“Commercial Interest” ● ‘exempt’ entities (per ACCME) ● ‘exempt’ entities (per ACCME) – 501-C non-profit organizations – Government organizations – Non-health care related companies – Liability insurance providers – Health insurance providers – Group medical practices – For-profit hospital – For profit rehabilitation centers – For profit nursing homes

“Free of Control” ● Absence of commercial interest control in: ● Identification of CNE needs ● Determination of educational objectives ● Selection and presentation of content ● Selection of all persons and organizations that will be in a position to control content ● Selection of educational methods ● Evaluation of the activity ● Absence of commercial interest control in: ● Identification of CNE needs ● Determination of educational objectives ● Selection and presentation of content ● Selection of all persons and organizations that will be in a position to control content ● Selection of educational methods ● Evaluation of the activity

Co-Provider Relationship Commercial interest can not take the role of non-accredited partner in a co-provider relationship

Resolution of COI ● Disclose financial relationship with a ● Disclose financial relationship with a commercial interest commercial interest ● ‘Pertinent’ financial relationships ● ‘Pertinent’ financial relationships ● Repercussions of refusal to disclose ● Repercussions of refusal to disclose ● Mechanism to identify and resolve COI ● Mechanism to identify and resolve COI ● Definition of COI ● Definition of COI

‘Pertinent’ financial relationships ● Individual in a position to control one benefits by personally receiving or by a close family member receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest, contracted research in some situations, etc. ● Individual in a position to control one benefits by personally receiving or by a close family member receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest, contracted research in some situations, etc. ● Usually associated with roles ● Usually associated with roles ● Financial relationship occurring within the past 12 months are “relevant” ● Financial relationship occurring within the past 12 months are “relevant”

Repercussions of Refusal to Disclose ● May not be a: ● May not be a: – Planning committee member – Planning committee member – A teacher – A teacher – An author – An author ● May not have: ● May not have: – Control of – Control of – Responsibility for – Responsibility for The development, management, presentation, or evaluation of the CNE activity

Definition of COI “…when an individual has an opportunity to affect CNE content with products or services from a commercial interest with which s/he has a financial relationship” ● “Opportunity to affect” includes content about specific agents/devices (NOT the whole disease class in which agents/devices used)

Appropriate Use of Commercial Support ● “Commercial Support” = financial, or ● “Commercial Support” = financial, or in-kind, contributions given by a in-kind, contributions given by a commercial interest commercial interest ● Given with the full knowledge and approval ● Given with the full knowledge and approval of the provider of the provider ● Provider must make ALL decisions. ● Provider must make ALL decisions. Receipt of support must not be contingent on Receipt of support must not be contingent on the Provider’s decisions. the Provider’s decisions.

Appropriate Use of Commercial Support Written agreement documenting terms Written agreement documenting terms ● Must be in writing – with signatures ● Must be in writing – with signatures ● Must include provider AND educational ● Must include provider AND educational partner or co-provider as well as well as partner or co-provider as well as well as commercial support entity commercial support entity ● Agreement must specify the entity is the ● Agreement must specify the entity is the source of commercial support source of commercial support

Appropriate Use of Commercial Support Expenditures for an individual providing CNE Expenditures for an individual providing CNE ● Provider must have written policies ● Provider must have written policies ● Provider (or co-provider or educational partner) ● Provider (or co-provider or educational partner) ● Must pay honoraria or reimbursement expenses ● Must pay honoraria or reimbursement expenses directly directly ● No other payment: director, planning ● No other payment: director, planning committee mbrs., teachers, authors, co-provider, committee mbrs., teachers, authors, co-provider, anyone else anyone else ● Honoraria/reimbursement for teacher/author role only ● Honoraria/reimbursement for teacher/author role only when they participate in other portions of the when they participate in other portions of the educational event educational event

Expenditures for Learners Expenditures for Learners ● Social events or meals cannot complete ● Social events or meals cannot complete with or take precedence over educational with or take precedence over educational events events ● Non-teacher/non-author: commercial support ● Non-teacher/non-author: commercial support may NOT pay for travel, lodging, honoraria, may NOT pay for travel, lodging, honoraria, personal expenses personal expenses ● Employees/volunteers of provider/co-provider/ ● Employees/volunteers of provider/co-provider/ educational partner: commercial support MAY educational partner: commercial support MAY pay for travel, lodging, honoraria, or personal pay for travel, lodging, honoraria, or personal expenses expenses

