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3 Foster Adaptability and Alignment There should be an unremitting effort to improve those health, education, and social security efforts, which have proved their value. . . . But good intent and high purpose are not enough; all such programs depend for their success upon efficient, responsible administration. Dwight D. Eisenhower (1953) RECOMMENDATION 2 Foster Adaptability and Alignment To improve the publicâs health and achieve the departmentâs goals, the secretary should align and focus the department on per- formance and encourage creative use of scientifically based ap- proaches to meet new and enduring challenges. a. The heads of all department units should ensure that their activities and operations are aligned with the departmentâs vision, mission, and goals and marshal their resources to achieve them. b. The secretary should reduce directly reporting senior-level officials to a manageable number. Al- though secretarial management styles differ, a rigorous decision-making process for both policy and operations must be established, along with accountability for results. c. The secretary should ensure a more prominent and powerful role for the surgeon general, who, in addition to leading the Commissioned Corps, should be a strong advocate for the health of the American people and work actively to educate Americans on important health issues. The secre- tary should work with the President and Con- gress to establish a process for identifying surgeon 55
56 HHS IN THE 21ST CENTURY general candidates for Presidential appointment that gives high priority to qualifications and lead- ership, and Congress is strongly urged to consider a longer term for this office. d. The secretary should work with the President and Congress to establish a selection process for the departmentâs senior-level officials that pro- tects the scientific and administrative integrity of major departmental units, promotes progress to- ward departmental goals, and is based primarily on the candidatesâ qualifications and experience. Congress again is strongly urged to consider longer terms for some of these officialsâ especially the directors of the National Institutes of Health (NIH) and the Centers for Disease Con- trol and Prevention (CDC), and the commissioner of the Food and Drug Administration (FDA)â which would provide critical continuity in the na- tionâs public health and scientific endeavors. e. The President should make timely appointments and Congress should expedite the confirmation process for key HHS officials, including the secre- tary, deputy secretary, surgeon general, and the heads of FDA and NIH. Secretarial appoint- ments, such as the director of CDC, also should be expedited. f. The secretary should ensure that all department health programs, including the reimbursement programs, reinforce public health priorities and strategies in order to provide a consistent frame- work for protecting the public from health risks, promoting health, preventing disease and disabil- ity, and providing health services for vulnerable populations in the most efficient, cost-effective ways. g. To maximize value in the health care system, the secretary must strengthen the scientific base and capabilities of the department and ensure that agenciesâ research findings are shared depart- ment-wide and that current best evidence is used
FOSTER ADAPTABILITY AND ALIGNMENT 57 for departmental decision making, including the Centers for Medicare and Medicaid (CMS) reim- bursement policy. h. Congress should allocate sufficient, predictable funding for NIH, CDC, FDA, and the Agency for Healthcare Research and Quality (AHRQ) in or- der to preserve and enhance these agenciesâ sci- entific missions. Congress should also establish a specific budget line for AHRQ that is independent of appropriations to other HHS agencies. i. To address the growing threat of food-borne ill- nesses, Congress should unify the U.S. Department of Agricultureâs (USDAâs) Food Safety and Inspec- tion Service and the food safety activities of FDA within HHS and ensure provision of adequate re- sources for high-quality inspection, enforcement, and research. SCOPE OF THE CHALLENGES As the organization charged with primary responsibility for ensuring the health and well-being of Americans, HHS must keep pace with rapid advances in many fieldsâbiomedical sciences, health care technologies, the organization of health care, information technologies, health and so- cial services research, and quality improvement. It also must keep abreast of emerging global threats to health, rising consumer expectations, and pressure for cost control and greater efficiency. As Chapter 2 shows, substantial evidence indicates problems in HHSâs structure and alignment. However, even with an optimal structure and admirable alignment across its many units, HHS would face an array of challenges that were unimaginable when the department was created in 1953. First, like any large American organization, it must adapt to new and overarching trends, including many described by the former comp- troller general: â¢ the need to respond to terrorism and other threats to security, â¢ a population marked by increasing diversity and older age, â¢ an accelerating pace of advances in science and technology, â¢ rapid evolution of information and communications technology,
58 HHS IN THE 21ST CENTURY â¢ new challenges and opportunities to maintain and improve qual- ity of life, â¢ variable and diverse governmental tools and structures (Walker, 2003), and â¢ the many serious and long-standing threats to health that may be resolved, in part, only through additional research. Second, globalizationâthe growing interdependence among enter- prises, economies, and governmentsâcomplicates any effort to improve or protect health, placing many risk factors beyond the departmentâs con- trol. For example, the globalization of the food supply has the potential to introduce a wide range of contaminants. Organisms that produce in- fectious diseases can now move rapidly through air travel and the movement of people across countries. Changing demographics, including high levels of immigration into the United States from every continent, introduce a greater range of health behavior and present cultural differ- ences that create communication and health education challenges. Third, the burdens imposed by disease and disability do not lend themselves to the equal or âfairâ distribution of government protections that citizens influenced by almost a half century of advances in civil rights and consumer advocacy now expect. Some diseases of great sever- ity, prevalence, and emotional cost have as yet no known treatment, so their victims suffer disproportionately. Some populations are at greater risk of certain diseases or complications, so they too suffer more than others. Children, the mentally ill and developmentally disabled, and other vulnerable groups cannot readily advocate for better health care for themselves. And, access to care is not uniformly available nationwide, since health professionals generally gravitate to larger, more prosperous communities, leaving many rural and low-income communities under- served. Fourth and finally, HHS has an extraordinarily broad reach through- out the U.S. health care system and many types of relationships: â¢ Through its payment programs, HHS exerts regulatory influence over virtually all acute care hospitals, most physician practices, and many other health care providers. It affects more than 80 million Medicare and Medicaid beneficiaries (U.S. Census Bu- reau, 2008) and influences the flow of health information they receive.
