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The Institute for Clinical and Economic Review (ICER) involves all key stakeholders in its appraisals of medical services and programs. The purpose of this document is to provide guidance to external stakeholder organizations regarding their involvement in each appraisal.
Organizations considered to be relevant stakeholders for a particular ICER appraisal include the following:
- National groups that represent healthcare professionals, patients, and/or caregivers with a broad or direct interest in the services and programs being evaluated in the appraisal;
- Regional or national research organizations with a broad or direct interest in the services and programs being evaluated in the appraisal; and
- Manufacturers of any tests and treatments being evaluated in the appraisal.
At the outset of the appraisal process, ICER will identify organizations meeting these criteria. Invitations will be extended to each qualifying organization to nominate individuals to serve on the advisory panel for the appraisal, known as the Evidence Review Group (ERG). Roles and responsibilities of ERG members are discussed in further detail here. Qualifying organizations will also be notified when selected ICER materials are posted, to provide an opportunity for such groups to make official comment. These milestones are documented in the flowchart on the ICER website.
It is important to note that, while qualifying organizations will be solicited for ERG nomination and official comment, the opportunity to comment publicly or privately on the components of an ICER appraisal is open to any individual or organization with an interest in the appraisal. For example, a manufacturer of a service or program not in the scope of the appraisal, but nevertheless relevant to the treatment of the condition under study, may wish to comment. ICER therefore makes public announcements on its website when relevant materials are posted or milestones reached. Written responses to all comment letters cannot be assured, but ICER will seek to address as many comments as feasible in writing.
As displayed on the flowchart, the involvement of qualifying organizations will be sought at multiple major milestones during each appraisal, as follows:
- As described above, qualifying stakeholder groups will be invited to recommend individuals to serve on the ERG for the appraisal. The ERG assists ICER in defining the appraisal scope, consulting on methods used during the appraisal, and reviewing and commenting on the primary findings.
- At the beginning of the appraisal process, ICER develops a series of key questions intended to form and refine the scope for the project. Qualifying stakeholder organizations will receive these key questions and the draft project scope via e-mail and will be invited to comment. Comments will be accepted up to 2 weeks following receipt of materials.
- ICER will produce slide sets for its “mid-cycle” conference calls (typically held in month 4 or 5 of the appraisal cycle). The purpose of these calls is to provide a preliminary view into the methods and findings of the systematic review and decision-analytic model for the ERG, and to refine or change aspects of the appraisal based on this interaction. Qualifying organizations will be sent these materials and invited to comment as in step 2 above.
- Qualifying stakeholder organizations will also be sent the draft appraisal report (typically in month 6 or 7 of the appraisal cycle) summarizing the scope, methods, and primary findings of the appraisal, along with an invitation for comment; in this instance, comments will be accepted up to 3 weeks following receipt of materials. Comments received by ICER at least 72 hours prior to the date of the final, in-person meeting of the ERG will be included in the meeting materials to be shared with ERG members.
- Qualifying stakeholder organizations will be notified when the final, in-person meeting of the ERG (typically held in month 7 or 8 of the appraisal cycle) is scheduled to discuss the draft appraisal report, and will be invited to send observers to attend (because space may be at a premium, observer attendance may need to be limited at ICER’s discretion). In addition, because this meeting is held in a public forum, other individuals or organizations may also request to attend as observers by e-mailing
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. Please note that, due to time constraints, there is no scheduled session for public comment at these meetings.
- Following publication of the final appraisal document, qualifying stakeholder organizations will again be notified and invited to submit comments; as in step 4 above, comments will be accepted up to 3 weeks following receipt of materials.
Comments may be submitted in writing (preferred) or via phone conference at the discretion of ICER staff. Qualifying stakeholder organizations should be aware that all written comments, along with ICER’s written responses, will be posted publicly on the ICER web site.
Questions or comments on this policy may be directed to Dan Ollendorf, Chief Review Officer of ICER, at (617) 726-8097, or
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.
ICER Stakeholder Policy
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