced by the new federal Sunshine Act reporting system starting on August 1, 2013.
How does the Mass. Law affect professional associations, event planners, hotels, convention centers and other venues that host events underwritten by pharmaceutical and medical device companies?
The Mass. Law does not impose any legal obligations on such parties, only on PMDMCs. Virtually all major PMDMCs are fully aware of the Mass. Law and already have a compliance program, reporting system and code of conduct in place that satisfies the Mass. Law, as well as the PhRMA and the AdvaMed Codes.
Under the code of conduct required under the Mass. Law, what types of financial relationships with health care practitioners are not allowed?
The following financial payments and gifts from PMDMCs to physicians and other practitioners are prohibited undewr the Mass Law:
- entertainment or recreational items of any value, including, but not limited to: tickets to the theater, sporting events or concerts, sporting equipment, or leisure or vacation trips;
- meals that are part of an entertainment or recreational event;
- payments of any kind, including cash or cash equivalents, equity, "in kind" or tangible items, except as consideration for permissible service contracts;
- any "complimentary" items such as pens, coffee mugs, gift cards, etc.; and
- any grants, scholarships, subsidies, supports, consulting contracts, or educational or practice related items given in exchange for prescribing, or using any drug or device.
The provision of any item or service for a fair market value charge is not prohibited.
These prohibitions are consistent with long standing federal fraud and abuse laws, trade and professional association codes, and CME standards. Furthermore, most academic medical center conflict of interest policies impose more stringent limitation on their faculty members.
Under the code of conduct required under the Mass. Law, what types of interactions with health care practitioners are permitted that are relevant to professional association events held at convention centers, meeting facilities, restaurants and other venues?
All usual and customary CME, third-party professional and scientific meetings held in convention centers, hotels or other special event venues are permitted under the Mass. Law regardless of whether they take place inside or outside Massachusetts.
What about meals and other food items? What can companies do to fund meals?
If meals are to be funded or provided directly by PMDMCs to Massachusetts physicians and other prescribers only modest meals can be provided at training or educational events or at a medical office or hospital setting, and at locations outside of a professional office or hospital setting. If PMDMCs underwrite the costs of a CME or non-CME meeting or conference and grant discretion to the event planner to plan and program the event, the event planner may use donated company funds toward the provision of meals and refreshments and provide the same for free to Massachusetts Physicians. This part of the Mass. Law applies regardless of whether the event is held inside or outside of Massachusetts.
Can PMDMCs fund scholarship programs to allow medical students, residents and interns to attend meetings and conferences?
Under the Mass. Law, such direct funding is not permitted for Massachusetts physicians. However, an event planner or medical society may use unrestricted funds contributed by a PMDMCs for a meeting or conference toward the cost of a scholarship program as long as it is run independently by a medical society or academic medical center without any company attribution or influence.
What annual financial disclosures are required under the Mass. Law?
A PMDMCs that markets to Massachusetts physicians must disclose each year to the Mass. DPH “the value, nature, purpose and particular recipient of any fee, payment, subsidy or other economic benefit with a value of at least $50 to any health care practitioners who prescribe as well as hospitals, nursing homes, pharmacists and health benefit plan administrators made in connection with the company’s sales and marketing activities. The reporting is triggered regardless of whether the interaction/financial relationship takes place inside or outside of Massachusetts. Starting on August 1, 2013 all payments and transfers of value worth $10 or more between most drug and medical device manufacturers and physicians, other professionals, and teaching hospitals must be reported to a federal data base and such reports will be made available to Massachusetts for use on its own data base with reports of sales and marketing activity not otherwise preempted by the Sunshine Act.
Does the Mass. Law require a professional society to have a different badge system for Massachusetts physicians?
No. Use of such a badge system , or posting signs in certain locations citing the prohibitions imposed under Massachusetts and other “gift ban” state laws, is entirely voluntary.
What kind of activities can a Massachusetts Physician participate in during a conference or trade show in Massachusetts and in other states?
They can participate in all activities, and at company satellite events they can be provided with modest meals and refreshments, if the event is sufficiently education, and does not contain any off-label promotion. Companies that provide such meals and refreshments at locations away from professional offices and hospital settings are also expected to file quarterly reports about these non-CME educational events to DPH. Mass. Physicians can be provided with free food and entertainment at meeting events if organized through and provided by a professional society, even if underwritten by PMDMCs.
Can PMDMCs host non-CME educational programs for Massachusetts physicians and other licensed prescribers who are allied professionals?
Yes. Massachusetts professionals are permitted to attend non-CME educational programs, as long as meals and refreshments are modest, there is no entertainment or off-label promotions and the PMDMC satisfies the quarterly Mass DPH reporting requirements.
Does the Mass. Law specifically prohibit single sponsorship of an item or activity?
No, as long as the funding is provided to the society and the society maintains responsibility and control of content, faculty and venue; the event is primarily dedicated to science and education; and, the society adheres to the ACCME Commercial Sponsorship Standards. To the extent the activity is CME and the grant is made from a PMDMC, the grant must be made from an educational division separate from the granting company’s sales and marketing division. The Mass. Law does prohibit grants provided in exchange for prescribing or using a certain drug or device.
Do PMDMCs have to disclose all exhibit, advertising and sponsorship dollars spent on trade shows and professional meetings or just events taking place in Massachusetts?
Neither is required by the Mass Law. While the Mass. Law applies equally to events and transactions occurring both inside and outside of Massachusetts, the reporting requirements do not cover grants and other fees paid to professional societies. Certain indirect payments to physicians and other covered recipients under the federal Sunshine Act may have to be reported to CMS.
Does the Mass. Law regulate CME events?
Yes. The Mass. Law requires CME events to meet ACCME, or other accrediting organization, standards for commercial support. These generally prohibit the sponsoring company from influencing or controlling the selection of speakers and content for the CME program.
How will the Federal “Sunshine Act” reporting requirements effect the Mass. Law?
Under Federal health reform (Section 6002 of the Patient Protection and Affordable Care Act of 2009), Starting on August 1, 2013, and annually thereafter, payments or transfers of values worth over $10 made by PMDMCs and biotechnology manufacturers operating in the U.S. to physicians (and certain other licensed professionals) and teaching hospitals must be tracked and will become reportable to CMS. The reported information, which will identify the recipient, amount, and nature of each payment, will become part of an online searchable and downloadable public database called OPENPAYMENTS, which is to g"go live" by September 30. 2014. While this Federal reporting system will not serve to preempt state laws regulating physician interactions – like the mandatory code of conduct for PMDMC under the Mass. Law – it preempts and replaces any state reporting system mandates – like the one under Mass. Law - to the extent that the state reporting system overlaps with the Federal reporting requirements. Thus, starting on August 1, 2013, the Federal “Sunshine” law will for the most part preempt the reporting of sales and marketing activity interactions with Massachusetts physicians or teaching hospitals under the Mass. Law.
How does the Sunshine Act and the Massachusetts Law impact international meetings?
Any relationships between companies that are subject to the reporting requirements under Massachusetts Law and the Sunshine Act would need to track and report payments and transfers of value to physicians that are reportable event if they took place during an international conference held outside the United States. Physicians from other countries are used to less restrictive standards on their financial relationships which can present a challenge to conference organizers.