1 you and me & cme:* a handbook for commercial support (*lousy grammar, but it rhymes!) c me...

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1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C M E Copyright 2008 (revised 01/01/14) by: Kathy J. Kavanagh Director, Continuing Medical Education New York Medical College Room 2N-C18 Sunshine Cottage Road (Skyline Drive) Phone: (914) 594-2530 Fax: (914) 594-2531 [email protected]

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Page 1: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

1

You and Me & CME:*A Handbook for Commercial Support

(*Lousy grammar, but it rhymes!) CME

Copyright 2008 (revised 01/01/14) by: Kathy J. KavanaghDirector, Continuing Medical EducationNew York Medical CollegeRoom 2N-C18 Sunshine Cottage Road (Skyline Drive)

Phone: (914) 594-2530Fax: (914) 594-2531 

[email protected]

Page 2: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

2

Quality CME activities play a vital role in the life-time

learning of physicians and other healthcare providers.

CME

Page 3: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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However, quality comes at a price.

Page 4: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Educational budgets have been stretched to the breaking point!

Page 5: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Expenses are Up!Revenue is Down!

Page 6: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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There just isn’t enough money left to cover CME activities.

Page 7: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Where can you go to find financial support for your CME

activity?

Page 8: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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It is perfectly ok to have outside companies support CME

activities.

CME Activity

Page 9: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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CME providers have enjoyed a long standing relationship with

commercial entities from industry.

Page 10: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients is considered to

be a “Commercial Interest”

Note: providers of clinical service directly to patients are not considered commercial interests.

Page 11: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Drug and device companies often contribute to, and may even fully

underwrite, CME activities. And, it is legal and acceptable as

long as the activity remains unbiased and well balanced.

Page 12: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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certain rules must be followed by the supporting companies, activity

director, activity planners, faculty, CME office, and participants.

To help ensure that activities remain unbiased

Page 13: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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To help protect the integrity of CME, both the ACCME and the AMA have developed guidelines

for gifts from industry.ACCME

AMA

Page 14: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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In 1990, The AMA drafted Opinion 8.061, “Gifts to

Physicians from Industry.”

Page 15: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Gifts to physicians – the highlights:

• Gifts should primarily entail a benefit to patients.

• Gifts should not be of substantial value.– Unacceptable gifts:

• A year’s membership to a country club• Diamond studded stethoscopes• Vacation trips to Tahiti

Page 16: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Acceptable gifts

• Modest meals• Relevant textbooks• Pens, notepads

Page 17: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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No gift should be accepted if there are strings attached.

ACME DRUGS

Page 18: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Subsidies from industry for CME activities may not be

given directly to any physician.

Wow!

Page 19: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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“The Standards for Commercial Support of Continuing Medical

Education” were adopted by the ACCME in 1992 and revised in 2004

Page 20: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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These standards outline the appropriate behavior of commercial supporters, accredited providers, activity faculty and planners, and

participants in a CME activity.

Page 21: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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The accredited provider (in our case, the NYMC CME Office) is

responsible for the content, quality, and scientific integrity of

all CME activities.

Page 22: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Commercial interests may not control the planning, content, or execution of the CME activity.

Page 23: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Commercial Interests may NOT act as a Joint Sponsor of

a CME activity.

Page 24: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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A commercial entity may NOT serve as the agent

providing a CME activity to learners.

Page 25: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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CME activities must promote improvements in healthcare and not a specific proprietary interest

of a commercial entity

Page 26: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Presentations must give a balanced view of therapeutic options.

If possible, only generic names should be used. However, If trade names are used, those of several companies should be used.

OptionA

OptionB

Presentation

Page 27: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Reports of scientific research must be objective and conform to the generally accepted standards

of experimental design, data collection, and analysis.

Page 28: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Even though it is no longer required, any

unlabeled or experimental use of a product discussed in a presentation should be

clearly identified as such to the audience, prior

to the presentation.

Page 29: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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After each activity, attendees and faculty must be asked if they felt

that the activity was commercially biased.

If bias was perceived, the provider must document steps that will be taken to detect and prevent bias in the future.

Page 30: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Commercial exhibits may be near CME activities if they do not

interfere with the presentation of the activity.

Exhibits

Symposium

Page 31: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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No commercial promotional materials* may be displayed or distributed in the room where the educational portion of the activity takes place.

*This includes pens, banners, notepads, samples, etc.

ACME Drugs - Where Just One Little

Pill’l Do It!

Page 32: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Funds for support of a CME activity must be given in the form

of an educational grant, with a written agreement that outlines

the terms of the support.

Page 33: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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These terms are outlined in a Letter of Agreement (LOA) often called a Commercial Support Agreement

Page 34: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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You will need a fully executed

Letter of Agreement for

each commercial supporter of a CME activity.

Agreement Agreement Agreement

AgreementAgreement

Agreement

Page 35: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Support can be in the form of an unrestricted

educational grant – where the company gives you a certain amount of money to spend for this activity

as you see fit,

Page 36: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Or the company can specify that the money be used only for

certain expenses.

Page 37: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Funds can cover supplies, services, food & beverage, and speaker

honorariums & expenses.

