ensuring independence in cme activities...from accme annual report data, 2011 criterion 8 the...

Ensuring Independence in CME Activities & Case Studies CME as a Bridge to Quality™ Accreditation Workshop

August 1-2, 2013

Copyright 2013 © – Accreditation Council for Continuing Medical Education – www.accme.org

For non-commercial educational use only. 1

Ensuring Independence

in CME Activities:

Compliance Expectations of

the ACCME’s Standards for

Commercial SupportSM

CME is Independent

What is the practice-based problem we

want to address?

Why does the problem exist?

What do we want to change?

Were we effective in producing change?

Is the problem solved? If not, start again.

How do we keep

commercial bias

out of education?

The Undesirable Outcome

Through their implicit or

explicit, control of, or

influence on, CME content,

commercial interests could

create commercial bias in

CME (favoritism) that could

result in a learner’s

inclination towards, or actual,

use of a product or service

that is more than is

necessary.


August 1-2, 2013



Since 1992, setting the

national standard…

• Effectiveness in improving practice

• Independence from commercial

interests

• Valid content

Mission critical as part of our public trust…

…to prevent misuse or overuse of products.

Content Validity

– True

– New or Important

– Free of commercial bias

Credibility or Face Validity

– Credentials

– Independent

– Transparency

The Standards for Commercial SupportSM

are a key part of ACCME’s overall strategy

to ensure validity of CME…

Shared Value

• Accreditation Council for Pharmacy Education (ACPE)*

• American Nurses Credentialing Center (ANCC)**

• American Osteopathic Association (AOA)

• American Academy of Family Physicians (AAFP)

• American Academy of Physician Assistants (AAPA)

• American Dental Association (ADA)

• Association of Regulatory Boards of Optometry (ARBO)

* Adopted fully as part of Accreditation Requirements

** Adopted as part of Joint Accreditation for the Health Care Team

http://www.accme.org/requirements/accreditation-requirements-cme-providers/standards-for-commercial-support




http://www.accme.org/requirements/accreditation-requirements-cme-providers/joint-accreditation-criteria-policies


August 1-2, 2013



In 2006, incorporated into

ACCME Accreditation Criteria as

Criteria 7-10

Compliance with ACCME’s Standards

for Commercial SupportSM

Criterion 7 – Independence

The provider develops

activities/ educational

interventions independent

of commercial interests.

Standards represented:

SCS 1 – Independence in

Planning

SCS 2 – Resolution of

Personal Conflicts of

Interest

SCS 6 – Disclosure

http://www.accme.org/requirements/accreditation-requirements-cme-providers/criteria/criterion-7


August 1-2, 2013



a) identification of CME needs;

b) determination of educational objectives;

c) Selection and presentation of content;

d) Selection of all persons and organizations that will be in a position to control the content of the CME;

e) Selection of educational methods;

f) Evaluation of the activity.

Standard 1:

Independence in Planning

1.1 CME decisions free of the control of commercial interest

1.2 Commercial interest is not joint sponsor

Standard 1:

Independence in Planning

As defined by ACCME…

“…any entity producing, marketing,

re-selling, or distributing health care

goods or services consumed by, or

used on patients.

The ACCME does not consider

providers of clinical service directly to

patients to be commercial interests.”

1.1 CME decisions free of the control of commercial interest

1.2 Commercial interest is not joint sponsor

on page 11

in your

syllabus

Standard 2:

Resolution of Personal COI

1. All relevant relationships disclosed

2. Continue with persons who disclose

3. Implement a mechanism to identify

and resolve conflicts of interest

http://www.accme.org/nodequeue/14

mailto:http://www.accme.org/requirements/accreditation-requirements-cme-providers/policies-and-definitions/definition-commercial-interest



August 1-2, 2013



Process STANDARD 2: Resolution of Personal Conflicts of interest

The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior

to the education activity being delivered to learners.

The ACCME considers

financial relationships to

create actual conflicts of

interest in CME when

individuals have both

–A financial relationship with a

commercial interest and

–The opportunity to affect the

content of CME about the

products or services of that

commercial interest.

How do these circumstances

create a conflict of interest?

The potential for maintaining

or increasing the value of the

financial relationship with the

commercial interest creates

an incentive to influence the

content of the CME – an

incentive to insert

commercial bias.

Process STANDARD 2: Resolution of Personal Conflicts of interest

The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior

to the education activity being delivered to learners.

