105 CMR, § 970.004
The following terms as used in 105 CMR 970.000 shall have the following meanings, unless the context or subject matter clearly require a different interpretation:
Annual Reports, the annual reports submitted by the Secretary of Health and Human Services to Massachusetts pursuant to Sec. 1128G(d)(2) of Part A of title XI of the federal Social Security Act.
Authorized Entity, the attorney general, the district attorney with jurisdiction over a violation, or the department of public health.
Biologic, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, immunoglobulin product, or analogous product, as defined by Section 351 of the Public Health Service Act applicable to the prevention, treatment, or cure of a disease or condition of human beings and regulated as a drug under the Federal Food, Drug, and Cosmetic Act.
Bona FideServices, an arrangement for services including, but not limited to, research, participation on advisory boards, collaboration with 501(c)(3) organizations dedicated to the promotion of health and the prevention of disease, and presentations at pharmaceutical or medical device manufacturing company-sponsored medical education and training including U.S. Food and Drug Administration (FDA) required education and training involved in producing safe and effective medical devices, provided such an arrangement is formalized in a written agreement specifying the services to be provided, based on the fair market value of the services and characterized by the following factors:
(a) a legitimate need for the services clearly identified in advance;
(b) a connection between the competence and expertise of the health care practitioner and the purpose of the arrangement;
(c) the number of health care practitioners retained is not greater than the number reasonably necessary to achieve the identified purpose;
(d) the retaining pharmaceutical or medical device manufacturing company maintains records concerning the arrangement and makes appropriate use of the services provided by the health care practitioner;
(e) the venue and circumstances of any meeting with the health care practitioner is conducive to the services and activities related to the services are the primary focus of the meeting; and
(f) the decision to retain a health care practitioner is not unduly influenced by a pharmaceutical or medical device manufacturing company's sales personnel.
Charitable Donation, the provision of financial support to a 501(c)(3) or the in-kind provision of drugs, biologics or medical devices for charity care of patients.
Clinical Trial, a genuine research project involving a drug or medical device that evaluates the safety or effectiveness of the particular drug, biologic or medical device in the screening, prevention, diagnosis, evaluation or treatment of a disease or health condition, or evaluates the safety or efficacy of the drug or medical device in comparison with other therapies, and which has been approved by the FDA and, if the trial involves volunteer human research subjects, it has been approved by a duly constituted Institutional Review Board (IRB) after reviewing and evaluating it in accordance with the human subject protection standards set forth at 21 C.F.R. Part 50, 45 C.F.R. Part 46, or equivalent standards of another federal agency.
Commissioner, the Commissioner of the Department of Public Health.
Covered Recipient, a person authorized to prescribe, dispense, or purchase prescription drugs or medical devices in Massachusetts, including a hospital, nursing home, pharmacist, health benefit plan administrator, or a health care practitioner. A person who otherwise meets this definition but is a bona fide employee of a pharmaceutical or medical device manufacturing company shall not be a covered recipient for the purposes of payments by that company. Additionally, consumers who purchase prescription drugs or medical devices are not covered recipients.
Conference or Meeting, any convening where responsibility for and control over the selection of content, faculty, educational methods, materials, and venue belongs to the event's organizers in accordance with their guidelines, held in a venue that is appropriate and conducive to informational communication and training about medical information, where:
(a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering); and
(b) the main purpose for bringing attendees together is to further their knowledge on the topic(s) being presented.
Department, the department of public health.
Genuine Research Project, a project intended to add to medical knowledge about the care and treatment of patients that constitutes a systematic investigation, designed to develop or contribute to generalizable knowledge when the results can be published by the investigator and reasonably can be considered to be of significant interest or value to scientists or health care practitioners working in the particular field of inquiry.
Health Care Practitioner, a person who prescribes prescription drugs for any person and is licensed to provide health care in Massachusetts, or a partnership or corporation comprised of such persons, or an officer, employee, agent or contractor of such person acting in the course and scope of his or her employment, agency or contract related to or in support of the provision of health care to individuals. Hospitals are not healthcare practitioners. Additionally, full time employees and board members of pharmaceutical or medical device manufacturers are not health care practitioners.
Hospital Setting;
(a) a hospital;
(b) academic medical center; or
(c) pharmaceutical or medical device specialized training facility, where the facility, as certified to the Department by the pharmaceutical or medical device manufacturing company, is specifically designed to approximate the conditions of a surgical suite, or the conditions of a working clinical laboratory or to provide medical training on large and/or technical medical devices, such as surgical equipment, implants, and imaging and clinical laboratory equipment.
