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3: Appropriate Use of Commercial Support


QUESTIONS RELATED TO SCS 3.1
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1) What is ‘commercial support?’ (SCS 3.1)
Commercial Support is financial, or in-kind, contributions given by a commercial interest, which is used to pay all or part of the costs of a CME activity.

2) Can the commercial support be spent directly by the commercial supporter on costs related to the CME activity? (SCS 3.1)
No. The commercial support must go first to the provider or a provider’s joint sponsor or a provider’s educational partner.

QUESTIONS RELATED TO SCS 3.2
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1) Can a commercial supporter direct the content of CME? (SCS 3.2)
No. The provider must ensure that the content of the CME truly remains beyond the control of the commercial supporter. The process to develop the CME must be independent of the commercial interest. Providers must not allow commercial supporters to directly (SCS 1.1) or indirectly (SCS3.2) control the content of CME.

2) What is the Provider to do if the commercial supporter says the content of the activity is not accurate – or unreasonably favors their product? (SCS 3.2)
The ACCME recognizes that commercial supporters may be held accountable to the U.S. Government for the claims or recommendations made in a CME activity they support. As a result the commercial supporter may feel compelled to raise issues with the provider about content. There is nothing wrong with the Provider receiving these comments in the spirit of patient safety and quality healthcare. However, the validity of the content of the CME should then be established by the Provider and through a process that reflects compliance with ACCME’s Content Validation Statements.

QUESTIONS RELATED TO SCS 3.3
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1) Can there be commercial support that the Provider does not know about? (SCS 3.3)
No. The Provider or its agents (e.g., staff, managers, educational partners or joint sponsors) must decide what commercial support will be accepted and how it will be spent or used.

2) How does the CME provider pay for its services in the production and distribution of a CME activity? Can they take a portion of the grant monies to pay for their activity-related expenses, e.g., certificates, mailings? (SCS 3.3)
Yes. The funds from commercial support may be used by the Provider to pay for the cost of the activity including for example, the distribution of certificates and other mailings, as required.

QUESTIONS RELATED TO SCS 3.4, 3.5, 3.6
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1) Must the commercial support be given as a single lump sum grant or payment? (SCS 3.4, 3.5, 3.6)
No – commercial support does not have to be in a single payment or grant.

2) Can you tell us what elements must be included in the written agreement? (SCS 3.4, 3.5, 3.6)
When there is commercial support there must be a written agreement that,
  • Itemizes how the Provider will use the commercial support in the development and presentation of the CME activity;
  • Itemizes the organizations involved in the activity (e.g., joint sponsors, education partners, managers);
    Specifies the organizational name of the commercial interest(s) that supplied the funds;
  • Specifies what funds or in-kind services will be given by the commercial supporter to support the provider’s activity; and
  • Is signed by the commercial interest and the accredited provider.


3) Can the commercial supporter require that the payment of the funds to the provider be conditional upon the provider delivering the activity, as promised? (SCS 3.4, 3.5, 3.6)
Yes.

4) Can a commercial supporter require in the written agreement that unexpended funds be returned to the commercial supporter? (SCS 3.4, 3.5, 3.6)
Yes.

5) Can we use a letter of agreement written by a commercial supporter? (SCS 3.4, 3.5, 3.6)
Yes. The agreement must describe the terms, conditions and purposes of the commercial support grant and be signed by the commercial supporter and the accredited provider.

6) Can a commercial supporter stipulate that if they do not approve of what was said -- or what will be said – that they will not pay the commercial support? (SCS 3.4, 3.5, 3.6)
No. This stipulation implies a control of content and acts as a disincentive to professional autonomy that is unacceptable in continuing medical education.

QUESTIONS RELATED TO SCS 3.7, 3.8
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1) Why is ACCME requiring that providers have their own policies and procedures governing honoraria? (SCS 3.7, 3.8)
The ACCME intends for the CME Provider to be the one to decide how much people are paid for their services as planners, faculty, and authors in CME activities.

QUESTIONS RELATED TO SCS 3.9
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1) Can a commercial supporter supplement their contributions to the activity by additional direct payments to people involved in the activity? (SCS 3.9)
No. All commercial support must be stipulated by a written agreement and must flow through the Provider and/or its educational partner. Only the Provider and/or its educational partner can make payments to people for their role(s) in the activity.

QUESTIONS RELATED TO SCS 3.10
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1) Can providers pay some of the expenses of people who are both faculty and learners? (SCS 3.10)
Yes – but CME providers need to be sure that these people have bona fide teaching roles. In the United States, physician learners are not to be given compensation or reimbursement for attending CME activities (see Opinion 8.061 of the Council on Ethical and Judicial Affairs of the American Medical Association). It is unacceptable for anyone other than the Provider, or its agents, to receive direct financial benefit from commercial support.

QUESTIONS RELATED TO SCS 3.11
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1) How can meals or social events compete with educational events? (SCS 3.11)
Meals or social events compete with educational events when they happen at the same time in a different location or when they are the main attraction at the educational activity.

2) Are meal-time speakers prohibited? (SCS 3.11)
No they are not prohibited. Working and learning through meal time is an efficiency often included in bona fide CME activities.

3) How can meals or social events take precedence over educational events? (SCS 3.11)
Using commercial support to pay for modest meals and social events at CME activities has been allowed for years. However, providers must avoid making meals or social events longer or more important or more costly than the educational activity, for example.

QUESTIONS RELATED TO SCS 3.12
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1) Whose expenses can be paid for out of the commercial support? (SCS 3.12)
Commercial support underwrites the Provider’s expenses for developing and presenting an activity. Commercial support can be used to pay for the expenses of teachers and authors as well others who are working for the Provider on the activity.

2) In the past we have provided scholarships to residents and fellows after a nomination and selection process in compliance with the 1992 SCS. According to the Updated 2004 Standard 3.12, is this still permissible?
Yes. Scholarships for Residents and Fellows fall under the purview of other organizations’ guidelines and standards (e.g., See the Ethical Opinion 8.061 of the Council of Ethical and Judicial Affairs of the AMA). It is not a topic addressed by the ACCME in the Updated Standards for Commercial Support. The existence of such scholarships and/or the compliance by the provider in the administration of such scholarships will not be reviewed by the ACCME’s accreditation process. ACCME will not be finding Providers out of compliance with SCS 3.12 for providing scholarships to Residents and Fellows.

3) Many providers produce CME activities paid for entirely by commercial support with no charge to the participants. Typically these activities include a modest meal. Commercial support has been used to pay for this meal as part of the activity. Are meals still allowed as part of CME activities in light of SCS3.12?
Yes. ACCME considers meals arranged by the Provider in conjunction with an activity to be an appropriate part of the expenses of a meeting and can be paid for out of the commercial support.

QUESTIONS RELATED TO SCS 3.13
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1) What kind of documentation of commercial support is expected? (SCS 3.13)
ACCME expects to be able to review income and expense statements for all CME activities. These statements must reflect:
  • Significant sources of income: Including income from commercial support, advertising and exhibit fees, tuition and registration fees, internal budget allocations and any other source that represents greater than 20% of total income.
  • Significant expenses: Including staff salaries, meeting costs, honoraria, faculty travel expenses and any other item that represents greater than 20% of total expense.


2) Can a commercial supporter ask for an accounting of how their commercial support has been spent? (SCS 3.13)
Yes. It is appropriate for an accounting of how the commercial support has been spent to be included in the written agreement between the Provider and the commercial supporter.

3) Does an accredited provider have to give a list of its participants to its commercial supporters? (SCS 3)
No. The ACCME has no specific policy on this matter. The decision is an organizational one for the provider.

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