Since July 2009, pharmaceutical
or medical device companies engaged in sales and marketing activities in
Massachusetts have been required to disclose the value, nature, purpose, and
particular recipient of any fee, payment, subsidy, or other economic benefit
with a value of at least $50 provided to any covered recipient in connection
with sales and marketing activities.
Covered recipient means any person authorized to prescribe,
dispense, or purchase prescription drugs, biologics, or medical devices. Sales and marketing activities are
defined as those intended to be used as follows:
- To influence the sale or the market share of a
prescription drug, biologic, or medical device or the prescribing behavior
of a covered recipient
- To market a drug or device
- To evaluate the effectiveness of a pharmaceutical or
medical device detailing sales force and any product education, training,
or research project that is designed or sponsored by the marketing
division of a pharmaceutical or medical device company or has marketing,
product promotion, or advertising as its purpose
Activities exempt from disclosure
include:
- Reasonable compensation for
bona fide services and out of pocket costs for genuine research and participation
in clinical trials
- The provision of
prescription drugs for use by patients
- The provision of
demonstration or evaluation units, in-kind items used for the provision of
charity care, and
- Confidential price
concessions such as rebates and discounts
Provision of Meals
The original law strictly
prohibited pharmaceutical and medical device companies from providing any meals
of any value to health care practitioners outside a hospital or the practitioner’s
office.
This section was amended
in 2012. Such companies may now provide meals and refreshments outside the
office or hospital in a non-CME setting, as long as they are of modest value,
while providing education and information about the benefits, risks and
appropriate uses of prescription drugs, devices, diseases or other scientific
information, in a setting conducive to informational communication.
The regulations define “modest
value” in the context of local standards, in amounts similar to what a health
care practitioner might purchase when dining at his or her own expense. The regulations
do not state any specific dollar amount or any range of value.
Still prohibited:
- Meals and refreshments
provided as part of entertainment or a recreational event
- Meals and refreshments
provided without an informational presentation
- Meals and refreshments
provided to a health care practitioner’s spouse or guest
Other Payments Prohibited
- Entertainment or recreational
items of any value, such as tickets to a sporting event or concert, or vacation trips
- Payments of any kind,
except as compensation for bona fide services
- Grants, scholarships, subsidies
or other items, in exchange for prescribing or disbursing prescription drugs,
biologics or medical devices
- Any remuneration, including
any rebate or “kickback,” that is prohibited under state or federal fraud and
abuse laws
Resources
