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Conference Name: CME vs. Promotion: Understanding MedEd Compliance

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CME vs. Promotion:Understanding MedEd

Compliance

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presents . . .

A 90-minute interactive audioconference

Tuesday, August 8, 2006

ii CME vs. Promotion: Understanding MedEd Compliance

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iiiCME vs. Promotion: Understanding MedEd Compliance

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iv CME vs. Promotion: Understanding MedEd Compliance

Dear colleague,

Thank you for participating in our “CME vs. Promotion: UnderstandingMedEd Compliance” audioconference with Keith Korenchuk, ChristopherKing, John DeHart, and Barbara A Fuchs, MSA, moderated by BryanCote. We are excited about the opportunity to interact with you directly andencourage you to take advantage of the opportunity to ask our experts yourquestions during the audioconference. If you would like to submit a questionbefore the audioconference, please send it to [email protected] and pro-vide the program date in the subject line. We cannot guarantee that yourquestion will be answered during the program, but we will do our best to takea good cross section of questions.

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200 Hoods LaneP.O. Box 1168

Marblehead, MA 01945Tel: 800/650-6787Fax: 800/639-8511

vCME vs. Promotion: Understanding MedEd Compliance

Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi

Speaker profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vii

Exhibit A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 Presentation by Keith Korenchuk, Christopher King, John DeHart, and Barbara A.Fuchs, MSA

Exhibit B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19CME Requirements by State

Exhibit C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23Resource Materials - Keith Korenchuk

Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

Contents

vi CME vs. Promotion: Understanding MedEd Compliance

Agenda

I. CME Legal DevelopmentsA. What’s new? (Cases, regulatory action, lessons learned analysis)B. What’s coming?C. How to prepareD. OIG, FDA and other regulatory developmentsE. Practical recommendations for improving internal controls as

surveillance heats up

II. Role of CME and Traditional Medical EducationA. What’s more beneficial to the marketer and why?B. Marketing/Sales “hands-off” policy for CMEC. CME as “value-added” service for physicians

III. Is CME worth it? If so, how do you improve your internal process for more effective education

A. Strategies to improve the brand team and medical affairs relationshipB. Stakeholder communicationC. MeetingsD. Negotiating spending for CME

IV. Gray Area Scenarios/Panel DiscussionA. Scenario presentedB. Analysis

Live Q&A

viiCME vs. Promotion: Understanding MedEd Compliance

Speaker profiles

Keith Korenchuk

Keith Korenchuk is a Partner at McGuire Woods, LLP, located in Washington, DC. He counsels and advisespharmaceutical, life sciences, medical device, and specialty pharmacy companies in the United States andaround the world. The focus of his work is on the regulatory and compliance challenges confronting these sec-tors under federal, state, and international laws. He provides guidance and assistance on matters ranging fromdesign and implementation of compliance systems, specific product launch, sales/marketing and complianceissues, internal and government investigations, and negotiation and implementation of strategic relationships toenable companies to achieve their business objectives in a complex operating and regulatory environment.

His experience includes serving as CEO of organizations focusing on pharmaceutical and healthcare sectorcompliance, as well as technology research and development; providing a full range of analysis, assessment,and guidance in pharmaceutical, life sciences, and healthcare regulatory and compliance matters; cochairing anational health law department of a top 100 American law firm; and coordinating, managing, and implementingcomplex strategic alliances, joint ventures, and business arrangements.

He is actively engaged in providing pharmaceutical, life sciences, medical device, and specialty pharmacy com-panies with regulatory, business, and compliance guidance, advice, and solutions.

Christopher King

Christopher King is a Managing Partner at CMEsolutions, LLC, located in Tucson, AZ. He has over 30 years ofexperience in developing products and markets in the pharmaceutical/biotech industry. Since 1997, he has beenManaging Partner of CMEsolutions. Chris began his career in the healthcare industry when he joined Pfizer,Inc., in 1975, and then Bayer in 1983 where he gained a broad range of industry experience in a series ofsales, marketing, and management positions in several therapeutic categories.

He is a graduate of Niagara University with a B.S. in Finance/Marketing.

John DeHart

John DeHart is a Managing Partner at CMEsolutions, LLC, located in Tucson, AZ. In 1978, He joined Bayer’sBiological Products Division. His career with Bayer represented almost 20 years in the sales, marketing, andmanagement of biological and pharmaceutical products. Before leaving Bayer in 1996, he was responsible forthe coordination and management of all immunological products worldwide, establishing both tactical and strate-gic objectives, with full budget responsibilities. He left Bayer to cofound CMEsolutions. He has a B.S. degreefrom Weber Sate University in Accounting, Finance, and Marketing.

viii CME vs. Promotion: Understanding MedEd Compliance

Barbara A. Fuchs, MSA

Barbara A. Fuchs is an Associate Director in Professional Education Support at Wyeth Pharmaceuticals. Shehas many years of experience as a healthcare professional, holding key clinical and administrative positions inhealthcare organizations including managed care. Prior to joining Wyeth, she served as the Executive Directorof a for-profit continuing medical education (CME) company. This has given her a unique perspective on theregulations governing CME as well as the grant process.

She is also an adjunct professor in the nursing program at Eastern University, a Certified Professional inHealthcare Quality, and a frequent faculty member at the Annual Meeting of the Alliance for Continuing MedicalEducation.

Bryan Cote, Moderator

Bryan Cote is an award-winning writer with more than 10 years of experience in healthcare journalism, publicrelations, and speech writing. As executive editor at HCPro, he writes and edits newsletters on Medicare reformand pharmaceutical reimbursement and compliance issues. He is the author of the MMA Impact Report Series,which included a report on the expected shift in infusion therapy to the hospital outpatient setting. In 2000, hewon a New England Press Association award for healthcare feature writing and in 1999 won a newsletter writ-ing award for his public relations work for Charlotte Hungerford Hospital in Connecticut.

Exhibit A

Presentation by Keith Korenchuk, Christopher King, John DeHart, and Barbara A. Fuchs, MSA

EXHIBIT A

2 CME vs. Promotion: Understanding MedEd Compliance

CME vs. Promotion:Understanding MedEd

Compliance

Presented by:

Keith Korenchuk, McGuire Woods LLP

Christopher King, CMEsolutions, LLC

John Dehart, CMEsolutions, LLC

Barbara Fuchs, Wyeth Pharmaceuticals

2

CME Legal Developments

� What's new, What's coming, How to prepare?

� Focus on 5 CME Minefields

� Reference Materials (Exhibit C)

3CME vs. Promotion: Understanding MedEd Compliance

EXHIBIT A

3

CME Minefield #1:Third Party Initiated Programs

� Standards

� Available Guidance

� “Independence”

� Monitoring/Auditing

4

CME Minefield #2:Program Funding Decisions

� Departmental Approval

� Integrity of Decision Making

� Permissible / Impermissible Linkages

EXHIBIT A


5

CME Minefield #3:Content/Program/Speaker Reviews

� Internal Standards

� Guidance

� Scientific / Marketing Boundaries

6

CME Minefield #4:Locations

� Resorts

� Cruise Ships

� Non-resort locations

� Appearances


EXHIBIT A

7

CME Minefield #5:Meals

� Types

� Linkage

� Guests

� Funding

8

Role of CME and TraditionalMedical Education

� Which is more beneficial to the manufacturerand why?

