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Objectives
Provide an overview of the OMJSA Medical Education Department and scientific areas of interest
Review the required elements for educational grant applications Provide an overview of our submission process and required
documents for the following companies: Janssen®
McNeil Pediatrics™Ortho-McNeil®Ortho-McNeil Neurologics® PRICARA™Ortho Women's Health & Urology®
Eligibility Requirements Requirements and New Updates
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Our Mission
To support educational programs with qualified organizations, that: are clinically relevant within scientific and medical areas of interest meet the needs of our customers comply with industry standards, regulatory and corporate
guidelines improve patient care and outcomes
To recognize the need for education at all levels, including national, regional and local activities.
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Scientific Areas of Interest
Janssen – www.janssen.com Schizophrenia Schizoaffective Disorder Bipolar Disorder
McNeil Pediatrics – www.mcneilpediatrics.net ADHD
Ortho-McNeil Neurologics – www.ortho-mcneilneurologics.com Epilepsy
Ortho Women’s Health and Urology
www.ortho-mcneilpharmaceutical.com Hormonal Contraception Interstitial Cystitis
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Scientific Areas of Interest (Con’t) PRICARA – www.pricara.com
Infectious Diseases • Multi-drug Resistance Organisms• Antimicrobial Stewardship• Antimicrobial Resistance
Pain• Acute and Chronic
Gastroenterology • Acid Reflux/GERD
ORTHO-MCNEIL – www.ortho-mcneil.com Cardiovascular
• VTE Prevention (Orthopedics)• Stroke Prevention in Atrial Fibrillation• Thromboembolic Disease (Other)
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Scientific Areas of Interest (Con’t) ORTHO-MCNEIL – www.ortho-mcneil.com
Infectious Diseases • Multi-drug Resistance Organisms• Antimicrobial Stewardship• Antimicrobial Resistance
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Medical Education ScopeActivities we CAN Support
Certified Continuing Education (CME/CPE/CEU) Non-certified educational activities Development of materials for patient or provider education Fellowships Travel Scholarships
Activities we CANNOT Support Education outside our therapeutic areas of interest Programs that have already occurred Promotional activities related to products of Operating
Companies supported by OMJSA Charitable contributions (Send Request to: [email protected])
Advisory boards
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Things to Consider When Requesting an Educational Grant
Normal organizational overhead, e.g., purchase of computer equipment, staff training
Reimbursement for the cost of obtaining CME credits incurred by attendees/learners
Funds used to pay for travel, lodging, conference expenses or honorarium for a customer presenting a poster or paper
Food and beverage expenses at non-accredited programs (exception for grand rounds “modest” food/beverage)
Applicant’s business expensesCommercial display feesCorporate sponsorship/membership fees
Examples of Line Items We Cannot Support
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Required Documents (see Forms link on company websites)
Letter of Request (LOR) Budget Template AgendaNew in 2009 A signed Eligibility Questionnaire from the Accredited
Provider and Educational Partner (if applicable) A signed Payee’s W-9 Form from the requested Payee
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Required Document (see Forms link on company websites)
Eligibility QuestionnaireRequired application component for all proposed educational
activities that will have credit/contact hoursNEW in 2009! Effective immediately, this document replaces the CE Provider
Questionnaire and Certification of Separation templates and is required for CME activities
Must be completed and signed by the Accredited Provider and uploaded within the “CE Provider Questionnaire” field of the application form
If an Educational Partner is involved, an Eligibility Questionnaire must also be completed and signed by this party and uploaded within the “Educational Partner Questionnaire” field of the application form
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Required Document (see Forms link on company websites)
Eligibility Questionnaire (Con’t) Electronic signature is accepted Assures OMJSA that accredited provider/educational
sponsor meets the standards set forth by J&J and abides by acceptable standards (e.g., ACCME, ANCC, ACPE, FDA, and OIG)
To be completed by the accredited provider and educational partner and included as part of the submission packet.
If accreditation status is Probationary Status, this will result in rejection of the grant application.
Note: After January 1, 2010, use of the CE Provider Questionnaire and Certification of Separation templates will result in the rejection of the request. – NEW in 2010!
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Required Document - LOR
Signed Letter of Request (LOR) on Accredited Provider’s /Requesting Organization’s Letterhead (electronic signatures acceptable)
LOR Should Include:
• CME/CE Activity – LOR on Accredited Provider’s letterhead
• Name or topic of program/event
• Date of program/event
• Accredited Providers must be Schools of Medicine, Pharmacy, or Nursing, Hospitals, Medical Societies, Professional
• Accreditation information (if CME activity)
• Program agenda and/or topics New in 2009
• Societies, or government agencies
• Criteria for selecting faculty
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Required Document – LOR (Con’t)
• Funding amount
• Organization’s 9-digit Federal Tax ID number
• Name and address to which the check should be made payable, and mailed if your request is approved.
New in 2009:
• Payee must be the accredited provider
• It is preferred that Accredited Providers receive funds from OMJSA. There may be exceptions to Educational Planners receiving funds from OMJSA but these exceptions are handled on a case by case basis.
• Exceptions must be addressed in the Accredited Provider’s LOR. New in 2010:
• Non-CME/CE Activity – LOR on requestor’s organization’s letterhead. Discussion of Johnson & Johnson products must be within approved product labeling and fairly balanced.
