5

U.S. Health Care and Policy

“Human beings, in all lines of work, make errors. Errors can be prevented by designing systems that make it hard for people to do the wrong thing and easy for people to do the right thing.” —To Err Is Human (IOM, 2000a)

This quote, from the preface of To Err Is Human: Building a Safer Health System, focuses on a single piece of health care quality: preventing medical errors. However, it signals a broader theme that has underpinned nearly all of the Institute of Medicine’s (IOM’s), and subsequently the National Academy of Medicine’s (NAM’s) and the Health and Medicine Division’s (HMD’s), work—a recognition that the system as a whole needs to be improved in order to realize the quadruple aim of satisfactory patient experience, improved population health, sustainable costs, and improved clinician well-being. The IOM, and later the NAM and the HMD, have produced a robust body of work aimed at understanding and influencing the complex and evolving contexts and components that make up the U.S. health care system. Throughout its history, the organization has taken a leading role in guiding improvements related to quality, access, value, and measurement with the goal of establishing a continuously improving health system.

This chapter contains examples of areas in which the IOM made distinctive contributions that helped shape and refine the policies, processes, and outcomes of U.S. health care related to quality and safety, health care professional education and patient empowerment, health care reform and the availability of health insurance, and health care for complex illnesses and conditions. Underlying all of the work highlighted in this chapter is a foundational theme of quality—from providing high-quality cancer and end-of-life care to enhancing the health care workforce and the health information technology (IT) infrastructure employed across the health care system. The activities described in this chapter were facilitated by IOM, NAM, or HMD staff alongside expert volunteers from among the NAM membership as well as externally.

BUILDING A CULTURE OF HEALTH CARE QUALITY

To Err Is Human, published in 2000, became one of the IOM’s most recognizable studies and put the organization on the map as the ultimate authority on health care quality. But the origins of the IOM’s focus on quality began many years earlier, with a study in response to the Omnibus Budget Reconciliation Act of 1986. As Medicare spending continued to grow through the 1970s and 1980s, the program came under increasing political scrutiny, and questions about how Medicare costs could be contained while also maintaining quality began to emerge (Davis and Burner, 1995; IOM, 1990b). The 1986 legislation included a provision that called for a study to define quality and develop a strategy for setting priorities to ensure that care delivered through Medicare met that definition. To complete the task, the IOM assembled a committee that worked from 1987 to 1990 to draft a three-part series of reports with a set of recommendations that offered an “ambitious and far-reaching strategic plan for assessing and assuring the quality of medical care for the elderly during the next decade” (IOM, 1990b, p. xi).

The first volume in the series—Medicare: A Strategy for Quality Assurance—was released in 1990. It highlighted “a broad concern among the health professions about the quality of health care” coupled with a “rising dissatisfaction about the health care system on the part of the public and policymakers” (IOM, 1990b, p. 1). The report, although centered on the Medicare program, considered quality of care across the health care system more broadly. The committee, which was chaired by NAM member and Councilor (2002–2004) Steven A. Schroeder,¹ defined health care quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge” (p. 4). In conjunction with the definition, the committee identified three main categories of quality deficiencies: overuse of unnecessary and inappropriate services, underuse of needed services, and “poor technical or interpersonal performance by practitioners and institutions” (p. xvi). According to the committee, neither Medicare nor the health care system had a “direct mandate to measure, assure or improve the quality of care” (Lohr and Harris-Wehling, 1991, p. 6). The report influenced medical practice and policy in the United States and expressed the IOM’s general vision of what the health care system should be.

When Kenneth Shine arrived as president of the IOM in 1992, he queried members about what priority topics the IOM should explore in the coming years. A significant number indicated that they would like to see the IOM become more active in the area of health care quality. At the time, Shine noted, Ford Motor Company was leveraging “quality” as a value to outsell Japanese car makers, and “everyone thought their doctor and hospital was quality.”² Under Shine’s leadership, therefore, the IOM launched a 3-year initiative on health care quality. This initiative was unique in that the request came from the IOM members rather than the government. Expansive in its thinking, the IOM Council envisioned the initiative cutting across all of the IOM’s boards. To define the scope and structure of the initiative, the IOM established a steering committee—chaired by external volunteer Walter J. McNerney³—that prompted the IOM Council to issue a white paper. The IOM printed 5,000 copies and widely disseminated the white paper to IOM members; congressional staff; key government stakeholders at the federal, state, and local levels; and health professional and consumer groups.⁴ The paper noted that the U.S. health care system was in a state of transition, moving from a “traditional” model—in which physicians had considerable

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¹ Steven A. Schroeder was the Chair of the Division of General Internal Medicine at the University of California, San Francisco, when this report was released.

² Private correspondence, Ken Shine to Laura H. DeStefano, April 18, 2020.

³ Walter J. McNerney was a Professor of Health Policy and a Consultant at the J.L. Kellogg Graduate School of Management at Northwestern University.

⁴ IOM Council Minutes, April 11–12, 1994, IOM/NAM Records.

autonomy—to a managed care model. As this transition proceeded, the paper emphasized that the nation could not lose sight of the “urgent need to monitor and improve the quality of health and the effectiveness of health care” (IOM, 1994c, p. viii).⁵

The steering committee continued to meet through 1995, while the IOM explored options to expand its health care quality portfolio.⁶ The key development from these efforts was the creation of the National Roundtable on Health Care Quality in 1995. The roundtable offered a “nonadversarial environment to explore ongoing rapid changes in the medical marketplace and the implications of those changes for the quality of health and health care in this nation” (IOM, 1998b, p. 5). The members of the roundtable, who came from government, academia, private industry, and the health media, initiated a variety of quality-related activities that included workshops, commissioned papers, and “periodic statements for the nation on quality of care matters” (IOM, 1998b, p. 5).

In the fall of 1996, the roundtable held a workshop on measuring quality. Although technical in nature, the workshop promulgated a new “process improvement” approach to quality that reversed previous assumptions. For example, this new approach suggested that quality controls could save money rather than cost money in the long run. Furthermore, quality needed to be incorporated into ongoing processes, rather than measured retrospectively. “Integrating Strategies for Health Care Improvements” became the subject of a second workshop the following year. In 1998, the roundtable released a statement outlining major conclusions from its work. The “Statement on Quality of Care” built on the IOM’s previous work related to Medicare and on the 1994 white paper from the IOM Council (IOM, 1998b). The statement highlighted the pressing need for improvements and indicated that health care quality in the United States would not improve until the nation “undertook a major, systematic effort to overhaul how we deliver health care services, educate and train clinicians, and assess and improve quality” (IOM, 1998b, p. 10).

The work of the National Roundtable on Health Care Quality and the IOM Council affirmed that health care quality was an appropriate focus for future IOM activities. At the beginning of 1997, Board on Health Care Services Chair and NAM member Don Detmer⁷ suggested the IOM’s efforts represented an “incomplete conceptual framework” with strategies that were too “imprecise to shape the future meaning of health care quality in our nation.” Shine emphasized the need for consistency in the IOM’s role in quality discussions and believed that the intersection between quality and value might be a good place for additional IOM work.⁸ The IOM proceeded by launching a Special Initiative on Health Care Quality that included a Quality Initiative Coordinating Committee, which was designed to oversee the IOM’s health care quality activities and ensure the consistency Shine envisioned.⁹

By March 1998, the Board on Health Care Services had prepared a proposal for a Committee on Quality of Health Care in America, which stemmed from a perceived lack of information on the prevalence of health care quality problems and how changes to care delivery might improve quality. The Board felt that the existing roundtable efforts were important, but that it was necessary to undertake a consensus study, with its ability to draw conclusions and make formal recommendations. The Executive Committee of the IOM Council approved the ambitious study in February 1998, and on August 11, 1998, Shine wrote to William C. Richardson, head of the Kellogg Foun-

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⁵ “America’s Health in Transition: Protecting and Improving the Quality of Health and Health Care,” in materials to accompany IOM Council Meeting, July 19, 1994, IOM/NAM Records.

⁶ “America’s Health Care in Transition: Protecting and Improving Health and the Quality of Health Care,” memo describing the key points of the Institute of Medicine Special Initiative, December 1999, IOM/NAM Records.

⁷ Don Detmer was the Vice President of Health Sciences at the University of Virginia during this time.

⁸ IOM Council Minutes, January 6–7, 1997, IOM/NAM Records.

⁹ “Draft Charge to the Quality Initiative Coordinating Committee,” in materials for IOM Council Meeting, January 6–7, 1997, IOM/NAM Records.

dation, confirming his appointment as chair of the committee.^10,11 Janet Corrigan, Senior Board Director of the Board on Health Care Services and a well-respected quality expert in her own right, would serve as the Director of the IOM’s Quality of Health Care in America project. Under Richardson and Corrigan’s leadership, the committee was organized into two subcommittees that worked semi-autonomously, holding independent meetings and information-gathering sessions: the Subcommittee on Quality Improvement Strategies for Health Care in the United States—chaired by NAM member Donald Berwick¹²—and the Subcommittee on Creating an External Environment for Quality—co-chaired by external volunteer J. Cris Bisgard¹³ and NAM member Molly Joel Coye.¹⁴ The committee with its subcommittees would eventually produce two reports: To Err Is Human: Building a Safer Health System (IOM, 2000a) and Crossing the Quality Chasm: A New Health System for the 21st Century (IOM, 2001d).

To Err Is Human: Building a Safer Health System

Released on November 29, 1999, the committee’s first report, To Err Is Human, illuminated the scale of medical errors and patient safety gaps in the United States. In the report’s preface, Committee Chair Richardson set the tone of the report, stating that humans in all lines of work made errors, but many could be prevented “by designing systems that make it hard for people to do the wrong thing and easy for people to do the right thing” (IOM, 2000a, p. ix). The report highlighted specific examples of startling medical errors that resulted in death (e.g., a chemotherapy overdose, use of incorrect drugs) or significant injury (e.g., amputation of the wrong limb). By extrapolating data from studies on adverse events in hospitals, the committee indicated that between 44,000 and 98,000 deaths could be attributed to medical errors, representing the eighth leading cause of death in the United States, noting that more people died from medical errors than died from motor vehicle accidents, breast cancer, AIDS, or workplace injuries.

Despite the magnitude of the problem, the committee stated that a cycle of inaction had developed, and emphasized that the status quo was unacceptable. Patients were being harmed by “the same health care system that is supposed to offer healing and comfort” (IOM, 2000a, p. 3). The report indicated that safety needed to be built into the care process using a systems approach to patient safety. The committee’s stated goal was to disrupt the cycle of inaction and offer a roadmap that would lead to improvements over the next 10 years. The committee made recommendations in four major areas: national efforts to “enhance the knowledge base about safety,” mandatory and voluntary reporting efforts to identify and learn from errors, efforts to “raise standards and expectations for improvements in safety,” and efforts to create safety systems and implement safe practices at the delivery level (p. 6). The committee acknowledged that significant changes would be required across the health care system to create a culture of safety. However, the estimated costs associated with preventable medical errors in terms of lives lost (as many as 98,000) and dollars spent ($17–$29 billion) indicated a resounding need for change.

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¹⁰ Board on Health Services, For Action, New Project, “Quality of Health Care in America,” March 10, 1998, IOM/NAM Records.

¹¹ Kenneth I. Shine to William Richardson, August 11, 1998, IOM/NAM Records.

¹² Donald Berwick was the President and the Chief Executive Officer of the Institute for Healthcare Improvement during this time. Berwick served as a member of the NAM Council from 2002 to 2007 and on the HMD’s Division Committee from 2016 to 2019.

¹³ J. Cris Bisgard was the Director of Health Services at Delta Airlines at the time.

¹⁴ Molly Joel Coye was the Senior Vice President and the Director of the Lewin Group’s West Coast office during this time.

To Err Is Human’s Impact

Upon its release, To Err Is Human received more media coverage than any report up to that point in the IOM’s history. The IOM for the first time had hired a public relations firm to boost the exposure of the report.¹⁵ Television networks ran stories on the release of the report, as did nearly all of the nation’s major newspapers. Coverage also extended beyond the United States, reaching Germany and England. The coverage came in waves, with many media outlets and newspapers running follow-up stories. As the report attracted media, it was also evaluated by the health care community. The Blue Cross Blue Shield Association applauded the report, and the American Medical Association issued a favorable statement. However, not all responses were positive. Troyen Brennan, who was affiliated with Brigham and Women’s Hospital, wrote a critical article in the New England Journal of Medicine in April 2000, highlighting potential flaws in the report’s methodology and questioning the practicality of its recommendations (Brennan, 2000).¹⁶ Lucian Leape, a committee member and professor at Harvard’s School of Public Health at the time, defended the IOM’s report in a July 2000 JAMA article, concluding that the report had “galvanized a national movement to improve patient safety” (Leape, 2000).

The report garnered immediate attention from the White House and President Clinton (Pear, 2000). Clinton made it clear that health care quality would become a policy priority for his administration. Following the meeting with Richardson and IOM staff, Clinton ordered a series of executive actions. He required that the private health insurance plans that participated in the Federal Employee Health Benefits Program implement quality improvement and patient safety initiatives. He also instructed federal agencies that administered health plans, such as the Department of Veterans Affairs (VA) and the Centers for Medicare & Medicaid Services (CMS), to evaluate and implement error reduction technologies where feasible. He announced the reauthorization of the Agency for Healthcare Research and Quality (AHRQ), and Congress then appropriated $50 million annually for patient safety research through AHRQ.¹⁷ The IOM developed a close working relationship with John Eisenberg, then the Director of AHRQ. Clinton also directed the Office of Management and Budget to develop additional error prevention and health care quality initiatives. The White House cited the IOM report as the basis for these actions,¹⁸ which would initiate some of the systematic changes the committee had envisioned in order to promote a safer health care system. The report also fed into the work of the National Quality Forum (NQF), which had been established less than 1 year prior, in 1999.