� Marketing/Sales "hands-off" policy for CME

� CME as "value-added" service for physicians

EXHIBIT A


9

Q. When considering CME versus

traditional medical education,

which is more beneficial to

the manufacturer and why?

10

A. It Depends!

Building advocacyRisk management

•Controlledsubstances

•Black box

Late lifecycleNew Indication

LaunchPre-launch

Post-launchLaunch

Therapeutic leadership

“Me-too”Combination therapies

DifferentiationDisease state awareness

When MedEd is beneficialWhen CME is beneficial


EXHIBIT A

11

Q. What should CME “Hands-Off”

mean to me and why?

12

A. Practical CME “Hands-Off”Considerations

As a marketer you need to avoid any perception ofbias and/or that you are offering an inducementto recommend or prescribe your product

� Oversight of grant process moved from marketing

and sales to medical affairs

� Distribution of activities limited to CME provider and

joint sponsor

� Sales materials must be outside the room of any live

activity

� All content must be controlled by CME provider

EXHIBIT A


13

How can Marketing and SalesParticipate?

� Can internally recommend physician unmet needs

� May internally recommend thought leaders

� Can distribute CME invitations

� Can attend CME live programs

14

Q. What is the real value of

CME?


EXHIBIT A

15

A. Physicians Depend On ItPhysicians are constantly challenged by patients and

payors to stay up to date with treatment guidelines, newtherapies, etc.

� Meets an unmet educational need

� Unbiased and evidence-based content

� Required for ongoing license

� Improves physician skills

� Improves patient care

“CME is my lifeblood for improved patient care”

16

A. Value to Commercial Supporter

� Builds a better corporate image

� Strengthens physician skills

� Helps to meet the educational needs ofphysicians

� Improves patient care

� Demonstrates therapeutic leadership

EXHIBIT A


17

Is CME Worth It?Improving Internal Processes for More Effective Education

� Strategies to improve the brand team andmedical affairs relationship

� Stakeholder communication

� Meetings

� Negotiating spending for CME

18

Improving the Brand Team and

Education Department Relationship

� Developing rapport

� Rules of engagement

� Encourage compliant participation


EXHIBIT A

19

Stakeholder Communication

� Critical to Success

� Weekly, Monthly, Quarterly

� Updates via email

� Ad hoc meetings

20

Business StrategyDevelopment

� Education strategist attends developmentmeetings to understand the focus of the brandfor the year.

� Includes focus on clinical trials in development,in progress, or completed

� Includes any market or other research analysis

� Includes discussion about anticipated level of

funding

EXHIBIT A


21

CME: Not Always the Answer

� “Me-too” products

• No real differentiation

• No current trials or papers

� High involvement by patients/patient advocatesin decisions

• No new breakthroughs, mature product

• Increase consumer not HCP education

� Current labeling very limited though some off-label use is occurring

• risk mitigation

22

Education Strategy Plan

� Education strategist attends Business StrategyDevelopment

� Education Plan and Budget are developed

� Plan and Budget are presented

� Budget is approved

� Funding is transferred to Education authority

� Plan is implemented


EXHIBIT A

23

Meetings

� Weekly

• Brand Team contact

�Status of current educational activities

�Discussion of any issues/concerns

�Opportunity for mutual training

• Other members of the Brand Team and/or

education team, as needed

�Close follow-up of specific challenges

24

Meetings (cont’d)

� Monthly

• Marketing and Education

�Launch of new education initiatives

�Review/description of approved proposals

�Review of the budget (running total)

�General accounts, not specific activities

�After initial funding, Marketing may add funding at

the beginning of each quarter*

EXHIBIT A


25

Meetings (cont’d)

� Monthly (2)

• Internal Associations contact and Education

Strategist

�Review of current overall plan

� Association Annual Meeting Sponsorship

� Resulting educational funding opportunities

�Coordinate attendance at Association annualmeetings or visits to Association headquarters

26

Meetings (cont’d)

� Quarterly

� Full team meeting may include Senior

Management and:

�Marketing

�Sales

�Global Medical Affairs

�Global Professional Relations

�Market research

�Legal

�Finance


EXHIBIT A

27

Meetings (cont’d)

� Quarterly (continued)

• Provides an opportunity for discussion of changes

in strategy or other “course corrections”

• Provides an opportunity for education/updates to

the broader team

28

Education Plan Development

� Review of business plan

� Review of the literature

� Review of previous education activitiesevaluations and outcomes data

� Assessment of synergies between business planand review identified

� Development of a needs assessmentincorporating identified educational gaps thatalign with the scientific interests of the company

EXHIBIT A


29

Education Plan (cont’d)

� Assessment of the target audiences

� Assessment of the types of activities mostappropriate to the needs of the learners

� There are no specific tactics described in theplan

30

Budget Development

� Development includes:

• Assessment of the learning strategies required

and an estimated budget for each

• Review of the previous year’s “spend”

• Overall funding level anticipated by the Marketing

Team for grant funding


EXHIBIT A

31

Negotiating Spending for CME

The education strategist must:

� Provide a compelling argument for the CME

funding requested and

� Be good stewards of the money

• Keep the team informed

• Demonstrate educational effectiveness

32

Negotiating spending for CME(cont’d)

� The education strategist must:

• Balance quality education with the scientific

interests of the company

• Understand the brand with respect to consumer

and/or promotional needs

• Share the results of objective educational

effectiveness outcomes data reflecting physician

change in behavior that ultimately improve patient

care

EXHIBIT A


33

Summary

� CME can be an important component of theBrand budget allocation

� Sharing of knowledge and training between the

Brand Team and the Education Strategist is keyto developing a successful education plan

� A successful education strategy can bemeasured by the outcomes of knowledge gain orbehavior change of the participants as a result ofthe education

� CME is not always the answer

34

Q & A Session

� New and recent cases: Any interestingimplications?

� Regulatory developments: Any interestingimplications?

� 2007 CME Focus: Where is the government goingto focus next?

� What CAN we do?

� Faculty selection: Any tactical ideas to handle thisin compliance, but more effectively?

Audience Questions

Exhibit B

CME Requirements by State

Source: CMEsolutions, LLC. Reprinted with permission.

EXHIBIT B


State Medical Licensure Requirements and Statistics, 2006/ 47

Continuing Medical Education for Licensure Reregistration

Fifty-eight boards (including Wyoming, as of January 1,2007) require anywhere from 12 hours (Alabama) to 50hours (several states) of continuing medical education(CME) per year for license reregistration. Some states alsomandate CME content, such as HIV/AIDS, risk manage-ment, or end of life palliative care. In addition, many states also require that a certain percentage of CME becategory 1, as measured, for example, through theAmerican Medical Association Physician’s RecognitionAward. Forty states accept the AMA PRA certificate asequivalent for purposes of licensure reregistration.

Additional Notes for Specific Licensing Jurisdictions

California—All general internists and family physicianswho have a patient population of which more than 25%are 65 years of age or older shall complete at least 20%of all mandatory continuing education hours in geriatricmedicine or the care of older patients.

All physicians and surgeons shall complete mandatorycontinuing education in the subjects of pain managementand the treatment of terminally ill and dying patients (one-time requirement of 12 credit hours, to be completed byDecember 31, 2006). Physicians practicing in pathology orradiology specialty areas are exempt from this requirement.