Any amount…within the past 12 months…

– Royalty – Intellectual property rights – Consulting fee – Payment for promotional talk

– Ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds)

– Other financial benefit

…Of person, spouse or partner.

The ACCME considers

financial relationships to

create actual conflicts of

interest in CME when

individuals have both

–A financial relationship with a

commercial interest and

–The opportunity to affect the

content of CME about the

products or services of that


Who needs to disclose to

the provider?

EVERYONE in control of content,

for example:

–Planners

–Teachers/Faculty

–Authors

–Reviewers


August 1-2, 2013



SCS Element 2.3 The provider must have

implemented a mechanism to

identify and resolve all

conflicts of interest prior to

the education activity being

delivered to learners.

…one can help fulfill the other

SCS Element 2.1 The provider must be able to

show that everyone who is in

a position to control the

content of an education

activity has disclosed all

relevant financial

relationships to the

provider.








SCS Element 2.1

No

“commercial

content”








SCS Element 2.1

No financial

relationships with

a commercial

interest


August 1-2, 2013



Specific examples

Sometimes the mechanism involves

specifying, “Who does what?” within

an activity

Sometimes the mechanism involves

content validation

Providers’ choice of “mechanism(s)”

to resolve potential conflicts of

interest may involve:

Planners

Managers

Faculty/ Authors

Staff

Reviewers

Providers’ choice of

“mechanism(s)” must involve:

Engagement by the provider in

a process that goes beyond

disclosure, with necessary

interventions to resolve conflict

of interest implemented before

the activity.


August 1-2, 2013



Planners

Managers

Faculty/ Authors

Staff

Reviewers

Standard 6: Disclosure

– Individuals’ disclosure of all in control of

content to learners (including no

relationships) prior to activity

– Disclosure of commercial support…

including the nature of in-kind support.

– No use of trade names or product group

message in disclosure

Commercial Support in CME (ACCME-Accredited Providers only)

Other income

Advertising and Exhibits Income

Total commercial support with monetary value of in-

kind commercial support excluded

Total commercial support with monetary value of

in-kind commercial support included (2010 and

earlier)

From ACCME Annual Report Data, 2011, p 28


http://www.accme.org/news-publications/publications/annual-report-data/accme-annual-report-data-2011



August 1-2, 2013



Managing Commercial

Support

81% of ACCME-Accredited Providers

receive commercial support…

… only 21% CME activities (22% of participation)

From ACCME Annual Report Data, 2011

Criterion 8

The provider

appropriately manages

commercial support.

Standards represented:

SCS 3 – Appropriate

Use of Commercial

Support

Standard 3: Appropriate

Use of Commercial Support

– Decisions & Approval

– Signed Written Agreements

– Written policies & procedures regarding Honoraria

and reimbursement of out-of-pocket expenses of

planners/authors…irrespective of receiving CS*

– No payments outside of agreement

– Expenditures for learners

– Accountability

*Some elements of Standard 3 (3.7, 3.8, 3.9, 3.10, 3.11) may apply

whether or not the provider receives commercial support.





http://www.accme.org/requirements/accreditation-requirements-cme-providers/standards-for-commercial-support/standard-3


August 1-2, 2013



Criterion 9

The provider maintains a

separation of promotion

from education.

Standard represented:

SCS 4 – Appropriate

Management of

Associated Commercial

Promotion

– Exhibit booths

– Commercial Advertising Print

Computer-based

Audio and video

Live, face-to-face

– Education materials: Agent providing

CME (distribution)

Standard 4: Managing

Commercial Promotion

Criterion 10

The provider actively

promotes improvements

in health care and NOT

proprietary interests of a


Standard represented:

SCS 5 – Content and

Format without

Commercial Bias







August 1-2, 2013



– must promote improvements or quality in healthcare

– balanced view of therapeutic options

Standard 5: Content and Format

without Commercial Bias

CME is Independent

What is the practice-based problem we

want to address?

Why does the problem exist?

What do we want to change?

Were we effective in producing change?

Is the problem solved? If not, start again.

How do we keep

commercial bias

out of education?

Case Studies for

Ensuring Independence in

CME Activities



August 1-2, 2013



Purpose

To help you recognize key components

in planning CME activities independent

from commercial interests.

– Case studies

– Does the case meet ACCME

expectations?