FOSTER ADAPTABILITY AND ALIGNMENT 59 â¢ Through grants and contracts, HHS relates to health departments in every state and territory and to the nationâs 2,800 local health departments (NACCHO, 2006). â¢ Through service, research, and payment programs, HHS re- sponds to hundreds of organizations advocating for people with low incomes or who have specific diseases or disabilities and their families, children in Head Start, and the elderly who need meals at home or supportive services. â¢ Through its operation of over 700 health facilities, HHS provides a vital source of health care to American Indians and Alaska Na- tives, groups who suffer disproportionately from the burden of chronic disease. â¢ Through regulation, HHS reaches the manufacturers and suppli- ers of pharmaceuticals and medical devices, food processors and cosmetics manufacturers, and health care providers and profes- sionals of all kinds and in all localities. â¢ Through its research agenda, HHS supports the nationâs bio- medical and health research community, health insurers, and health plans. â¢ Finally, through its funding for health professions training, HHS interacts with the medical schools and other health professions educational programs that represent the future health care work- force. In short, HHS is an integral and central figure in a technology- intensive sector that now makes up nearly one-sixth of the nationâs econ- omy (Catlin et al., 2008), which continues to grow rapidly, and that vi- tally concerns every individual, family, employer, and community in the nation. HHS must be able to adapt to changing circumstances in a timely manner, take an active part in reforms of the health system, and solve problems creatively, using solid evidence and sound science. AN IMPROVED ALIGNMENT Alignment, or unification of strategy and activities throughout an or- ganization, has become extraordinarily important in progressive parts of the private sector, infusing employees of large firms with a sense of common purpose and a common approach to the future. Alignment also has been working its way into some parts of the public sector, such as the
60 HHS IN THE 21ST CENTURY Department of Defense. HHS should go further in embracing this con- cept across its health and human services agencies. When programs are uncoordinated or operate at cross-purposes, less value is obtained. It will not be possible to align all department activities with the rec- ommended small number of goals, owing to agenciesâ and programsâ existing responsibilities and commitments, many of which are congres- sionally mandated. However, a concerted effort should be made, espe- cially within the departmentâs major units, to evaluate their current missions, goals, responsibilities, and available resources to ensure that, insofar as possible, they are aligned with the departmentâs overarching vision, mission, and goals. Related Recommendation a. The heads of all department units should ensure that their activities and operations are aligned with the departmentâs vision, mission, and goals and marshal their resources to achieve them. LIMIT THE NUMBER OF PEOPLE REPORTING TO THE SECRETARY Many of this reportâs recommendations begin with âThe secretaryâ not because the committee believes that every decision should emanate from the secretaryâs office, but simply because the person in that position bears ultimate responsibility for departmental operations. While the sec- retary needs a good rapport with the President, in addition to strong lead- ership and management skills, the committee places equal importance on the need for these skills among agency heads, who also must possess strong scientific and technical expertise and be able to work as a team led and coordinated, through some internal arrangement, by the secretaryâs office. Currently, 30 official positions report directly to the secretary (HHS, 2008). These positions are as powerfully endowed as the administrator of the Centers for Medicare and Medicaid Services, which is responsible for 85 percent of all HHS expenditures, and as narrowly focused as the di- rector of the Center for Faith-Based and Community Initiatives. The sur-
FOSTER ADAPTABILITY AND ALIGNMENT 61 geon general is not among those who report directly to the secretary and possibly should be. Management theory and research generally suggest that the larger the organization, the fewer the number of people who should report directly to its chief executive officer (Hattrup and Kleiner, 1993). With such a wide a span of control, the secretary has little time to work with indi- viduals on their plans for new and existing programs, implementing strategies, or improving operations. The secretaryâs role should be to concentrate on major emerging problems, or controversies, and on a handful of major initiatives, such as health reform, on the departmentâs budget and key appointments, and to serve as âambassadorâ for the de- partment to other cabinet agencies, Congress, and the private health sec- tor. To create a new level of senior officialsâincluding perhaps an un- dersecretary, powerful assistant secretaries, or some other configura- tionâmight require congressional approval, but would follow the norm of other cabinet-level departments. HHS now has no undersecretary; by contrast, most departments have about three. While the committee en- dorses the need for streamlined reporting to the secretary, it does not make recommendations about specific configurations of positions and responsibilities, noting that such choices may be a matter of style or preference. To illustrate how such officials could possibly be deployed: â¢ A subcabinet-level position could be created for each of HHSâs four main âbusiness linesâ: reimbursement, regulation, research, and direct services provision. The difficulty with the business lines approach is that many agencies are deeply involved in some combination of these activities. However, there are advantages in clustering agencies by their primary function. â¢ Such an official could oversee cross-cutting departmental func- tions around policy, operations, information technology, com- munications, and budget. â¢ A subcabinet-level official could oversee all of the agencies of the Public Health Service (PHS), whose functions should com- plement and reinforce each other. This would have the advantage of bringing more coherence to the various agencies. This model was used for a number of years when the assistant secretary for health (ASH) oversaw these agencies. â¢ A subcabinet-level official could oversee cross-department ac- tivities, envisioned in Recommendation 5.