Florida—Physicians may complete a 1-hour CME courseon end-of-life and palliative health care in lieu of therequired 1-hour CME course on HIV/AIDS, provided thephysician completed the HIV/AIDS course in the imme-diately preceding biennium (2-year licensure term).

Physicians may complete a 1-hour CME course on end-of-life and palliative health care in lieu of the required 1-hour CME course on domestic violence, provided thephysician completed the domestic violence course in theimmediately preceding biennium (2-year licensure term).

Maryland—Partial CME credit is offered for AmericanBoard of Medical Specialties (ABMS) certification, selectpeer review, serving as a intervenor or monitor on a physi-cian rehabilitation committee or professional committee,and serving as a preceptor for resident physicians or med-ical students in LCME-accredited schools. For first licenserenewal, the CME requirement is waived, but the licenseemust have completed an approved orientation program.

Pennsylvania—Regulation on the amount of category 1hours required is currently being drafted.

Washington Osteopathic—Other certificates accepted asequivalent include current certification of CME from med-ical practice academies and original certification or recerti-fication within 6 years by a specialty board.


EXHIBIT B

48 / State Medical Licensure Requirements and Statistics, 2006

Table 15Continuing Medical Education for Licensure Reregistration

Required Average AMA/AOA/AAFP/ACOGNumber of CME Hours Category 1 Hours Certificates Accepted State-Mandated CME Content/Hours per Year(s) per Year Required as Equivalent Additional Notes

Alabama 24 hrs 2 yrs 12 24 ACOG, AAFP

Alaska 50 hrs 2 yrs 25 25 AMA PRA, ABMS, AOA, APA

Arizona 40 hrs 2 yrs 20 ABMS, GME 40 hrs within 2-yr timeframe

Arizona DO 40 hrs 2 yrs 20 20 Category 1-A only

Arkansas 20 hrs 1 yr 20 20 AMA PRA

California* 100 hrs 4 yrs 25 100 AMA PRA, AAFP, CMA, CAFP Pain management/geriatric medicine (see note)

California DO 150 hrs 3 yrs 50 90 AMA PRA, AAFP, CMA, CAFP, AOA 60 hrs Category 1-A or 1-Bpain management/geriatric med

Colorado none

Connecticut none

Delaware 40 hrs 2 yrs 20 40 AMA PRA, AOA

DC none

Florida* 40 hrs 2 yrs 20 40 AMA PRA HIV/AIDS, domestic violence, TB,end of life palliative care, med error

Florida DO 40 hrs 2 yrs 20 20 HIV/AIDS, domestic violence, risk (AOA Category 1-A) management, FL rules/laws,

use/abuse of controlled substances,2 hrs prevention of medical errors

Georgia 40 hrs 2 yrs 20 40 AOA, AAFP, ACOG, ACEP

Guam 100 hrs 2 yrs 50 50 AMA PRA, AOA, AAFP, ACOG, ACEP

Hawaii 40 hrs 2 yrs 20 40 AMA PRA

Hawaii DO none

Idaho 40 hrs 2 yrs 20 40 AMA PRA, ABMS, AOA

Illinois 150 hrs 3 yrs 50 60 AMA PRA, AOA

Indiana none

lowa 40 hrs 2 yrs 20 40 Child/dependent adult abuse

Kansas 50 hrs 1 yr 50 20 AMA PRA, AAFP, ABMS, GME, AOA

Kentucky 60 hrs 3 yrs 20 30 AMA PRA, ABMS One-time domestic violence course for primary care physicans; HIV/AIDS; course must be approvedby Kentucky Cabinet for Hlth Svcs

Louisiana 20 hrs 1 yr 20 20 AMA PRA One-time board orientation course

Maine 100 hrs 2 yrs 50 40 AMA PRA, ABMS, AAFP

Maine DO 100 hrs 2 yrs 50 20 AMA PRA, AOA

Maryland* 50 hrs 2 yrs 25 50 AMA PRA (see note)

Massachusetts 100 hrs 2 yrs 50 40 AMA PRA, GME Study board reqs; risk mgmt

Michigan 150 hrs 3 yrs 50 75

Michigan DO 150 hrs 3 yrs 50 60 60 hrs Category 1-A or 1-B

Minnesota 75 hrs 3 yrs 25 75 AMA PRA, AOA, MOCOMP

Mississippi 40 hrs 2 yrs 20 40 ABMS, AOA, AAFP, ACOG

Missouri 50 hrs 2 yrs 25 50 AAFP

Montana none

Nebraska 50 hrs 2 yrs 25 50 AMA PRA

Nevada 40 hrs 2 yrs 20 40 AMA PRA Ethics (2 hrs), 20 hrs in specialty;4 hrs bioterrorism

Nevada DO 35 hrs 1 yr 35 10 AMA PRA

EXHIBIT B


State Medical Licensure Requirements and Statistics, 2006/ 49

New Hampshire 150 hrs 3 yrs 50 60 AMA PRA, ABMS Credits reported to NH Med Soc

New Jersey 100 hrs 2 yrs 50 40 AOA Cultural competence

New Mexico 75 hrs 3 yrs 25 75 AMA PRA, ABMS, AAFP, ACOG

New Mexico DO 75 hrs 3 yrs 25 75 AMA PRA, ABMS, AAFP, ACOG, Active membership in AOA mayUSMLE replace 75 hours of CME

New York none Infection control, child abuse

North Carolina 150 hrs 3 yrs 50 60

North Dakota 60 hrs 3 yrs 20 60 AMA PRA, AOA, AAFP, MOCOMP

Ohio 100 hrs 2 yrs 50 40 AMA PRA CME must be OSMA/OOA-certified

Oklahoma 60 hrs 3 yrs 20 60 AMA PRA, ABMS

Oklahoma DO 16 hrs 1 yr 16 16 16 hrs of Category 1, 1 hr of which must be CME on prescribingcontrolled substances (every 2 yrs)

Oregon none

Pennsylvania 100 hrs 2 yrs 50 20 AMA PRA 12 hrs patient safety/risk mgmt

Pennsylvania DO 100 hrs 2 yrs 50 20 Regulations being drafted 20 hrs Category 1-A;12 hrs risk management

Puerto Rico 60 hrs 3 yrs 20 40 AMA PRA

Rhode Island 40 hrs 2 yrs 20 40 AMA PRA, AOA HIV universal precautions/blood-borne pathogens; end of lifeeducation/palliative care

South Carolina 40 hrs 2 yrs 20 40 ABMS, AOA, ACOG equivalent

South Dakota none

Tennessee 40 hrs 2 yrs 20 40 AMA PRA, AAFP

Tennessee DO 40 hrs 2 yrs 20 40 AOA, AAFP

Texas 24 hrs 1 yr 24 12 AMA PRA, AAFP, AOA Of 12 hrs Category 1, at least 1 hr in ethics/prof. responsibility

Utah 40 hrs 2 yrs 20 20 AMA PRA

Vermont none

Vermont DO 30 hrs 2 yrs 15 AMA PRA At least 12 of 30 hrs mustbe osteopathic med education

Virgin Islands 40 hrs 1 yr 40 25 AMA PRA

Virginia 60 hrs 2 yrs 30 30 Of Category 1, 15 hrs must be interactive

Washington 200 hrs 4 yrs 50 80 AMA PRA, ABMS, AAFP, ACOG

Washington DO* 150 hrs 3 yrs 50 60 AMA PRA, AOA, others (see note)

