Mission

ICER's mission is to lead innovation in comparative effectiveness research through methods that integrate considerations of clinical benefit and economic value.  Through a unique collaboration with patients, clinicians, manufacturers, insurers and other healthcare stakeholders, ICER develops tools to support patient decisions and medical policy that share the goal of achieving maximum value for every healthcare dollar.

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Policy on Interactions with External Partners and Potential Influences on Judgment


Note: All existing Partners HealthCare policies, including the Interim Policy Statement on Interactions with Industry, govern ICER’s actions.  This “Interactions with External Partners” statement is not intended to contradict, supersede or override existing Partners’ policies.  Its sole purpose is to provide additional transparency to ICER’s interactions with its stakeholders.

Overview
The Institute for Clinical and Economic Review (ICER), based at the Institute for Technology Assessment at Massachusetts General Hospital, provides independent evaluation of the clinical effectiveness and comparative value of health care interventions.  There are several features of ICER’s focus and methodology that distinguish it from other comparative effectiveness assessment organizations.  First, ICER engages more deeply throughout the assessment process with all stakeholders, including patients, clinicians, manufacturers, purchasers, and payers.  ICER also includes as part of all its assessments the results of cost-effectiveness analysis, and continues to work with stakeholders to refine a rating system for comparative clinical effectiveness and comparative value to guide health care decisions.  Lastly, ICER works with all stakeholders to develop and evaluate applications of evidence to create innovative patient-clinician decision support tools, insurance benefit designs, and coverage and payment policies.  Through these activities ICER seeks to achieve its ultimate mission of informing public policy and spurring innovation in the use of evidence to improve the value of health care for all.

In order to ensure the integrity of its research and policy development activities, and to mitigate potential negative impacts, ICER has developed this statement on internal standards for conflicts of interest, interactions with external partners and its approach to managing potential influences on judgment among all participants in its appraisal and policy development work.  

Governance
ICER is part of the Massachusetts General Hospital (MGH) Institute for Technology Assessment (ITA), within the Radiology Department.  As such, ICER is subject to the governance and oversight of the ITA, the Radiology Department and ultimately MGH and Partners.  ICER’s activities are led by a senior management team.  Work is conducted in collaboration with various academic institutions and research organizations based on expertise with a particular topic and/or therapeutic area.  In addition, ICER has established a diverse Advisory Board to inform the strategic direction of ICER’s work.  Advisory board members represent all the major stakeholder groups in comparative effectiveness research, including purchasers, payers, device and pharmaceutical manufacturers, providers, patients, and experts in health policy and ethics.  ICER relies on its Advisory Board to provide frank and constructive feedback on ICER’s strategic direction and operational priorities.

Membership on the Advisory Board is solely at the invitation and discretion of ICER’s senior management team.  While many Advisory Board member companies provide ICER with unrestricted financial support, financial support of ICER is not a guarantee, nor a requirement, of Advisory Board membership. 

Setting the Research Agenda
The research agenda for ICER is developed with guidance from a Stakeholder Priorities Committee.  The Stakeholder Priorities Committee consists of select Advisory Board members, individuals nominated by the Advisory Board, and other experts and individuals chosen at ICER’s discretion.  ICER seeks to produce appraisals on topics of importance to all stakeholders, and for which its distinctive methods will help decision makers facing important questions about the evidence on clinical effectiveness and value.  ICER also uses existing prioritization efforts (Institute of Medicine, National Priorities Partnership, etc.) to inform its decision making.

Funding
To meet ICER’s goals of objectivity and transparency, ICER accepts funding from a diverse set of sources (including government agencies, private philanthropies, non-profit foundations, health plans, manufacturers).  The ultimate decisions within and across research projects are ICER’s alone.

In order to ensure transparency and independence, ICER accepts funding from external partners in three distinct categories: unrestricted grants and gifts; clinical research agreements; and project management contracts.  Working with members of the Massachusetts General Hospital (MGH) Development Office, the Partners Clinical Research Office and the MGH Office of the General Counsel, ICER staff evaluate potential partnerships and explore the appropriate funding mechanisms in order to decide if a partnership fits with the strategic goals of ICER and if establishing a funding relationship is appropriate.  Unrestricted grants and gifts are processed through the MGH Development Office; project management contracts are executed through the MGH Office of the General Counsel; and clinical research contracts are developed in conjunction with the Partners Clinical Research Office.  By establishing guidelines and categories for financial arrangements with external partners, ICER seeks to remain transparent and independent with respect to the conduct of its comparative effectiveness appraisals.

Conflicts of Interest and Potential Influences on Judgment
Internal Conflict of Interest Standards
ICER’s policies for avoiding conflicts of interests in its work meet and exceed the standards outlined by Partners HealthCare’s Interim Policy Statement on Interactions with Industry.  ICER is prohibited from taking funding from health plans or manufacturers for specific studies or appraisals.  ICER staff do not take honoraria from or enter consulting agreements with health plans or manufacturers.  Further, ICER staff are prohibited from owning individual securities in companies with products that may be subject to a comparative effectiveness appraisal, including health plans, pharmaceutical, biotechnology and medical device manufacturers.  Ownership of pharmaceutical, biotechnology or medical device stock in a mutual fund over which the employee has no trading control is permitted.  

For Advisory Board Members
In order to avoid any potential conflict of interest with the mission of ICER, ICER has adopted the following statement to guide its Advisory Board on issues of potential influences on judgment, disclosure and recusal.  

  • The Advisory Board does not govern ICER in any way.  The function of the Advisory Board is solely to provide perspective and advice to ICER staff on how ICER can best fulfill its mission.  
  • Because there are organizations represented on the Board who compete in the healthcare marketplace, ICER staff and all Advisory Board members will refrain from any discussion that could provide the basis for an inference that members considered any action that might restrain trade in any way.
  • At no time will the Advisory Board discuss the scientific or methodological merits of any specific technology appraisal.  However, if a topic arises during an Advisory Board meeting that could have competitive repercussions in a therapeutic area in which manufacturing industry representatives compete, they must disclose to the Board that they have a potential conflict and leave the room during the remainder of that discussion.  Meeting minutes will document the recusal.  Given that the Advisory Board is removed from discussions that involve consideration of specific interventions it will be extremely unlikely that this form of recusal would be required at any time.

For Evidence Review Group Members
The Evidence Review Group (ERG) is an independent group brought together by ICER composed of academic experts, patients, clinicians, epidemiologists, ethicists, and medical policy representatives of stakeholder groups including health plans and manufacturers.  

To help guide members of the ERG, ICER has drafted the following policy for participants in ICER’s comparative effectiveness appraisals:

  • ERG members will have a wide range of potential influences on their judgment, including financial conflicts of interest, reputational concerns and personal or family experiences with a technology or its comparators.  
  • ICER requires full disclosure of all potential influences of judgment by the participants of its ERGs.  There will be no threshold for potential influences on judgment: all potential influences, no matter how “small,” must be disclosed.   This requirement for full disclosure will be made clear to prospective participants in an ERG before they are accepted as a member.  The disclosure itself will be made public as an integral part of ICER appraisal documents.
  • There will be no threshold of potential influences on judgment that will require the recusal of an ERG member.
  • Because of the inclusive design of the ERGs, the advice, comments, and any votes taken by members of ERGs will be viewed as solely advisory in nature to ICER and will not in any way be dispositive.