62 HHS IN THE 21ST CENTURY â¢ Alternatively, the departmentâs major health-related line func- tions, including key agency heads (such as NIH, FDA, CDC, CMS) and the surgeon general, could report directly to the secre- tary, while other agency heads and staff functions could report to a single subordinate, such as the deputy secretary. Having a smaller number of senior subcabinet-level officials report- ing directly to the secretary would enable better management and coordi- nation of agency directors, aid in the development of cross-cutting policies, facilitate collaboration, and ensure consistency (alignment) across agencies, while allowing individual agency directors to focus on their agency responsibilities and pay less attention to political pressures. While day-to-day operations could be managed by a new senior official (or officials), agency heads should, of course, always have direct access to the secretary for major policy decisions, budget planning, and in times of crisis. The committee also recognized a number of disadvantages to this approach, strongest among them that it could dissuade some talented individuals from accepting appointment to high-profile and influential postsâsuch as the directorships of FDA, NIH, and CDCâif it moved them a level down the chain of command and limited direct access to the secretary. The scope of responsibilities of the agency heads would re- main the same with this streamlined approach, but the coherence of agency activities to the departmentâs mission would be enhanced. Tal- ented and experienced individuals will be attracted to top HHS positions because of their confidence in the leadership and direction of the depart- ment. The committee recognizesâand recent experience indicatesâthat individual secretaries will have different management styles and that some will want to centralize management in their office, while others will rely more heavily on subcabinet officials, such as an ASH, to man- age the department. There are instances in which both styles have worked well. In either case, secretaries generally should encourage initia- tive and creativity at the program level. Often the best ideas come from the agency heads who are most deeply involved in the specifics of their unitâs work. Whatever internal configuration is chosen for the secretaryâs office, the objective should be to encourage feedback loops across departmental units, so that they communicate with and learn more readily from each other, can align policies and programs more effectively, and work toward common goals. Whether that coordination rests with one or two people in
FOSTER ADAPTABILITY AND ALIGNMENT 63 the secretaryâs office or by closer collaboration among a larger group of senior officials, it needs to happen. Similarly, regardless of the secretaryâs management style, it is essen- tial that there be in place a process for making policy and operational decisions that is rigorous, so that decisions are made based on the best evidence; clear, so that the departmentâs many agencies and programs can stay in alignment; and efficient, so that the processes are not redun- dant and that decisions are responsive and timely. This process includes consideration of how the organization will be accountable for the results of the decision and how it will measure or evaluate the decisionâs results. Related Recommendation b. The secretary should reduce directly reporting senior-level officials to a manageable number. Al- though secretarial management styles differ, a rigorous decision-making process for both policy and operations must be established, along with accountability for results. AN EMPOWERED SURGEON GENERAL Americans have learned to look to, and trust, the U.S. surgeon gen- eral for impartial, scientifically valid information about health risks and health improvement: â¢ In 1964 Surgeon General Luther L. Terry issued the landmark report declaring smoking hazardous to health. â¢ In the 1970s Surgeon General Julius B. Richmond advanced childhood immunizations and many other health promotion and disease prevention measures. â¢ In the 1980s Surgeon General C. Everett Koop, living up to his iconic status as a âstraight talker,â demanded greater attention to HIV/AIDS. â¢ In the 1990s Surgeon General David Satcher advocated action to provide mental health parity, reduce health disparities, and end discrimination based on sexual orientation, and reinvigorated the campaign to control tobacco.
64 HHS IN THE 21ST CENTURY Since the Office of Surgeon General was established in 1871, only 17 individuals have held the office on a permanent (not âactingâ) basis. The surgeon general holds the three-star rank of vice admiral, reports to the ASH, and serves a four-year term, which can be renewed for a sec- ond term. Since the expiration of Richard Carmonaâs four-year term in July 2006, the United States has not had a permanent surgeon general. The surgeon general also oversees the operation of the 6,000 public health professionals in the Commissioned Corps of the Public Health Service, who serve in full-time capacities in agencies and programs throughout the federal government. Commissioned Corps members are available around the clock to meet public health emergencies anywhere in the United States and, sometimes, the world. Because of the emer- gency nature of these assignments, the surgeon general must have a smoothly operating management structure and good communication with the ASH, the assistant secretary for preparedness and response, and other HHS agencies involved in emergency response, in order to enable rapid mobilization. 1 The President appoints the surgeon general, subject to Senate con- firmation, and on occasion these appointments have proved controver- sial. Surgeon General Joycelyn Elders held an expansive view of sex education, which made her a lightning rod for criticism and led to her exit from office (Elders, 1996). After Surgeon General Richard Carmona left office, he accused the administration of silencing him on embryonic stem cell research, abstinence-only sex education, contraception, climate change, prison health, and mental health, and discouraging him from supporting the Special Olympics (Harris, 2007). In July 2007 testimony before the House Committee on Oversight and Government Reform, former Surgeon General C. Everett Koop said that, when working on his report on HIV/AIDS and a subsequent mailer, he and the secretary had to maintain strict secrecy throughout the proc- ess. If they had âfollowed protocol and had every word scrutinized by the secretaryâs secretariat,â he said, âthese reports, because of their nature and plain speaking, would not have seen the light of dayâ (Koop, 2007). Although the nationâs senior health advocate should speak with discre- tion, the surgeon general should be free to openly discuss important 1 In recent years, the surgeon general has deployed these well-trained individuals to re- spond to the terrorist attacks of 9/11 and to natural disasters, including Hurricanes Katrina and Rita and the Indian Ocean tsunami, where they provided medical and public health services and humanitarian assistance.
FOSTER ADAPTABILITY AND ALIGNMENT 65 health topics and educate the public on evidence-based prevention and health promotion strategies. To ensure the independence of this uniquely trusted officeâand the politically unfettered advocacy for improved health of the American peo- pleâthe surgeon general should not be subject to an appointment proc- ess influenced by partisan pressures. 2 Alternatives to help guarantee the surgeon generalâs independent voice include the following: â¢ Establish the custom that a prestigious committee oriented to science and health would identify and review candidates and recommend a panel of three or four highly qualified candidates, from which the President could choose (similar to the appoint- ment process for the undersecretary for health in the Department of Veterans Affairs; the process, specified in law [38 USC Â§305], also stipulates that the appointment should be âwithout regard to political affiliation or activityâ). â¢ Establish a tradition that such a committee would authoritatively evaluate the Presidentâs choice of a prospective surgeon gen- eralâs credentials before the appointment is sent to the Senate. â¢ Secure bipartisanship support prior to an appointment, for exam- ple, by consultation with the chair and ranking member of the Senate Committee on Health, Education, Labor, and Pensions. These types of processes would respond to most of the reforms rec- ommended by a recent National Academies committee as ways to ensure the best science and technology appointments for government by ad- dressing the need to attract the best leadership; make appointments speedily; provide continuity; improve the process by which candidates are nominated, cleared, and confirmed; and broaden the pool of potential candidates (NRC, 2008). Such processes could be equally well employed in filling other top departmental positions, such as those discussed in the next section. 2 The role of the surgeon general has been taken up by some members of the 110th Congress, including proposed legislation that would strengthen the role of the surgeon general as Americaâs health advocate (the Surgeon General Restoration Authority Act [S. 1777] and the Surgeon General Independence Act [H.R. 3447]).
