Independent Medical Education Frequently Asked Questions (FAQs)

1. What is the Sunshine Act?

Astellas IME adheres to The Physician Payment Transparency Program (commonly referred to as the Sunshine Act and Open Payments) and will report all appropriate payments to covered recipients for all grants approved after August 1, 2013.

The U.S. Sunshine Act (the Act) implements the physician payment reporting provisions of the Affordable Care Act (ACA) of 2010. The Act requires Astellas and other applicable manufacturers of products reimbursed by Medicare or Medicaid to track all payments or "transfers of value" made to U.S. physicians and U.S. teaching hospitals (covered recipients) beginning August 1, 2013. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) and publicly posted on a government website on September 30, 2014 and then annually on June 1st thereafter.

The Grant Applicant/Education Partner is responsible to report to Astellas all appropriate payments to covered recipients for all approved grants. These payments will be captured at the time of grant reconciliation (45 days after the end of the activity) and submitted to Astellas in addition to other required documentation.

2. What’s the difference between IME grants and Charitable contributions?

An Independent Medical Education grant provides funding to support evidence-based education that is non-promotional and non-commercial across therapeutic areas and is relevant to the current educational needs of health care providers and patients.

A charitable contribution is funding (including monetary, products, or other assets) provided for a charitable purpose, without a commercial motive, and on an unconditional basis to a qualified 501(c)(3) or otherwise IRS tax-exempt charitable organization to support the organization’s general operations or specific activities.

3. How will I know that my request has been received?

An email will be sent to the requestor upon submission. Please refer to flowchart.

4. Will an Astellas representative be able to assist me with the application process or keep me apprised of my grant’s status?

No. You may contact the Astellas Grants Office for assistance at 1-866-521-AGMS (2467) or via email at grants@astellas.com.

5. Are there any guarantees of approval for grants?

No. Submission of a grant request is not a guarantee of approval.

6. When I should I know if my grant has been approved or denied?

Most contribution decisions occur at an average of 60 days. This is contingent upon the grant request being complete and not requiring additional information. All grant applications must be made at least 60 days in advance.

Grant requests related to satellite symposium initiatives at a professional meeting, may take in excess of 60 days.

Fellowship grant requests are due by November 1 and are reviewed by the following January.Click to view Fellowship Document

7. Is there a limit to the number of requests submitted within a period (e.g. within a year)?

Astellas does not limit the number of requests it will consider from a single organization.

8. May an institution submit multiple grants at the same time?

Yes. Astellas will review multiple requests from the same organization, regardless of whether they are submitted at the same time or different times.

9. Can I complete part of the online grant request and come back to it later?

Yes. You must click “Save & Continue Later” at the bottom of the page to save your request and continue it later. Also, at any time before the submission of a grant request, you will have the opportunity to come back and make changes to the request.

10. If my activity has already started, may I still submit a grant?

No. Grant requests may only be submitted for activities that have yet to occur. Activity start dates must begin no earlier than 60 days after a grant request has been submitted for review.

11. If my grant is approved, does Astellas require any sort of acknowledgment?

Yes. Astellas requires recognition of educational grant support as defined in the ACCME Standards of Commercial Support (Standard 6).

12. If I have an educational partner, are they required to submit anything?

Yes. Astellas holds the accredited provider responsible for the compliant execution of the approved funded activity in alignment with the grant request. All partners (educational or third-party) designated on the grant request must sign and submit the letter of agreement (LOA) and participate -- as appropriate -- in the reconciliation process.

13. What is reconciliation?

There are two types of reconciliation: financial and outcomes.

1. Financial reconciliation consists of detailed activity expenditure documentation and certification that funds were used for the approved activity. These are due 45 days after the end date specified in the approved grant application.

2. Outcomes submission consists of completion of an outcomes module and uploading any supporting documentation. These are due 90 days after the end date in the approved grant application.

NOTE: System-generated reminder emails will be sent periodically to the requestor until reconciliation is complete. All past-due financial/outcomes reconciliations must be completed prior to the review of any new grant request submission.

14. Is there anything that would prevent and/or delay a grant from being considered?

Yes. Outstanding financial and/or outcomes reconciliations must be completed as previously identified in the Astellas Grants Management System (AGMS) prior to review of any new grant submission. Grant requests must be free from any sales or commercial influence or involvement.

Failure to submit requested/required materials – even if due to technical difficulties – will delay the review of any current or future grants.

15. What should I do if the scope of my activity changes?

If the status of a grant activity changes materially from the what was submitted in the original grant request, the requestor must immediately inform the Astellas Grants Office of the change and provide detailed documentation at least 21 days prior to the program’s earliest start date (regardless of whether that was the original start date or the revised start date). Any change in the activity design, methodology, or program execution requires notification, review, and approval by Astellas prior to implementation. Change of scope requests will be considered only if the following information is included:

  • Reason for change
  • Revised detailed budget
  • Detailed impact to previously approved request

Requests can take up to 20 business days for the Astellas Grants Office to review. Astellas reserves the right to discontinue support if it determines that the changes to the program will negatively affect the quality or impact of the program. If support is discontinued, the requestor must return funding in full.

16. What should I do if my activity dates change?

The Requestor should notify the Astellas Grants Office and confirm any activity date changes for grants in review as soon as they are known. For approved grants, the original requestor may access the grant through the requestor inbox and edit via the “edit program date” link. Revised dates must be within or less than 6 months from the original proposed activity date. Astellas will contact the original requestor if further clarification is needed on date changes. Failure to change dates prior to the start of the program may result in Astellas withdrawing support.

17. What should I do if I have money left over from my grant?

All funds remaining from a grant provided by Astellas are expected to be returned. Please send a check made payable to Astellas Scientific and Medical Affairs, Inc. to:

Astellas Pharma
Attn: Patricia Jassak
1 Astellas Way
ASMA, South Building
Northbrook, IL 60062

Additionally, please make sure to include the Grant ID number either in the memo section of the check or in any accompanying documentation. An Astellas W-9 can be downloaded here.

18. If my activity scope changes and I would like to request for additional funding, what is the process?

Any change in the activity design, methodology, or program execution requires notification, review, and approval by Astellas prior to implementation. Requests for additional funding will be considered only if the following information is included:

  • Reason for change
  • Revised detailed budget
  • Request for additional funding on official letterhead (if applying for additional funding)
  • Detailed impact to previously approved request

Requests can take up to 20 business days for the Astellas Grants Office to review.

19. What if my descriptions, agenda, budget, etc. do not fit into the allotted space?

You will have the opportunity to upload supporting documentation at the end of the Grant Request Form.

20. What if I have my own Letter of Agreement?

All Astellas Educational grants must abide by the Letter of Agreement issued by Astellas. If you have any questions on the agreement terms, please contact the Astellas Grants Office at 1-866-521-AGMS (2467) or via email at grants@astellas.com.

21. What is a Request for Additional Information and how much time do I have for completion?

A Request for Additional Information (RAI) is made when more information is needed to consider your grant request. The request will be sent via email. The Astellas Grants Office will follow-up on the original request via email after 14 calendar days. If the Astellas Grants Office has not received all necessary information within 14 calendar days of the follow-up request, the grant request may be closed.

22. I need help distributing invitations to my activity. Can Astellas help?

Only if the request is included in the original grant submission.

23. What should I do if I experience technical difficulties with the AGMS?

For assistance, please contact the Astellas Grants Office at 1-866-521-AGMS (2467) or via email at grants@astellas.com.

It is the responsibility of the grant requestor to notify Astellas’ Grants Office of any technical difficulties.