Congress was also quick to respond to the report. Senator James Jeffords (R-VT) asserted that the number of fatalities and injuries associated with medical errors must be reduced, stating that the Senate Committee on Health, Education, Labor, and Pensions would spearhead a “comprehensive approach to improving patient safety.” His colleague Arlen Spector (R-PA) called the report “a matter of enormous importance” and vowed that the Appropriations Subcommittee on Labor, Health and Human Services and Education would hold hearings to determine how much money should be appropriated to respond to the problem (Goldstein, 1999; Pear, 1999; Philadelphia Inquirer, 1999). The Senate Appropriations Committee included language in the appropriations bill for fiscal year 2001 that instructed the AHRQ to initiate “the development of guidance on the collection of uniform data on patient safety.” Meanwhile, states also pursued laws to reduce medical errors. For example, Florida established a Commission on Excellence in Health Care to develop a statewide strategy for improving health care delivery through “meaningful reporting standards.” The state of

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¹⁵ Private correspondence, Kenneth Shine to Laura H. DeStefano, April 18, 2020.

¹⁶ IOM Council Minutes, October 17–18, 2000. IOM/NAM Records.

¹⁷ Impact of IOM Reports (Database), IOM/NAM Records.

¹⁸ “Clinton-Gore Administration Takes New Steps to Improve Health Care Quality and Ensure Patient Safety,” December 7, 1999, White House news release, IOM/NAM Records.

Washington passed a law that required its Department of Health to publicly disclose information it received regarding medical errors, and by 2007, at least 23 states had implemented similar requirements for reporting medical errors.¹⁹

In July 2005, President George W. Bush enacted the Patient Safety and Quality Improvement Act of 2005, which cited the IOM’s report To Err Is Human as its impetus (see Figure 4-8). The overarching purpose of the legislation was to “improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients” (AHRQ, n.d.). One of the provisions of the law established Patient Safety Organizations (PSOs), which would be designed “to collect, aggregate, and analyze confidential information reported by health care providers.” Three years after the law was enacted, the Department of Health and Human Services (HHS) released regulations for the PSOs, which had been recommended by the IOM report. In 2008, a New York Times article credited To Err Is Human as the catalyst for the growing patient safety movement in the United States (Sack, 2008).

Crossing the Quality Chasm, 2001

The IOM released the Committee on Quality of Health Care in America’s second report—Crossing the Quality Chasm: A New Health System for the 21st Century—on March 1, 2001. While To Err Is Human concentrated specifically on medical errors and patient safety, the new report “focused more broadly on how the health care delivery system can be designed to innovate and improve care.” According to the report, the health care system required fundamental change; incremental improvements would not be sufficient. Despite many technological advances, “a highly fragmented delivery system that largely lacks even rudimentary clinical information capabilities” resulted in “poorly designed care processes characterized by unnecessary duplication of services and long waiting time and delays” (IOM, 2001d, p. 3).

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¹⁹ Impact of IOM Reports (Database), IOM/NAM Records.

In its report, the committee envisioned a redesigned health care system that would be safe, effective, patient-centered, timely, efficient, and equitable—a mantra that would be repeated often in health policy circles and would become recognized as the six dimensions of quality. The redesigned health care system would need to ensure that health care delivery was evidence-based, leveraged available health information technologies, realigned payment structures with quality goals, and engaged and prepared health care professionals. To achieve this vision, the committee offered 10 guiding principles:

1. “Care is based on continuous healing relationships.
2. Care is customized according to patient needs and values.
3. The patient is the source of control.
4. Knowledge is shared and information flows freely.
5. Decision making is evidence-based.
6. Safety is a system property.
7. Transparency is necessary.
8. Needs are anticipated.
9. Waste is continuously decreased.
10. Cooperation among clinicians is a priority” (IOM, 2001d, pp. 8–9).

The committee’s recommendations added specificity to its general framework. For example, the committee called on Congress to establish a “Health Care Quality Innovation Fund” to invest in projects that would lead to improved quality. The committee also called on the AHRQ to identify 15 or more of the most common, top-priority conditions and then work with stakeholders to create care processes and action plans to ensure the delivery of consistent, quality-based care for the identified conditions.

Crossing the Quality Chasm’s Impact

Following the release of the report, most of the major television and newspaper outlets featured stories on it, all of which included reference to the previous report, To Err Is Human. Committee members were interviewed and widely quoted in the articles, and Molly Joel Coyle participated in a series of radio interviews that reached listeners in the major metropolitan areas across the United States.²⁰ Together the committee’s two reports “laid out a vision for how the health care system and related policy environment must be radically transformed in order to close the chasm between what we know to be good quality care and what actually exists in practice” (NASEM, n.d.i). To Err Is Human had captured the nation’s attention in a way the IOM had never done before, and put the IOM at the center of a media storm of unprecedented size. The IOM declaration that preventable medical errors killed more people than many of the leading causes of death caught the nation’s attention. Crossing the Quality Chasm followed up on the success of the first report and defined strategies that should be used to reinvent the U.S. health care system to ensure that high-quality care was readily available in communities across the country (NASEM, n.d.i).

In response to the IOM’s work and its two new quality reports, the Robert Wood Johnson Foundation (RWJF) partnered with the Institute of Healthcare Improvement to create a $26 million, five-part demonstration project called “Pursuing Perfection: Raising the Bar for Health Care Performance,” which operated from 2001 to 2008. The demonstration project sought to “improve the performance of the seven participating health care institutions” and “demonstrate to the broader

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²⁰ Saira Moini to Janet Corrigan, Linda Kohn, Shari McGuire, Susan Turner-Lowe, and Barbara Rice, March 20, 2001, transmitting “Dissemination Plans and Reports,” March 19, 2001, CQHCA Files, IOM/NAM Records; “Fax Alert, U.S Health Care System Is Experiencing a Quality Gap, Says IOM,” Radio Interviews Friday, March 2, 2001, CQHCA files, IOM/NAM Records; Draft Script, News/Broadcast Network, Inc., February 28, 2001.

provider community that ideal care is attainable” (RWJF, 2010, p. 1). Upon completion of the project, RWJF concluded that “the organizations transitioned from ‘devoted but average performers’ to national leaders in health care improvement” (p. 1). One of the grantees, the Henry Ford Health System’s Behavioral Health Services, set a goal of eliminating deaths by suicide among its patient population by completely redesigning care delivery around the IOM’s six dimensions of health care quality. Approximately 11 years after the implementation of the redesign, the average annual rate of suicide in the health care system’s patient population dropped 80 percent—from approximately 110 per 100,000 in 1999 to approximately 36 per 100,000 in 2010—which included one year in which the health care system met its goal of zero suicides (2009) (Coffey and Coffey, 2016).

To Err Is Human and Crossing the Quality Chasm continue to have an impact on health care quality and safety nearly two decades after the first report was released. This continued impact is due, in part, to the ongoing commitment and subsequent studies released by the IOM, the NAM, and the HMD (described below), which over the years have led to important policy changes and an increased commitment to quality across the U.S. health care system overall. Citing widespread public and private patient safety efforts and initiatives that were sparked by To Err Is Human and Crossing the Quality Chasm, AHRQ released a report in 2014 that indicated that hospitals and health care providers nationwide made fewer mistakes in treating patients between 2010 and 2013, sparing at least 50,000 lives and saving $12 billion in health care spending (AHRQ, 2015). The report indicated that there was a cumulative decrease of 1.3 million hospital-acquired infections, representing a 17 percent decline during the same timeframe.

The Quality Chasm Series

Having established itself as a leader in the promotion of health care quality in the United States, the IOM launched a new initiative that focused on “operationalizing the vision described in the Quality Chasm report.” The initiative included a new series of reports and activities that would be geared toward implementing the IOM’s vision for health care quality and a culture of safety. The timing of this initiative coincided with an increased national focus on health care quality and safety, as well as patient-centered care and evidence-based medicine in an effort to reduce unnecessary costs while increasing value throughout the U.S. health care system. During this timeframe, numerous programs and initiatives were launched throughout the health care system. For example, CMS initiated a series of pay-for-performance initiatives in the early 2000s based on guidance from organizations such as the NQF and the National Committee for Quality Assurance (NCQA) (CMS, 2005). At this time, organizations and agencies such as the NQF, the NCQA, the Institute for Healthcare Improvement, The Joint Commission, the AHRQ, the CMS, and many others were also looking for opportunities to establish and apply measures that could be used to improve the health care system. As health information technologies and electronic medical records were being implemented more broadly, these new technologies allowed for the possibility of more robust data collection and analysis to serve as the foundation to guide future improvements (Burstin et al., 2016; Chassin and Loeb, 2011; IHI, 2018; The Joint Commission, n.d.).

The first three reports in the series were released in 2003. Picking up on a recommendation from Crossing the Quality Chasm, the first report—Priority Areas for National Action: Transforming Health Care Quality—identified 20 priority areas for the AHRQ, which could be used to guide public and private health care sectors toward improving the quality of health care being delivered in the United States (IOM, 2003h). The authoring committee of this report was chaired by NAM member George J. Isham.²¹ The next three reports released in the series looked at improving leader-

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²¹ George J. Isham was the Medical Director and the Chief Health Officer at HealthPartners, Inc., in Minneapolis during this time.

ship in health care quality, implementing successful health care demonstration projects on a larger scale, and improving health professional education (see Box 5-1).

In January 2004, the IOM hosted a “Quality Chasm Summit,” which was designed to demonstrate that the redesign of the health care system described in the Quality Chasm report was both possible and already under way in some communities. The summit examined “a discrete subset of the priority areas”²² from the IOM’s 2003 report that included “asthma, chronic heart failure, major depression, diabetes, and pain control in advanced cancer” (IOM, 2004a, p. ix). In planning the summit, the committee, which was chaired by NAM member Reed V. Tuckson,²³ identified six cross-cutting themes that served as the basis of working sessions during the summit: “measurement, information and communications technology, care coordination, patient self-management support, finance, and community coalition building” (p. 2). The overarching goal of the summit was to foster change and establish momentum, moving beyond the blueprints and guidance laid out in the reports. During the summit, leaders from 24 national-level organizations, referred to as national champions, committed to supporting continued community efforts to improve health care quality while also translating those local efforts to a larger scale.

Eventually the Quality Chasm series grew to include a dozen reports that were released between 2003 and 2015 (see Box 5-1). Following the creation of the NAM and the HMD in 2015, the focus on health care quality carried over to both organizations. The desire to apply the ideas developed in the Quality Chasm series on a global scale led to the 2018 publication of Crossing the Global Quality Chasm: Improving Health Care Worldwide, which was developed under the auspices of the HMD. The report followed from the World Health Organization’s sustainable development goals and argued that quality needed to become as “central an agenda as universal health coverage itself.” The report noted that the problems identified in the Quality Chasm series, such as fragmentation, misaligned financing, and poor training, applied not only to the U.S. health care system but to many of the health care systems around the globe. The nations of the world needed to come together “to close the enormous gaps that remain between what is achievable in human health and where human health stands today” (NASEM, 2018b) with a focus on the six dimensions of quality defined in Crossing the Quality Chasm. The committee, which was co-chaired by

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²² Ann Greiner to Bruce Alberts, March 19, 2003, Files of the Quality Chasm Summit, IOM/NAM Records.

²³ Reed V. Tuckson was the Senior Vice President of Consumer Health and Medical Care Advancement at UnitedHealth Group in Minnetonka, Minnesota, during this time.

Donald Berwick alongside external volunteer Sania Nishtar,²⁴ stated that quality improvements would “require investment, responsibility, and accountability on the part of health system leaders” at the global level (p. 6).

The findings and recommendations from the IOM’s Quality Chasm Series resulted in a variety of impacts, from the local to the national level, with the common goal of improving patient safety and health care quality in the United States. The IOM’s 2007 report, Preventing Medication Errors (IOM, 2007f), which was drafted by a committee co-chaired by NAM member J. Lyle Bootman²⁵ and external volunteer Linda R. Cronenwett,²⁶ resulted in a range of notable changes based on its recommendations. For example, in February 2008, the BayCare Health System and University of Southern Florida Health announced that they would “lead the deployment of free, web-based electronic prescribing to all physicians in the Tampa Bay area as the regional sponsors of National ePrescribing Patient Safety Initiative (NEPSI).” The purpose of NEPSI was to remove the barriers to electronic prescribing as a mechanism to reduce errors associated with handwritten prescriptions. On the federal level, the Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 was introduced in both the House and Senate in response to the IOM’s recommendation to implement electronic prescribing for all prescriptions by 2010. In July 2008, HHS Secretary Michael Leavitt announced a new program in which Medicare would provide incentive payments to health care providers who used e-prescribing. Extrapolating data presented in the IOM report, HHS estimated that the new program could save Medicare as much as $156 million over a period of 5 years due to reductions in medication errors and increased efficiencies associated with e-prescribing.²⁷

As the NAM established its new programs and ongoing activities in 2015, the organization continued the IOM’s focus on quality, which became a cross-cutting theme that was a core part of its work. For example, the NAM’s Action Collaborative on Clinician Well-Being and Resilience focused on supporting the well-being of the health care workforce, as burnout among health care workers has been shown to lead to low-quality care and an increase in medical errors (NAM, n.d.b). In 2019, the NAM published a consensus report that built on the work of the CWB Action Collaborative titled Taking Action Against Clinician Burnout: A Systems Approach to Professional Well-Being (NASEM, 2019h). The report cited To Err Is Human as a foundation for the study and a model for systemic change that was needed in the area of clinician well-being. The NAM’s other programs (e.g., the NAM Leadership Consortium: Collaboration for a Value & Science-Driven Health System, Future of Nursing 2020–2030 Initiative, Vital Directions for Health and Health Care Policy Initiative) also featured high-quality health care as an underlying driver to realizing improvements in health and well-being for populations across the United States. The NAM’s programs are discussed in more detail in Chapter 7.