• Statement of how disclosure of financial support will be made to program participants (see the Guidelines section for specific language)
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Request For Grant Applications – RFGAs (NEW in 2009)(see Forms link on company websites)
OMJSA may occasionally issue notifications of funding availability in the form of RFGAs
RFGAs may be broadly disseminated to potential applicants and/or posted on the OMJSA Medical Education website
RFGAs do not replace the spontaneous process of grant submissions (OMJSA has an open submission process)
Questions regarding the RFGA process or regarding specific RFGAs may be directed to [email protected]
Organizations may opt-out of receiving RFGAs by following the link embedded in each RFGA, or by sending an email to [email protected]
Note: RFGA responses in review may have a status of composing as a function of our process
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Totality Status / Customer Status Definitions
Status Applicant Definition
- Composing In Process (Processing)
- Withdrawn (RFGAs) Declined
- Review In Review
- Request for More Information Applicant must submit more information
- Declined Not approved/denied
- Contracting Awaiting signed Educational Grant Agreement
- Approved Approved
- Procurement Initiated Payment being executed or
Pending Reconciliation
- Closed Payment mailed and copy of signed EGA was e-mailed to applicant
Grant Status Definitions
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Grant Submission Process
1 MINIMUM OF 10 WEEKS PRIOR TO PROGRAM
Organization submits complete grant request package on-line through the appropriate operating company website. A notification will be sent to the primary email address on file upon receipt of the application. OMJSA reserves the right to deny requests not submitted in this timeframe.
No faxed or mailed requests will be accepted.
2 CHECK GRANT STATUS ON-LINE
Grant status is available on-line. To access the status, you will need to provide the grant identification number and the email address of the primary contact on file with the grant application.
3 AFTER REVIEW AND APPROVAL
EGA e-mailed to the organization for signature. A written agreement must be executed between OMJSA and the institution prior to the date of program and disbursement of funds. The agreement must be signed and returned within 15 days.
Go to company website (Read Guidelines section)
Submit/View Request Check Grant Status
Funding in any calendar year does not guarantee funding in subsequent years.
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Key Information To Consider
Review the “Therapeutic Areas of Interest” page to ensure funding is available before completing an application
Review the OMJSA Guidelines for areas of interest and download necessary forms (templates provided)
View Quick Reference Guide and FAQs for assistanceComplete and save attachments before submitting an
application (60 minutes timeout)Ensure that the Eligibility Questionnaire is signed by the
Accredited Provider and Educational Partner (if applicable) for CME/CE applications
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Key Information To Consider (Con’t)
The Requestor Information and Primary Contact information must both be from the Accredited Provider
Payee will be the Accredited Provider.Print and save confirmation page. You will need this
information to check the on-line status of your grant.A grant identification number and primary contact email
address is required to check the submission statusGrant identification number will facilitate all communications
about your application
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Key Information To Consider (Con’t)
When OMJSA requests more information Needs Assessment - new information should be bolded
and underlined Submit additional information within 5-10 business days,
unless otherwise specified Indicate Grant Identification # in Subject line of e-mail Failure to respond after the above timeline will prompt
system to deny request and a new submission will be required
For university/teaching institution sponsored activities, payments can only be directed to the institution or medical education department, not to a Department
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Document Submission Consideration
System is compatible with the following document types only: Word (.doc) Excel (.xls) PowerPoint (.ppt) PDF (.pdf)
Zip (.zip) files are not acceptedMaximum file size is 20 megabytesCombine files to condense the number of attachments (e.g., use
tabs within Excel for multiple budget templates)Name files appropriately (e.g., LOR, Agenda)A maximum of 6 documents can only be attached.
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Disclosure Statement - Required
The recommended language regarding disclosure of financial support is:
“Supported by an educational grant from (insert companyname), Division of Ortho-McNeil-Janssen Pharmaceuticals,
Inc., administered by Ortho-McNeil Janssen ScientificAffairs, LLC”.
Company logos will be provided upon request.
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Budget Adjustment
Applicants may be offered less financial support than requestedApplicants are required to adjust line items within budget
template to conform to approved grant amountRevised budget template is to be re-submitted within 10
business daysRequest for the signed EGA is contingent upon the receipt of
the adjusted budget
Note: If approved grant amount is same as requested, no action is needed
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Reconciliation of Paid Grants (Effective as of 4Q08)
Applicants are required to reconcile post activity using the approved budget template that was submitted with the application (refer to information in the “Requested Funding from OMJSA” column)
Provide activity materials:Grants >$25,000 (Completion of Verification of Education Activity
form - New in 2010, Summary of Activity Evaluations, and Activity Outcomes Measurement, if applicable)
Grants <$25,000 (Completion of Verification of Education Activity form - New in 2010, Final Agenda, and Summary of Activity Evaluations)
Financial audits will be conducted based upon selection by OMJSA
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Reconciliation of Paid Grants (Con’t)(Effective as of 4Q08)
Unused/excess funds must be returned within six months following the completion of all activities supported by this grant
Accounting Purposes – J&J Tax ID #22-2203696Program Monitoring – OMJSA reserves the right to monitor
supported activities to ensure appropriate standards are met
Note: Failure to comply with this reconciliation and return of unused/excess funds requirement, may risk approval of future requests.
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Public Posting: Transparency Process
Release Date: October, 2008Based on Johnson & Johnson’s policies, actual payments
made to grant recipients will be posted for public transparency on our operating division websites on a quarterly basis.
Information reported will include: Name and location of the payee Name and location of the accredited provider, if different The dollar amount paid Title of activity Program start date
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Contact Information
Contact Information Requests for funding should be submitted to
www.OMJSAMedEd.jnj.com - NEW in 2010!
Contacts for Further Information General Questions for grant submissions:
» Contact OMJSA @ 1-866-447-2687 or forward an e-mail to [email protected]
Technical Assistance:» If you are experiencing problems with the web page, please email
the System Administrator at [email protected]