Deadline Approaches - Submission of Massachusetts Disclosure Report

The pharmaceutical industry, in a number of states, is currently required to track, and in some cases report on, promotional activities, such as gifts, meals, consulting fees, and grants provided to healthcare professionals. These disclosures consist of the value, nature and purpose of gifts, payments, or other economic benefits provided to healthcare professionals in the advancement of a drug product or service. It is vital that all companies understand and comply with current marketing and advertising disclosure laws. With the state’s first disclosure report due in less than one month, it is critical that companies understand the Massachusetts reporting requirements for physician payments.

Below is summary of the legislation and frequently asked questions.

Effective Date	July 1, 2010
Disclosure Limit	$50
Reportable Items	Any fee, payment, subsidy or other economic benefit with a value of at least $50 to any covered recipient in connection with the company’s sales and marketing activities
Report Due	July 1, 2010 (for activities occurring during the period July 1, 2009 – December 31, 2009)
Reporting Responsibility	Company's Compliance Officer
Responsible Party	Any pharmaceutical or medical device manufacturing company which includes any pharmaceutical or medical device manufacturing company or distributor
Report To	Massachusetts Department of Public Health; Email:pharmameddata@massmail.state.ma.us; Disclosure Report Example (CSV) The subject line of emails should contain only the manufacturer’s Department-assigned user ID and company name. If you do not have any data to disclose for this period, send an e-mail to this address stating that fact. The Department will deem such emails as meeting the requirement for filing an annual disclosure report.
Fee	$2,000
Fine	Not more than 5,000 per transaction or occurrence

What does this regulation do?
The regulation:

• Establishes a code of conduct that must be adopted by pharmaceutical and medical device companies.
• Requires companies to designate a compliance officer and to establish a compliance program pursuant to the regulatory requirements.
• Requires disclosure of certain financial interactions between the industry and covered recipients. 

Who are "covered recipients" for the purposes of disclosure? (Click the link to read more)

 Any person authorized to prescribe, dispense or purchase prescription drugs, biologics or medical devices in the commonwealth. This includes hospitals, nursing homes, pharmacists, health benefit plan administrators, and health care practitioners. Full time employees and board members of pharmaceutical and medical device manufacturing companies acting in that capacity, and consumers who purchase prescription drugs, biologics or medical devices are excluded.

Does the regulation apply to activities outside Massachusetts?

The Massachusetts Code of Conduct provisions apply to activities that either take place in Massachusetts or involve a Massachusetts-licensed “health care practitioner.” The disclosure requirements apply to any “sales and marketing activity” directed at and benefiting a Massachusetts covered recipient. Therefore, activities occurring outside of Massachusetts are subject to the regulation if they involve a Massachusetts-licensed “health care practitioner” or covered recipient.

Sales and marketing activities include:

• Advertising, promotion, or other activity that is intended to be used or is used to: 
• Influence sales or market share of a prescription drug, biologic, or medical device;
• Influence or evaluate the prescribing behavior of a covered recipient to promote a prescription drug, biologic, or medical device;
• Market a prescription drug, biologic, or medical device; or
• Evaluate the effectiveness of a professional pharmaceutical or medical device detailing sales force. 

• Product education, training, or research that is designed or sponsored by the marketing division of a pharmaceutical or medical device manufacturer, or which has marketing, product promotion, or advertising as its purpose; and
• Other payments with a value of $50 or more to a covered recipient, except as expressly excluded.

For more information on this or other state law regulatory compliance issues, please contact us at info@qpharmacorp.com, or contact Alexis directly at 973-656-0011 ext. 3180.