66 HHS IN THE 21ST CENTURY Related Recommendation c. The secretary should ensure a more prominent and powerful role for the surgeon general, who, in addition to leading the Commissioned Corps, should be a strong advocate for the health of the American people and work actively to educate Americans on important health issues. The secre- tary should work with the President and Con- gress to establish a process for identifying surgeon general candidates for Presidential appointment that gives high priority to qualifications and lead- ership, and Congress is strongly urged to consider a longer term for this office. A PROTECTED CORPS OF SCIENTIFIC LEADERS Continuity, competence, and scientific integrity will be enhanced to the extent that heads of HHSâs science agenciesâprimarily NIH, CDC, FDA, and AHRQâare appointed without regard to politics and may re- main in their positions for fixed terms that may straddle presidential tran- sitions. Given the importance of these positions to protecting the publicâs health, they should be filled quickly after vacancies occur. Indeed, any new secretaryâs team should be put in place without undue delays. When the White House and the secretary select top departmental of- ficialsâand when Congress considers their confirmationâthey should not impose an ideological test, but should look for leadership and man- agement qualifications, as well as scientific or technical expertise. The latter is of particular importance because the secretaryâs primary skills are likely to be focused on management and leadership. These depart- mental officials must be able to â¢ assess competing scientific opinions and recognize when the sci- ence remains inconclusive, â¢ balance scientific interests and uncertainty with the practicalities of resource limitations, â¢ authoritatively fend off doctrinaire demands while respecting di- verse human values, and
FOSTER ADAPTABILITY AND ALIGNMENT 67 â¢ have a strategic perspective to enable them to anticipate and shape the evolution of cutting-edge research, public health and human services program initiatives, and regulatory oversight. As a previous IOM committee remarked, âHealthy organizations re- quire effective and stable leadershipâ (IOM, 2007). Once key officials are selected, they need to be in place long enough to appreciate fully the challenges, pressures, and opportunities their agencies face; to under- stand the strengths and weaknesses of major units and staff leaders; to effectively plan ways to build on strengths and shore up deficits; to be- come effective advocates for their agencies; to build productive relation- ships with the secretary, key agency staff, and important players outside the agency; and, in general, to carry out the administrationâs, depart- mentâs, and agencyâs immediate and long-term priorities. Such facility is not acquired overnight, which is one reason the committee endorses prompt filling of key scientific agency positions. The committee is also persuaded that it would be helpful for Con- gress and the secretary to consider whether longer fixed-term appoint- ments would be beneficial in establishing continuity and improving performance. Previous reports from the Government Accountability Of- fice (GAO) and the National Academy of Sciences have reported that turnover in government agency leaders âis linked with a focus on short- term goals and uncertain accountability and that fixed terms â¦ help to ensure stability and strengthen an agencyâs leadershipâ (IOM, 2007). The committee recognizes that an administration or secretary may have strong candidates of their own for these positions and that solid, trusting working relationships between the secretary and agency heads are essential. However, if agency head appointments are, as recom- mended, based on leadership, management skills, and scientific exper- tise, with minimal political considerations, then incumbents to these positions may well survive a change in administration. The committee recommends that multiyear, fixed terms be considered, 3 because it would support greater management and intellectual continuityâespecially for research projects with long trajectoriesâavoid at least some turnover that may be unnecessary, decrease the amount of time that top leadership 3 Note that the director of the National Science Foundation and the commissioner of the Social Security Administration currently have six-year terms; that commissioners of the Federal Communications Commission have five-year terms; and that past IOM commit- tees likewise recommended a six-year term for the NIH Director and FDA Commis- sioner.
68 HHS IN THE 21ST CENTURY posts are vacant, and might attract more individuals to serve, particularly when a vacancy occurs in the latter stages of an administration. Nothing in this recommendation is meant to suggest that the Presi- dent or secretary would not have the authority to remove individuals for cause, at any stage in their tenure. A potential problem with this ap- proach, in a new administration, could be that the incumbent would be seen as an âoutsiderâ in an almost wholly new department team and not integrate well with the new staff. Of course conflicts among staff mem- bers can occur regardless of whether they are holdovers or brand new, and such impediments to teamwork are a not uncommon management problem. Related Recommendations d. The secretary should work with the President and Congress to establish a selection process for the departmentâs senior-level officials that pro- tects the scientific and administrative integrity of major departmental units, promotes progress to- ward departmental goals, and is based primarily on the candidatesâ qualifications and experience. Congress again is strongly urged to consider longer terms for some of these officialsâ especially the directors of NIH and CDC, and the commissioner of FDAâwhich would provide critical continuity in the nationâs public health and scientific endeavors. e. The President should make timely appointments and Congress should expedite the confirmation process for key HHS officials, including the secre- tary, deputy secretary, surgeon general, and the heads of FDA and NIH. Secretarial appoint- ments, such as the director of CDC, also should be expedited.