West Virginia 50 hrs 2 yrs 25 50 AMA PRA, ABMS (partial) 2 hrs end-of-life pain management

West Virginia DO 32 hrs 2 yrs 16 16 Board-recognized equivalent 2 hrs end-of-life management

Wisconsin 30 hrs 2 yrs 15 30 AMA PRA

Wyoming 60 hrs 3 yrs 20 60 AMA PRA Effective Jan 1, 2007

Abbreviations

ABMS—certification or recertification by a member board of the American Board of Medical Specialties; AMA PRA—American Medical Association Physician’sRecognition Award; AOA—American Osteopathic Association; AAFP—AmericanAcademy of Family Practice; ACOG—American College of Obstetricians andGynecologists; APA—American Pediatric Association; CMA—California MedicalAssociation; CAFP—California Academy of Family Physicians; CME—continuing medicaleducation; FLEX—Federation Licensing Examination; GME—graduate medical educa-tion; MOCOMP—Royal College of Physicians and Surgeons of Canada; OSMA—OhioState Medical Association; USMLE—United States Medical Licensing Association

Table 15 (continued)Continuing Medical Education for Licensure Reregistration

Required Average AMA/AOA/AAFP/ACOGNumber of CME Hours Category 1 Hours Certificates Accepted State-Mandated CME Content/Hours per Year(s) per Year Required as Equivalent Additional Notes

* Refer to introductory text to this table for more information on this state’s regulations.

Note: All information should be verified with licensing board; medical licenses are granted to those physicians meeting all state requirements—at the discretion of the board.

Exhibit C

Resource Materials - Keith Korenchuk

Source: Keith Korenchuk. Reprinted with permission.

EXHIBIT C


1

RESOURCE MATERIALS

Keith M. KorenchukPartner

McGuireWoods LLPWashington D.C.

[email protected]

2

The Roadmap Through the

Minefield in Three Parts

• The Concerns

• The Guidance

• The Specific Challenge Areas


EXHIBIT C

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Part I: The Concerns

• The Antikickback Statute

• FDA Requirements

• Off-label Promotion

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The Concerns:

The Antikickback Statute

Although liability under the anti-kickback statute ultimately turns on a party’s intent, it is possible to identify arrangements or practices that may present a significant potential for abuse.

Initially, a manufacturer should identify any remunerative relationship between itself (or its representatives) and persons or entities in a position to generate federal health care business for the manufacturer directly or indirectly.

The next step is to determine whether any one purpose of the remuneration may be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program.

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The Concerns:

• FDA Requirements

• Off-label Promotion

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Part II: The Guidance

• FDA Guidance

• OIG Compliance Guidance

• PhRMA Code

• ACCME Guidance on CME


EXHIBIT C

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Part III: Specific Challenge

Areas

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CME Minefield #1:

Company Initiated Programs

• Risks

• Available Guidance

• Critical Issues

• Are they ever acceptable?

EXHIBIT C


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FDA Guidance:

Programs and materials performed and disseminated by companies are subject to the labeling and advertising provisionsof the Federal Food, Drug, and Cosmetic Act.

Discussions of unapproved uses, which can be an important

component of scientific and educational activities, are not

permissible in programs that are or can be (because the

provider is not functionally independent) subject to substantive

influence by companies that market products related to the

discussion. FDA recognizes that industry-supported activities

can be both nonpromotional and educational.

These provisions require the company to ensure that the

content does not promote unapproved uses, and that

discussions of the company’s products are not false or

misleading and do not lack fair balance.

10

FDA Guidance:

In determining whether an activity is independent of the substantive influence of a company, FDA examines whether and to what extent the company is in a position to influence the presentation of information related to its products or otherwise transform an ostensibly independent program into a promotional vehicle.

FDA is concerned that companies may influence the content of educational programs both directly and indirectly. Directly, by being involved in the selection of speakers or in the treatment of topics. Indirectly, through the nature of the relationship between the

company and the provider.


EXHIBIT C

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OIG Guidance: Kickbacks

• Does the arrangement or practice have a potential to interfere with, or

skew, clinical decision-making? Does it have a potential to undermine

the clinical integrity of a formulary process? If the arrangement or

practice involves providing information to decision-makers, prescribers,

or patients, is the information complete, accurate, and not misleading?

• Does the arrangement or practice have a potential to increase costs to

the federal health care programs, beneficiaries, or enrollees? Does the

arrangement or practice have the potential to be a disguised discount to

circumvent the Medicaid Rebate Program Best Price calculation?

• Does the arrangement or practice have a potential to increase the risk of

overutilization or inappropriate utilization?

• Does the arrangement or practice raise patient safety or quality of care

concerns?

Manufacturers should ask the following questions, among others, about any problematic arrangements or practices they identify:

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PhRMA Code: Educational or

Professional Meetings

Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty healthcare professionals. Similarly funding should not be offered to compensate for the time spent by healthcare professionals attending the conference or meeting.

EXHIBIT C


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CME Minefield #2:

Third Party Initiated Programs

• Standards

• Available Guidance

• “Independence”

• Monitoring/Auditing

14

OIG Guidance: Education

Absent unusual circumstances, grants or support for educational activities sponsored and organized by medical professional organizations raise little risk of fraud or abuse, provided that the grant or support is not restricted or conditioned with respect to content or faculty.

Pharmaceutical manufacturers often provide funding to other sponsors of CME programs. Manufacturers should take steps to ensure that neither they, nor their representatives, are using these activities to channel improper remuneration to physicians or others in a position to generate business for the manufacturer or to influence or control the content of the program.


EXHIBIT C

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PhRMA Code: Third-Party

Educational or Professional

MeetingsAny financial support should be given to the conference’s

sponsor which, in turn, can use the money to reduce the overall

conference registration fee for all attendees. Responsibility for

and control over the selection of content, faculty, educational

methods, materials, and venue belongs to the organizers of the

conferences or meetings in accordance with their guidelines.

Financial support should not be offered for the costs of travel,

lodging, or other personal expenses of non-faculty healthcare

professionals attending CME, either directly to the individuals

attending the conference or indirectly to the conference’s

sponsor. Similarly funding should not be offered to compensate

for the time spent by healthcare professionals attending the

conference or meeting.

16

ACCME Standard:

Independence

• Identification of CME needs;

• Determination of educational objectives;

• Selection and presentation of content;

• Selection of all persons and organizations that will be in

a position to control the content of the CME;

• Selection of educational methods;

• Evaluation of the activity.

A CME provider must ensure that the following decisions were made

free of the control of a manufacturer.

A manufacturer cannot take the role of non-accredited partner in a

joint sponsorship relationship.

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ACCME Standard: Appropriate

Use of Manufacturer Support

The CME provider must make all decisions regarding the

disposition and disbursement of manufacturer support.

A CME provider cannot be required by a manufacturer to

accept advice or services concerning teachers, authors, or

participants or other education matters, including content,

from a manufacturer as conditions of contributing funds or

services.

All manufacturer support associated with a CME activity must

be given with the full knowledge and approval of the CME

provider.

18

ACCME Standard:

Written Agreement

The agreement must include the CME provider, even if the support is given directly to the CME provider’s educational partner or a joint sponsor.

