Presentation by Pat Cerundolo, Partner, Foley Hoag LLP
Presentation by Pat Cerundolo, Partner, Foley Hoag LLP Presentation by Pat Cerundolo, Partner, Foley Hoag LLP
I. Code of Conduct• Requires DPH to adopt a standard marketing code of conduct for all pharmaceuticalor medical device manufacturing companies that employ a person to sell or marketdrugs or devices in MA to health care practitioners– Only pharma and med device manufacturers that “participate in aCommonwealth health care program” are covered•“Commonwealth health care program” is undefined– Non-wholesale drug distributors are covered– Omits inclusion of medical device distributors• Code shall be “no less restrictive than the most recent version of the PhRMA andAdvaMed codes”– PhRMA and AdvaMed codes serve as the regulatory floor© 2008 2009 Foley Hoag LLP. All Rights Reserved.Presentation Title | 4
Code of Conduct - Prohibits• Payments to practitioners for meals that are– Part of an entertainment event– Offered without an informational presentation made by a marketing agent, orwithout the agent being present– Outside of the practitioner’s office or hospital “setting” (undefined)– Provided to spouse or other guest• Providing or paying for entertainment or recreation items of any value to anynonemployee practitioner• Sponsorships of CME seminars not accredited by ACCME• Cost of travel, lodging or other personal expenses of non-faculty at conferencesand meetings• Funding for time spent by practitioners participating in conferences• Direct payment for meals at conferences and meetings• Payments in cash or cash equivalents except as compensation for services• Grants, scholarships, contracts or practice items in exchange for prescribing drugsor using medical devices© 2008 2009 Foley Hoag LLP. All Rights Reserved.Presentation Title | 5
- Page 1 and 2: MGL c. 111N - Pharmaceutical andMed
- Page 3: Overview• Section 14 of Cost Cont
- Page 7 and 8: II.Compliance Requirement• Requir
- Page 9 and 10: Enforcement• Enforced by the Atto
Code of Conduct - Prohibits• Payments to practitioners for meals that are– Part of an entertainment event– Offered without an informational presentation made <strong>by</strong> a marketing agent, orwithout the agent being present– Outside of the practitioner’s office or hospital “setting” (undefined)– Provided to spouse or other guest• Providing or paying for entertainment or recreation items of any value to anynonemployee practitioner• Sponsorships of CME seminars not accredited <strong>by</strong> ACCME• Cost of travel, lodging or other personal expenses of non-faculty at conferencesand meetings• Funding for time spent <strong>by</strong> practitioners participating in conferences• Direct payment for meals at conferences and meetings• Payments in cash or cash equivalents except as compensation for services• Grants, scholarships, contracts or practice items in exchange for prescribing drugsor using medical devices© 2008 2009 <strong>Foley</strong> <strong>Hoag</strong> <strong>LLP</strong>. All Rights Reserved.<strong>Presentation</strong> Title | 5
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