office for interactions with industry industry support for partners educational activities office...
Post on 15-Dec-2015
215 Views
Preview:
TRANSCRIPT
Office for Interactions with Industry
Industry Support for Partners Educational Activities
Office for Interactions with Industry
Kaley Klanica and Erin StewartOctober 20, 2010
2
Office for Interactions with Industry
“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?
3
Office for Interactions with Industry
•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?
4
Office for Interactions with Industry
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
5
Office for Interactions with Industry
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
6
Office for Interactions with Industry
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
7
Office for Interactions with Industry
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
8
Office for Interactions with Industry
Multifunder Rule Fellowship Budget Conference Budget Travel Educational Materials/Textbooks
Guidelines Approved
9
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
10
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.
11
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 Expenses
Overhead/Indirect Costs Speaker Expenses (lodging,
meals, transportation) Venue
Prohibited Expenses Attendee Expenses (parking,
travel) Faculty Dinners Gifts for participants Social Events
12
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
13
Office for Interactions with Industry
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.
14
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
15
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!**
16
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
(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.
17
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: PHSOII@partners.org
Education grants phone line: 617-643-7833
Educational Grants Contacts: Jennifer Riconda: 617-724-3772; jriconda@partners.org (MGH, Spaulding) Erin Stewart: 617-643-8659; ecstewart@partners.org (BWH, Faulkner, McLean, NSMC) Kaley Klanica: 617-724-8081; kklanica@partners.org (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
top related