Safety and Quality of Abortion Care

The IOM first examined the public health impact of abortion in 1975, just 2 years after the U.S. Supreme Court’s decision in Roe v. Wade legalized abortion in the United States. Legalized Abortion and the Public Health: Report of a Study contained a comprehensive analysis of the scientific evidence that was available at the time (IOM, 1975). The organization did not revisit the subject until 2018, when the National Academies released a study on The Safety and Quality of Abortion

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²⁴ Sania Nishtar was the founder of Heartfile, a health policy organization in Islamabad, Pakistan.

²⁵ J. Lyly Bootman was the Dean and a Professor at the University of Arizona College of Pharmacy and the Founding and the Executive Director of the University of Arizona Center for Health Outcomes and PharmacoEconomic (HOPE) Research at the time.

²⁶ Linda R. Cronenwett was a Professor and the Dean of the School of Nursing at the University of North Carolina at Chapel Hill when this report was published.

²⁷ Impact of IOM Reports (Database), IOM/NAM Records.

Care in the United States that examined the current state of the science, drawing on evidence from randomized clinical trials, systematic reviews, and epidemiological studies. The report found that the quality of abortion care varied according to where a patient lived and noted that state regulations aimed at limiting access to abortion threatened the provision of safe care (NASEM, 2018j).²⁸

A VALUE AND SCIENCE-DRIVEN HEALTH SYSTEM

Recognizing the intricate connections across evidence, quality, and value and the need for a more permanent convening activity to explore these connections and catalyze change across the health care system, the IOM launched the Roundtable on Evidence-Based Medicine in April 2005. J. Michael McGinnis, then a senior scholar and visiting fellow, assumed leadership of the roundtable. The roundtable’s mission was to create a neutral venue in which stakeholders, such as health care providers, employers, payers, and researchers, could discuss ways to generate and apply better data to clinical decision making, thus improving quality and assuring value. The roundtable’s mission complemented the six dimensions of quality, with particular emphasis on greater efficacy in health care services. In 2010, the Roundtable on Evidence-Based Medicine evolved into the Roundtable on Value & Science-Driven Health Care. The new iteration of the roundtable developed a charter to guide its activities that included a vision, goals, and a set of core concepts and principles. The roundtable promoted science-driven health care, indicating that, “to the greatest extent possible, the decisions that shape the health and health care of Americans … will be grounded on a reliable evidence base, will account appropriately for individual variations in patient needs, and will support the generation of new insights on clinical effectiveness” (IOM, 2011d, pp. xi–xii).²⁹

The overarching goal of the roundtable was to foster a “learning health system” that cultivated and supplied “the best evidence for the collaborative health care choices of each patient and provider” (p. xi). Throughout its 10-year history the roundtable released 20 publications, most of which comprised the roundtable’s Learning Health System series (NAM, 2017a). The series featured summaries of presentations and discussions from the roundtable’s workshops, as well as papers from leading experts. During this time, the roundtable also released numerous discussion papers and commentaries designed to stimulate advances and the implementation of science in health care. Over the course its work, the roundtable established six “innovation collaboratives” in areas such as best practices, clinical effectiveness research, and digital learning, which were developed to encourage information sharing and accelerate change.³⁰

Best Care at Lower Cost

Building on the work of the Roundtable on Value & Science-Driven Health Care, the IOM convened a committee, chaired by NAM member Mark D. Smith,³¹ to offer recommendations on how to transform the U.S. health care system into a learning health care system. The study examined the challenges and opportunities related to quality and safety, health outcomes, cost and value, and access and equity. The committee highlighted the rapid growth of biomedical research, advances in innovative treatments and therapies, and the ability to manage chronic conditions that were once fatal. However, the committee concluded that the health care system continued to fall

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²⁸ In June 2024, the U.S. Supreme Court overturned the Roe v. Wade decision, threatening access to safe abortion care for millions of women in the United States, particularly women of color, poor women, and women living in rural areas (see https://www.nationalacademies.org/news/2022/06/decision-to-overturn-roe-v-wade-could-worsen-reproductive-health-in-u-s-exacerbate-health-inequities).

²⁹ “IOM Program Plan & Operations Overview 2005,” pp. 10–11, IOM/NAM Records.

³⁰ See https://nam.edu/programs/value-science-driven-health-care.

³¹ Mark D. Smith was the President and the Chief Executive Officer at the California Health Care Foundation at the time.

short in fundamental ways; for example, clinical practice and education lagged behind scientific research, and care continued to be fragmented and uncoordinated, resulting in an estimated $750 billion in unnecessary health care spending in 2009 (IOM, 2013e). The committee summarized three “imperatives” for change: “the rising complexity of modern health care, unsustainable cost increases, and outcomes below the system’s potential” (NAM, n.d.a).

The committee’s 2013 report, Best Care at Lower Cost: The Path to Continuously Learning Health Care in America, emphasized that it was possible to improve health care quality and reduce costs by realizing a vision in which “science and informatics, patient-clinician partnerships, incentives, and culture are aligned to promote and enable continuous and real-time improvement in both the effectiveness and efficiency of care” (IOM, 2013e, p. 17). The committee offered 10 recommendations along with specific strategies that could be employed to fulfill its vision for a continuously learning health care system. The recommendations reinforced messages from previous IOM work. While they seemed idealistic in some ways, many of them depended on creating tools to apply and disseminate already existing knowledge.

Measuring What Matters

Achieving a learning health care system requires access to high-quality data from defined quality measures. In 2015 the IOM released Vital Signs: Core Metrics for Health and Health Care Progress. The committee, which was chaired by NAM member David Blumenthal,³² was tasked with reviewing existing quality measures, identifying gaps in those measures and systems, and establishing priorities for measures that would contribute to a “continuously learning and improving health system” (NASEM, n.d.j). The study was conducted at a time when the number of measures was expanding rapidly and policy makers were focused on “measuring the value of health services and rewarding providers who improved it.” The committee concluded that “although many of these measures provide useful information, their sheer number, as well as their lack of focus, consistency, and organization, limits their overall effectiveness in improving performance of the health system” (IOM, 2015a). To remedy the situation, the committee identified “a set of standardized measures required at national, state, local, and institutional levels” and recommended steps “to implement and refine” the measures. The 15 core measures—which included life expectancy, overweight and obesity, and addictive behavior—were meant to be “parsimonious, outcomes-oriented, reflective of system performance, meaningful and had utility at multiple levels.” Through its recommendations, the committee’s overarching goal was to ensure “better health at lower cost for all Americans” (Blumenthal and McGinnis, 2015; IOM, 2015a,b).

Health Information Technology and Digital Infrastructure

Measuring quality and health outcomes with the goal of improving clinical decision making and overall health care required a robust health IT infrastructure. From early discussions of health IT, the IOM supported the introduction, use, and integration of electronic medical records, data collection systems, and telemedicine as a mechanism to improve health care. For example, in 1991 the IOM released a report called The Computer-Based Patient Record: An Essential Technology for Health Care. The committee that produced the report, which was chaired by Don Detmer,³³ concluded that electronic records should be “the standard for medical and all other records related to health care” (IOM, 1997a, p. 50). The IOM also examined the potential benefits of telemedicine and how new technologies could be implemented to expand access to care in the 1996 report

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³² David Blumenthal was the President of The Commonwealth Fund during this time.

³³ Don E. Detmer was a Professor of Surgery and Business Administration and the Vice President for Health Sciences at the University of Virginia when this report was released.

Telemedicine: A Guide to Assessing Telecommunications for Health Care, which was drafted by a committee chaired by John Ball.³⁴ This report presented a framework for assessing the quality, accessibility, and cost of these technologies (IOM, 1996b). Despite the potential benefits of health IT solutions, the IOM recognized the importance of maintaining privacy when capturing and using electronic data in health care and research in a number of reports, including Health Data in the Information Age: Use, Disclosure, and Privacy (IOM, 1994b), Protecting Data Privacy in Health Services Research (IOM, 2000n), and Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age (NAS et al., 2009).

Health IT and data collection efforts in the digital age were also discussed by the Roundtable on Value & Science-Driven Health Care. For example, the roundtable held a workshop in 2010 that resulted in a workshop summary called Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Health Care (IOM, 2011j). Workshop participants discussed how advances in health information technology could reshape the delivery of health care in fundamental ways, from communication between care providers and patients to instant access to the most up-to-date evidence base. In addition to the potential benefits, the summary and workshop participants also considered potential security risks, privacy concerns, and possible interoperability issues associated with the wide-scale implementation of health IT systems.

In 2012, the IOM released Health IT and Patient Safety: Building Safer Systems for Better Care—a consensus report that bridged the IOM’s interests in quality and safety with the appropriate use of technology in a learning health care system. The committee, chaired by NAM member Gail L. Warden,³⁵ recognized that health IT was not a panacea for the system’s problems. As the report noted, “designed and applied inappropriately, health IT can add an additional layer of complexity to the already complex delivery of health care” (IOM, 2012d, p. 2). If, however, the technologies were “designed, implemented, and used appropriately, [they could] be a positive enabler to transform the way care is delivered (IOM, 2012d, p. 2). The report called for a coordinated effort to better understand the possible safety risks of health IT by encouraging better information flow, establishing mechanisms for reporting and investigating injuries and deaths connected with health IT failures, and taking proactive steps to “ensure that health IT is developed and implemented with safety as a primary focus” (IOM, 2012d, p. 13). In 2013, HHS released its “Health IT Patient Safety Action and Surveillance Plan,” which was built on the IOM’s recommendations and was designed to guide health IT activities across HHS and improve health care safety through the implementation of health IT. The plan, which also called for private-sector collaboration, included an appendix that compared the recommendations from the IOM report with HHS’s proposed actions (ONC, 2013).

The NAM Leadership Consortium

When the NAM was created in 2015, the Roundtable on Value & Science-Drive Health Care evolved into the NAM Leadership Consortium: Collaboration for a Value & Science-Driven Health System, becoming one of the NAM’s largest and most active programs. The Consortium provides “a trusted venue for national leaders in health and health care to work cooperatively toward their common commitment to effective, innovative care that consistently adds value to patients and society” (NAM, n.d.c). The initial membership of the consortium included several members of the former IOM roundtable, including NAM member Mark McClellan, a past commissioner of the FDA and administrator of CMS, as the chair (see Box 5-2). The consortium continued the roundtable’s tradition of holding workshops, operating standing forums called “innovation collaboratives,” and publishing discussion papers and commentaries through the NAM Perspectives platform. The consortium also expanded its portfolio to include NAM special publications (see Chapter 7).

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³⁴ John R. Ball was the Chair, the President, and the Chief Executive Officer of the Pennsylvania Hospital in Philadelphia during this time.

³⁵ Gail L. Warden was the President Emeritus of the Henry Ford Health System in Detroit when this report was released.

By 2021, the Leadership Consortium had converted its former “innovation collaboratives” to “Action Collaboratives” under the new NAM model (see Chapter 7). Those Action Collaboratives included:

• Culture, Inclusion, and Equity: Advancing a culture of health equity and engagement that places the needs of people and communities at its core.
• Evidence Mobilization: Supporting the conditions necessary for transforming real-world experiences into valuable data that are routinely used to improve population and patient-level health.
• Digital Health: Fostering improvements and innovation in digital infrastructure so that health technology is developed and applied in ways that consistently lead to better population and patient-level health.
• Value Incentives and Systems: Supporting payment systems that incentivize value and population health.

In 2021, the Consortium undertook a comprehensive sector-by-sector assessment of the health system’s response to the COVID-19 pandemic, with an emphasis on determining opportunities for improvement (described further in Chapter 7).

HEALTH DISPARITIES AND HEALTH EQUITY

As the IOM developed its Quality Chasm series, it also undertook a parallel effort to study one of the six dimensions of quality identified in Crossing the Quality Chasm—equity. Although the IOM had considered disparities in health care previously (IOM, 1991b, 1993b, 1996c, 2000c), this new initiative would be the first time the IOM delved deeply into health disparities and potential solutions to ensure greater equity across the U.S. health care system. Health equity would emerge as one of the organization’s ongoing priorities that would be examined across a wide range of reports, workshops, and other activities.

In 1999, Congress requested an IOM study focused on “understanding and reducing racial and ethnic disparities in health care.” The goal of the study was to assess racial and ethnic differences in health care that could not be attributed to factors such as insurance coverage or the ability to pay. The study would also concentrate on the role of bias, discrimination, and stereotyping in health outcomes.³⁶ The resulting report, Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care, was released in 2002 and would be recognized as one of the IOM’s seminal works. During its deliberations, the committee, which was chaired by NAM member and Councilor (1985–1987) Alan R. Nelson,³⁷ identified a large body of evidence that indicated that racial and ethnic minorities in the United States received lower quality health care, were less likely to receive routine medical care, and experienced higher rates of morbidity and mortality than non-minority populations. For example, African Americans had higher rates of mortality from heart disease, cancer, diabetes, and AIDS than any other racial or ethnic group.³⁸ The committee found evidence that “stereotyping, biases, and uncertainty on the part of healthcare providers can all contribute to unequal treatment” (IOM, 2003b, p. 1). The conditions in which clinical encounters took place—which included “high time pressure, cognitive complexity and pressures for cost-containment”—-

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³⁶ Susanne A. Stoiber to Mary Ann Mink, Supervisory Contract Specialist, Office of Minority Health, June 22, 2000, IOM/NAM Records.

