The Department of Health and Human Services, Office of the Assistant Secretary
for Health and
The Center for Medicare and Medicaid Services
Pilot Project to Reduce Disparities in Adverse Drug Events
Information Sheet
Background
Since the publication of the Institute of Medicine’s (IOM) report, Unequal Treatment:
Confronting Racial and Ethnic Disparities in Healthcare,1 there is an increased focus on
assessing and understanding the causes of disparities in the quality of, and access to, care of
diverse populations. Race/ethnicity, primary language, cultural differences, age, gender, literacy,
and other factors including provider as well as patient biases and stereotyping have been
identified as aspects in clinical decision making and patient compliance that result in disparities
in health outcomes. However, despite the efforts of the healthcare community to address the
issues that cause these disparities, more work is needed.
Recently, the Office of the Assistant Secretary of Health (OASH) and Office of Disease
Prevention and Health Promotion (ODPHP) published, The National Action Plan for the
Prevention of Adverse Drug Events2, which provides an outline of current efforts and
opportunities for eliminating preventable Adverse Drug Events (ADEs) across all patients
receiving medical care. The focus of the Action Plan is on three drug categories: anti-coagulants,
diabetes agents (hypoglycemic events), and opioids, which have a disproportionate number of
negative outcomes in sub-groups compared to the general population. In addition to ADEs,
OASH ODPHP is actively engaged in reducing disparities in healthcare associated infections
(HAI) and 30-day readmissions. These three preventable adverse events have a significant
impact on patient lives and the cost of care.
To better understand and effectively address factors contributing to disparities related to ADEs,
the Centers for Medicare and Medicaid Services (CMS) in partnership with OASH/ODPHP and
the MITRE Corporation are engaging hospitals and hospital networks/ systems that were
participants in the Hospital Engagement Network (HEN) program to partner in an innovative
root cause analysis designed to help hospitals identify contributing factors. Through this
partnership, organizations will gain new insights into the disparities experienced by their
patients, the effectiveness of programs they and others have instituted to reduce disparities, and
lessons learned from other leading healthcare providers.
1
Smedley BD, Stith AY, Nelson AR, editors. Institute of Medicine, Committee on Understanding and Eliminating
Racial and Ethnic Disparities in Health Care. Unequal treatment: confronting racial and ethnic disparities in health
care. Washington: National Academies Press; 2002.
2
U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014).
National Action Plan for Adverse Drug Event Prevention. Washington, DC: Author.
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Goal of the Pilot Project
Selected organizations will be invited to participate in the analysis of key drivers causing
disparities in adverse healthcare associated outcomes, including ADEs, HAIs, and 30-day
readmissions by providing data on disparities and potential interventions. The analysis will
inform future HHS actions to reduce disparities, improve quality of care, and support best
practices.
Benefits of Participation
Participating hospitals will receive continued technical support from OASH to advance their
organization’s efforts to reduce disparities in ADEs, and garner national support and recognition
as leaders in reducing ADEs for patient populations. Below are some of the benefits of
participating in this effort:
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Participation in a peer-to-peer learning collaborative with other participating
organizations from across the nation to share best approaches and resources for
addressing disparities in ADEs and other adverse healthcare associated outcomes.
Participants will work in collaboration with the OASH/ODPHP to share results and
recommendations that will inform the national action plans for improving the quality and
safety for all patients as well as address improvements in national data sources.
Participants may gain a more robust understanding of unrealized factors contributing to
disparities, resulting in practices that will reduce costly avoidable adverse events – e.g.,
early death, disability, and hospitalizations - thus further improving the quality of the care
provided to all.
Participants will be provided with the results of an advanced/cutting edge analysis of
their data that may yield new insights and guide development of effective interventions.
The pilot also offers technical assistance to participants in preparing peer reviewed
articles for publication of their approaches and its impact on reducing disparities.
Participation may lead to the identification of additional financial support for efforts to
reduce disparities in adverse healthcare associated outcomes.
Minimal Effort Required
 The only data that will be shared is data currently being collected by the
hospital/network/system. OASH will not require organizations to report on measures not
currently used by the organization for adverse event reporting and tracking.
