industry-support education

Office for Interactions with Industry

Industry Support for Partners Educational Activities


Kaley Klanica and Erin StewartOctober 20, 2010

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“A new system for funding accredited continuing medical education should be developed that is free of industry

influence.”IOM Report on Conflict of Interest in Research, Medical Education and

Practice, April 2009

“Commercial sponsorship could be maintained if the appropriate safeguards are implemented to prevent undue

commercial influence and preserve the integrity and independence of CME.”

Lewis Morris Chief Counsel OIG, US Department of Health and Human Services Testimony to the Senate Special Committee on Aging, July 29, 2009

Industry-support education

Why are we so worried?

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•Physician Payments Sunshine Act and Health Reform

•Massachusetts Pharmaceutical & Medical Device Manufacturer Code of Conduct

•Pharma/Device Companies’ Transparency Sites

•Partners HealthCare

•Harvard

•Peer Institutions

•Stanford

•Michigan

•Memorial Sloan Kettering Cancer Center

Industry-support education

What is being done to address the issues?

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OII/ERB

OII•Provides staffing support to Committee on Conflicts of Interest (CCOI) and Education Review Board (ERB).

•Implements policies regarding interactions with industry

•Processes all educational grants

ERB•Chaired by:

•Jonathan Borus, MD (BWH)•Lawrence Friedman, MD (NWH)

•17 Members•Broad representation•BWH, MGH, Faulkner, NWH•Surgery, Psychiatry, Orthopaedics, Palliative Care, Nursing, and other PHS entity departments•Many members have a broad background in medical education •External members

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Education Activity Approval Flow Chart

Proposal for Support Submitted

to Company

Company Awards Support (financial

or in-kind)

Department NotifiesOII & Submits

RequiredPaperwork

OII Processes Support

OII/ERB Approves and Finalizes

Support

Upon Request, DeptProvides Financial Reconciliation to Company and/or

OII/ERB

EducationalActivity

Required Paperwork:

1. Intake Form2. Budget3. Letter of

Agreement

Required Paperwork:

1. Intake Form2. Budget3. Letter of

Agreement

HMS/Accredited Provider

ERB Company

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What is Industry?

Pharma/Device CompaniesExamples: Pfizer, AstraZeneca, Medtronic

Biotechnology CompaniesExamples: Amgen, Genzyme

For-Profit CompaniesExamples may include: Nike supporting an obesity program or a program on fitness or exercising

Other funding sourcesExamples may include: foundations funded by pharma/device companies (e.g. Ortho Research and Education Foundation, OMeGA Foundation, Eli Lilly Foundation)

What is a Partners Educational Activity?

Continuing Medical Education

Non-Accredited Educational Conferences or Presentations

Clinical Fellowship Program

Patient Education Program

Educational Tools and Resources (website and newsletter)

Skills Building Training Course/Seminar

Industry and Educational Activity

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No industry influence – Partners and/or the Accredited Provider retains control over all aspects of the program

Control of Content (requirements for discussing a company’s product or asking for specific speakers or attendees)

Event (requesting a specific location, time or date) Fellowship program (requirements for selection of fellows or detailed clinical data)

Funding for each program must come from more than one company

All conferences must meet ACCME or comparable standards

More rigorous processes to screen potential conflicts of interest and to monitor content of programs

Collect COI forms from speakers and course directors Slide review

Company does not have any expectation of receiving anything tangible in return for their donation:

NO: IP or royalties, free booth/exhibit space, free admission

Budget complies with ACCME standards and PHS guidelines

Key Criteria for Educational Support

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Multifunder Rule Fellowship Budget Conference Budget Travel Educational Materials/Textbooks

Guidelines Approved

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Multifunder Rule

No industry support for a program unless program support comes from more than one company

Companies must contribute a substantial amount “70/30 Safe Harbor”-no company should provide more than 70%

of the total industry support

1st grants can be processed/approved without a 2nd grant, but they cannot be spent!

In-kind support excluded

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Fellowship Budgets

•Provide detail for your budget

•Budgets must include all external revenue (commercial support, clinical revenue, etc.)

•Indicate number of trainees in the program

•Expenses must be legitimate (e.g. office supplies, pager/pda, program director’s salary)

•If program expenses are less than revenue generated, the excess must be returned to the company in an amount proportional to the amount the company contributed to the total revenue.

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Conference Budgets

All CME and non-CME conferences must comply with the ACCME Standards for Commercial Support

Allowable Expenses (within reason)

Accreditation Fees AV Advertising/Printing/Production Food and drink during program Honoraria (no more than $2500/day)

Management Fees/Admin Expenses

Overhead/Indirect Costs Speaker Expenses (lodging,

meals, transportation) Venue

Prohibited Expenses Attendee Expenses (parking,

travel) Faculty Dinners Gifts for participants Social Events

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Industry Travel Support

Trainees only

From non-profit org. that got industry funding Course must be academic Payment can be made directly to trainee

From industry directly Course must be academic Payment must go to dept, not trainee Do not need 2nd funder

Travel “pool” Program director selects courses Must have multiple funders

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Industry Travel Support

Prohibited: Industry covers personal expenses for fellow to attend industry-

sponsored training Includes device trainings/certification programs that are “mandatory”

Industry agrees to reimburse fellows’ expenses at a conference (even if conference is academic)

It is always acceptable to attend these programs, the question is whether it is permissible to use industry funds to cover the expenses.

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Educational Materials + Textbooks

Permitted Company gives books to department, and department distributes

to library or trainees Two companies give monetary support, and department buys

books for library or trainees

**Books must be academic in nature and selected/endorsed by program director**

Prohibited Company gives books directly to trainees Bookplates with company’s name/logo

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Quality Control/ Quality Improvement

Did the actual expenditures comply with guidelines?

CME Budgets Actual expenses Unexpected costs/revenue Tuition

Fellowship Budgets Actual expenses Clinical revenue

**Track necessary information so that budget can be reconciled after program ends!**

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Apply early in the application cycle/apply to many companies OII has a 30-day advance notice deadline; follow up on your application! Firewalls and Certificates of Separation—send to OII! Grand rounds: apply for the entire academic year Avoid naming faculty/speakers in your application

Properly define the parties in your CME application Companies use your application to auto-generate the LOA. Must include the Accredited Provider (usually HMS) and the Education Partner

(BWH) OII reviews ALL LOAs and coordinates signatures

Course Directors/Program Directors and/or Administrators are not authorized signatories for the hospitals.

Read the Letter of Agreement! Requirements for disclosure, audits, reconciliation and return of excess/unused funds

—you are responsible for complying with these terms!

Please reference the OII intranet site for other useful tips and ideas.Please reference the OII intranet site for other useful tips and ideas.

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OII website: http://pulse.partners.org/OII/index.html• Education FAQs, guidelines and templates• ERB membership and meeting dates• Policies, including conflict of interest

OII e-mail box: [email protected]

Education grants phone line: 617-643-7833

Educational Grants Contacts: Jennifer Riconda: 617-724-3772; [email protected] (MGH, Spaulding) Erin Stewart: 617-643-8659; [email protected] (BWH, Faulkner, McLean, NSMC) Kaley Klanica: 617-724-8081; [email protected] (general)

Other resources Harvard Medical School Department of Continuing Education

http://cme.hms.harvard.edu/ ACCME Standards for Commercial Support

http://www.accme.org/index.cfm/fa/faq.home/Faq.cfm

Resources

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industry-support education

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