³⁷ Alan R. Nelson was a retired physician and serving as a special advisor to the Chief Executive Officer of the American College of Physicians-American Society of Internal Medicine when this report was released.

³⁸ National Academy of Sciences, “Understanding and Reducing Racial and Ethnic Disparities in Health Care,” Proposal No. 00-IOM-170-01, June 2000, IOM/NAM Records.

could “enhance the likelihood that these processes will result in care poorly matched to minority patients’ needs” (IOM, 2003b, p. 1).

Eliminating disparities required a range of solutions that took into account the underlying complexities and causes of unequal treatment (IOM, 2003b). The committee offered 19 recommendations that included increasing awareness, better data collection and monitoring, and specific interventions at the health system level and also at the legal, regulatory, and policy levels. For example, the committee called for increasing the “proportion of underrepresented U.S. racial and ethnic minorities” (p. 2) in the health care workforce and cross-cultural education for health care professionals. The committee also believed that expanded patient education could lead to greater empowerment and more engagement in decision making.

Like many of the IOM’s previous reports, Unequal Treatment received notable attention from the media with coverage from several of the nation’s major news outlets. Following the release of the report, the W.K. Kellogg Foundation announced a $3.6 million initiative to “increase the diversity of America’s health professions education programs at all levels of preparation.” This initiative included funding for a follow-up IOM study to identify barriers that prevent schools and universities from recruiting and admitting minority candidates. This study ultimately resulted in the 2004 IOM report In the Nation’s Compelling Interest: Ensuring Diversity in the Health Care Workforce (described below). The Unequal Treatment report was also the basis of legislation called the Health Equity and Accountability Act of 2009, which was introduced by Donna Christensen, U.S. Virgin Islands Delegate. The bill included several provisions that were directly in line with recommendations from the report, such as charging the CMS Office of Mental Health to consider reimbursement programs that reward quality care provided to minority populations and bolstering the HHS Office for Civil Rights to strengthen accountability.³⁹

In addition to health disparities associated with racial and ethnic minorities, the IOM also explored disparities experienced by lesbian, gay, bisexual, and transgender (LGBT) populations in its 2011 report, The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. The report, which was drafted by a committee chaired by NAM member Robert Graham,⁴⁰ found that as these populations became more “visible in society and more socially acknowledged,” there was an overall lack of information available about the health status and health needs of these populations (IOM, 2011e). In its deliberations, the committee found evidence indicating that LGBT youth had higher rates of substance use, depression, and suicide than heterosexual populations. To fill existing knowledge gaps and ensure better access to high-quality, patient-centered care, the report developed a research agenda that laid out specific priority areas (e.g., social influences, health care inequalities, transgender health needs) across the lifespan. The committee concluded that “building the evidence base on LGBT health issues will not only benefit LGBT individuals but also provide new research on topics that affect heterosexual and non-gender-variant individuals as well” (p. 6).

The 2011 release of The Health of Lesbian, Gay, Bisexual, and Transgender People resulted in numerous actions at the federal level to improve research and reduce health disparities for these populations. For example, HHS announced new draft standards for the collection of health data and included LGBT populations for the first time, highlighting the “need for collection of gender identity and sexual orientation data on federally supported surveys,” which had been emphasized by the IOM report. The National Institutes of Health (NIH) also took action based on the report, creating a cross-NIH coordinating group in 2011 called LGBT Research Coordinating Committee and releasing a funding opportunity announcement for research related to sexual and gender minorities.

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³⁹ Impact of IOM Reports (Database), IOM/NAM Records.

⁴⁰ Robert Graham was the Professor of Family Medicine and Robert and Myfanwy Smith Chair in the Department of Family Medicine at the University of Cincinnati College of Medicine when this report was released.

In 2016, the agency also designated sexual and gender minorities as a health disparities population in research and developed a strategic plan to guide the NIH’s research related to these populations over a 5-year period from 2016 to 2020. At a state level, in 2014, New York Governor Andrew Cuomo announced that New York State would launch a new multi-agency program to improve data collection for LGBT New Yorkers, citing the IOM’s report as a factor in creating this new effort.⁴¹

Recognizing that health disparities went beyond the health care delivery system, the IOM also looked at disparities that occurred in health research. For example, the NIH commissioned an IOM study to evaluate its research programs for ethnic minorities and the medically underserved. The Unequal Burden of Cancer: An Assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved was released in 1999 and indicated that “not all segments of the United States population” had received the full benefits of advances in understanding and treating cancer. The committee, which was chaired by M. Alfred Haynes,⁴² made a series of recommendations on how to remedy these disparities and called on the NIH’s Office of Research on Minority Health to play a more active role in “coordinating, planning” and facilitating research regarding cancer among ethnic minority and medically underserved populations (IOM, 1999b). In 2006, the IOM released a second report assessing the NIH’s research programs, Examining the Health Disparities Research Plan of the National Institutes of Health: Unfinished Business. The report assessed the NIH’s research plan to determine if it was providing the intended structure and coordination across the NIH’s institutes and research programs to reduce, and ultimately eliminate, health disparities. In its report, the committee, chaired by NAM member Gerald E. Thomson,⁴³ provided a series of recommendations to improve the NIH’s strategic planning process to close gaps related to planning, coordination, and funding allocation in connection to disparities research funded by the NIH (IOM, 2006b).

To establish a more permanent convening body to promote health equity, the IOM established the Roundtable on the Promotion of Health Equity in 2007. The roundtable sought to “promote health equity and eliminate disparities” through activities and discussion aimed at “advancing the visibility and understanding of the inequities in health and health care among racial and ethnic populations; amplifying research, policy, and community-centered programs; and catalyzing the emergence of new leaders, partners and stakeholders.” Throughout its history, the roundtable held more than two dozen meetings that looked at housing, incarceration, drug control policies, and culture as factors related to health equity as well as equity concerns of specific populations such as African Americans, Native Americans, older adults, people with disabilities, and people living in rural communities. In 2010, the roundtable hosted a workshop to assess progress that had been made in eliminating health disparities during the previous decade. The workshop brought together representatives from Walgreens and the HHS’s Office of Minority Health, who subsequently established an important working collaboration to improve health for the uninsured. As a result of this collaboration, Walgreens contributed more than $10 million in vouchers for free flu vaccinations during the 2011 flu season that were then distributed by HHS to approximately 350,000 eligible individuals in 15 communities across the United States (Infection Control Today, 2010).

Continuing to explore options for eliminating disparities and ensuring health equity, the HMD released a five-part series in 2016 and early 2017 that examined social risk factors that could influence health outcomes for Medicare beneficiaries (see Box 5-3). The committee was also asked to provide a set of methods that could be used to account for these risk factors in Medicare payment programs. Together, the reports defined a conceptual framework that included specific indicators

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⁴¹ Impact of IOM Reports (Database), IOM/NAM Records.

⁴² M. Alfred Haynes was the Former President and the Dean of the Drew Postgraduate Medical School and the Former Director of the Drew-Meharry-Morehouse Consortium Cancer Center in Rancho Palos Verdes, California.

⁴³ Gerald E. Thomson was the Lambert and Sonneborn Professor of Medicine Emeritus and the Senior Associate Dean Emeritus at the Columbia University College of Physicians and Surgeons during this time.

for social risk factors along with health care outcomes that could be employed by Medicare’s quality measures and payment programs. The committee also provided guidance on data sources and data collection methods that could be used by Medicare and reviewed strategies adopted by high-performing health care systems to improve quality of care and health outcomes for socially at-risk populations. In the final report, the committee, which was chaired by NAM member Donald M. Steinwachs,⁴⁴ concluded that “accounting for social risk factors [in Medicare payment programs] is necessary but insufficient by itself to achieve health equity” (NASEM, 2017e). The committee urged caution in modifying payment programs, noting that “quality measurement and payment policies affect the lives of real patients.” However, the committee believed that accounting for social risk factors in combination with other strategies could promote greater equity for Medicare beneficiaries.

Meanwhile, following the 2015 IOM-NAM transition, the NAM established its Culture of Health Program, supported by the RWJF, to advance the evidence base for policies that support equitable good health for everyone in America (described in Chapter 7). The Program’s definition of a culture of health, or a state in which everyone has “the opportunity to be healthy and reach their full potential no matter who they are or where they live” became not only the credo of the Program, but also a centering value for all of the NAM’s programmatic activities (NAM, n.d.k). In 2018, “accelerating health equity” was explicitly added to the NAM’s mission statement as an outcome of its strategic planning process (NAM, 2017d).

Health Literacy

In 2004, the IOM released a report called Health Literacy: A Prescription to End Confusion. The report initiated the IOM’s ongoing examination of health literacy—one of the many factors that can contribute to health disparities and impede the realization of health equity. For example, studies indicate that individuals with lower levels of health literacy have less knowledge about managing chronic illnesses and health-promoting behaviors, decreased ability to actively participate in health decision making, lower compliance with prescribed therapies, and poorer overall health status (IOM, 2004b). Data also suggest a linkage between lower levels of health literacy and increased health care utilization (e.g., increased number of hospitalizations and emergency room visits) and health care expenditures. In its report, the IOM committee, which was chaired by NAM member

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⁴⁴ Donald M. Steinwachs was a Professor at the Johns Hopkins Bloomberg School of Public Health at the time these reports were released.

David Kindig,⁴⁵ adopted the definition of health literacy as “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions” (IOM, 2004b; Ratzan and Parker, 2000). Health literacy stemmed from a combination of social and individual factors that were mediated by education, culture, and language.

The 2004 report estimated that as many as 90 million people in the United States might not be able to fully understand or act upon complex health information, not only affecting health outcomes but also hampering the health care system’s ability to provide effective, high-quality health care (IOM, 2004b). The report offered eight recommendations to improve health literacy in the United States, calling upon the government, private funders, educators, and the health care system to take action. For example, secondary schools should “incorporate health-related tasks, materials, and examples into existing lesson plans,” and health care professional educators should “incorporate health literacy into their curricula and areas of competence” (p. 15). The committee concluded that “without improvements in health literacy, the promise of scientific advances for improving health outcomes will be diminished” (p. 3) The report served as the basis for multiple pieces of legislation introduced in Congress, including the National Health Literacy Act of 2007 and the Promoting Health as Youth Skills in Classrooms and Life Act of 2011.⁴⁶

Following the release of the report, the IOM launched the Roundtable on Health Literacy in 2005 to provide a long-term platform to bring together a variety of experts and stakeholders in a neutral setting “to support the development, implementation, and sharing of evidence-based health literacy practices and policies” (NASEM, n.d.k). The roundtable envisioned “a society in which the demands of the health and health care systems are respectful of and aligned with people’s skills, abilities, and values.” With more than a dozen sponsors and almost 30 members, the roundtable hosted nearly 40 public meetings and released more than 30 publications. The roundtable’s activities explored a wide range of topics that intersected with health literacy, including oral health; behavioral and mental health; oncology; aging; palliative care; and immigrants, refugees, and migrant workers. The roundtable also reviewed specific topics such as health literacy and informed consent, discharge instructions, and medication labels. In October 2012, as a result of the 2004 report, Health Literacy: A Prescription to End Confusion, and the roundtable’s ongoing work, the U.S. Pharmacopeial Convention (USP) released universal standards for simplifying the content and appearance of prescription labels. The USP credited the IOM’s work for inspiring the new, patient-friendly standards, which USP leadership began developing after participating in a 2007 roundtable workshop.⁴⁷

Following the creation of the HMD, the Roundtable on Health Literacy continued its work and began partnering with other HMD roundtables and forums to cover cross-cutting topics of interest to a wider audience of stakeholders. For example, in 2016, the roundtable collaborated with the Roundtable on the Promotion of Health Equity to host a workshop that resulted in a publication called People Living with Disabilities: Health Equity, Health Disparities, and Health Literacy: Proceedings of a Workshop, which considered the “intersections of health equity, health disparities, health literacy, and people living with disabilities” (NASEM, 2018c, p. 1). In 2019, the Roundtable on Health Literacy co-hosted a workshop with the National Cancer Policy Forum on health literacy and communication strategies in oncology. The workshop examined “opportunities, methods, and strategies to improve the communication of information about cancer care at the level of the clinic visit, the health care organization, and the community” (NASEM, n.d.l).

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⁴⁵ David Kindig was at the Wisconsin Public Health & Health Policy Institute of the University of Wisconsin–Madison during this time.

⁴⁶ Impact of IOM Reports (Database), IOM/NAM Records.

⁴⁷ Ibid.

THE HEALTH CARE WORKFORCE AND INFORMAL CAREGIVERS

An integral part of the IOM’s vision for improving health and health care quality in the United States involved an emphasis on the health care workforce and a reconfiguration of the relationship between health care providers and patients. The IOM recognized that fulfilling the six dimensions of quality—ensuring care that is safe, effective, patient-centered, timely, efficient, and equitable—required modifications to the education and training for health care providers, as well as the composition of the health care workforce. However, health care providers and the health care system were not solely responsible for all facets of care; informal caregivers and the day-to-day care they provided could also affect health outcomes and overall well-being, especially for older adults. Actively engaging and empowering patients, their caregivers, and loved ones as partners was crucial to achieving high-quality care and better health outcomes and quality of life.

