Voluntary Codes
MassMEDIC MeetingAre You Ready to Comply with
Massachusetts’ New Pharmaceutical and Medical Device Code of Conduct
Law?
Linda D. Bentley, Esq.January 23, 2009
Voluntary Codes
AdvaMedPhRMAOIGAMA
AdvaMed
Code of Ethics on Interactions with Health Care Professionals
• 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
• 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– Grants– Meals and Refreshments– Faculty Expenses– Advertisements and Demonstration
• Sales, promotional and other business meetings– 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-F7E9-4081-B219-12D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestatedEffective20090701.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• 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• 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%202008.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
– 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/042803pharmacymfgnonfr.pdf
American Medical Association (AMA)
Ethical Guidelines for Gifts to Physicians from Industry
• 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 CenterBoston, MA 02111
(617) [email protected]
www.mintz.com