FOSTER ADAPTABILITY AND ALIGNMENT 69 AN INTEGRATED PUBLIC HEALTH AGENDA HHSâs challenges are especially profound in the public health arena. Public health, in contrast to health care, focuses on disease and injury prevention rather than treatment, and on measures to improve and safe- guard the health of entire populations rather than individual patients. 4 Flexibility, adaptability, and creativity will allow HHS to respond effec- tively to urgent public health challenges as they arise and make progress toward solving persistent public health problems facing the American people. HHSâs ultimate role is to improve and safeguard the health and well- being of the American people. âGood healthâ at the personal level de- pends on the individualâs biology and genetics, behavior, lifestyle, and social, economic, and physical environment, as mediated by public health, social, economic, and environmental factors, and health care over the course of an individualâs life (Figure 3-1). âPopulation healthâ de- pends on the same factors, but at the â30,000-foot level.â Population health also can be influenced by conditions determined by governmental public health and social services infrastructure (both federal and state), communities, health care delivery systems, employers and business, the media, and academia (IOM, 2002a). This means that many important factors affecting healthâat either levelâlie outside the control of the departmentâs health and human services agencies, and that the depart- ment influences several other factors only indirectly. Exercising so little direct influence, HHS must be focused in its health promotion efforts and evolve with changing circumstances, and it must be the leading advocate within the federal government, and with the American people, for achieving population health. The federal government provides financial support for the nationâs health in a variety of ways, which include providing direct payment for about a quarter of the nationâs health care services (mostly through Medicare and Medicaid), tax breaks on premiums that are paid by em- ployers, and funding for most of the countryâs public health activities. Its investments in health care services dwarf spending on public health. Less than three percent of combined government and private health expendi- tures, and only six percent of government health expenditures, are di- rected to public health (Catlin et al., 2008). With so few resources, the public health system must be efficient and well aligned, as well as flexi- 4 A 1988 Institute of Medicine report articulated core public health functions at the fed- eral, state, and local level (IOM, 1988).
70 HHS IN THE 21ST CENTURY ble and creative, to serve the American people adequately. Federal pro- grams must learn and share all they can from on-the-ground experiences at the state and local levels to promote quality improvements. Some prominent former HHS leaders have advocated that a popula- tion-health model be implemented across the department (Boufford and Lee, 2001). In 2002, the Institute of Medicine recommended adoption of âa population health approach that considers the multiple determinants of health.â That committee also recommended strengthening the govern- mental public health infrastructure (both federal and state), building part- nerships across diverse communities, enhancing communication within the public health system, and, like the authors of this report, recom- mended improved systems of accountability and strengthening evidence for decision making (IOM, 2002a). a Over the life span b Living and working conditions may include: â¢ Psychosocial factors â¢ Employment status and occupational factors â¢ Socioeconomic status (income, education, occupation) â¢ The natural and built c environments â¢ Public health services â¢ Health care services FIGURE 3-1 Key factors in personal and population health. a Social conditions include economic inequality, urbanization, mobility, cultural values, and attitudes and policies related to discrimination. b Other national conditions might include major sociopolitical shifts, such as re- cession, war, and government collapse. c The built environment includes transportation, water and sanitation, housing, and urban planning (Worthman, 1999). SOURCE: Adapted from Dahlgren and Whitehead (1991), as printed in The Future of the Publicâs Health in the 21st Century (IOM, 2002b).
FOSTER ADAPTABILITY AND ALIGNMENT 71 The committee believes that evidence-based public health strategies should infuse all departmental programs, including the reimbursement and research programs. This model would, for example: emphasize pre- vention in Medicare and Medicaid and in NIH, enabling these different types of programs to positively reinforce each other; recognize the im- portance of supporting services, such as the nutrition programs provided by the Administration on Aging that in the past 36 years have served sen- iors more than six billion meals, or the vital work of Head Start, which produces not just educational outcomes for participating children, but improvements in their health and beneficial effects on parents. Attributes of an integrated public health agenda, in addition to help- ing create an aligned and coherent mission, as discussed above and in Chapter 2, would include the following: â¢ Insistence that public health interventions, as well as medical services, create valueâthey should produce improvements or benefits for the greatest number of individuals, to the most vul- nerable populations, to the greatest degree possible, and at the lowest cost. â¢ Calculation of the full value of public health servicesâvalue should not be determined by just measuring the costs and bene- fits to the health sector, but should also include estimates of so- cietal costs and benefits. For example, public health programs to urge the use of child car seats can prevent injuries that would not only require expensive medical care (health costs), but also spe- cial education (education costs) and lifelong disability payments (social welfare costs and lost productivity). â¢ An emphasis on health behavior, disease prevention, and health literacyâhealth literacy requires that individuals have the capac- ity to obtain, process, and understand basic health information and services so they can make appropriate health decisions (HHS, 2000); at the same time, it requires that the information provided be culturally and linguistically appropriate. â¢ Interdepartmental and cross-departmental approachesâ representatives of diverse units of HHSâand in some cases, other departments 5 âshould coordinate related activities to avoid 5 The Departments of Agriculture, Defense, Education, Energy, Homeland Security, In- terior, Labor, Transportation, Treasury, Veterans Affairs, and the Environmental Protec- tion Agency all play a role in some aspect of health policy (see Box 2-1).
72 HHS IN THE 21ST CENTURY gaps, duplication, and contradictory or inconsistent federal poli- cies. â¢ Fostering effective partnershipsâpartnerships may be with state and local health and human services departments, health care providers and professionals, consumer groups, organizations that represent and serve people with chronic diseases or disabilities and their family caregivers, and other community-based organi- zations. â¢ Strict avoidance of partisan politics in program design and in se- lection of personnel (Shalala, 1998). â¢ Adopting only those policies that are supported by evidence of effectiveness or are consistent with established public health or health services research findings. â¢ Focusing on, and investing in, human capitalâattention to im- proving the workforce within and outside the department is nec- essary, to ensure high performance within HHS, the public health sector, and the health care system in general (Walker, 2003; see also Chapter 5). Effective leadership by the secretary is essential to charting and inte- grating the public health agenda. As Secretary Leavitt has said (Schaeffer, 2007): My job as âthe leaderâ is to decide where we ought to go, to be effective in persuading other people that thatâs the right destination, organizing all of the elements to conspire toward that end, and then making sure that thereâs a system and a series of incentives that enable it. Related Recommendation f. The secretary should ensure that all department health programs, including the reimbursement programs, reinforce public health priorities and strategies in order to provide a consistent frame- work for protecting the public from health risks, promoting health, preventing disease and disabil- ity, and providing health services for vulnerable populations in the most efficient, cost-effective ways.