Education and Training for Health Care Providers

Over the years, the IOM examined many aspects of the health care workforce in determining how to provide the best care possible to meet specific needs of populations. For example, in the nation’s efforts to fortify the workforce for the aging baby boomer population, the IOM reviewed the composition of the workforce and the skillsets needed to care for an older population. In the spring of 2008, the IOM released Retooling for an Aging America: Building the Health Care Workforce, a report that evaluated the current health care workforce in light of the health care needs of an aging population. The committee, which was chaired by NAM member John W. Rowe,⁴⁸ concluded that the workforce was neither large enough nor adequately trained to care for the unique needs of older Americans. The committee recommended ways in which the workforce, as well as informal caregivers such as family members and friends, could be better trained. The report also highlighted the need for programs to recruit and retain geriatric specialists, including physicians and nurses (IOM, 2008b).

The 2008 report spurred a wide range of policy discussions and actions that were geared toward better preparing the health care system and workforce for the needs of the quickly aging population. For example, a provision of the Patient Protection and Affordable Care Act (ACA), which was signed by President Obama in March 2010, expanded the Geriatric Academic Career Awards program to include advanced practice registered nurses, clinical social workers, pharmacists, and psychologists. The provision was directly in line with the IOM report’s recommendation, which had called for inclusion of health professionals from disciplines other than allopathic and osteopathic in the award program. Also in line with the IOM’s recommendations, other provisions in the legislation supported family caregiver training through federally funded geriatric education centers and additional training for the direct care workforce.⁴⁹ Recognizing the severity of the situation, the VA established a task force to address the health care workforce challenges presented by the aging veteran population and also released their Geriatrics and Extended Care Strategic Plan, which leveraged the IOM’s recommendations but also considered the unique nature of the VA’s beneficiaries, 52 percent of whom were over the age of 65.⁵⁰

The IOM took a closer look at the mental health and substance abuse workforce for older adults in its 2012 report, The Mental Health and Substance Use Workforce for Older Adults: In Whose Hands? This follow-on study, which was chaired by NAM member Dan G. Blazer,⁵¹ estimated that

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⁴⁸ John W. Rowe was a Professor in the Department of Health Policy and Management at the Mailman School of Public Health of Columbia University at the time.

⁴⁹ Impact of IOM Reports (Database), IOM/NAM Records.

⁵⁰ Ibid.

⁵¹ Dan G. Blazer was the J.P. Gibbons Professor of Psychiatry and Behavioral Sciences and the Vice Chair for Education and Academic Affairs at the Duke University Medical Center in Durham, North Carolina, when this report was released.

the population over the age of 65 would reach more than 72 million by 2030, and that approximately one in five older adults would have at least one mental health or substance use concern (e.g., dementia, depression, alcohol abuse). In its report, the committee called for urgent action and leadership to establish a better prepared workforce, noting that no single solution would be sufficient to ensure the availability of a well-trained cadre of health care professionals (IOM, 2012e).

Throughout its history, the IOM also focused more broadly on education and training for health care providers. For example, in 2002 the IOM hosted the Health Professions Education Summit, which was designed to explore strategies to update education and training for health care professionals to align with care delivery in the 21st century. The summit, which was organized by a committee co-chaired by external volunteer Edward M. Hundert⁵² and NAM member Mary Wakefield,⁵³ resulted in a publication called Health Professions Education: A Bridge to Quality (IOM, 2003c). Following up on that theme, the IOM released a report in 2009 called Redesigning Continuing Education in the Health Professions, which considered continuing education across the health professions and also the possibility of establishing a national institution for continuing education (IOM, 2010c).

In 2004, the IOM assessed the diversity of the health care workforce in its report, In the Nation’s Compelling Interest: Ensuring Diversity in the Health Care Workforce. The report noted that the diversifying population of the United States required a more diverse health care workforce. Available evidence indicated that greater diversity was “associated with improved access to care for racial and ethnic minority patients, greater patient choice and satisfaction, and better educational experiences for health professions students” (IOM, 2004d, p. 1). Therefore, the committee, which was chaired by NAM member Lonnie R. Bristow,⁵⁴ made recommendations to change admissions policies and practices, provide better financial support, and shift institutional climates to encourage greater diversity among the health care workforce in the United States.

As the health care system evolved and more emphasis was placed on collaborative, team-based care, interest in interprofessional education (IPE) models and the linkages across IPE, safety, quality, cost, and patient outcomes and satisfaction grew. In response to a request from the sponsors of the IOM’s Global Forum on Innovation in Health Professional Education, the IOM convened a committee to analyze “the available data and information to determine the best methods for measuring the impact of interprofessional education on specific aspects of health care delivery and the functioning of health care systems.” In 2015, the IOM released Measuring the Impact of Interprofessional Education on Collaborative Practice and Patient Outcomes, which called on relevant stakeholders to “commit resources to a coordinated series of well-designed studies” that assessed the association between “interprofessional education and collaborative behavior” (IOM, 2015c, p. 5). To inform the development of the necessary studies, the committee, which was chaired by external volunteer Malcolm Cox,⁵⁵ created a conceptual model that included the “education-to-practice continuum, a broad array of learning, health, and system outcomes, and major enabling and interfering factors” (IOM, 2015c, p. 28).

In 2014, the IOM released a report on a specific topic in the education and training for health care providers—the financing of graduate medical education in the United States. The report, Graduate Medical Education That Meets the Nation’s Health Needs, indicated that approximately $15 billion of public funding had been used to support graduate medical education through Medicare, Medicaid, the VA, and the HHS’s Health Resources and Services Administration (IOM, 2014b).

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⁵² Edward M. Hundert was the President of Case Western University at the time of the summit.

⁵³ Mary Wakefield was the Director of the Center for Rural Health at the School of Medicine and Health Sciences at the University of North Dakota at this time.

⁵⁴ Lonnie R. Bristow was a retired physician and the former President of the American Medical Association at this time.

⁵⁵ Malcolm Cox was an Adjunct Professor at the Perelman School of Medicine of the University of Pennsylvania at the time.

However, the committee, chaired by Donald M. Berwick,⁵⁶ concluded that given that level of funding over almost a half-century, there was “a striking absence of transparency and accountability for producing the types of physicians that today’s health care system requires” (IOM, 2014b, p. 16). Although the committee recommended maintaining the current level of funding for graduate medical education, it stated that significant amendments were required to develop a physician workforce that is better suited to meet the dynamic health care needs of the nation. The report offered six goals and four recommendations that the CMS, Congress, and other stakeholders could use to reform the governance and financing of graduate medical education through Medicare (Sklar, 2014).

In addition to education and training for the health care workforce, the IOM also considered the environment in which health care professionals and students worked and the impact that those environments had on the delivery of high-quality care and patient safety. The IOM’s report Keeping Patients Safe: Transforming the Work Environment of Nurses reviewed the environments in which nurses work (e.g., hospitals, nursing homes, clinics) and made recommendations for how to improve working conditions for nurses in order to promote greater patient safety (IOM, 2004h). In August 2012, Massachusetts implemented one of the report’s recommendations and became the 17th state to enact a ban on mandatory overtime for nurses.⁵⁷

In 2003, the Accreditation Council for Graduate Medical Education (ACGME) implemented national standards that “mandated an 80-hour weekly average for all residents along with implementing other minimum requirements for time off from the hospital” (IOM, 2009a, p. 28). Following the release of these common duty hour standards, there was an uptick in interest and scrutiny on resident work hours in hospitals. In 2007, Congress directed HHS to commission an IOM study “to examine the relationship between resident duty hours and patient safety” (p. 29). During its deliberations, the committee considered a range of possible consequences of resident duty hours on patient safety—for example, the potential effects of reducing time spent in hospitals on residents’ educational experience, the impact of increasing the number of handovers during patient care, and the potential risks associated with long hours and sleep deprivation. In 2008, the IOM released a report called Resident Duty Hours: Enhancing Sleep, Supervision, and Safety. Although the report was controversial in the medical field, it led to significant changes in the way future physicians were trained. The committee, which was chaired by NAM member and Councilor (1997–2002) Michael M. E. Johns,⁵⁸ stated that the current restrictions on work hours, which allowed residents to work 30-hour shifts and up to 80 hours per week, resulted in fatigue that could jeopardize patient safety by increasing the risk for medical errors. The committee recommended that residents not be allowed to work more than 16-hour shifts and that greater emphasis be placed on handovers from one shift to the next (IOM, 2009a). In 2011, the ACGME updated its resident duty hours guidelines once more, implementing the IOM’s recommendation to limit residents’ shifts to 16 hours for first-year residents (Choma et al., 2013). However, by 2021, ACGME had removed the 16-hour requirement, stating that it was “incompatible with the actual practice of medicine and surgery in many specialties, excessively limiting in configuration of clinical services in many disciplines, and potentially disruptive of the inculcation of responsibility and professional commitment to altruism and placing the needs of patients above those of the physician” (ACGME, 2021, p. 52).

The Future of Nursing

With more than 3 million registered nurses in the United States in the first decade of the 21st century, nurses make up the largest contingent of the health care workforce. During the past century,

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⁵⁶ Donald M. Berwick was the former President and the Chief Executive Officer of the Institute for Healthcare Improvement.

⁵⁷ Impact of IOM Reports (Database), IOM/NAM Records.

⁵⁸ Michael M. E. Johns was the Chancellor at Emory University when this report was released.

the role of nurses in the health care system has evolved, with shifts in scope of practice, advances in technology, health care provider shortages, greater emphasis on primary care and preventive services, and an increased strain on the health care system due to an aging population. The IOM emphasized the importance of nurses in the health care workforce and the care that they provide in its report Nursing and Nursing Education: Public Policies and Private Actions (IOM, 1983). More than two decades later, the organization launched an initiative designed to maximize the value and contributions of nurses to the health care workforce and system. In the 21st century, the IOM, the RWJF, and many other stakeholders recognized the vital role of nurses in providing high-quality care and also the need to expand and enhance the nursing workforce. In 2009, the IOM introduced a joint initiative with the RWJF to assess the future of nursing in the United States. The initiative—which was chaired by NAM member Donna Shalala, the former HHS Secretary and future U.S. Congresswoman⁵⁹—was the first time the IOM had partnered with another organization to complete a consensus study. The initiative was supported by a blend of IOM and RWJF staff, who were engaged throughout the study process.⁶⁰ The staff worked jointly with the committee to develop a research strategy and communications plan to ensure that the report would have the greatest possible reach and potential for change. In conducting its work, the committee held three regional forums—in Los Angeles, Philadelphia, and Houston—that focused on acute care, care in the community, and education, respectively. Each of the forums resulted in a separate publication that informed the overall consensus study and the committee’s final report.

The committee’s report, The Future of Nursing: Leading Change, Advancing Health, was released in September 2010. It offered a blueprint for transforming the nursing profession in three key areas—education, practice, and leadership—with an emphasis on enhancing the profession to achieve greater quality, access, and value throughout the health care system. To realize this transformation, nurses needed to “practic[e] to the full extent of their education and training,” “achieve higher levels of education and training,” and “be full partners … in redesigning [health] care in the United States,” working as equal partners with other health care professionals (IOM, 2011f). The committee also called for better data to support “effective workforce planning and policy making” (IOM, 2011g, p. 4). In its work, the committee examined the varied educational pathways that led to a registered nurse license (e.g., community colleges, universities) and recommended that 80 percent of nurses should hold a baccalaureate degree by 2020 and that the number of nurses with doctorates should double by that time in an effort to expand the number of nurse educators.⁶¹

The 2010 Future of Nursing initiative and consensus report attracted wide attention across the health care industry, in political spheres, and from the media. After its release, the report became the most downloaded IOM report of all time and the second most downloaded report of all time across the entire National Academies.⁶² Shortly after the release of the report, the RWJF, in partnership with the AARP, launched a “Future of Nursing: Campaign for Action” initiative. The campaign sought to organize “action coalitions” in all 50 states to help realize the report’s recommendations at the state level, where decision and policy making about licensing and education frequently occur. Major themes of the campaign included advancing education, developing and leveraging nursing leadership, and promoting nursing diversity. The recommendations from the IOM report, combined with the implementation efforts of the Campaign for Action, resulted in policy change in numerous states related to scope of practice for nurses. For example, several states removed barriers to prac-

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⁵⁹ Shalala served as the U.S. Representative for Florida’s 27th congressional district from January 3, 2019, to January 3, 2021.

⁶⁰ Donna Shalala and Linda Bolton to Members of the Robert Johnson Foundation Initiative on the Future of Nursing, at the Institute of Medicine, July 1, 2009, Future of Nursing Files, IOM/NAM Records.

⁶¹ Harvey Fineberg to Risa Lavizzo-Mourey, September 30, 2010, Future of Nursing Files, IOM/NAM Records.