Eligibility Criteria
Eligibility criteria for voluntary participation among the current Partnership for Patients HENS in
a subsequent pilot study of racial/ethnic and other (age, sex, socioeconomic status, geography,
health literacy, primary language) disparities in adverse healthcare-associated outcomes (HAIs,
ADEs, and 30-day readmissions) are as follows:
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Participant must have a long-term sustainment plan beyond the current termination date
of December 2014 for Partnership for Patients for ensuring the continued participation of
hospitals within their network, that includes the collection and sharing of aggregate data
for tracking purposes.
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Participant has an established system for tracking and monitoring hospital progress
towards operational metrics and improvement metrics amongst participating hospitals.
The system must collect a minimum of patient level data on age, sex, race, and ethnicity.
Optional data fields include health literacy, zip code, or census tract of residence,
education status, income data, and language data (whether English is primary language).
Participating hospital networks must be currently engaged in stratifying patient
demographic data to identify disparities in various adverse healthcare-associated
outcomes (HAI, ADE, and 30-day readmissions). In addition, certain hospitals may also
wish to address Adverse Drug Events (ADEs) or engage in collecting aggregated data on
ADEs or other adverse healthcare-associated outcomes for a vulnerable population.
Participants must be currently engaged in implementing data driven quality improvement
activities designed to reduce racial/ethnic and other disparities in adverse healthcareassociated outcomes (HAI, ADE, and 30-day readmissions) through quality improvement
approaches. Alternatively, participants may be engaged in quality improvement activities
designed to identify appropriate metrics and care management approaches to prevent
ADEs.
Participating networks must include hospitals that serve racially and ethnically diverse
patient populations.
Participants must have the ability to commit to participating in the pilot project for at
least one year, preferably longer if future support becomes available. Participants must
also be able to share their network data with the OASH contractor, MITRE, for the
project period.
Roles and Responsibilities for Participants:
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Participation in the pilot requires a commitment from the hospital (or hospitals within a
health system or former hospital engagement network) to complete the 12 month project
period.
Ideal candidates will be currently engaged in addressing disparities in ADEs or other
adverse healthcare associated outcomes (HACs, HAIs, or 30-day readmissions) or
addressing ADE prevention in a vulnerable population not currently addressed by the
National ADE Action Plan.
Participating organizations must have a data collection system in place that enables them
to stratify ADE and other targeted adverse healthcare associated outcomes incidence by
race, ethnicity, language, and other patient data.
Participants will be required to share their data with the OASH contractor who will
analyze their data for root causes (or analyze the results of their root cause analysis).
Additional Clarifying Questions:
Q:
A:
Are you looking for any hospital size/hospital type?
Yes. We are interested in diverse types of organizations, but are primarily focused on care
settings where HAIs, ADEs and 30-day readmissions could occur, and where they types of data
described below, are being collected.
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Q:
A:
Will participating hospitals be required to submit patient level data to you for this project?
Yes, we are very interested in patient level data, as this allows for the most rigorous analysis to
occur. However, if other types of data exist, we are open to learning about them to see if they
still might be relevant. MITRE would develop a data use agreement with any partners providing
data. This would include detailed information on the secure, HIPPA-compliant storage and
analytic environment MITRE operates.
Q:
A:
How often will this data need to be submitted?
For this first year of the project, we are currently interested in historic data. A complete dataset
would only need to be submitted once.
Q:
Is there an application for this or will any hospital that is interested be accepted into the
project?
There is no application to complete. However, once hospitals identify interest, we have a series
of evaluative questions to ask about the type, quality and relevance of their data. Based on the
results of this evaluation, we will make a recommendation to ODPHP on whether they should
consider acquiring the data for the project. There may be some modest resources available to
participating organizations to help offset their costs of providing the data.
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Is there a maximum number of hospitals that you will take for this and when is the deadline for
submitting the hospital's name to your team?
There is no fixed number of hospitals we are willing to work with. Rather, we will work to strike
to achieve a balance between the number of hospitals, the type of data they are able to share
and our ability to best answer our research questions. Priority will likely be given to those
hospitals who come forward early. We are eager to develop data use agreements and take
possession of data ASAP, optimally by the end of this month/early February.
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