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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

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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. - PowerPoint PPT Presentation

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Page 1: Voluntary Codes

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

Page 2: Voluntary Codes

Voluntary Codes

AdvaMedPhRMAOIGAMA

Page 3: Voluntary Codes

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

Page 4: Voluntary Codes

AdvaMed

Compliance Program

• Annual certification to AdvaMed signed by CEO and COO

• Published on AdvaMed web site

Page 5: Voluntary Codes

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

Page 6: Voluntary Codes

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

Page 7: Voluntary Codes

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

Page 8: Voluntary Codes

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

Page 9: Voluntary Codes

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

Page 11: Voluntary Codes

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

Page 12: Voluntary Codes

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

Page 13: Voluntary Codes

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

Page 14: Voluntary Codes

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

Page 15: Voluntary Codes

PhRMA Code

http://www.phrma.org/files/PhRMA%20Marketing%20Code%202008.pdf

Page 16: Voluntary Codes

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

Page 17: Voluntary Codes

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

Page 18: Voluntary Codes

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

Page 20: Voluntary Codes

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

Page 21: Voluntary Codes

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”

Page 22: Voluntary Codes

AMA Code

http://www.ama-assn.org/ama/pub/category/8405.html

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Linda D. Bentley, Esq.Mintz Levin Cohn Ferris Glovsky and Popeo, P.C.

One Financial CenterBoston, MA 02111

(617) [email protected]

www.mintz.com