The written agreement must specify the manufacturer that is the source of commercial support.

Both the manufacturer and the CME provider must sign the written agreement between the manufacturer and the CME provider.


EXHIBIT C

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ACCME Standard: Appropriate Management of Associated

Commercial PromotionArrangements for commercial exhibits or advertisements cannot influence planning or interfere with the presentation, nor can they be a condition of the provision of commercial support for CME activities.

Product-promotion material or product-specific advertisement of any type is prohibited in or during CME activities. Live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CME.

Educational materials that are part of a CME activity, such as slides, abstracts and handouts, cannot contain any advertising, trade nameor a product-group message.

Print or electronic information distributed about the non-CME elements of a CME activity that are not directly related to the transfer of education to the learner, such as schedules and content descriptions, may include product-promotion material or product-specific advertisement.

A provider cannot use a commercial interest as the agent providing a CME activity to learners.

20

FDA Guidance: Relationship Between Provider and

Supporting Company

FDA will consider whether there are legal, business, or other

relationships between the manufacturer and the CME

provider that could place the manufacturer in a position

whereby it may exert influence over the content of the activity

(e.g., a provider that is owned by, or is not viable without the

support of, the company supporting the activity).

FDA will consider whether individuals employed by the CME

provider and involved in designing or conducting scientific or

educational activities are also involved in advising or

otherwise assisting the manufacturer with respect to sales or

marketing of the manufacturer’s product.

EXHIBIT C


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FDA Guidance:

Written Agreement

One means of documenting the measures taken to

ensure independence of an activity is to have a written

agreement between the CME provider and the

supporting manufacturer. This document should reflect

that the CME provider will be solely responsible for

designing and conducting the activity, and that the

activity will be educational, nonpromotional, and free

from commercial bias. While not required, a written

agreement, coupled with the factors described above,

can provide valuable evidence as to whether an activity

is independent and nonpromotional.

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CME Minefield #3:

Program Funding Decisions

• Departmental Approval

• Integrity of Decision Making

• Permissible / Impermissible Linkages


EXHIBIT C

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OIG Guidance:

Educational GrantsFunding that is conditioned, in whole or in part, on the purchase of product implicates the fraud and abuse statute, even if the educational or research purpose is legitimate.

To the extent the manufacturer has any influence over the substance of an educational program or the presenter, there is a risk that the educational program may be used for inappropriate marketing purposes.

To reduce the risks that a grant program is used improperly to induce or reward product purchases or to market product inappropriately, manufacturers should separate their grant making functions from their sales and marketing functions.

Manufacturers should establish objective criteria for making grants that do not take into account the volume or value of purchases made by, or anticipated from, the grant recipient and that serve to ensure

that the funded activities are bona fide.

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Meetings

Any financial support should be given to the conference’s

sponsor which, in turn, can use the money to reduce the

overall conference registration fee for all attendees.

Financial support should not be offered for the costs of travel,

lodging, or other personal expenses of non-faculty healthcare

professionals attending CME or other third-party scientific or

educational conferences or professional meetings, either

directly to the individuals attending the conference or

indirectly to the conference’s sponsor. Similarly funding

should not be offered to compensate for the time spent by

healthcare professionals attending the conference or

meeting.

EXHIBIT C


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CME Minefield #4:

Content / Program / Speaker

Reviews

• Internal Standards

• Guidance

• Scientific / Marketing Boundaries

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OIG Guidance:

Education

To the extent the manufacturer has any influence over the

substance of an educational program or the presenter, there

is a risk that the educational program may be used for

inappropriate marketing purposes.

The manufacturer should have no control over the speaker or

content of the educational presentation.

Manufacturers should take steps to ensure that neither they,

nor their representatives, are using these activities to

channel improper remuneration to physicians or others in a

position to generate business for the manufacturer or to

influence or control the content of the program.


EXHIBIT C

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ACCME Standard: Resolution of

Personal Conflicts of Interest

The CME 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 with any

manufacturer to the CME provider.

The ACCME defines “relevant’ financial relationships” as

financial relationships in any amount occurring within the past

12 months that create a conflict of interest.

An individual who refuses to disclose relevant financial

relationships will be disqualified

The CME provider must have implemented a mechanism to

identify and resolve all conflicts of interest prior to the

education activity being delivered to learners.

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ACCME Standard: Use of

Commercial Support

A CME provider cannot be required by a

manufacturer to accept advice or services

concerning teachers, authors, or participants or

other education matters, including content, from a

manufacturer as conditions of contributing funds or

services.

All manufacturer support associated with a CME

activity must be given with the full knowledge and

approval of the CME provider.

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ACCME Standard: Expenditures for an individual providing CME

The CME provider must have written policies and procedures governing honoraria and reimbursement of out-of-pocket expenses for planners, teachers and authors.

The CME provider, the joint sponsor, or designated educational partner must pay directly any teacher or author honoraria or reimbursement of out-of-pocket expenses in compliance with the CME provider’s written policies and procedures.

If teachers or authors are listed on the agenda as facilitating or conducting a presentation or session, but participate in the remainder of an educational event as a learner, their expenses can be reimbursed and honoraria can be paid for their teacher or author role only.

30

ACCME Standard: Content and

Format without Commercial Bias

The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a manufacturer.

Presentations must give a balanced view of therapeutic options. If the CME educational material or content includes trade names, where available trade names from several companies should be used, not just trade names from a single company.


EXHIBIT C

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FDA Guidance:

Independence

In determining whether an activity is independent of the

substantive influence of a manufacturer, FDA examines

whether and to what extent the manufacturer is in a position

to influence the presentation of information related to its

products or otherwise transform an ostensibly independent

program into a promotional vehicle.

FDA is concerned that manufacturers may influence the

content of educational programs both directly and indirectly.

Directly, by being involved in the selection of speakers or in

the treatment of topics. Indirectly, through the nature of the

relationship between the manufacturer and the CME

provider.

32

FDA Guidance: Content and Selection of

Presenters and Moderators

FDA will consider whether the CME provider has maintained

full control over the content of the program, planning of the

program’s content, and over the selection of speakers and

moderators.

FDA will look at whether the manufacturer has engaged in

scripting, targeting points for emphasis, or other actions

designed to influence the program’s content. FDA will

consider if the manufacturer has suggested speakers who

are or were actively involved in promoting the manufacturer’s

products or who have been the subject of complaints or

objections with regard to presentations that were viewed as

misleading or biased in favor of the manufacturer’s products.

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FDA Guidance: The Focus

of the ProgramFDA will consider whether the intent of the manufacturer and the

CME provider is to produce an independent and nonpromotional

activity that is focused on educational content and free from

commercial influence or bias. FDA will also consider whether the

title of the activity fairly and accurately represents the scope of

the presentation.

FDA also will look at the focus of the activity to determine if the

central theme is based on a single product marketed by the

manufacturer or a competing product, except when existing

treatment options are so limited as to preclude any meaningful

discussion of alternative therapies. Emphasis on a newer or, in

the view of the presenter, more beneficial treatment modality

should be provided in the context of a discussion of all

reasonable and relevant options.

34

FDA Guidance: Audience SelectionFDA will consider whether invitations or mailing lists for supported

activities are generated by the sales or marketing departments of the

manufacturer, or are intended to reflect sales or marketing goals (e.g., to

reward high prescribers of the company’s products, or to influence

“opinion leaders”).

