On March 11, 2009 the Massachusetts Department of Public Health (“DPH”) issued the first comprehensive state regulations of Pharmaceutical and Medical Device Manufacturer Rules of Conduct (the “Mass. Rules”) in marketing to physician and other health care practitioners.

The GBCVB has compiled the following short list of frequently asked questions (FAQ’s) to assist our members and customers on how to host medical related meetings in the Commonwealth. A more extensive list of FAQ’s can be found in the guidebook.

A drug / device manufacturer established and endowed a charitable foundation many years ago that provides a variety of charitable donations to U.S charities, including to local civic organizations (such as local Boys and Girls Clubs), to organize that serve and help the homeless and migrant workers, underprivileged children, family support groups, local schools and school-based educational programs, advanced medical education programs (including fellowships), volunteer organizations, national patient groups, and provide scholarship for children of company employees.  Although the charitable organization was endowed by a manufacturer required to comply with the Massachusetts disclosure requirements, and that manufacturer makes occasional ongoing donations to the foundation, the charitable foundation itself is a separate legal entity, with a separate board of directors.  The foundation is recognized  bu the U.S Internal Revenue Service as tax exempt pursuant to Section 501 (c)(3) of the Internal Revenue Code.  Further, the foundation's IRS Form 990 filings are available via the public website, www.guidestar.org .  These filings include descriptions of the foundation's charitable activities and  the recipient, purpose and amount of each donations made by the foundation. 

Does the charitable foundation, as a separate legal entity that has no involvement in the manufacturing of drugs or devices, qualify as a "manufacturer" for purposes of the tracking and disclosure requirements?  Is the charitable foundation required to report  its donations , if those donations are made to Massachusetts  health care professionals who are recognised  by the IRS as tax-exempt pursuant to Section 501(C)(3)  of the Internal Revenue Code?

ANSWER:
The charitable foundation may be considered an agent of the pharmaceutical or medical device manufacturing company ("particular") if for compensation or reward, it does any act to to promote, oppose or influence the prescribing  of a particular prescription drug, medical device, or category of prescription drugs or medical devices or engages in detailing, promotional activities or other marketing of prescription drugs or medical devices in the Commonwealth 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.  Thus, the drug or device manufacturer is responsible for ensuring that the charitable foundation is acting in compliance with the Department's regulations and must report any donation the Massachusetts covered recipients.

A pharmaceutical or medical device manufacturer is comprised of a number of different business units may of which manufacture and/or market prescription drugs.  It also has a clinical laboratory.  Must the clinical laboratory have a compliance program, a training and auditing system and generally comply with the marketing code of conduct its other divisions are subject to?

ANSWER:
No, unless the clinical laboratory for compensation or reward does any act to promote, oppose or influence the prescribing of a particular prescription drug, medical device, or category of prescription drugs or medical devices or engages in detailing, promotional activities or other marketing of prescription drugs or medical devices in the commonwealth to any physician, hospital, nursing home, pharmacist, health benefits plan administrator, other health care practitioners or person authorized to prescribe, dispense or purchase prescription drugs.

Are private (not affiliated with any hospitals) MRI company service providers subject to the regulation?

ANSWER:
No, unless the MRI  service provider for compensation or reward does any act to promote, oppose or influence the prescribing of a particular prescription drug, medical device, or category of prescription drugs or medical devices or engages in detailing, promotional activities or other marketing of prescription drugs or medical devices in the commonwealth 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.

Is running a reimbursement hotline considered "sales and marketing activities?"  A company runs a reimbursement hotline that contracts with PMDMCs to provide services.  After a doctor makes a decision to use a specific drug or specific medical device, and after the patient's insurance carrier refuses to authorize payment, the doctor than calls the reimbursement hotline.  Staff at the hotline handle the appeal of the rejection, and are usually successful.  Does this service conflict with the new Massachusetts pharmaceutical and medical device marketing law and regulations?

ANSWER:
No.  A reimbursement hotline is not considered " sales and marketing activity" under the Massachusetts  regulations because: (1) it does not fall within the definition of a sales and marketing activity of 105 CMR 970.004 and because the service does not influence purchasing or prescribing behavior as it is not used until after the pharmaceutical or medical device is already selected for use.

Is there a mechanism in place for health care practitioners and other covered recipients to review the financial data the companies provide before it is posted on the website?  Will there be a means to correct any data that was mis represented by the companies?

