Voluntary Codes

1. 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

2. Voluntary Codes AdvaMed PhRMA OIG AMA

3. 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

4. AdvaMed Compliance Program • Annual certification to AdvaMed signed by CEO and COO • Published on AdvaMed web site

5. 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

6. 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

7. 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

8. 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

9. 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

10. AdvaMed Code http://www.advamed.org/NR/rdonlyres/61D30455-F7E9-4081-B219-12D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestatedEffective20090701.pdf

11. 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

12. 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

13. 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

14. PhRMA Other InformationalPresentations • 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

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

16. 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

17. 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

18. 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

19. OIG Guidance http://www.oig.hhs.gov/fraud/docs/complianceguidance/042803pharmacymfgnonfr.pdf

20. 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

21. 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”

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

24. Linda D. Bentley, Esq.Mintz Levin Cohn Ferris Glovsky and Popeo, P.C.One Financial CenterBoston, MA 02111(617) 348-1784LDBentley@mintz.comwww.mintz.com