In the case of a live presentation, FDA will consider whether there was

an opportunity for meaningful discussion or questioning provided during

the program.

FDA will consider whether information about the manufacturer’s product

presented in the scientific or educational activity is further disseminated

after the initial program, by or at the behest of the manufacturer, other

than in response to an unsolicited request or through an independent

provider.

FDA will consider whether there are promotional activities, such as

presentations by sales representatives or promotional exhibits, taking

place in the meeting room.


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CME Minefield #5:

Locations

• Resorts

• Cruise Ships

• Non-resort locations

• Appearances

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OIG Guidance: Relationships with

Physicians and Other Persons

Any time a pharmaceutical manufacturer provides anything of

value to a physician who might prescribe the manufacturer’s

product, the manufacturer should examine whether it is

providing a valuable tangible benefit to the physician with the

intent to induce or reward referrals.

If goods or services provided by the manufacturer eliminate

an expense that the physician would have otherwise incurred

(i.e., have independent value to the physician), or if items or

services are sold to a physician at less than their fair market

value, the arrangement may be problematic if the

arrangement is tied directly or indirectly to the generation of

federal health care program business for the manufacturer.

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Meetings

A conference or meeting shall mean any activity

held at an appropriate location, where (a) the

gathering is primarily dedicated, in both time and

effort, to promoting objective scientific and

educational activities and discourse (one or more

educational presentations(s) should be the highlight

of the gathering), and (b) the main incentive for

bringing attendees together is to further their

knowledge on the topic(s) being presented.

38

CME Minefield #6:

Meals

• Types

• Linkage

• Guests

• Funding


EXHIBIT C

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OIG Guidance: Relationships

with Physicians and Other

Persons

Any time a pharmaceutical manufacturer provides anything of value to a physician who might prescribe the manufacturer’s product, the manufacturer should examine whether it is providing a valuable tangible benefit to the physician with the intent to induce or reward referrals.

40

PhRMA Code: Meals

Financial support for meals or receptions maybe

provided to the CME sponsors who in turn can provide

meals or receptions for all attendees. A company also

may provide meals or receptions directly at such

events if it complies with the sponsoring organization’s

guidelines. In either of the above situations, the meals

or receptions should be modest and be conducive to

discussion among faculty and attendees, and the

amount of time at the meals or receptions should be

clearly subordinate to the amount of time spent at the

educational activities of the meeting.

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ACCME Standard:

Expenditures for learners

Social events or meals at CME activities cannot

compete with or take precedence over the educational

events.

The provider may not use commercial support to pay

for travel, lodging, honoraria, or personal expenses for

non-teacher or non-author participants of a CME

activity. The provider may use commercial support to

pay for travel, lodging, honoraria, or personal expenses

for bona fide employees and volunteers of the provider,

joint sponsor or educational partner.

42

CME Minefield #7:

Alliances

• Institutions

• Education Partners

• Standards / Monitoring


EXHIBIT C

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OIG Guidance: Education

Manufacturers should take steps to ensure that

neither they, nor their representatives, are using

these activities to channel improper

remuneration to physicians or others in a position

to generate business for the manufacturer or to

influence or control the content of the program.

44

ACCME Standard:

Independence

• Identification of CME needs;

• Determination of educational objectives;

• Selection and presentation of content;

• Selection of all persons and organizations that will be in

a position to control the content of the CME;

• Selection of educational methods;

• Evaluation of the activity.

A CME provider must ensure that the following decisions were made

free of the control of a commercial interest.

A commercial interest cannot take the role of non-accredited partner in

a joint sponsorship relationship.

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CME Minefield #8:

Non-CME Medical - Education

• Is it alive?

• What standards / restrictions

46

FDA Guidance:

A company-supported educational activity or part

thereof that does not relate to the company’s

products or a competing product, or suggest a use

for the company’s products, would not be

considered a promotional activity under FDA

guidance.


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CME Minefield #9:

Grants

• Product ties

• Specific or General

• Commitments

48

OIG Guidance:

Educational Grants

Funding that is conditioned, in whole or in part, on the purchase

of product implicates the fraud and abuse statute, even if the

educational or research purpose is legitimate.

Manufacturers should separate their grant making functions from

their sales and marketing functions.

Manufacturers should establish objective criteria for making

grants that do not take into account the volume or value of

purchases made by, or anticipated from, the grant recipient and

that serve to ensure that the funded activities are bona fide.

When evaluating educational or research grants provided by

manufacturers to physicians, manufacturers should determine if

the funding is based, in any way, expressly or implicitly, on the

physician’s referral of the manufacturer’s product.


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PhRMA Code: Scholarships and

Educational Funds

Financial assistance for scholarships or other educational

funds to permit medical students, residents, fellows, and

other healthcare professionals in training to attend carefully

selected educational conferences may be offered so long as

the selection of individuals who will receive the funds is

made by the academic or training institution.

“Carefully selected educational conferences” are generally

defined as the major educational, scientific, or policy-making

meetings of national, regional, or specialty medical

associations.

Resources

RESOURCES


The following articles appeared in the last year since July 2005 in the DAILY

newsletter ePharm5. To request a free trial or for more details on our coverage,

please call ePharmaceuticals at 877/437-4276 or e-mail [email protected]

New site for neurologists offers free CME, news, peer discussion

A new Web site developed by neurologists for neurologists launched last week with freeevidenced-based CME courses and other content. The site, from neurology education networkIssues in Neurology, will offer Web-based CME courses presented by recognized neurologyexperts, as well as information about other live educational events that are offered through the network. The site includes updated neurology news, information about upcoming events, anddiscussion boards where members can interact with peers and thought leaders. Issues inNeurology is sponsored by Scienta Healthcare, an ACCME-accredited provider. The site waslaunched in conjunction with the American Headache Society's annual meeting in Los Angeleslast week.

MedsiteCME adds animated video to eCME site

MedsiteCME has added multimedia in the form of animated videos to its online CME casestudies, the company reports. The addition of multimedia to the case-based CME programsallows physicians to view and interact with patient videos, diagnostic imaging, and animated mechanisms. The video makes it easier for physicians to visualize procedures and anatomy in an interactive manner, Medsite says. MedsiteCME maintains more than 450,000 physicians in itsdatabase and is supported by unrestricted educational grants from more than 20 pharmacompanies. An example of three neurology cases with multimedia can be found at MedSiteCME.Earlier this month, The New England Journal of Medicine added to its Web site peer-reviewededucational videos that aim to teach procedures and specialized physical examinations(ePharm5, 4/17/06).

GSK-sponsored CME site teaches docs about human papillomavirus

GlaxoSmithKline (GSK) is sponsoring a new online CME resource for healthcare professionalsabout human papillomavirus (HPV) while it awaits FDA approval for its HPV vaccine, Cervarix.The site, HPVResource.org, provides peer-reviewed journal articles, interactive conferences withHPV and cervical cancer opinion leaders, and downloadable podcasts of medical presentations.The site also includes a three-dimensional, animated view of HPV disease progression. Userscan receive CME credit for participating. The site is also sponsored by the Postgraduate Institutefor Medicine and produced by medical education company M2 Communications, whose other clients include AstraZeneca, Pfizer, and Wyeth. Last week an FDA advisory panel recommendedMerck's HPV vaccine, Gardasil, for approval. Merck is also running a TV and Web campaign toeducate consumers about cervical cancer, HPV, and Pap tests (ePharm5, 4/25/06).