FOSTER ADAPTABILITY AND ALIGNMENT 73 A STRENGTHENED SCIENCE BASE A recent report examining presidential appointments affirms (NRC, 2008): The nation requires exceptionally able scientists and en- gineers in top executive positions and on federal advi- sory committees to weigh available data, to consider the advice of scientists and technical specialists, and in the case of presidential appointees to make key manage- ment, programmatic, and policy decisions. In HHS, the kinds of scientific expertise needed are broad: they in- clude biomedical scientists doing laboratory and clinical research, behav- ioral scientists, statisticians and epidemiologists, health services researchers, policy analysts, economists, and others applying their skills to solving problems that range from the size of a molecule to the size of the health care system. Although much of this report dwells on the applied sciences, espe- cially health services research and systems analysis, the committee rec- ognizes that basic biomedical research is essential to achieving continued medical progress. Many significant diseases still do not have effective prevention or treatment options. Prime examples are Alzheimerâs dis- ease, pancreatic cancer, autism, amyotrophic lateral sclerosis, schizo- phrenia, and many genetic conditions. These are not the ânew threatsâ to which this report often refers, but rather well-known problems that re- quire new knowledge or new approaches to solve. The department explicitly acknowledges the importance of scientific research. As one of four goals in its five-year strategic plan, its âscien- tific research and developmentâ goal aims to âadvance scientific and biomedical research and development related to health and human ser- vicesâ (HHS, 2007). The objectives supporting this goal would â¢ strengthen the pool of qualified health, biomedical, and behav- ioral science researchers; â¢ increase basic scientific knowledge to improve human health and human development; â¢ conduct and oversee applied research to improve health and well-being; and
74 HHS IN THE 21ST CENTURY â¢ communicate and transfer research results into clinical, public health, and human service practice (HHS, 2007). To the greatest extent feasible, HHS policies and programs should incorporate and be informed by current scientific knowledge and evi- dence-based practices. Using results of applied research on program ef- fectiveness and valid evaluations, as discussed in Chapter 4, HHS also should promote best practices in health care, public health, and program management. For this to happen, the department needs to strengthen its science base across the board. A credible, transparent process should also be developed to resolve scientific disputes that arise when evidence does not provide definitive answers or when there are disagreements among experts in the interpretation of that evidence. Especially when scientific findings are inconclusive, the door is opened for policy decisions that are based on nonscientific grounds and âpolitical pressureâ from various sources. But in all cases, policy should rely most heavily on best available scientific evidence. There are many examples, from the current and previous administrations, in which politi- cal interference has influenced policy and diverged from sound, available evidence. These include decisions relating to fundamental HHS respon- sibilities: â¢ Biomedical research funding has been affected, such as the elimination of federal funding for embryonic stem cell research on cell lines established after 2001, despite the potential value of such research (IOM, 2005). â¢ Federal funding for needle-exchange programs, a proven HIV/AIDS prevention strategy, has been withheld since 1988, al- though these programs are effective in reducing the spread of HIV without increasing illegal drug use or encouraging new us- ers (IOM, 1995). â¢ Effective family planning methods, such as contraceptives, have not been promoted, but instead, an âabstinence-onlyâ approach has been embraced (Union of Concerned Scientists, 2004), de- spite its ineffectiveness in reducing sexually transmitted infec- tions and unintended pregnancies (DiCenso et al., 2002; Underhill et al., 2007). â¢ Findings contained in scientific reports have been compromised and scientists muzzled. Former Surgeon General Richard Car- mona said that âtop officials delayed for years and tried to âwater
FOSTER ADAPTABILITY AND ALIGNMENT 75 downâ [his] landmark reportâ on the effects of secondhand smoke (Harris, 2007). Former Surgeon General David Satcherâs initial attempts to publish a report on sexual health in the late 1990s were thwarted by the White House in light of increased political sensitivity to these issues (Satcher, 2007). â¢ Testimony before congressional committees. CDC Director Julie Gerberdingâs statement before a Senate committee on the health effects of global warming was cut in half by the White House, with references to the health effects of climate change removed (Revkin, 2007). The departmentâs policy-making role is credible only to the extent that it is based on sound science. In the regulatory sphere, for example, the link between valid, reliable information and policies must be strong enough to meet legal challenges, as well as critiques by members of Congress, the news media, organizations representing various HHS con- stituencies, and the public. In short, decision makers must have access to scientific findings, transparent methods of reviewing them, free of influ- ence by the regulated industries, and plausible ways to resolve questions when scientific findings conflict or are inconclusive (Wagner and Stein- zor, 2006). Basing policy on the best science can directly serve patient interests and protect the publicâs health. Through the years, policies developed by Medicare have played a leadership role in clinical areas by, for example â¢ mandating the replacement of hospital wards with semiprivate rooms, which helps control the spread of infection; â¢ ending racial segregation of hospitals, which led to better care for African Americans; â¢ covering influenza immunizations (CDC, 1993); â¢ providing data that permitted analysis of both costs and effec- tiveness of selected new medical technologies (Coye and Kell, 2006; Hlatky et al., 2005); â¢ using quality rankings to promote certain best practices in inpa- tient care and group practice by physicians; â¢ using evidence-based quality measures in producing hospital and state report cards and in pay-for-performance (P4P) quality in- centive initiatives (IOM, 2006); and â¢ implementing âcoverage with evidence development,â a new concept of making evidence generation a condition of coverage.
