Transcript www.massmedic.com

Voluntary Codes
MassMEDIC Meeting
Are You Ready to Comply with Massachusetts’
New Pharmaceutical and Medical Device Code
of Conduct Law?
Linda D. Bentley, Esq.
January 23, 2009
Voluntary Codes
AdvaMed
PhRMA
OIG
AMA
AdvaMed
Code of Ethics on Interactions with Health Care Professionals
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Updated code approved by Board in December 2008
Takes effect on July 1, 2009
Target audience is all companies, not only AdvaMed members
Health Care Professionals are individuals or entities involved
in provision of health care services and/or items to patients,
which purchase, lease, recommend, use, arrange for the
purchase or lease of or prescribe a company’s medical
technology
AdvaMed
Compliance Program
• Annual certification to AdvaMed signed by CEO and COO
• Published on AdvaMed web site
AdvaMed
Seven Elements of Effective Compliance Programs
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Written policies and procedures
Compliance officer and committee
Effective training and education
Effective lines of communication
Internal monitoring and auditing
Enforcement through publicized disciplinary guidelines
Prompt responses and corrective actions
AdvaMed
Support of Third-Party Educational Conferences
• Permissible support for bona fide independent conferences
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Grants
Meals and Refreshments
Faculty Expenses
Advertisements and Demonstration
• Sales, promotional and other business meetings
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Bona fide professional interest in information
Appropriate location
Reasonable travel costs
Modest meals and refreshments
AdvaMed
Consulting Arrangements
• Bona fide services for which legitimate need
• Written agreement
– description of services
– fair market value
• Limited input from sales personnel
• Royalty payments
– not tied to use or promotion of product
AdvaMed
Other Activities
• Entertainment and recreation
• Modest meals
– permitted on and off-site depending on circumstances
• Research and educational grants and charitable donations
– develop objective criteria for donations
– not controlled by sales personnel
• Evaluation and demonstration products
AdvaMed
Educational items; Prohibition on Gifts
– strict prohibition on non-educational gifts (branded or
unbranded)
– permits items that benefit patients or have educational
function if value < $100
– textbooks and anatomical models exempted from $100 cap
AdvaMed Code
http://www.advamed.org/NR/rdonlyres/61D30455-F7E9-4081B21912D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestatedEffe
ctive20090701.pdf
PhRMA
Code on Interactions with Healthcare Professionals
• Effective January 1, 2009
– Separate code on conduct of clinical trials and communication
of clinical trial results
– Target audience - all companies that interact with healthcare
professionals about pharmaceuticals
• Encourages public commitment to abide by Code
– Annual certification signed by CEO and CCO
– Listed on PhRMA web site
PhRMA
Support for CME and Educational Meetings
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Bona fide independent educational program
Develop objective criteria
No marketing or sales department involvement
Provide $$ to meeting sponsor not healthcare professional
No company involvement in program content or choice of
speakers
• No logistic support for non-faculty healthcare professionals
PhRMA
Educational Items
• Permitted if primarily for education of patients or healthcare
professionals and cost < $100
• May not have independent value outside professional
responsibilities
• Offered only occasionally
Consulting arrangements
• Bona fide arrangement
• Company records regarding appropriate use of services
• Venues of meetings conducive to consulting services- no
recreational or entertainment events
PhRMA
Other Informational Presentations
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Presentation of scientific and clinical information
Modest meals
In-house only if sales presentation
Appropriate setting
Prohibited gifts
– Entertainment or recreational items of any value
PhRMA Code
http://www.phrma.org/files/PhRMA%20Marketing%20Code%202
008.pdf
Office of the Inspector General (OIG)
Compliance Program Guidance for Pharmaceutical
Manufacturers
• Issued April 2003
• Target audience is drug and biologics companies
• Encourages development and implementation of written
compliance program
• Related to anti-kickback statute
• Areas of Potential Risk
– Educational Grants
• Separate grant-making and sales/marketing functions
– Research Funding
OIG
Kickbacks and Other Illegal Remuneration
• Gifts and Entertainment
• Cites PhRMA Code (2002 version)
– Adherence could reduce risk of fraud and abuse by
demonstrating a good faith effort to comply
OIG
Relationships with Physicians
• Personal Service Safe Harbor
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Written signed agreement
Description of services
Specific payment arrangements
Legitimate need
Services actually provided
Fair market value
OIG Guidance
http://www.oig.hhs.gov/fraud/docs/complianceguidance/0428
03pharmacymfgnonfr.pdf
American Medical Association (AMA)
Ethical Guidelines for Gifts to Physicians from
Industry
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Target audience is physicians
Purpose is education
Permits gifts that benefit patients and are of modest value
Permits individual gifts that relate to physician’s work
Physicians should not accept meeting-related payments
directly from industry
AMA
• Permits faculty at conference to accept reasonable
honoraria and logistical support
• Payments for bona fide consulting services permitted
• Student/intern/resident beneficiaries of conference grants
chosen by academic institution
• Prohibits gifts with “strings attached”
AMA Code
http://www.ama-assn.org/ama/pub/category/8405.html
Linda D. Bentley, Esq.
Mintz Levin Cohn Ferris Glovsky and Popeo, P.C.
One Financial Center
Boston, MA 02111
(617) 348-1784
[email protected]
www.mintz.com