Verispan survey: 87% of physicians earned eCME credits in 2005

Doctors' use of the Internet for health research, earning CME credits, and participating in onlineevents continues to grow, according to Verispan's 2005 ePromotion Annual Study. For example,87% of physicians said they earned eCME credits in 2005, compared to 81% in 2004, and 40% of


RESOURCES

doctors said they are earning more than one-fifth of their CME credits online. The survey ofapproximately 1,000 physicians across 14 specialties showed that 44% spend between one andthree hours online for health research during the average week, and 84% believe the Internet hasa positive impact on their knowledge of medical conditions and new products. As physicians' timeonline increases, so has pharma spending. According to the survey, pharmas spent $280 million to reach doctors online in 2005, a 27% increase from the year before.

New MedsiteCME Web site tools provide access to KOL roundtables

New features on MedsiteCME's Web site provide physicians with more in-depth disease resources and access to expert discussions in their fields. The new educational ResourceCenters give physicians information about specific diseases using e-newsletters, news feeds,treatment guidelines, conference calendars, interactive CME cases, and an Ask-the-Faculty tool.The Roundtables section publishes information and supporting monographs from key opinionleader roundtables. The site has also added teleconferencing, which allows physicians to dial inor go online to hear experts speak, according to MedsiteCME. Last summer, Medsite partnered with Yahoo! Health to bring physician-level drug information to consumers (ePharm5, 6/21/05).MedsiteCME, a division of Medsite, is supported by unrestricted educational grants from majorpharmas, including Pfizer, Wyeth, and Bayer.

Nearly 4,500 clinicians receive credits from AZ-sponsored online CME

Three months after completing an online and offline CME program about depression, cliniciansand primary care physicians (PCPs) are more frequently screening depressed patients for bipolar disorder, according to newly released outcomes data about the program. The eight-month,AstraZeneca-funded program from CME LLC (ePharm5, 5/25/05) provided online educationalactivities and CME credits to nearly 4,500 clinicians, Barbara Winkelman, vice president ofmarketing & multimedia for CME LLC, tells ePharm5. Online CME activities included archivedteleconferences, clinical puzzles, Q&A sessions about various treatment challenges, and anonline video program, she says. The program also helped identify future learning opportunities.For example, although the participating PCPs screened more often for bipolar disorder, theydidn't identify the recommended Mood Disorder Questionnaire as the tool that should be used,says Winkelman.

Web site helps physicians empower patients, includes eCME

A new Web site aims to help healthcare providers engage patients in actively managing their own health. The site, from managed-care company ValueOptions, gives clinicians in its networkaccess to clinical content, including nearly 4,000 articles about more than 200 health topics.Clinicians can also access news, professional treatment guidelines, screening tools, and CMEopportunities, according to the site. Doctors have the option of printing out material from the siteto share with patients or directing patients to the site so they can access the recommended resources themselves. The site is also available in Spanish.

Pharma sponsorship opportunities available on MedPage Today site

Bristol-Myers Squibb, Sanofi Pharmaceuticals, and AstraZeneca are among the pharmasadvertising on MedPage Today's online coverage of medical meetings, according to the site.MedPage Today is offering pharmas the chance to provide educational grants to fund coverageof medical meetings and same-day CME accreditation, according to the company. The coverageincludes live reporting from medical meetings and video interviews with key opinion leaders. InSeptember, the site, which reaches more than 300,000 U.S. physicians, added the Fingertip Formulary Online, a tool containing formulary information for virtually all U.S. health plans

RESOURCES


(ePharm5, 9/16/05). Search for "MedPage Today" on ePharm InDepth and to read all of our pastMedPage Today coverage.

Mediwire launches Part D network, CME platform

Mediwire Network, a syndicated online content network for physicians, has added new features toits network of more than 110 Web sites, including a Medicare Part D network and a CMEplatform, according to the company. The network has also added medical association partnerssuch as the Los Angeles County Medical Association, the American Medical Group Association,the Nebraska Medical Association, and the Southern Medical Association. Mediwire also saysthat pharmas can use its awareness-creation programs to position accredited and non-accreditedphysician education and on-label content. Mediwire was launched in April by Advanstar(ePharm5, 4/8/05) and now reaches more than half a million unique users.

New e-CME program can be customized to pharma

Medical marketing firm Lathian has launched an e-CME program that can recruit physicians, trackparticipation, and be branded to the sponsoring pharma, according to the company. Lathian canrecruit e-CME participants from its database, and then aggregate data about any single e-CMEprogram, such as how much time participants spent in a session, market survey responses, andrequests for information after the program. The e-CME program uses interactive multimedia toolssuch as streaming video and audio and graphics. During the sessions, which are typically 30-60 minutes long, participants can also click links to see a glossary of terms, learn more on a topicalWeb site, or talk to an expert via a live chat, according to the Web site. Go to Lathian.com tolearn more and to see an e-CME demo.

Ortho-Clinical Diagnostics adds eCME to education Web site

Johnson & Johnson company Ortho-Clinical Diagnostics has added online continuing medicaleducation courses and credits on its educational Web site, Ortho-wire.com, according to thecompany. The site for transfusion medical professionals allows users to take certain coursesonline instead of via distance learning programs that require travel or sending educationalmaterials by mail. The accredited courses include materials that vary in level of difficulty and usemultimedia and interactive learning tools, according to the site, which was launched earlier thisyear. Ortho-wire.com also includes an educational learning assessment tool; an ask the expertsection, which was added in September; and a learning library with additional articles. A surveylast month showed that nearly two out of three doctors believe that educational grants frompharma have a positive effect on CME (ePharm5, 9/23/05).

eCME gains ground, docs OK with pharma funding

Despite concerns to the contrary, 92% of doctors say pharmaceutical sponsorship of CMEactivities has no influence on their decision to participate, according to the annual Physician CMEInsight Study from Pri-Med. In fact, nearly two out of three doctors believe that educational grantsfrom pharma have a positive effect on CME. In addition, 45% of doctors said the opportunity toget specific product information plays a part in their CME selection. The survey also showed thatonline CME continues to grow. Although live forums are still the most popular, accounting for 56%of CME activity, about 12% of physicians' accredited CME hours are delivered online, up 50% inthe past two years. Fifty-three percent of surveyed physicians also say they plan to increase their use of e-CME in the next year. However, online courses are still considered more of asupplement to live forums, according to Pri-Med.

Mobile CME helps docs get education whenever, wherever


RESOURCES

Mobile CME applications should be short and punchy, easy-to-use, and provide information froma range of specialties, Bob MacAvoy, vice president of medical education for Epocrates, saidyesterday during the PMC presymposium. The courses should be about 15-30 minutes in lengthand typically consist of an educational article that doctors can read on their mobile devices, anelectronic post-test, and an e-mail certificate that is sent once the activity is successfullycompleted. These short activities, which are archived for a year, cater to a doctor's busy life. "Thefuture of CME is really helping it fit into a doctor's schedule," he said. Although 85% of doctorssurveyed by Epocrates said they would like a mobile CME option, the majority also said theywould be unwilling to pay for it, opening the door for grants and sponsorships from pharma,educational institutions, and other stakeholders.