⁶² National Academies internal data, December 2021.

tice for advanced practice registered nurses (APRNs), ensuring that APRNs could practice without direct physician supervision.⁶³

The RWJF-AARP Campaign for Action also led to a 2014 request from the RWJF for the IOM to assess changes in the field of nursing over the previous 5 years and review progress made by the RWJF-AARP campaign.⁶⁴ The resulting consensus study—Assessing Progress on the Institute of Medicine Report The Future of Nursing—was released in December 2015 as a report of the National Academies of Sciences, Engineering, and Medicine following the creation of the NAM and the HMD. The committee, which was chaired by NAM member Stuart H. Altman,⁶⁵ concluded that much had changed in the health care industry since the release of the previous report and that the campaign had made “significant progress toward implementing the [report’s] recommendations” (NASEM, 2016e). However, more work was needed to fulfill the promise of the report’s recommendations. In order to promote continued progress, the new report offered recommendations related to removing barriers to practice and care, achieving higher levels of education, promoting diversity, collaborating and leading in care delivery and redesign, and improving workforce data infrastructure (NASEM, 2016e).⁶⁶

With 2020 approaching, the timeline set in the original Future of Nursing Initiative, the National Academies launched a new consensus study to “extend the vision for the nursing profession into 2030 and … chart a path for the nursing profession to help our nation create a culture of health, reduce health disparities, and improve the health and wellbeing of the U.S. population in the 21st century” (NASEM, n.d.m). Supported by the RWJF, the committee, which was co-chaired by Wakefield⁶⁷ and fellow NAM member David R. Williams,⁶⁸ hosted three regional town hall events reviewing themes related to education, research, and practice; payment and care for complex health and social needs; and high tech to high touch.

The Future of Nursing 2020–2030: Charting a Path to Achieve Health Equity was released on May 11, 2021 (NASEM, 2021e). The report’s key finding was that “nursing in the next 10 years will demand a larger, more diversified workforce prepared to provide care in different settings, to address the lasting effects of COVID-19, to break down structural racism and the root causes of poor health, and to respond to future public health emergencies” (NASEM, 2021b). The committee identified several key needs to help the nursing workforce reach its full potential and advance health equity in the United States: strengthening nurse education; promoting diversity, equity, and inclusion in nursing education and the workforce; investing in school and public health nurses; protecting nurses’ health and well-being; preparing nurses for disaster and public health emergency response; and increasing the number of PhD-prepared nurses (NASEM, 2021b).

The Role of Informal Caregivers

In conjunction with physicians, nurses, physical and occupational therapists, social workers, and other health care professionals, informal caregivers, such as family, friends, and neighbors, are

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⁶³ Impact of IOM Reports (Database), IOM/NAM Records.

⁶⁴ Robert Wood Johnson Foundation and AARP, “Future of Nursing: Campaign for Action—Campaign Overview,” n.d., in Future of Nursing Files, IOM/NAM Records; Clyde Behney to Melanie Adams, Robert Wood Johnson Foundation, September 16, 2014, Institute of Medicine, Board on Health Sciences Policy, “Evaluation of the Future of Nursing Campaign for Action,” September 2014, Proposal 10002323, Future of Nursing Files, IOM/NAM Records.

⁶⁵ Stuart H. Altman was the Sol C. Chaikin Professor of National Health Policy at the Heller Graduate School of Social Policy of Brandeis University in Weston, Massachusetts, when the report was released.

⁶⁶ Victor Dzau to Stuart Altman, March 25, 2015, Future of Nursing Files, IOM/NAM Records.

⁶⁷ Mary K. Wakefield was the Visiting Distinguished Professor in the Practice of Health Care at Georgetown University and also the Visiting Professor and a Distinguished Fellow at The University of Texas at Austin during this time.

⁶⁸ David R. Williams was the Florence and Laura Norman Professor of Public Health and the Chair of the Department of Social and Behavioral Sciences at the Harvard T.H. Chan School of Public Health at the time.

playing an increasingly important and varied role in the day-to-day care of older adults. In 2016, the HMD explored the role of family caregivers in its report Families Caring for an Aging America. During its deliberation, the committee found that more than 17.7 million people in the United States took care of an older adult due to that individual’s physical, mental, or cognitive health status or limitations. The care that informal caregivers provide ranges from occasional assistance with simple household tasks to long-term care that involves coordinating medical care and medication schedules for a loved one with complex conditions such as terminal cancer or dementia. The committee noted that family caregivers were often the key to ensuring access to needed health care and community-based services. While informal caregivers can play a crucial role in the health and well-being of older adults, this potentially stressful role can take a toll on the caregivers. An extensive body of evidence indicates that caregivers for older adults face an increased risk of depression, anxiety, emotional distress, social isolation, chronic illnesses, and impaired health behaviors, as well as an increased risk for experiencing economic harms, such as loss of income.

In its report, the committee, which was chaired by external volunteer Richard Schulz,⁶⁹ offered 11 recommendations focused on ways federal and state government agencies could better meet the needs of informal caregivers and support them in their role. For example, the committee suggested expanded funding and wider implementation of “evidence-based caregiver services” and the “adoption of federal policies that provide economic support to working caregivers” (NASEM, 2016f, p. 3). The committee also called on the health care system to identify and engage caregivers and “provide them [with] evidence-based supports and referrals to services in the community” (NASEM, 2016g, p. 10). The committee concluded that “today’s emphasis on person-centered care needs to evolve into a focus on person- and family-centered care” (NASEM, 2016g, p. 35), noting that “if the needs of caregivers are not addressed, we risk compromising the well-being of our elders and their families” (NASEM, 2016g, p. 258).

COMPLEX AND SERIOUS HEALTH CONDITIONS

Throughout its history, the IOM provided guidance on how the nation should approach complex and serious diseases and health conditions, such as cancer, cognitive decline and dementia, and dying (described below). In 2016, the HMD created an institutional structure for ongoing discussions related to care for complex and serious health conditions, with the creation of the Roundtable on Quality Care for People with Serious Illness. The roundtable was developed to foster an “ongoing dialogue about critical policy and research issues,” with the explicit purpose of advancing the findings and recommendations from previous reports such as Dying in America (IOM, 2015d). With more than 30 sponsors, the roundtable released 7 publications in its first 3 years, all of which cut across themes from the IOM, the NAM, and the HMD’s bodies of work in a timely way. For example, the roundtable hosted workshops related to quality measures for serious illnesses, pain management and opioids, health equity, palliative care, and better integration of patients and caregivers into care for serious illnesses.

Cancer

Coordinating and advancing cancer research (described in Chapter 4) and improving the delivery of cancer care constituted an important priority for the IOM from its very start. For example, when President Richard Nixon declared war on cancer in 1971—suggesting a national plan to cure cancer—IOM President John Hogness testified before Congress. In his testimony, Hogness

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⁶⁹ Richard Schulz was the Director of the University Center for Social and Urban Research at the University of Pittsburgh when this report was released.

emphasized that cancer encompassed many complex diseases and was not a single disease that could easily be cured. He offered advice on how best to conduct Nixon’s campaign without interrupting promising ongoing research related to the causes and treatments of the various different types of cancer.

Twenty-six years after Hogness’s statement on cancer policy, the IOM established the National Cancer Policy Board in March 1997. The board was developed to initiate studies related to the “prevention, control, diagnosis, treatment, and palliation of cancer” (IOM, 1999c, p. 1). One of the board’s first tasks was a study that resulted in a 1999 report called Ensuring Quality Cancer Care. The report, issued by the board rather than a separate study committee, exposed a wide gap between an ideal system of cancer care and current delivery mechanisms, which were deemed to be ad hoc and fragmented in nature. In the field of breast cancer, for example, the report identified quality problems related to the “underuse of mammography to detect cancer early, lack of adherence to standards for diagnosis …; inadequate patient counseling regarding treatment options; and underuse of radiation therapy and adjuvant chemotherapy after surgery” (IOM, 1999c, p. 216).

The report offered 10 recommendations to establish a cohesive national cancer care system that would ensure access to high-quality care. The committee, which was chaired by NAM member Peter Howley,⁷⁰ called for the development and implementation of evidence-based guidelines, as well as a core set of quality measures. The report also laid out the elements of quality cancer care, which included an agreed-upon care plan that outlines the goals of care, access to high-quality clinical trials, coordinated care and services, and access to psychosocial services and compassionate care. In terms of data, the committee recommended a national data system that provided quality benchmarks, studies focused on care management, the care received by recently diagnosed individuals, and the care received by specific populations (e.g., racial and ethnic minorities, older adults).⁷¹

Following this first report on the quality of cancer care, the IOM conducted other studies related to cancer care with an emphasis on the psychosocial needs of patients and survivors throughout their journey. A cancer diagnosis could be devastating, and the effects of a diagnosis and treatment went beyond the health care system, sometimes creating or exacerbating problems related to employment, schooling, transportation, family dynamics and relationships, caregiving roles, and mental health concerns such as depression and anxiety. The IOM’s first cancer report to specifically investigate the psychosocial needs of patients was its 2004 report Meeting Psychosocial Needs of Women with Breast Cancer (IOM and NRC, 2004). In 2006, the IOM released From Cancer Patient to Cancer Survivor: Lost in Transition, which was drafted by a committee chaired by NAM member Sheldon Greenfield.⁷² The report considered the psychosocial, functional, and health needs of individuals who had completed primary cancer treatment and had entered a new phase of life as a cancer survivor (IOM and NRC, 2006). The report informed the Comprehensive Cancer Care Improvement Act of 2007, which was introduced by U.S. Representatives Lois Capps (D-CA) and Tom Davis (R-VA) and 25 other co-sponsors. The bill sought to implement the recommendations of the IOM report and included provisions for providing Medicare coverage of comprehensive cancer care planning, establishing a Medicare hospice care demonstration program, and providing grants for programs related to palliative care and symptom management for patients with cancer, clinician education, and other related research areas.⁷³

In its 2008 report Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs

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⁷⁰ Peter Howley was the George Fabyan Professor and the Chair of the Department of Pathology at the Harvard Medical School during this time.

⁷¹ “Findings and Recommendations—Cancer Care Report,” in materials for National Cancer Policy Board, 7th Meeting, July 30–31, 1998, Woods Hole, IOM/NAM Records.

⁷² Sheldon Greenfield was the Director of the Center for Health Policy Research at the University of California, Irvine, when the report was released.

⁷³ Impact of IOM Reports (Database), IOM/NAM Records.

the IOM expanded on its 2004 report, delving into the complexities of the psychosocial needs for all patients with cancer, not just those with breast cancer. These psychosocial needs can easily be overlooked by a health care system focused on providing cutting-edge treatments to save or prolong life. The committee, which was chaired by NAM member and Councilor (2011–2017) Nancy E. Adler,⁷⁴ concluded that high-quality cancer care was not possible without providing comprehensive care that also addresses patients’ and families’ psychosocial needs (IOM, 2008c). During a March 2008 congressional briefing on the report, the National Cancer Institute’s (NCI’s) Director of the Division of Cancer Control and Population Sciences, Robert Croyle, stated that the IOM’s report had served as the basis of several NCI programmatic decisions related to continuing funding for centers of excellence in patient-centered communications, supporting community cancer centers, administering patient experience surveys, pursuing measurement of patient outcomes, and encouraging research focused on the whole patient. In 2013, Congressman Steve Israel (D-NY) introduced the Improving Cancer Treatment Education Act of 2013, which was developed to provide comprehensive treatment education for patients with cancer under Medicare, citing two IOM reports: Cancer Care for the Whole Patient (IOM, 2008c) and Ensuring Quality Cancer Care (IOM, 1999c).⁷⁵

In 2005, a structural reorganization converted the National Cancer Policy Board into the National Cancer Policy Forum (NASEM, n.d.n). As with the IOM’s other roundtables and forums, the National Cancer Policy Forum was a convening activity that was designed to bring together interested experts and stakeholders in a neutral environment to host public workshops and facilitate discussion regarding high-priority concerns across the field. The forum grew to include 20 sponsors and 44 members in 2021 (NASEM, 2021c). In the years between 2005 and 2019, the forum released 44 workshop summaries that covered a broad range of topics related to cancer science and research, diagnosis and treatment, and public health and health policy concerns related to cancer. The forum’s work was cross-cutting and touched on topics the IOM had reviewed more broadly in other studies, such as the health impacts of obesity, the health of children and adolescents, care quality and value, health disparities, and health IT and patient privacy (NASEM, 2021d).

In 2013, the IOM revisited the quality of cancer care in the United States, releasing a report called Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis, which incorporated work from the National Cancer Policy Forum (IOM, 2013g). In its report, the committee, which was chaired by NAM member Patricia A. Ganz,⁷⁶ concluded that the cancer care system was “in crisis due to a growing demand for cancer care, increasing complexity of treatment, a shrinking workforce, and rising costs” (IOM, 2013g, p. 1). To respond to this crisis and echoing themes from the 1997 quality report, the committee developed a six-part conceptual framework that involved actively engaged patients at the center of care and an adequately trained and coordinated team-based workforce that provided evidence-based care and employed a learning health IT system. The framework also called for translating available evidence into “clinical practice, quality measurement, and performance improvement,” while ensuring cancer care that was both accessible and affordable (IOM, 2013h, p. 11). The report emphasized the importance of a continuum of cancer care, from prevention and risk reduction to screening, diagnosis, and treatment to survivorship and end-of-life care.

As with many of the IOM’s health care quality-focused reports, Delivering High-Quality Cancer Care was the source of initiatives to improve the quality of care delivered to patients with cancer in the United States. Citing the IOM’s report and its recommendations. In 2015, CMS released a request for applications through its Center for Medicare & Medicaid Innovation that called for new

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⁷⁴ Nancy E. Adler was a Professor of Medical Psychology and the Vice-Chair of the Department of Psychiatry at the University of California, San Francisco, during this time.

⁷⁵ Impact of IOM Reports (Database), IOM/NAM Records.