76 HHS IN THE 21ST CENTURY Related Recommendation g. To maximize value in the health care system, the secretary must strengthen the scientific base and capabilities of the department and ensure that agenciesâ research findings are shared depart- ment-wide and that current best evidence is used for departmental decision making, including the CMS reimbursement policy. STABILIZED RESEARCH FUNDING Scientific research projects typically extend well beyond a single fis- cal year. Predictability in funding is important, and delays in budget ap- provals can be especially injurious to the large, multiyear, multi- institutional, multidisciplinary projects that now distinguish scientific inquiry (IOM, 2003), from which so much has been learned about dis- ease risk factors and treatments (NHLBI, 2007). HHSâs use of, and support for, science can be impeded by uncertain- ties about the departmentâs annual budget, especially during extended congressional consideration. For example, the 2009 HHS budget appears unlikely to be adopted until February 2009, with the government operat- ing under a continuing resolution bill enacted in September 2008. Under previous continuing resolutions, NIH has given investigators with ongo- ing projects 80 percent of their approved budgets for the continuing reso- lution period, typically a few months. Unfortunately, when a budget is delayed until over a third of the fiscal year has elapsed, this can have a significant impact on research funding. Because of the below-inflation percentage increase in the 2009 proposed Presidentâs budget for NIH, if the agency is funded at that level, it may be forced to award fewer grants in fiscal year 2010 (Bhattacharjee et al., 2008). Budget delaysâand any perception that HHS is a less-than- hospitable environment for scientistsâcompound difficulties in recruit- ing and retaining the quality and quantity of scientists needed to support agency missionsâwhether in the biomedical sciences, social sciences, biostatistics and epidemiology, or health services research. Budgets of HHS science agencies have fluctuated greatly in recent years. NIH and CDC experienced large increases after 2000 (see Figure 1-3 in Chapter 1) and then saw little growth or experienced actual reduc-
FOSTER ADAPTABILITY AND ALIGNMENT 77 tions in funding. Multiyear budget planning for these vital agencies would be helpful. Serious concerns also have been raised about the ade- quacy of funding of HHS science agencies, with the news media report- ing that recent budget cuts threaten gains in the publicâs health (Fox, 2008; Harris, 2008; Trapp, 2008). Since 2002, AHRQ has not had its own separate budget allocation, but receives funds from other PHS agencies through a PHS evaluation set-aside. This has left the agencyâs budget an order-of-magnitude smaller than every other major PHS agency except FDA, whose budget is still five times that of AHRQ. 6 AHRQâs mission is to support, con- duct, and disseminate research that improves access to care and the out- comes, quality, cost, and utilization of health care servicesâin other words, to increase the value of the health care services Americans re- ceive. Research projects in AHRQâs diverse portfolio investigate nearly every aspect of the U.S. health care system, and AHRQ works with both the public and the private sectors to conduct and sponsor research and translate its research findings into improved clinical practice. The agency also attempts to refine decision-making techniques and practices, such as comparative effectiveness studies and evidence-based medicine. To make progress in developing and applying critical analytic tools to todayâs health care organization, delivery, and financing challenges, AHRQ requires a more reliable and viable funding stream. Giving AHRQ an independent budget, adequate to its task, is essential to achiev- ing the accountability and the value-based health system the committee envisions. Related Recommendation h. Congress should allocate sufficient, predictable funding for NIH, CDC, FDA, and AHRQ in order to preserve and enhance these agenciesâ scientific missions. Congress should also establish a specific budget line for AHRQ that is independent of ap- propriations to other HHS agencies. 6 In 2007, the program level budget for AHRQ was $319 million and for FDA just over $2 billion.
78 HHS IN THE 21ST CENTURY A FORTIFIED STRUCTURE OF FOOD SAFETY REGULATION There are many opportunities for reorganization within HHSâand indeed across federal departmentsâthat would bring more coherence, reduce overlaps and redundancy, and create more efficiency. Changes of this sort can be extremely difficult, time consuming, and highly contro- versial. They involve obtaining new authorizing legislation, the reas- signment of large budgets and significant numbers of people, the opposition of powerful special interest groups, both expected and unex- pected disruptions in work, and other implementation difficulties. Crea- tion of the new Department of Homeland Security was a case in point: Only at a time when Congress and the nation felt a sense of severe crisis could such a massive reorganization have occurred so swiftly, but even with that utmost sense of urgency, the transition was far from smooth. For these reasons, the IOM committee so far has avoided suggesting the reorganization of agencies within HHS or across departments. How- ever, the seriousness of the food safety issue prompted the committee to use it as an example of a public health issue that HHS cannot address adequately within its current structure, which is the reason some reorganization would be both logical and advantageous, despite the difficulties. Proposed consolidation of the food safety activities of FDA and the USDAâs Food Safety and Inspection Service (FSIS) is not merely illustrative, however, since its potential to benefit the health of the American public is so great that it is included among the committeeâs recommendations. 7 Nowhere is the weakness of HHSâs science base more apparent or potentially harmful than in FDAâs food safety regulatory activities. A candid report recently prepared for the FDA Science Board found (FDA Subcommittee on Science and Technology, 2007): The nationâs food supply is at risk. Crisis management in FDAâs two food safety centers, Center for Food Safety and Applied Nutrition and Center for Veterinary Medi- 7 Food safety issues have garnered a great deal of attention in Congress. A search for bills in the 110th Congress related to âfood safetyâ returns over 100, with some calling for improved coordination and unification of the food safety inspection activities (e.g., H.R. 2297 and H.R. 7143), which the Senate Committee on Governmental Affairs con- cluded was necessary over 30 years ago when it called for a single food safety agency (Senate Committee on Governmental Affairs, 1977).
FOSTER ADAPTABILITY AND ALIGNMENT 79 cine, has drawn attention and resources away from FDAâs ability to develop the science base and infrastruc- ture needed to efficiently support innovation in the food industry, provide effective routine surveillance, and con- duct emergency outbreak investigation activities to pro- tect the food supply. FDAâs inability to keep up with scientific advances means that American lives are at risk. 8 [Emphasis added.] In part, this state of affairs reflects deficits in both the number and the expertise of FDAâs scientific workforce: â[D]espite the significant increase in workload during the past two decades, in 2007 the number of appropriated personnel remained essentially the sameâresulting in ma- jor gaps of scientific expertise in key areas.â¦ The turnover rate in FDA science staff in key scientific areas is twice that of other government agenciesâ (FDA Subcommittee on Science and Technology, 2007). In fact, in the past three years, one-fifth of the science staff and 600 inspec- tors have left FDAâs Center for Food Safety and Applied Nutrition (TFAH, 2008). Within the department, the organization of food safety responsibili- ties and information technology infrastructure is inadequate (FDA Sub- committee on Science and Technology, 2007). There are three separately managed components of FDA with major food safety responsibilitiesâ the Center for Food Safety and Applied Nutrition, the Center for Veteri- nary Medicine, and the Office of Regulatory Affairs, which oversees FDAâs field force and controls the majority of the agencyâs food safety resources. FDA has established an assistant commissioner for foods âto provide advice and counsel to the Commissioner on strategic and sub- stantive food safety and food defense mattersâ (FDA, 2007a). However, there is no FDA official whose full-time job is food safety and who has line and budget authority over the three food safety operating compo- nents. Moreover, monitoring any food-related outbreaks that occurâthe 8 The Subcommittee on Science and Technology concluded that âscience at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.â The report indicates that the science base of the entire agency is lacking, not just in the area of food safety, and is in need of reinforcement (FDA Subcommittee on Science and Technology, 2007). A discussion earlier in this chapter calls for a strengthened science base for HHS, includ- ing FDA.