Use problem-based learning to engage docs in CME

Using problem-based learning methods is key for CME programs to affect positive change inphysician behavior and patient outcomes, Ray A. Wolf, PharmD, senior manager of nationaleducation & strategy at Sanofi-Aventis, said yesterday during the PMC presymposium. Problem-based learning uses real-world situations that physicians can relate to and is more outcome-related. Because physicians can apply classroom situations to their own patients, practice, and experience, problem-based learning promotes deeper understanding, Wolf said. It also creates a more stimulating learning environment, which not only engages the physicians, but promotescollaboration with colleagues and instructors. This method improves motivation and knowledgeretention among physicians, Wolf added, emphasizing the importance of active participation.

Survey: Convenience, access drive docs' e-CME use

More than 70% of primary care physicians (PCP) who use e-CME say convenience and "anytimeaccess" are the top usage drivers, according to a survey from CME provider Pri-Med. More than40% say they use e-CME Web sites to search for specific information about conditions theirpatients have, and another 40% say they use e-CME Web sites to follow up on information theyreceived during a live event. Nearly two out of three PCPs use the Internet every day to findclinical or professional information, while 17% say the Web is their preferred source for CME--a 70% increase from 2003. Two-thirds of PCPs have participated in e-CME in the past year, and nearly half say they plan to increase their participation in the next year. Other popular onlinedestinations for PCPs are Web sites designed specially for doctors and sites that provide links toclinical resources, says Pri-Med.

Medscape to provide e-CME, online coverage for AIDS conference

Medscape, WebMD's physician portal, will be the source of online CME for the International AIDSSociety's (IAS) Conference on HIV Pathogenesis and Treatment, according to a report fromWebMD. Medscape will develop the e-CME activities based on the data and scientificdevelopments presented during the conference and will post them on the Medscape Web sitewithin four weeks of the end of the conference. Medscape will also provide exclusive online access to IAS scientific discussions and forums, including daily news reporting, physiciancommentary, and interviews with AIDS researchers about conference findings, according toWebMD. The third annual conference will be held in Rio de Janeiro, Brazil, on July 24-27.Conference sponsors include several major pharmas, such as Pfizer, GlaxoSmithKline, and Roche.

Forrester: Medscape most popular online destination for docs

Ninety-two percent of physicians have visited Web sites for clinical information, according to anew study from Forrester Research. The survey of 1,331 U.S. doctors shows that Medscape,WebMD's physician portal, is the most popular online destination, with 71% of physicians

RESOURCES


reporting they've visited it. The survey also found that doctors use the Web to research drug information more than any other clinical topic, and many doctors use pharma-sponsored sitessuch as MerckMedicus (32%) and MDLinx (17%). Links to a broad range of medical information,access to the latest evidence-based clinical guidelines, and e-CME opportunities are the biggestvalue-adders to clinical sites, according to the study. Doctors also say established brands andapproval or endorsement from professional organizations lend credibility to Web sites. For a copyof the full report, go to forrester.com.

These articles appeared in the last year since July 2005 in the DAILY newsletter

ePharm5. To request a free trial or for more details on our coverage, please call

ePharmaceuticals at 877/437-4276 or e-mail [email protected]


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Do your sales reps understand compliance risks?

The pharmaceutical industry widely recognizes continuing medical education (CME) as

an effective and necessary way to keep healthcare providers up to date on clinical

developments. However, with increased scrutiny and regulation from the likes of the

Office of Inspector General (OIG) and the Accreditation Council for Continuing Medical

Education (ACCME), pharmaceutical companies and their sales representatives walk a

fine line with regard to providing financial support for CME activities.

The CME Online Training for Pharmaceutical Sales Reps—which includes a quiz,

answer key, and certificate of completion—will help sales reps understand CME's

importance to physicians and other healthcare providers, as well as the legal issues that

affect a pharmaceutical company's support for CME.

This interactive training gives you an overview of the two primary forms of CME

activity; provides in-depth reviews of the organizations with major roles in CME,

including the FDA, PhRMA, and the OIG; and discusses the relationship between CME

accreditation and the ACCME.

Use this CME Online Training to:

• Raise understanding of personal and professional risks of non-compliant behavior

• Establish a training process that is scalable and easily managed and maintained

• Demonstrate company-wide commitment to compliance ‘from the top down’

• Customize modules to reflect your “Code of Conduct” or specific SOP

CONTACT US

For more information on ePharmaceuticals Online Compliance Training call our

Customer Service Team at 877/437-4276 or e-mail [email protected].

RESOURCES


CME Training Handbook For Pharmaceutical Sales Reps

To request a free sample, or for information on bulk or custom orders, please call ePharmaceuticals at 877/437-4276 or e-mail [email protected]

The CME Training Handbook for Pharmaceutical Sales Reps—which includes a quiz, answer key, andcertificate of completion—will help sales reps understand CME's importance to physicians and otherhealthcare providers, as well as the legal issues that affect a pharmaceutical company's support for CME.

HANDBOOK CONTENT

1. Introduction2. What is CME?

o Types of CME3. Organizations with major roles in CME

o The FDAo PhRMA o The OIG

4. CME accreditation and the ACCMEo CME trendso ACCME's interventiono The ACCME Standardso Standard 1: Independenceo Standard 2: Resolution of personal conflicts of interesto Standard 3: Appropriate use of commercial supporto Standard 4: Appropriate management of associated commercial promotionso Standard 5: Content and format without commercial biaso Standard 6: Disclosures relevant to potential commercial bias

5. Lessons learned6. Frequently asked questions

7. Final exam

To request a free sample, or for information on bulk or custom orders, please call

ePharmaceuticals at 877/437-4276 or e-mail [email protected].

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Speaker resourcesKeith KorenchukMcGuire Woods, LLPWashington Square1050 Connecticut Avenue NW Suite 1200Washington, DC 20036-5317E-mail: [email protected] Phone: 202/857-1749

Christopher KingCME SolutionsP.O. Box 68680Tucson, AZ 85737E-mail: [email protected] Phone: 520/818-3037

John DeHartCME SolutionsP.O. Box 68680Tucson, AZ 85737E-mail: [email protected] Phone: 520/544-2938

Barbara A. Fuchs, MSAWyeth Pharmeceuticals500 Arcola Rd. F4320Collegeville, PA 19426E-mail: [email protected] Phone: 484/865-5021

HCPro sites

HCPro: www.hcpro.comIt is HCPro’s mission to meet the specialized information, advisory, and education needs of the healthcareindustry and learn from and respond to our customers with services that meet or exceed the quality theyexpect. Visit HCPro’s Web site at www.hcpro.com and take advantage of our new Internet resources. At hcpro.com, you will find

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HCPro continues to offer the expert advice and practical guidance you’ve come to rely on to meet your dailychallenges. This valuable information will be available to you 24 hours a day, 7 days a week via the Internet.

The Greeley Company, A Division of HCPro: www.greely.comGet connected with leading healthcare consultants and educators at The Greeley Company’s Web site atwww.greeley.com. This online service provides the fastest, most convenient, and most up-to-date informationabout our quality consulting and national training offerings to healthcare leaders. Visitors will find a completelisting of all of our products and services, including consulting services, seminars and conferences, and linksto other HCPro offerings.

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