Worksheet on page 45

Let’s discuss…

Independence

Case #1 A provider shares office space with a related organization

which is an ACCME-defined commercial interest. While

they never joint-sponsor with the commercial organization,

sometimes during their planning process the provider will

ask the editors from the commercial interest to do a

courtesy review of CME content. The provider will then

make changes to the content based on the editor’s

feedback.

Does this meet ACCME’s expectations for

Independence? Why or why not?


August 1-2, 2013



Case #2

Central Medical Center joint sponsors activities with

several local clinics and small community hospitals.

Recently, they have also agreed to joint sponsor an activity

developed and being presented by MedDevice medical

device manufacturer. Central Medical Center determined

that the activity would meet their educational needs, since

the activity is about a device recently purchased by the

surgery department—and the staff don’t know how to use

it.

Does this meet ACCME’s expectations for

Independence? Why or why not?

Let’s discuss…

Mechanisms to Identify

Conflicts of Interest

The CME Planning Committee for Western

Association of Surgeons meets 3 times a year

to plan their CME activities. The association

asks all speakers for their CME activities to

disclose relevant financial relationships in

order to assess whether or not a speaker has a

conflict of interest to resolve.

Does this meet ACCME’s expectation for identifying COI? Why or why not?

Case #3


August 1-2, 2013



In order to identify any conflicts of interest, MECC USA asks all planners and faculty for their CME activities to disclose any significant financial relationships that they or their spouse/partner has with manufacturers of products or services that will be discussed in the activity which are:

Over $5000

Last 12 months

When a relationship exists, they ask for the name of CI and nature of financial interest.

Does this meet ACCME’s expectation for identifying COI? Why or why not?

Case #4

Let’s discuss…

Mechanisms to

Resolve Conflicts of

Interest

Oz Medical School uses a form to gather

information about relevant financial relationships

from their planners and speakers. On the

bottom of this form, the person completing it is

asked to indicate how they will be resolving their

own conflict of interest (if applicable).

Does this meet ACCME’s expectation

for resolving COI? Why or why not?

Case #5


August 1-2, 2013



Provider A’s procedure:

– Collects information regarding relevant financial relationships from everyone who is in control of content

…then, implements one of following:

a. Recuse person(s) from presenting content that is related to their financial relationship(s)

b. Cites multiple examples of published evidence that support clinical recommendations made in the content

c. Conducts a “peer review” of materials; content is modified if bias is detected.

Does this meet ACCME’s expectation for

resolving COI? Why or Why Not?

Case #6

Let’s discuss…

Disclosure of Relevant

Financial

Relationships

Case #7

At the top of the handout materials for a Tumor

Board session, the provider has included the

following information:

“None the members of the Western Medical School

CME Committee, who planned this CME Activity, have

any financial relationships to disclose relating to the

content of the cases selected. In addition, Dr. Jones,

who is facilitating this session, has no relevant financial

relationships to disclose.”

Does this meet ACCME’s expectation for disclosure of

relevant financial relationships? Why or why not?


August 1-2, 2013



Let’s discuss…

Appropriate Use of

Commercial Support

Provider ABC has scheduled a well-known speaker who expects $2,000 honorarium.

ABC’s policy limits honoraria to $1,500.

Speaker offers to get additional $500 directly from a commercial interest.

Does this meet ACCME’s expectation for the

appropriate use of commercial support? Why or why not?

Case #8

Case #9

During the week following their Annual Conference, the

National Specialty Association is reviewing their

documentation for the meeting, which was commercially

supported by educational grants from Companies A, B,

and C.

• For Companies A & B, the provider has a letter of agreement

signed by both the commercial supporter and one of their staff

members.

• For company C the provider has a copy of the agreement that it

completed electronically when they were awarded the grant.


appropriate use of commercial support?

Why or why not?


August 1-2, 2013



Let’s discuss…

Separation of Promotion

from Education

Case #10

• For each of the past 10 years, Pharma ABC has both been a major

exhibitor (“Silver Level”) at Provider Y’s Annual Meeting, and has

provided commercial support for a CME symposium on new

approaches for treating heart disease

• At another cardiology meeting, a Brand Manager from Pharma ABC

mentions to Provider Y that they may reduce the size of their exhibit

hall sponsorship this year.

• Provider Y sends an e-mail to Pharma ABC’s Medical Education

Director explaining that Pharma ABC may not be eligible to provide

grant support for the CME symposium if they don’t exhibit at the

“Silver Level”.


separation of promotion from education? Why or why not?

ensuring independence in cme activities...from accme annual report data, 2011 criterion 8 the...

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