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.

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 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).

FIGURE 5-1

President George W. Bush signs the Patient Safety and Quality Improvement Act of 2005, at a signing ceremony on Friday, July 29, 2005, at the Eisenhower Executive Office Building in Washington, DC. SOURCE: White House photo by Eric Draper, White House (more...)

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.

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

BOX 5-1

The Institute of Medicine’s Quality Chasm Series.

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 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 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

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 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 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).

BOX 5-2

Initial Membership of the National Academy of Medicine Leadership Consortium: Collaboration for a Value & Science-Driven Health System (October 2015).

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 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 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).

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 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). 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 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 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).

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 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 Needsthe 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 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.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, 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).

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

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.”

FIGURE 5-2

President Barack Obama signs the Patient Protection and Affordable Care Act into law in the East Room of the White House, March 23, 2010. SOURCE: Photo by Lawrence Jackson, White House Archives.

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 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.