⁷⁶ Patricia A. Ganz was a Distinguished University Professor at the University of California, Los Angeles, Schools of Medicine and Public Health, and the Director of Cancer Prevention and Control Research at the Jonsson Comprehensive Cancer Center.

models of oncology care aimed at “testing the effects of better care coordination, improved access to practitioners, and appropriate clinical care on improving health outcomes at a lower cost” (CMS, 2015). In 2015, the American Society of Clinical Oncology released a conceptual framework that was designed to assess the value of new cancer therapies based on clinical benefit (efficacy), toxicity (safety), and cost (efficiency). The framework cited the IOM’s Delivering High-Quality Cancer Care report and focused heavily on efficacy, safety, efficiency, patient centeredness, timeliness, and equity—elements identified by the IOM as essential to high-quality care.⁷⁷

Cognitive Aging and Dementia

Understanding cognitive aging and preventing cognitive decline and dementia are among the most complex challenges the health care system and health scientists have ever faced. As the U.S. population ages and life expectancy in many countries around the globe increases, it is becoming more pressing to find solutions to these challenges and better understand cognitive aging. By 2030, all of the 73 million baby boomers living in the United States will be over the age of 65 (U.S. Census Bureau, 2019). Although cognitive aging is a normal part of life that comes with both positive and negative experiences, the effects of aging on the brain and cognition vary widely across individuals. In 2015, the IOM released a report called Cognitive Aging: Progress in Understanding and Opportunities for Action, which focused on cognitive aging rather than neurodegenerative dementia, such as Alzheimer’s disease. The committee, which was chaired by Dan G. Blazer,⁷⁸ conducted in-depth assessments to characterize the current knowledge base related to “definitions and terminology, epidemiology and surveillance, prevention and intervention, education of health professionals, and public awareness and education (IOM, 2015i, p. 2).” In its report, the committee offered specific actions for individuals (e.g., remaining active, staying socially engaged, getting enough sleep, reducing cardiovascular risk factors) and health care providers (e.g., identifying risk factors for cognitive decline, reviewing patients’ medications, discussing cognitive health concerns). The report also reviewed opportunities to improve public education and engagement and described options for strengthening community-based and public health services designed to support older adults and their families in light of their cognitive aging needs (IOM, 2015i).

In 2016, the IOM reviewed a sometimes-overlooked risk factor in cognitive decline and dementia: hearing loss (NASEM, 2016h). Its report, Hearing Health Care for Adults: Priorities for Improving Access and Affordability, considered hearing loss as a public health concern and offered recommendations geared toward “improving hearing and communication abilities for individuals and across the population” (NASEM, 2016i, p. 3). Among other things, the report emphasized the social aspects of hearing loss, from diminished social engagement—a potential risk factor for cognitive decline and dementia—to the social stigma associated with hearing aids. The report was the subject of multiple pieces of legislation introduced in Congress, including a bill called the Over-the-Counter Hearing Aid Act of 2016. The bill was enacted into law in 2017, making hearing aids available over the counter to those with mild to moderate hearing loss.⁷⁹

In 2015, the NIH commissioned a study to evaluate available evidence related to the “effectiveness, comparative effectiveness, and harms of interventions associated with preventing, or delaying the onset” of age-related cognitive decline, cognitive impairment, and dementia (NASEM, 2017g, p. 5). In 2017, the HMD released Preventing Cognitive Decline and Dementia: A Way Forward.

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⁷⁷ Impact of IOM Reports (Database), IOM/NAM Records.

⁷⁸ Dan G. Blazer was the J.P. Gibbons Professor of Psychiatry Emeritus at the Duke University Medical Center when this report was released.

⁷⁹ Impact of IOM Reports (Database), IOM/NAM Records.

Following its evidence review, the committee, which was chaired by Alan I. Leshner,⁸⁰ concluded that there was enough “encouraging although inconclusive evidence” to highlight the potential beneficial effects of interventions related to cognitive training, blood pressure management for those with hypertension, and increased physical activity. The committee also identified areas that were ripe for additional research, such as diabetes and depression treatment; interventions related to sleep, diet, and social engagement; and new anti-dementia treatments. In providing its priority research areas, the committee called for high-quality prevention research with improved methodologies that involved “a diverse set of population, with variation across racial and ethnic backgrounds, socioeconomic status, age at the time of intervention initiation, and risk of dementia” (p. 11). In 2018, the HMD released a follow-on letter report called Considerations for the Design of a Systematic Review of Care Interventions for Individuals with Dementia and Their Caregivers. The report, which was produced by a committee chaired by NAM member Eric B. Larson,⁸¹ provided guidance for AHRQ’s review of evidence for care interventions that addressed behavioral and psychological symptoms, as well as other symptoms, overall functioning, and quality of life. The AHRQ’s systematic review process had been used to assess the evidence base for the 2017 report (NASEM, 2018e).

Prior to the release of these consensus studies, the Forum on Neuroscience and Nervous System Disorders, which was established in 2006, also held a number of public meetings that resulted in workshop summaries related to Alzheimer’s disease and dementia: Future Opportunities to Leverage the Alzheimer’s Disease Neuroimaging Initiative (IOM, 2011k), Alzheimer’s Diagnostic Guideline Validation: Exploration of Next Steps (IOM, 2012q), and Neurodegeneration: Exploring Commonalities Across Diseases (IOM, 2013n). In addition to its dementia-specific work, the forum’s work more broadly “examines significant—and sometimes contentious—issues concerning scientific needs and opportunities, priority setting, and policies related to neuroscience and nervous system disorders research; the development, regulation, and use of interventions for the nervous system; and related ethical, legal, and social implications” (NASEM, n.d.o).

End-of-Life Care

Another topic that remained a consistent priority on the IOM’s agenda was end-of-life and associated palliative care. The IOM long realized that care at the end of life represented a crucial responsibility of the health care system that was often overlooked or delivered too late. Improving care at the end of life is an important component of the continuum of care that also requires equitable access to high-quality, evidence-based care, as well as care for any other type of complex or serious illness. The IOM’s interest in end-of-life care dated back to 1984, when it published Bereavement: Reactions, Consequences, and Care. The report, which was written by a committee chaired by external volunteer Morris Green,⁸² focused on the needs of grieving survivors as part of care for the dying, highlighting another aspect of death that needed to be considered by the health care system (IOM, 1984b).

A little more than a decade later, the IOM released its first major work on end-of-life care—Approaching Death: Improving Care at the End of Life. This 1997 report facilitated the introduction of hospice care as an integral part of the U.S. health care system and called on physicians, nurses,

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⁸⁰ Alan I. Leshner was the Chief Executive Officer Emeritus of the American Association for the Advancement of Science at this time.

⁸¹ Eric B. Larson was the Vice President for Research at the Kaiser Foundation Health Plan of Washington and the Executive Director and a Senior Investigator at the Kaiser Permanente Washington Health Research Institute when this report was released.

⁸² Morris Green was the Lesh Professor and the Chair of the Department of Pediatrics at the Indiana University School of Medicine at the time.

social workers, and other members of the care team to make a commitment to improving care for dying patients. The committee, which was chaired by NAM member and Councilor (2003–2008) Christine Cassel,⁸³ stated that death should be “free from avoidable distress and suffering for patients, families, and caregivers; in general accord with patients’ and families, wishes; and reasonably consistent with clinical, cultural, and ethical standards” (IOM, 1997b, p. 4). In order to better meet the needs of people approaching death, the committee envisioned a whole-community model, which would require systematic modifications related to the organization and financing of care, the legal aspects of care, and the education and training of health care providers. Better outcomes data and tools would also be required to establish and track accountability associated with the quality of end-of-life care. The report sought to elevate palliative care to a defined medical specialty and area of expertise as another component of “a humane care system that people can trust to serve them well as they die” (IOM, 1997b, p. 13).

In 2001, the IOM reviewed end-of-life care for patients with a terminal cancer diagnosis in its report Improving Palliative Care for Cancer. As with the IOM’s report on the psychosocial needs of cancer patients, the committee pointed out that palliative care, education, and research were other areas often overlooked in the pursuit of new therapies and potential cures for the various types of cancer. Despite the nearly half million people who died from cancer each year, the committee found that less than 1 percent of the NCI’s budget was dedicated to education or research on palliative care (IOM and NRC, 2001). Building on the themes and recommendations from the IOM’s 1997 report Approaching Death, the committee, which was chaired by NAM member Arnold J. Levine,⁸⁴ offered 10 recommendations that were designed to develop and implement more effective palliative care options within cancer care, integrate palliative care as part of high-quality cancer care, improve communication with patients and their families about palliative care options, and enhance data collection and quality measures for end-of-life care for cancer patients (IOM and NRC, 2001). Following the release of the report, the American College of Physicians released new guidelines for end-of-life care, stating that, “end of life care has been identified by the Institute of Medicine as one of the priority areas to improve quality of health care. We hope that these guidelines would benefit physicians taking care of patients with seriously disabling or symptomatic chronic conditions” (ACP, 2008).

The 2003 report, When Children Die: Improving Palliative and End-of-Life Care for Children and Their Families, expanded on the IOM’s previous work to explore the unique needs of children with life-threatening medical conditions and their families. The report emphasized the crucial roles of health care providers and the health care system in providing “competent, compassionate, and consistent care [that meets the children and families’] physical, emotional, and spiritual needs” (IOM, 2003d). In order to build a more child- and family-centered system, the committee recommended that stakeholders work together to develop clinical guidelines, institutional protocols, and information programs for palliative, end-of-life, and bereavement care. In terms of financing, the committee stated that hospice services for children should be covered by public (e.g., Medicaid) and private insurers, and that eligibility restrictions related to life expectancy should be eliminated. Public and private insurers also needed to amend their reimbursement policies to cover the time needed to explain a child’s condition to parents and provide necessary counseling and guidance. Reinforcing the 1997 report’s call to promote palliative care as a specialty, the committee, which was chaired by external volunteer Richard E. Behrman,⁸⁵ encouraged better training for those who worked with children and families in palliative, end-of-life, and bereavement care (IOM, 2003d).

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⁸³ Christine Cassel was the Chair of the Department of Geriatrics and Adult Development at Mount Sinai Medical Center in New York during this time.

⁸⁴ Arnold J. Levine was the President of The Rockefeller University in New York when this report was released.

⁸⁵ Richard E. Behrman was the Executive Chair of the Federation of Pediatric Organizations, Education Steering Committee, and a Clinical Professor of Pediatrics at Stanford University and the University of California during this time.

The report served as a compelling call to action, received extensive media coverage, and attracted political attention. Most of the newspapers that covered the report led with its primary finding that “too often, children with fatal or potentially fatal conditions and their families fail to receive competent, compassionate and consistent care that meets their physical, emotional, and spiritual needs” (IOM, 2003d, p. 3). In the medical sphere, the New England Journal of Medicine lauded the IOM’s commitment to explore and publicize end-of-life issues (Faulkner, 2003; McFeatters, 2002; Robernicks, 2002). A few days after the release of the report, Behrman, a distinguished pediatrician, met with NIH staff to discuss the report. He then participated in a congressional briefing in the fall of 2002. In response to the report, Senators Michael DeWine (R-OH) and Chris Dodd (D-CT) and Representatives Deborah Pryce (R-OH) and John Murtha (D-PA) drafted legislation called the Children’s Compassionate Care Act that was based on the report’s recommendations.⁸⁶

The next installment in the IOM’s end-of-life series, Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life, was released in 2014 following a politically charged debate in the country regarding end-of-life care. A provision of the ACA, which had gained some bipartisan support and an endorsement from the AARP, would have authorized Medicare reimbursement for end-of-life counseling, such as discussions with physicians about options for end-of-life care. Opponents of the ACA seized on the provision, with some stating that it would create “death panels” that would allow the federal government to participate in end-of-life decisions. The provision was removed from the final version of the bill to quiet some of the opposition. However, the debate had brought new attention to end-of-life issues and motivated the IOM to launch a study to revisit end-of-life care and assess advances that had been made since its 1997 report (IOM, 2015d).

The report, which was funded by an anonymous donor, elaborated on and reinforced messages from the earlier reports. The committee found that progress had been made since the 1997 report, noting that hospice had become a mainstay in end-of-life care and that palliative care was now a regular part of care in larger hospitals. However, training for health care professionals was lacking, and systematic changes were needed to improve the delivery of care. The committee, which was chaired by NAM member and Councilor (2007–2012) Philip A. Pizzo,⁸⁷ called for comprehensive end-of-life care that was seamless, of high quality, accessible around the clock, and consistent with an individual’s values and preferences. In its report, the committee noted that palliative care should be delivered by a well-trained, interdisciplinary team that included board-certified hospice and palliative care physicians, nurses, social workers, and chaplains. To ensure high-quality care, new standards were needed for clinician-patient communication that were “measurable, actionable, and evidence-based.” The committee also discussed the need for greater public engagement and education about end-of-life planning, care, and decision making (IOM, 2015d). In July 2015, citing the IOM’s report, the CMS announced that Medicare would begin to reimburse health care providers to counsel patients about end-of-life care and “advance care planning,” a term that was meant to emphasize that individuals should make their own end-of-life wishes known and that those wishes should be revisited at different stages in life.⁸⁸

The end-of-life reports demonstrate how the IOM developed a persistent, action-oriented agenda that not only wove together themes from across the end-of-life reports but also drew upon themes from the IOM’s other work. Throughout its history, the IOM delivered reports that were meant to facilitate change across the U.S. health care system in the interest of providing high-quality, evidence-based care that was also person- and family-centered and accessible. The end-of--

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⁸⁶ Impact of IOM Reports (Database), IOM/NAM Records.

⁸⁷ Philip A. Pizzo was the Former Dean and David and Susan Heckerman Professor of Pediatrics and of Microbiology and Immunology and the Founding Director, Stanford Distinguished Careers Institute, Stanford University, Stanford, California when this report was released.

