“Commercial Interest” ● ‘exempt’ entities (per ACCME) ● ‘exempt’ entities (per ACCME) – 501-C non-profit organizations – Government organizations – Non-health

““Commercial Interest”Commercial Interest”

● ‘ ● ‘exempt’ entities (per ACCME)exempt’ entities (per ACCME)– – 501-C non-profit organizations501-C non-profit organizations

– – Government organizationsGovernment organizations

– – Non-health care related Non-health care related companiescompanies

– – Liability insurance providersLiability insurance providers

– – Health insurance providersHealth insurance providers

– – Group medical practicesGroup medical practices

– – For-profit hospitalFor-profit hospital

– – For profit rehabilitation centersFor profit rehabilitation centers

– – For profit nursing homesFor profit nursing homes

““Free of Control”Free of Control”

● ● Absence of commercial interest control in:Absence of commercial interest control in:

● ● Identification of CNE needsIdentification of CNE needs ● ● Determination of educational objectivesDetermination of educational objectives ● ● Selection and presentation of contentSelection and presentation of content ● ● Selection of all persons and organizations Selection of all persons and organizations that will be in a position to control content that will be in a position to control content ● ● Selection of educational methodsSelection of educational methods ● ● Evaluation of the activityEvaluation of the activity

Co-Provider RelationshipCo-Provider Relationship

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

relationshiprelationship

Resolution of COIResolution of COI

● ● Disclose financial relationship with aDisclose financial relationship with a

commercial interestcommercial interest

● ‘ ● ‘Pertinent’ financial relationshipsPertinent’ financial relationships

● ● Repercussions of refusal to discloseRepercussions of refusal to disclose

● ● Mechanism to identify and resolve COIMechanism to identify and resolve COI

● ● Definition of COIDefinition of COI

‘‘Pertinent’ financial Pertinent’ financial relationshipsrelationships

● ● Individual Individual in a position to control onein a position to control one benefits by benefits by personally receiving or by a close family personally receiving or by a close family member receiving a member receiving a salarysalary, , royaltyroyalty, , intellectual intellectual property rightsproperty rights, , consulting feeconsulting fee, , honorariahonoraria, , ownership interestownership interest, , contracted researchcontracted research in some in some situations, etc.situations, etc.

● ● Usually associated with rolesUsually associated with roles

● ● Financial relationship occurring within the past Financial relationship occurring within the past 12 months are “relevant”12 months are “relevant”

Repercussions of Refusal to Repercussions of Refusal to DiscloseDisclose

● ● May not be a:May not be a:

– – Planning committee memberPlanning committee member

– – A teacherA teacher

– – An authorAn author

● ● May not have:May not have:

– – Control ofControl of

– – Responsibility forResponsibility for

The development, management, presentation, or The development, management, presentation, or evaluation of the CNE activityevaluation of the CNE activity

Definition of COIDefinition of COI

“…“…when an individual has an opportunity to affect when an individual has an opportunity to affect CNE content with products or services from a CNE content with products or services from a commercial interest with which s/he has a commercial interest with which s/he has a financial relationship”financial relationship”

● “● “Opportunity to affect” includes content about Opportunity to affect” includes content about specificspecific agents/devices (NOT the whole disease agents/devices (NOT the whole disease class in which agents/devices used)class in which agents/devices used)

Appropriate Use of Commercial Appropriate Use of Commercial SupportSupport

● ● ““Commercial Support” = financial, or Commercial Support” = financial, or

in-kind, contributions given by a in-kind, contributions given by a

commercial interestcommercial interest

● ● Given with the full knowledge and approvalGiven with the full knowledge and approval

of the providerof the provider

● ● Provider must make ALL decisions.Provider must make ALL decisions.

Receipt of support must not be contingent Receipt of support must not be contingent onon

the Provider’s decisions.the Provider’s decisions.


Written agreement documenting Written agreement documenting termsterms

● ● Must be in writing – with signaturesMust be in writing – with signatures

● ● Must include provider AND educational Must include provider AND educational

partner or co-provider as well as well aspartner or co-provider as well as well as

commercial support entitycommercial support entity

● ● Agreement must specify the entity is the Agreement must specify the entity is the

source of commercial supportsource of commercial support


Expenditures for an individual providing CNEExpenditures for an individual providing CNE

● ● Provider must have written policiesProvider must have written policies ● ● Provider (or co-provider or educational partner)Provider (or co-provider or educational partner) ● ● Must pay honoraria or reimbursement expensesMust pay honoraria or reimbursement expenses directlydirectly

● ● No other payment: director, planning No other payment: director, planning committee mbrs., teachers, authors, co-provider, committee mbrs., teachers, authors, co-provider, anyone elseanyone else ● ● Honoraria/reimbursement for teacher/author role Honoraria/reimbursement for teacher/author role

onlyonly when they participate in other portions of thewhen they participate in other portions of the educational eventeducational event