ANSWER:
No, such a system is not anticipated at this time.  Health care practitioners or other covered recipients that dispute any of the reported information should contact the manufacturer who submitted the reports.  Manufacturers will be afforded an opportunity  to correct data submitted to the Department of Public Health in error. 

Is the provision of coffee or other snacks or refreshments at a booth at a conference considered a prohibited meal?

ANSWER:
No.

Do the Massachusetts regulations permit a PMDMC to cover reasonable expenses ( including travel, lodging, and mean expenses) of Massachusetts-licensed  health care practitioners in connection with bona fide employment recruitment activities?

ANSWER:
PMDMCs may reimburse costs and provide meals to Massachusetts-licensed health care practitioners in connection with bona fide recruitment activities, but must disclose such reimbursement and expenditures as "bona fide services"

Correction to a previous FAQ ( April 2009, Subsection G Reporting, #9):
If a PMDMC hires a market research company to conduct a double-blind study of health care practitioners, where the health care practitioners are paid an honorarium by the market research company, but the PMDMC does not know which health care practitioners participated in the study and the health care practitioners who participated do not know what pharmaceutical or medical device manufacturing company was involved, is the information subject to disclosure?

ANSWER:
No.  The regulations seek to create transparency around payments to health care practitioners by PMDMCs that may influence prescriber behavior.  Where the health care practitioner participates in a market research study, but is not paid by the PMDMC involved, the payment  need not be reported.

Many physicians have Massachusetts licenses, but have never practiced here (i.e foreign medical graduates, physicians who did their training in Massachusetts, etc.).  Do the code of conduct restrictions apply to health care practitioners practicing outside of Massachusetts?

ANSWER:
Any physician with an active license many practice medicine in Massachusetts.  Thus, the regulations apply to industry interactions with all physicians who have an active Massachusetts license and are authorized to prescribe.

Many manufacturers report on employees of a physician that fall within the regulatory definition of "health care practitioners" by name, without providing a unique identifier?

ANSWER:
No.  A unique identifier must accompany all disclosures.  If a payment of $50.00 or more is made to an employee of a physician, it must be reported.  If the employees does not have a unique identifier and no facility identifier is available, payments to employees of physicians may be reported under the physician's unique identifier.

Company A manufactures a product (covered by the regulation) and sells the product to Company B.  Company B labels the product as their own and markets the product directly to HCPs.  Company B pays Company A royalties for the right to sell the products.  Does Company A need to report that marketing activities of Company B?  Or, is the Company B responsible for reporting its payment activities?

ANSWER:
All marketing activities subject to 105 CMR 970.00 must be reported.  Manufacturers are responsible for reporting payments to Massachusetts covered recipients, even if those payments are made by the  manufacturer's agent.  In this instance, the manufacturer responsible for disclosure is Company A and the manufacturer's agent is Company B.  Thus, Company A should report all payments made to Massachusetts covered recipients on its behalf by Company B.

Section 970.00(2)(g) of the regulations requires that manufacturers give health care practitioners the opportunity to request that their prescriber data be withheld from  company sales representatives and not be used for marketing purposes.  Is there a list on file with Massachusetts (or in a database) concerning which physicians have requested that their prescriber data be withheld?

ANSWER:
The Department of Public Health will neither collect information on nor maintain a list of health care practitioners that request that their prescriber data be withheld from sales and marketing representatives.  The Department advises Massachusetts physicians to opt-out through the AMA Prescription  Data Restriction Program ("PDRP").  A practitioner need not be a member of the AMA to avail himself or herself of the AMA PDRP, which is explained in helpful documentation at :  http://www.ama-assn.org/ama1/pub/upload/mm/432/pdrp_brochure.pdf

When a pharmaceutical company's Office of Medical Affairs responds to a health care professional's  unsolicited request for information regarding the company's products, is this excluded from the Massachusetts definition of required reporting since the information provided is scientific, not sales or marketing related?

ANSWER:
Any provision of marketing or other product-related materials to a Massachusetts health care practitioner must comply with the Code of Conduct restrictions in the regulations and may be subject to disclosure, regardless of whether the manufacturer or the health care professional initiated the contact.

The answers above are intended for general education purposes and should not be construed to serve as legal advice. Anyone having specific legal questions should consult their own legal counsel for advice.

GBCVB
4/22/2010