Training S Slide des Background & Introduction Wha hat i - PowerPoint PPT Presentation

Effec ective J e January 1 1, 2 2020 Training S Slide des

Background & Introduction  Wha hat i is A Adv dvaMed ed? Advanced Medical Technology Association – “AdvaMed” – is the world’s largest trade association of medical technology and diagnostics manufacturers  Wha hat i is t the he AdvaMed Code of Ethics on Interactions with Health Care Professionals in the United States – the “AdvaMed U.S. Code” – provides medical Adva vaMed Code? ? technology and diagnostics makers with baseline compliance principles  Why d does es i it m matter er? AdvaMed U.S. Code addresses key legal risk areas, like the Federal Anti- Kickback Statute, the U.S. Physician Payments Sunshine Act, and other important laws governing our industry’s business activities  Original AdvaMed Code launched in 1993 and again in 2003  Revised and restated AdvaMed Code launched in 2009

Background & Introduction  Why d did t d the he Incorporate lessons from new government guidance, settlements & medtech indus dustry enforcement actions  Review and pull from other industry guidance on critical topics revi evise t se the he Adva vaMed (transparency, inventory management, PODs) U.S. Code?  Address evolving legal standards and business models  Harmonize principles shared with other medtech associations’ (APACMed, MedTech Europe) codes  Clarify existing Code language where needed  Improve user-friendliness & readability When hen d does the he Jan. 1, 2020 upda dated C d Code bec ecome ef e effec ective? e?

Background & Introduction  Wha hat i is t the he Feder ederal Federal law that makes it illegal to offer, pay, solicit, or receive payments or items of value in exchange for the purchase, sale, or use of goods or services that the Ant nti-Kickb kback k Federal government reimburses (for example, under Medicare) Statute te?  Simply put, it is illegal to pay kickbacks for business  This means that interactions with HCPs must be carefully analyzed to prevent unlawful inducement Wha hat i is t the he U.S.  Federal law designed to increase transparency of financial relationships in the health care industry and uncover potential conflicts of interest Physi sician P Paymen ents s Sunsh unshine A e Act?  Requires manufactures of ,medical devices, drugs, biological, and medical supplies to publicly report to the Centers for Medicare & Medicaid Services all payments and transfers of value made to physicians and teaching hospitals in the United States  This means that details about certain interactions with HCPs will become public

Features of the AdvaMed U.S. Code Cornerstone Values • Consult the Corner nerstone V e Values es to help analyze arrangements not addressed under the Code • Values guide day ay-to- day b busi usine ness s dec ecisi sions and Fall 2020 Summer 2021 January 15, 2022 Fall/Winter 2020 Fall 2021 June 2020 remind us about the industry’s patien ent- cen entric focus

Features of the AdvaMed U.S. Code Interpretive Principles • Be aware of the following:  Applies to all interactions with U.S. HCPs – doesn’t m matter i if you interact i insid ide o or outsid ide t the United ted S Sta tates tes  Applies to interactions with U.S. HCPs, ev even en i if an e employee o e or agent of a Company p pays o out o of pocket h himself lf/herself lf  Applies to all i l interactions li linked to m medic ical t l technolo logy

Features of the AdvaMed U.S. Code Compliance Program Infographic • Snapshot of the comple lexit ity of an effective medtech compliance program • Everyone p plays a an important r role in complia lianc nce! • If you don’t know if a business activity is appropriate, ask your mana nager er, your manage ger’s m manage ger, or your Company complia liance o e offic icer

Features of the AdvaMed U.S. Code Glossary Health Ca Care P Professi ssional: A Health Care Professional is any person or entity: (a) Authorized or licensed in the U.S. to provide health care services or items to patients; or (b) Who is involved in the decision to purchase, prescribe, order, or recommend a Medical Technology in the U.S. The term includes individ idual c l clin inic icia ians (for example, physicians, nurses, and pharmacists, among others), prov ovid ider e entit itie ies (for example, hospitals and ambulatory surgical centers), and administr trati tive p personnel at provider entities (for example, hospital purchasing agents). The term does not include Health Care Professionals who are bona fide employees of a Company, while acting in that capacity.

AdvaMed U.S. Code Topics • Consult ltin ing A g Arrangements with U U.S. S. H Healt lth C Care P Professio ionals ls • Comp mpan any-Conducte ted T Tra raining & & Ed Educa cation onal P Pro rograms • Comp mpan any-Conducted B Business M Meetings • Supporting T Third-Par arty E Educational G Gran ants, R Research G Gran ants, C Char aritab able D Donations, a and C Commercial al Sponsorships • Join intly ly-Conducte ted Ed Educa cation on & & Marketing P Pro rograms • Busin iness C Courtesie ies f for Healt lth C Care P Professio ionals ls ( (Travel, L l, Lodgin ging, Me , Meals ls, E , Educatio ional I l Items) • Prohib ibit itio ion o on G Gifts, E , Entertain inment, , and R Recreatio ion • Communic icatin ing f g for t the S Safe & & Effectiv ive U Use o of Me Medic ical T l Technolo logy • Prov oviding H Health th E Eco conom omics cs & Reimbursement t Inform ormation on • Demon onstr trati tion on, E Evaluati tion on, a and C Consignment P t Product ct • Representativ ives P Provid idin ing T Technic ical l Support i in the C Clin inic ical l Settin ing

AdvaMed U.S. Code Training - Consulting Arrangements (II) Q: Q: What d does t the A AdvaMed U U.S. C Code m mean b by “ “consulti ting a g arrangements”? Any time a medtech manufacturer hires an HCP to provide services, this is considered a consulting arrangement. Examples:  Providing education & training services  Speaking on behalf of the Company  Conducting proctorships or preceptorships  Serving on advisory boards  Working on product research and development  Acting as a clinical trial site or investigator Q: Q: What d does t the C Code r require f for c consulti ting a g arrangements w with H HCPs?   Company must have a legitim itimate te n need for the services Compensation must be consistent with the fair m marke ket v value of the services in an arm’s length transaction   Consultants s selected b bas ased o on q qual alificat ations to meet the need Written a agreement describing all of the services and all of the (for example: specialty, years of experience; location; practice compensation to be provided setting; speaking & publication experience; clinical research experience; podium presence, etc.)  Cannot select consultants based on past, present, or anticipated product use, referrals, or purchases   Engage only as m many c consultan ants a as needed to meet the needs Sales p s perso sonnel c cannot control o or unduly influence the decision to engage an HCP to provide consulting services

AdvaMed U.S. Code Training - Consulting Arrangements (II) • Additional clarity in Code: Key ey r reminder ers:  Description of “legitimate need” • Certain consulting arrangements – including amount of compensation  Guidance on developing an objective, consistent “fair market value” – are publicly disclosed under the (FMV) Sunshine Act  Valuation methods vary, but in all instances, a Company should use objective criteria (e.g., specialty, experience, practice setting, etc.) • Important to meet baseline Code and document evaluation requirements to minimize risk under Federal Anti-Kickback  Explanation of limits on sales involvement in consulting selection Statute  Avoids the perception that HCP was engaged to secure or reward for purchasing, using, or recommending products  Mitigating HCPs’ conflicts of interest  Conflicts of interest may arise for HCPs, and steps may need to be taken to address them