Expenditures for LearnersExpenditures for Learners

● ● Social events or meals cannot completeSocial events or meals cannot complete

with or take precedence over educational with or take precedence over educational

eventsevents

● ● Non-teacher/non-author: commercial supportNon-teacher/non-author: commercial support

may NOT pay for travel, lodging, honoraria,may NOT pay for travel, lodging, honoraria,

personal expensespersonal expenses

● ● Employees/volunteers of provider/co-Employees/volunteers of provider/co-provider/provider/

educational partner: commercial support MAYeducational partner: commercial support MAY

pay for travel, lodging, honoraria, or personalpay for travel, lodging, honoraria, or personal

expensesexpenses

Expenditures for LearnersExpenditures for Learners

● ● The provider must be able to produce The provider must be able to produce accurateaccurate

documentation detailing the receipt and documentation detailing the receipt and

expenditure of commercial supportexpenditure of commercial support

Management of Commercial Management of Commercial PromotionPromotion

● ● Commercial exhibits and advertisements areCommercial exhibits and advertisements are

Promotional activitiesPromotional activities

● ● Arrangements for commercial exhibits orArrangements for commercial exhibits or

advertisements cannot influence planningadvertisements 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 provision of commercial support for CNE activitiesactivities


● ● Product promotion material is prohibited Product promotion material is prohibited

in or during CNE activitiesin or during CNE activities

● ● Product-specific advertisement of any Product-specific advertisement of any typetype

is prohibited in or during CNE activitiesis prohibited in or during CNE activities

● ● Avoid the juxtaposition of advertising andAvoid the juxtaposition of advertising and

education material on the same products oreducation material on the same products or

topicstopics

● ● CNE must be kept separate from staffedCNE must be kept separate from staffed

exhibits, promotional presentations, printedexhibits, promotional presentations, printed

or electronic advertisementsor electronic advertisements


CNE must be kept separate from staffed exhibits, CNE must be kept separate from staffed exhibits, promotional presentations, printed or electronic promotional presentations, printed or electronic

advertisementsadvertisements..

● ● Ads & promotional materials may not be visibleAds & promotional materials may not be visible

on the computer screen at the same time as theon the computer screen at the same time as the

CNE content.CNE content.

● ● Ads & promotional materials may not be Ads & promotional materials may not be ‘interleafed’‘interleafed’

between computer ‘windows’ or screens of the between computer ‘windows’ or screens of the

CNE content.CNE content.


● ● Educational materials that are part of a CNE Educational materials that are part of a CNE activity (slides, abstracts, handouts, etc.) shall activity (slides, abstracts, handouts, etc.) shall not contain any advertising, trade name, or a not contain any advertising, trade name, or a product-group message.product-group message.

● ● Information about the non-CNE elements of a Information about the non-CNE elements of a CNE activity that are not directly related to the CNE activity that are not directly related to the transfer of education to the learner (schedules, transfer of education to the learner (schedules, content descriptions, etc.) MAY INCLUDE product content descriptions, etc.) MAY INCLUDE product promotion material.promotion material.


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

Content & Format without Content & Format without Commercial BiasCommercial Bias

● ● Content or format of a CNE activity OR its related Content or format of a CNE activity OR its related materials MUST promote improvements or quality materials MUST promote improvements or quality in health care (not the business interest of an in health care (not the business interest of an entity with a commercial interest)entity with a commercial interest)

Content & Format without Content & Format without Commercial BiasCommercial Bias

● ● Presentation must five a balanced view of Presentation must five a balanced view of therapeutictherapeutic

optionsoptions

– – Use of generic names is helpful to Use of generic names is helpful to impartialityimpartiality

– – If trade names used, use names from If trade names used, use names from severalseveral

companies, not just a single companycompanies, not just a single company

DisclosuresDisclosures

FINANCIAL relationship of those WITH CONTROL over CNE FINANCIAL relationship of those WITH CONTROL over CNE contentcontent

– – May be disclosed verballyMay be disclosed verbally

● ● Written verification of verbal disclosure Written verification of verbal disclosure

must be available to ANCC for review.must be available to ANCC for review.– – Representative of the provider inRepresentative of the provider in

attendance attests in writingattendance attests in writing: : disclosuredisclosure

(includes disclosure of no relationship or(includes disclosure of no relationship or

conflicts to disclose)conflicts to disclose)

● ● Written verification must be complete within oneWritten verification must be complete within one

month of the activity.month of the activity.


FINANCIAL relationship of those WITH CONTROL over CNE FINANCIAL relationship of those WITH CONTROL over CNE ContentContent

– – Relevant financial relationships information must include: Relevant financial relationships information must include: name of the individual, name of the commercial interest name of the individual, name of the commercial interest (‘s), and nature of the relationship the person has with (‘s), and nature of the relationship the person has with each commercial interest.each commercial interest.

– – Learners must be informed of the Learners must be informed of the absenceabsence of a relevant of a relevant financial relationship.financial relationship.


● ● COMMERCIAL SUPPORT for the CNE ACTIVITYCOMMERCIAL SUPPORT for the CNE ACTIVITY– – Learners must be informed of all support from Learners must be informed of all support from

entities with commercial interests.entities with commercial interests.● ● If other than monetary support, theIf other than monetary support, the

nature of the support must be disclosednature of the support must be disclosed– – The use of a trade name or a product-groupThe use of a trade name or a product-group

message must not be used in the disclosuremessage must not be used in the disclosure ● ● TIMINGTIMING

– – Disclosure must occur prior to the beginning Disclosure must occur prior to the beginning ofof

the CNE activitythe CNE activity

DIALOGUEDIALOGUE

Documents

“Commercial Interest” ● ‘exempt’ entities (per ACCME) ● ‘exempt’ entities (per ACCME) – 501-C non-profit organizations – Government organizations – Non-health