Overview of OII All Staff Meeting 1/19/10

Industry Support for Partners
Educational Activities
Office for Interactions with Industry
Kaley Klanica and Erin Stewart
October 20, 2010
Office for Interactions with Industry
Office for Interactions with Industry
Industry-support education
Why are we so worried?
“A new system for funding accredited continuing medical
education should be developed that is free of industry
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
Office for Interactions with Industry
Industry-support education
What is being done to address the issues?
•Physician Payments Sunshine Act and Health Reform
•Massachusetts Pharmaceutical & Medical Device Manufacturer
Code of Conduct
•Pharma/Device Companies’ Transparency Sites
•Partners HealthCare
•Peer Institutions
•Memorial Sloan Kettering Cancer Center
Office for Interactions with Industry
•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
•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
•Many members have a broad background in medical education
•External members
Office for Interactions with Industry
Education Activity Approval Flow Chart
OII/ERB Approves
and Finalizes
Required Paperwork:
1. Intake Form
2. Budget
3. Letter of Agreement
Proposal for
Support Submitted
OII Processes
Department Notifies
OII & Submits
Company Awards
Support (financial
or in-kind)
Upon Request, Dept
Provides Financial
Reconciliation to
Company and/or
Office for Interactions with Industry
Industry and Educational Activity
What is Industry?
Pharma/Device Companies
Examples: Pfizer, AstraZeneca, Medtronic
Continuing Medical Education
Biotechnology Companies
Examples: Amgen, Genzyme
Non-Accredited Educational
Conferences or Presentations
For-Profit Companies
Clinical Fellowship Program
Examples may include: Nike supporting an
obesity program or a program on fitness or
Other funding sources
Examples 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
Patient Education Program
Educational Tools and Resources
(website and newsletter)
Skills Building Training
Office for Interactions with Industry
Key Criteria for Educational Support
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
Office for Interactions with Industry
Guidelines Approved
Multifunder Rule
Fellowship Budget
Conference Budget
Educational Materials/Textbooks
Office for Interactions with Industry
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
Office for Interactions with Industry
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.
Office for Interactions with Industry
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
 Overhead/Indirect Costs
 Speaker Expenses (lodging,
meals, transportation)
 Venue
Prohibited Expenses
 Attendee Expenses (parking,
 Faculty Dinners
 Gifts for participants
 Social Events
Office for Interactions with Industry
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
Office for Interactions with Industry
Industry Travel Support
 Prohibited:
 Industry covers personal expenses for fellow to attend industrysponsored 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.
Office for Interactions with Industry
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
Office for Interactions with Industry
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!**
Office for Interactions with Industry
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
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.
Office for Interactions with Industry
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
 ACCME Standards for Commercial Support
Office for Interactions with Industry
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