⁸⁸ Impact of IOM Reports (Database), IOM/NAM Records.

life reports enabled the IOM to speak with a consistent voice in health policy conversations across the United States.

HEALTH CARE REFORM AND UNINSURANCE

Health care reform and equitable access to high-quality health care were long-term priorities for the IOM. Although the topic of health care reform was often politically charged, the IOM approached it through careful review of public, health-related programs and opportunities to improve those programs. Medicare was one such program that the IOM revisited frequently, starting in the IOM’s early days when the organization weighed in on questions about expanding Medicare benefits using a disease-by-disease approach (e.g., end-stage renal disease) in the 1970s (see Chapter 2). The IOM continued its review of the Medicare program with a three-part series in the 1990s called Medicare: A Strategy for Quality Assurance (see above). In 2000, the IOM released a report called Extending Medicare Reimbursement in Clinical Trials,⁸⁹ which led to an executive order signed by President Clinton that required Medicare to cover routine medical costs for beneficiaries participating in clinical trials in an effort to encourage expanded clinical trials participation among older adults (IOM, 2000d; White House, 2000). The executive order was followed by a national coverage decision through Medicare that implemented the president’s executive order and detailed specific benefits that would be provided through the Medicare program.⁹⁰

The IOM reviewed Medicare provider reimbursements and incentives in its 2007 report, Rewarding Provider Performance: Aligning Incentives in Medicare (IOM, 2007m).⁹¹ In many ways, the IOM’s body of work offered advice on incremental changes to the Medicare program that could be translated to improvements in the U.S. health care system more broadly. However, many of the IOM’s committees highlighted the need for more robust and far-reaching systematic changes and reforms across the health care system, stating that incremental change was not sufficient.

One of the primary goals of health care reform efforts in the United States has been to reduce the number of people living without health care insurance. From 1978 through 1990, the number of uninsured individuals under the age of 65 increased by 14.2 million, growing from 12 percent of the population to 17 percent of the population. For the next 17 years (1990–2007), the uninsurance rate in the United States hovered around 17 percent, with 43.3 million people without insurance in 2007 (CDC, 2009). Despite periods of economic growth and low rates of unemployment, the rates of uninsurance in the United States persisted (IOM, 2004e). Rates of uninsurance vary by socioeconomic factors (e.g., education, employment, income), demographic factors (e.g., race and ethnicity, gender, age), as well as geographic location (IOM, 2001e). The consequences of uninsurance affect individuals, families, communities, states, and the nation as a whole and range from poorer health outcomes to strains on emergency departments and the health care system to financial and economic repercussions across all levels (IOM, 2002b, 2003e, 2009b).

As each U.S. president considered questions of health care reform and options for national health insurance, the IOM stood ready to offer non-partisan advice. For example, the Clinton administration developed a proposal for national health insurance in the early 1990s. Following Clinton’s failed attempt at reform, President George W. Bush worked toward the smaller goal of adding prescription drug coverage to Medicare in 2003. Although this achievement provided a much-needed benefit to older adults and individuals with disabilities, it did not provide improvements for the general population. Americans who were not eligible for Medicare or Medicaid or

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⁸⁹ The committee that drafted this report was chaired by Henry J. Aaron, who was at the Brookings Institution in Washington, DC, when this report was released.

⁹⁰ Impact of IOM Reports (Database), IOM/NAM Records.

⁹¹ The committee that was responsible for this report was chaired by Steven A. Schroeder, who was a Distinguished Professor of Health and Health Care at the University of California, San Francisco, during this time.

were not covered through employers’ health plans continued to face the consequences of living without health insurance. Other access challenges existed for those individuals and families who had some degree of coverage through employer health plans but who could not afford deductibles and copays.

In response to growing concerns about uninsurance in the United States, the IOM, with funding from the RWJF, launched a 3-year effort to examine the consequences of uninsurance at the individual, family, community, and national levels. In conducting its work, the committee was organized into six subcommittees that would each contribute a report to the series between September 2001 and January 2004 (see Box 5-4).

Each report in the series built on the previous reports, with the final report offering the committee’s principles and recommendations, along with its vision to have everyone in the United States covered by insurance by 2010. The committee, which was co-chaired by NAM members Mary Sue Coleman⁹² and Arthur Kellermann,⁹³ stated that health care coverage should be universal, continuous, affordable for individuals and families, and affordable and sustainable for society, also noting that coverage should “enhance health and well-being by promoting access to high-quality care that is effective, efficient, safe, timely, patient-centered, and equitable” (IOM, 2004e, p. 9).

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⁹² Mary Sue Coleman was the President of the Iowa Health System and the University of Iowa and the President of the University of Michigan during this time.

⁹³ Arthur Kellermann was a Professor and the Chair of the Department of Emergency Medicine and the Director of the Center for Injury Control at Emory University in Atlanta when these reports were released. Kellermann served as a member of the NAM Council from 2013 to 2016.

The committee used evidence presented in the previous reports to emphasize the need for universal coverage to eliminate gaps in coverage and costs associated with uninsurance. When the final report was released in January 2004, Executive Officer Susanne Stoiber described the series as the “most comprehensive evidence base yet developed on who is uninsured, why, and what the impact is on individuals, families, communities and the nation.”⁹⁴

Five years after the release of the IOM’s uninsurance series and without significant political action to reform the health care system or expand health care coverage in the United States, the IOM revisited the topic in 2009, releasing America’s Uninsured Crisis: Consequences for Health and Health Care. The new report found that rates of insurance coverage continued to decline and that the population of Americans without insurance had reached more than 45 million (more than 17 percent of the population). The committee, which was chaired by external volunteer Lawrence S. Lewin,⁹⁵ pointed to “literature on health consequences [that] is more robust than that available to the previous committee—lack of insurance coverage does have health consequences, and there is new literature to confirm an important but previously unanswered question: newly providing coverage to the previously uninsured does in fact improve things” (IOM, 2009b, p. xii). The committee also found that large uninsured populations in communities could undermine the quality and timeliness of care for those with insurance. The report reiterated messages from the uninsurance series, stating that “coverage matters” and that “expanding health coverage to all Americans is essential” (IOM, 2009b, pp. xii, 9). In its single recommendation, the committee called on the President and Congress to work with other stakeholders to achieve universal coverage.

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⁹⁴ Susanne Stoiber to IOM Council, January 12, 2004, IOM/NAM Records.

⁹⁵ Lawrence S. Lewin was an executive consultant in Maryland when this report was released.

Essential Benefits and Preventive Health Services for Women

President Obama revived efforts to establish national health insurance coverage, and in spite of much opposition and criticism, Congress passed the ACA in 2010 (see Figure 5-2). The 2010 legislation marked a crucial inflection point in the political debate over expanding access to health care and controlling cost—perpetual areas of concern for the IOM. Not only did the ACA make significant changes to the financing and organization of insurance coverage by expanding Medicaid and individual insurance markets, but it also prompted studies to guide and evaluate the changes that would result from the legislation. For example, HHS called on the IOM to help develop criteria for determining the “essential health benefits” (EHBs), or the minimum set of benefits that health insurance plans had to cover through the state-based “purchasing exchanges.”

In response to the HHS request, the IOM released Essential Health Benefits: Balancing Coverage and Costs in 2012. The committee, which was chaired by John R. Ball,⁹⁶ interpreted its task as “finding the right balance between making coverage available to individuals” and keeping costs at an affordable level for individuals, employers, public funders, and taxpayers. The IOM advised that the essential health benefit package should maximize the number of people with insurance coverage while protecting the most vulnerable. In line with the IOM’s previous studies, the components of the essential health benefit package also needed to be safe, effective, and demonstrate improvements in health outcomes. The committee also indicated that future modifications of the EHBs should be transparent, participatory, data driven, and encouraging to innovation (IOM, 2012o). In response to the committee’s report, the Essential Health Benefits Coalition, which represents employers from various sectors, advised HHS to adopt the report’s first recommendation,⁹⁷ which suggested that “the starting point in establishing the initial EHB package should be the scope of benefits and design provided under a typical small employer plan in today’s market” (IOM, 2012f, p. 7).

Another study that stemmed from the ACA involved identification of the preventive health services that would be fully covered by health plans without a patient copay. In particular, the HHS asked the IOM “to conduct a review of effective preventive services to ensure women’s health and well-being.” The IOM’s report Clinical Preventive Services for Women: Closing the Gaps was released in 2011 and included recommendations for a range of preventive services that should be covered. For example, the committee, which was chaired by NAM member Linda Rosenstock,⁹⁸ called for “a fuller range of contraceptive education, counseling, methods, and services” along with improvements in screening for cervical cancer and HIV, counseling related to sexually transmitted infections, and screening and counseling for interpersonal and domestic violence. The committee also highlighted the importance of preventative services for pregnant women (e.g., screening for gestational diabetes) and recommended that at least one comprehensive “well woman” visit be covered annually (IOM, 2011h).

On August 1, 2011, less than 2 weeks after the release of the report, HHS adopted the IOM’s recommendations for preventive health services for women that outlined the specific services that should be covered with no out-of-pocket costs under the provision of the ACA. Based on the HHS’s adoption of the IOM’s recommendations, health plans were required to cover a full range of preventive services for women without cost sharing, including annual well-woman visits, screening for gestational diabetes, breastfeeding support, HPV testing, counseling related to sexually transmitted

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⁹⁶ John R. Ball was the Former Executive Vice President at the American Society for Clinical Pathology when this report was released.

⁹⁷ Impact of IOM Reports (Database), IOM/NAM Records.

⁹⁸ Linda Rosenstock was the Dean of the School of Public Health at the University of California, Los Angeles, during this time.

infections, HIV screening, contraception methods and counseling, and screening and counseling for interpersonal and domestic violence.⁹⁹

Between 2014 and 2016, when insurance coverage-related provisions of the ACA were implemented, uninsurance rates in the United States dropped by 7 percent—from 17 percent in 2013 (approximately 44.4 million uninsured) to 10 percent in 2016 (approximately 26.7 million uninsured (Tolbert et al., 2020). As provisions of the ACA (including the individual mandate) were challenged in court and the implementation of the law evolved, rates of uninsurance in the United States started increasing again. In 2018, the uninsurance rate stood at 10.4 percent, with approximately 27.9 million people without insurance (Tolbert et al., 2020). In 2015, on the cusp of the 2016 U.S. presidential election, the newly formed NAM launched a major initiative to inform the future reform efforts in terms of the nation’s health, health care, and biomedical sciences. The initiative, called Vital Directions for Health and Health Care, was designed “to provide expert guidance on 19 priority issues for U.S. health policy” with “three overarching goals … better health and wellbeing; high-value health care; and strong science and technology” (NASEM, n.d.q). The initiative is described in greater detail in Chapter 7.

Prescription Drugs

Continuing the IOM’s work to reform the health care system, the NAM partnered with the HMD to take on a pressing challenge for the nation: the cost of prescription drugs. In the first two decades of the 21st century, the increasing cost of prescription drugs became a serious concern for many Americans who struggled to pay for needed medications, some of which had more than doubled in price in a short period of time (e.g., insulin, Epi Pens) (Kodjak, 2019; Rapaport, 2017). The Presidents’ Committee of the National Academies of Sciences, Engineering, and Medicine, along with six health foundations and the American College of Physicians, sponsored a study to explore opportunities to make prescriptions more affordable without hindering innovation or the development of new drugs. The resulting report, Making Medicines Affordable: A National Imperative, was published in 2018. The report stated that the pharmaceutical industry was “fraught with discordant viewpoints, divergent priorities, and conflicts of interest” (NASEM, 2018d, p. 3). The imperative of “consumer access to effective and affordable medicine” was “not being adequately served by the biophysical sector today” (NASEM, 2018d, p. 4). To resolve some of these concerns, the committee, which was chaired by NAM member Norman Augustine,¹⁰⁰ recommended expanding access to generic drugs and applying more of the government’s purchasing power to “improve drug valuation methods” (NASEM, 2018d, p. 6).

One year after the release of the report, Victor Dzau made the price of prescription drugs the topic of the 2018 President’s Forum at the NAM’s annual meeting. As part of the forum, Dzau invited HHS Secretary Alex M. Azar II to present. In his remarks, Azar argued that people had the right to know a drug’s price when it was advertised on television (Pear, 2018). The Secretary’s comments were followed by a panel discussion that featured a senator, experts from the pharmaceutical and health care industries, and another official from HHS.

CONCLUSION

In a multitude of ways, the IOM, and subsequently the NAM and the HMD, have played a sustained and essential role in advising the nation, the government, and the health care industry on

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⁹⁹ Impact of IOM Reports (Database), IOM/NAM Records.

¹⁰⁰ Norman Augustine was the Former Chair and the Chief Executive Officer of Lockheed Martin Corporation when this report was released.

how best to improve health care and set health policies designed to ensure equitable access to high-quality, evidence-based health care for all Americans. Throughout its history, the IOM expanded its reach to cover a wide range of topics related to the delivery of health care and improvement of the health care system. Even though modifications to the U.S. health care system have been slow and have come with varying degrees of success, the IOM served as a steady and unbiased voice, consistently calling for change and providing recommendations to guide that change. Although the transition from the IOM to the NAM and the HMD was a historic shift for the organization, its members, and its staff, the transition did not interrupt the focus of the organization or its commitment to achieving better health in the United States through an improved health care system. The creation of the NAM and its action-oriented portfolio of programs augmented the previous work of the IOM and the continuing work of the HMD. The NAM’s drive to build stronger collaborations afforded new opportunities to facilitate the implementation of the organization’s recommendations and further influence change across the health care system.

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