Medical Device, an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, which is:
(a) recognized in the official National Formulary or the United States Pharmacopeia or any supplement thereto;
(b) intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, in persons or animals; or
(c) intended to affect the structure or function of the body of a person or animal, and which does not achieve its primary intended purposes through chemical action within or on such body and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Modest Meals and Refreshments, food and/or drinks provided by or paid for by a pharmaceutical or medical device manufacturing company or agent to a health care practitioner that, as judged by local standards, are similar to what a health care practitioner might purchase when dining at his or her own expense.
Non-faculty, a health care practitioner who does not serve as a speaker or provide actual and substantive services as a faculty organizer or academic program consultant for a continuing medical education (CME) event, third-party scientific or educational conference, or professional meeting.
Person, a business, individual, corporation, union, association, firm, partnership, committee or other organization.
Pharmaceutical or Medical Device Manufacturer Agent, a person who, while employed by or under contract with a pharmaceutical or medical device manufacturing company, engages in detailing, promotional activities or other marketing of prescription drugs, biologics, or medical devices in Massachusetts to any physician, hospital, nursing home, pharmacist, health benefits plan administrator, other health care practitioner or person authorized to prescribe, dispense or purchase prescription drugs, biologics or medical devices; provided, however, that "pharmaceutical or medical device manufacturer agent" shall not include a licensed pharmacist, licensed physician or any other licensed health care practitioner with authority to prescribe prescription drugs, biologics or medical devices who is acting within the ordinary scope of the practice for which he or she is licensed, a wholesale drug distributor licensed under M.G.L. c. 112, § 36A, a representative of such a distributor who promotes or otherwise markets the services of the wholesale drug distributor in connection with a prescription drug or a retail pharmacy registered under M.G.L. c. 112, § 37 if such person is not engaging in such practices under contract with a manufacturing company.
Pharmaceutical or Medical Device Manufacturing Company, any entity that:
(a) is engaged in the production, preparation, propagation, compounding, conversion or processing of prescription drugs, biologics, or medical devices, either directly or indirectly, by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis; or
(b) is directly engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs, biologics, or medical devices;
provided, however, that "pharmaceutical or medical device manufacturing company" shall not include a health care practitioner, physician practice, home health agency, hospital licensed under M.G.L. c. 111, § 51, a wholesale drug distributor licensed under M.G.L. c. 112, § 36A or a retail pharmacy registered under M.G.L. c. 112, §§ 37 through 39C.
Prescription Drugs, drugs upon which the manufacturer or distributor has placed or is required by federal law and regulations to place the following or a comparable warning: "Caution federal law prohibits dispensing without prescription."
Sales and Marketing Activities, for the purposes of disclosure under 105 CMR 970.009, sales and marketing activities include advertising, promotion, or other activity that is intended to be used or is used to influence sales or the market share of a prescription drug, biologic or medical device; to influence or evaluate the prescribing behavior of a covered recipient to promote a prescription drug, biologic, or medical device; to market a prescription drug, biologic, or medical device; or to evaluate the effectiveness of a professional pharmaceutical or medical device detailing sales force. Sales and marketing activities also include any product education, training, or research project that is designed or sponsored by the marketing division of a pharmaceutical or medical device manufacturing company or has marketing, product promotion, or advertising as its purpose.
Sales and marketing activities also include the provision of any fee, payment, subsidy or other economic benefit with a value of at least $50 to a covered recipient except as follows: Sales and marketing activities do not include clinical trials and genuine research, particularly where the primary purpose is to generate data in support of an application filed with the FDA seeking approval for a new drug, biologic or medical device or "new use" or similar marketing or labeling claim requiring FDA approval. Clinical trials that are posted on clinicaltrials.gov will be deemed exempt from disclosure. Sales and marketing activities also shall not include the provision of prescription drugs to a covered recipient solely and exclusively for use by patients, demonstration or evaluation units, in-kind items used for the provision of charity care, or confidential price concessions established in contracts between pharmaceutical or medical device manufacturing companies and insurers, pharmacies, pharmacy benefit managers or health plan administrators and their affiliates that are offered in connection with the acquisition of drugs, biologics or medical devices or the management of a health plan's formulary.
Secretary, the Secretary of the United States Department of Health and Human Services.
105 CMR, § 970.004