Commercial Interest

1

• Commercial Interest
• ? 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

2
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

3
Co-Provider Relationship

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

4
Resolution of COI

• ? Disclose financial relationship
  with a
• commercial interest
• ? Pertinent financial
  relationships
• ? Repercussions of refusal to
  disclose
• ? Mechanism to identify and
  resolve COI
• ? Definition of COI

5
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.
• ? Usually associated with roles
• ? Financial relationship occurring within the
  past 12 months are relevant

6
Repercussions of Refusal to Disclose

• ? May not be a
• Planning committee member
• A teacher
• An author
• ? May not have
• Control of
• Responsibility for
• The development, management, presentation, or
  evaluation of the CNE activity

7
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)

8
Appropriate Use of Commercial Support

• ? Commercial Support financial, or
• in-kind, contributions given by a
• commercial interest
• ? Given with the full knowledge and
  approval
• of the provider
• ? Provider must make ALL decisions.
• Receipt of support must not be contingent
  on
• the Providers decisions.

9
Appropriate Use of Commercial Support

• Written agreement documenting terms
• ? Must be in writing with
  signatures
• ? Must include provider AND
  educational
• partner or co-provider as well
  as well as
• commercial support entity
• ? Agreement must specify the entity is
  the
• source of commercial support

10
Appropriate Use of Commercial Support

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

11
Expenditures for Learners

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

12
Expenditures for Learners

• ? The provider must be able to produce
  accurate
• documentation detailing the receipt
  and
• expenditure of commercial support

13
Management of Commercial Promotion

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

14
Management of Commercial Promotion

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

15
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
• on the computer screen at the same time as
  the
• CNE content.
• ? Ads promotional materials may not be
  interleafed
• between computer windows or screens of
  the
• CNE content.

16
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.

17
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.

18
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)

19
Content Format without Commercial Bias

• ? Presentation must five a balanced view of
  therapeutic
• options
• Use of generic names is helpful to
  impartiality
• If trade names used, use names from
  several
• companies, not just a single company

20
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.
• Representative of the provider in
• attendance attests in writing disclosure
• (includes disclosure of no relationship or
• 
  conflicts to disclose)
• ? Written verification must be complete within
  one
• month of the activity.

21
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.

22
Disclosures

• ? COMMERCIAL SUPPORT for the CNE ACTIVITY
• Learners must be informed of all support from
  
• entities with commercial interests.
• ? If other than monetary support, the
• 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
• ? TIMING
• Disclosure must occur prior to the beginning
  of
• the CNE activity

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DIALOGUE