Expenditures for Learners ● The provider must be able to produce accurate ● The provider must be able to produce accurate documentation detailing the receipt and documentation detailing the receipt and expenditure of commercial support expenditure of commercial support

Management of Commercial Promotion ● Commercial exhibits and advertisements are ● Commercial exhibits and advertisements are Promotional activities Promotional activities ● Arrangements for commercial exhibits or ● Arrangements for commercial exhibits or advertisements cannot influence planning advertisements cannot influence planning ● Arrangements for commercial exhibits or ● Arrangements for commercial exhibits or advertisements cannot be a condition of the advertisements cannot be a condition of the provision of commercial support for CNE activities provision of commercial support for CNE activities

Management of Commercial Promotion ● Product promotion material is prohibited ● Product promotion material is prohibited in or during CNE activities in or during CNE activities ● Product-specific advertisement of any type is prohibited in or during CNE activities is prohibited in or during CNE activities ● Avoid the juxtaposition of advertising and ● Avoid the juxtaposition of advertising and education material on the same products or education material on the same products or topics topics ● CNE must be kept separate from staffed exhibits, promotional presentations, printed exhibits, promotional presentations, printed or electronic advertisements or electronic advertisements

Management of Commercial Promotion CNE must be kept separate from staffed exhibits, promotional presentations, printed or electronic advertisements. ● Ads & promotional materials may not be visible ● Ads & promotional materials may not be visible on the computer screen at the same time as the on the computer screen at the same time as the CNE content. CNE content. ● Ads & promotional materials may not be ‘interleafed’ ● Ads & promotional materials may not be ‘interleafed’ between computer ‘windows’ or screens of the between computer ‘windows’ or screens of the CNE content. CNE content.

Management of Commercial Promotion ● Educational materials that are part of a CNE activity (slides, abstracts, handouts, etc.) shall not contain any advertising, trade name, or a product-group message. ● Information about the non-CNE elements of a CNE activity that are not directly related to the transfer of education to the learner (schedules, content descriptions, etc.) MAY INCLUDE product promotion material.

Management of Commercial Promotion ● A provider shall not use an entity with a commercial interest as the agent providing a CNE activity to learners, e.g. distribution of self-study CNE activities or arranging for electronic access to CNE activities. ● A provider shall not use an entity with a commercial interest as the agent providing a CNE activity to learners, e.g. distribution of self-study CNE activities or arranging for electronic access to CNE activities.

Content & Format without Commercial Bias ● Content or format of a CNE activity OR its related materials MUST promote improvements or quality in health care (not the business interest of an entity with a commercial interest) ● Content or format of a CNE activity OR its related materials MUST promote improvements or quality in health care (not the business interest of an entity with a commercial interest)

Content & Format without Commercial Bias ● Presentation must five a balanced view of therapeutic ● Presentation must five a balanced view of therapeutic options options – Use of generic names is helpful to impartiality – If trade names used, use names from several – If trade names used, use names from several companies, not just a single company companies, not just a single company

Disclosures FINANCIAL relationship of those WITH CONTROL over CNE content – May be disclosed verbally ● Written verification of verbal disclosure must be available to ANCC for review. must be available to ANCC for review. – Representative of the provider in attendance attests in writing : disclosure attendance attests in writing : disclosure (includes disclosure of no relationship or (includes disclosure of no relationship or conflicts to disclose) conflicts to disclose) ● Written verification must be complete within one month of the activity. month of the activity.

Disclosures FINANCIAL relationship of those WITH CONTROL over CNE Content – Relevant financial relationships information must include: name of the individual, name of the commercial interest (‘s), and nature of the relationship the person has with each commercial interest. – Learners must be informed of the absence of a relevant financial relationship.

Disclosures ● COMMERCIAL SUPPORT for the CNE ACTIVITY ● COMMERCIAL SUPPORT for the CNE ACTIVITY – Learners must be informed of all support from entities with commercial interests. entities with commercial interests. ● If other than monetary support, the nature of the support must be disclosed nature of the support must be disclosed – The use of a trade name or a product-group message must not be used in the disclosure message must not be used in the disclosure ● TIMING ● TIMING – Disclosure must occur prior to the beginning of the CNE activity the CNE activity

DIALOGUE