Page 38: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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All honoraria payments and reimbursement of travel expenses

must be made in accordance with the provider’s written policies.

Policies &

Procedures

Page 39: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Note that money MUST come through the department or CME

Office and CANNOT be paid directly to any speaker or to

directly purchase any food or beverage.

Page 40: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Funds can also not be used to pay travel, lodging, registration fees, or personal expenses for

non-faculty attendees.

Page 41: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Travel, lodging, honoraria, or personal expenses may be paid to bona fide employees and volunteers involved

with the activity.

Page 42: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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The provider must make all decisions regarding the

disbursement of commercial support monies

Page 43: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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All Commercial support must be acknowledged in printed announcements and conference materials. The acknowledgement may not reference any specific product(s).

Page 44: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Commercial support can be acknowledged by making the statement “We gratefully acknowledge {name of company} for their generous support of this educational activity” on

• The brochure or announcement

• The syllabus

• A sign by the check-in desk

• The participant evaluation form

•All of the above

Thank You for your support!

Page 45: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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The CME Office must be able to furnish the commercial supporter with a full accounting of the expenditure of all funds given in support of an activity.

Page 46: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Social events at CME activities may not compete with or take

precedence over the educational events.

Page 47: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Disclosure, It’s not a dirty word!

Page 48: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Each Activity Faculty and planning member must disclose any significant

relationships to the audience.

Hi, My Name is …

Page 49: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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But only relationships that are relevant to this CME activity.

Page 50: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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This includes relationships with any entity producing,

marketing, re-selling, or distributing

health care goods or services consumed by, or used on, patients, and/or provider of any service

discussed in their presentation.

Page 51: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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For each relevant company, the faculty member must tell

the audience that either:

•They have no significant relationship(s).

•They have a relationship (and then state the nature of the relationship).

•They are refusing to disclose any information regarding relationships.

Page 52: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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An individual who refuses to disclose will be barred from having any control over the activity and from participating in the activity as a planner, presenter,

or author.

Page 53: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Just because someone has a relationship with a company doesn’t mean they can’t be an activity faculty

or planning member.

Page 54: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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It is the provider’s responsibility to review the disclosure information to

determine if there is the potential for a conflict of interest.

Page 55: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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If the potential for conflict of interest is identified, the provider must take steps

to resolve it.

Page 56: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Sample Mechanisms for Resolving COI

• End the Relationship• Have an impartial person review the

presentation content to ensure it is well-balanced and unbiased

• Remove the person from participating in the planning and presentation of the activity

• Inform the individual of his/her duty to ensure that the presentation is well balanced and free from bias

Page 57: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Example: • Clarence Clinician, MD has been invited to

give a talk about stress-reduction interventions at your annual conference

• Dr. Clinician indicates that he owns 50% of the stock of “Stressbusters” the manufacturer of a pill that lowers adrenaline levels

• It could be perceived that Dr. Clinician might be biased towards the Stressbusters drug over other therapeutic options

Stress Out

Page 58: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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This doesn’t mean Dr. Clinician can’t be a part of our conference.

Page 59: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Steps must just be taken to ensure that his presentation is unbiased and well-balanced.

Page 60: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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NYMC has chosen to require individuals with the potential for COI to

sign a Good Practices Agreement.

Page 61: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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This agreement outlines the requirements for the content and presentation of CME activities.

Page 62: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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By signing this agreement, the faculty or planning member is attesting to

his/her commitment to ensuring the activity complies to all CME

requirements

Page 63: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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It is ultimately up to the audience to decide if the presentation is unbiased.

Page 64: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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If we resolved the potential Conflict of Interest, why do

speakers and planners, still have to disclose?

My Name isClarence ClinicianAnd I own stock In StressBusters.

Page 65: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Because, the audience needs to

know with which companies a speaker has a relationship,

to be able to determineIf the presentation

is influenced.

Page 66: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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So that they can decide if the presentation was fair and balanced.

Page 67: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Because Disclosure is so important, it should be made in at

least two different ways.

• A composite statement listing all faculty and their relationships should be included in the hand-outs and posted at the check-in desk.

• The Activity Director should make an announcement at the start of the activity directing the audience to where they can find the information.

• Each Activity Faculty member should make their disclosure at the start of their presentation.

Page 68: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Remember, the rules are there to guide all parties involved in CME

down the right path.

Page 69: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Don’t be afraid to ask questions about commercial

support and disclosure.

Page 70: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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“Who You Gonna Call?”

Director, Kathy J. Kavanagh

Asst. Director, Margaret Astrologo

Phone: (914) 594-2530 Fax: (914) 594-2531

Email: [email protected] Website: www.nymc.edu/cme

Page 71: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Together, CME and Industry can produce high quality educational programs.

Page 72: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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Programs that will assist physicians in giving better

medical care to their patients.

Page 73: 1 You and Me & CME:* A Handbook for Commercial Support (*Lousy grammar, but it rhymes!) C ME Copyright  2008 (revised 01/01/14) by: Kathy J. Kavanagh

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And, after all, that is what CME is all about!

CME