80 HHS IN THE 21ST CENTURY vital food safety epidemiology functionâis managed and operated by CDC. Ensuring the safety of the food supply is an expandingâand visi- bleâgovernmental responsibility. 9 In the era of globalization, when the United States increasingly uses foreign sources for raw and processed foods, contamination of food sources has become much more common. Sixty percent of the fresh fruits and vegetables and 75 percent of the sea- food that Americans consume is imported, but FDA inspects only an es- timated one percent of these imports (TFAH, 2008), and some analysts estimate that tests for U.S.-produced foods dropped nearly 75 percent between 2003 and 2006 (Bridges, 2007). Bacteria and other potentially injurious organisms are transported easily across the nation or between countries in containers or through human travel; chemical contamination can occur in processing, storage, or transport, especially in nations with lax inspection systems. These problems have been illustrated in recent, widely publicized outbreaks of food-borne illnesses, such as the 2008 Salmonella outbreak, involving imported raw jalapeÃ±o and serrano peppers, which affected some 1,400 individuals (CDC, 2008). What the Government Accountability Office has called âthe patch- work nature of the federal oversight of food safetyâ compromises the federal governmentâs ability to keep up with fast-evolving food safety challenges (GAO, 2007). Food regulation is diffused across at least 12 agencies, including FDA, USDAâs FSIS, the National Marine Fisheries Service of the Commerce Department, the Environmental Protection Agency (regulating pesticides) (IOM, 1998), and the Department of Homeland Security (coordinating federal food security activities). Costly duplication and potentially dangerous inconsistencies result, affecting such jointly regulated aspects as importation facilities (GAO, 2007). As one of many examples of costly duplication and inefficiency, USDA and FDA inspect different types of imported food, but they do not share resources. USDA officials are present every day in import inspec- tion facilities, many of which also receive and store FDA-regulated products. But FDA inspectors appear less frequently, so foods often âre- 9 The USDA, which is responsible only for meat, poultry, and processed egg products, spends twice as much on food safety as does FDA, which is responsible for all other foodstuffs. USDAâs FSIS has a budget of more than $1 billion (USDA, 2008a) and a workforce of more than 9,000 (USDA, 2008b), many of whom are deployed at inspection sites around the country.
FOSTER ADAPTABILITY AND ALIGNMENT 81 main at the facilities for some time,â since USDA has no jurisdiction over them (Walker, 2007). Although many agencies are involved in food safety, none âhas ulti- mate authority or responsibility, so accountability for the total system is limited. No one person in the federal government has the oversight and accountability for carrying out comprehensive, preventive strategies for reducing food-borne illnessâ (TFAH, 2008). Further, FDAâs food safety authority, like its authority over drugs, was constructed decades ago and does not reflect current manufacturing and distribution processes (IOM, 2007). The system remains ill equipped to meet emerging challengesâas an Institute of Medicine (IOM) report concluded a decade ago (IOM, 1998), even before the terrorist events of 2001 heightened concerns about the security of our food supply. Con- gress should assess the large collection of food safety laws regulating various commodities to determine whether they should be updated and coordinated, in light of an evolving industry, improved science for de- tecting hazards, trends in contamination, and globalization of food prod- ucts and ingredients. The goal should be to mount a public health- oriented regulatory program that not only would prevent food-borne ill- nesses, but also would make rational use of federal food safety resources. Because of shortcomings and gaps in the existing regulatory struc- ture, the IOM committee recommends uniting the food safety responsi- bilities of the two largest agencies involvedâFDA and FSISâwithin HHS, as the most appropriate locus for comprehensive regulation. The committee considered other alternatives including maintaining the cur- rent division of responsibility or uniting food safety responsibilities within FSIS. The recent and problematic food safety issues described in this chapter strongly indicate the need for strengthening our ability to monitor the safety of our food supply. The committee believed that the problems cannot be solved within the current structures. There are at least five major reasons for the choice of unifying food safety responsi- bilities within HHS: 1. The department is dedicated solely to protecting the public, in contrast to USDA, which has additional, industry-fostering pur- poses, and it is important to immunize food safety regulation from potential undue industry influence. 2. The department is oriented to disease prevention, health promo- tion, and public health generally. Placing food safety responsi- bilities within HHS could more effectively link those functions
82 HHS IN THE 21ST CENTURY to the overall mission of the department. For example, within HHS, food inspection functions would be closer to the surveil- lance functions carried out by the CDC. 3. The Committee recognizes the strengths of the FSIS program and the scientific expertise it provides (currently, FDA relies on USDA for much of the science base of food safety regulation). A thoughtful and careful transfer of FSIS functions to HHS and its multiple science-based resources could enhance the capability to more effectively coordinate the use of science to enhance food safety. 4. HHS has full regulatory authority over drugs, and the distinction between foods and drugs is diminishing. We have the advent of ânutriceuticalsâ and greater acceptance of âhealth foodsâ and supplements, and foods are increasingly exposed to antibiotics, irradiation, pesticides, and other chemical interventions, as well as genetic modification. 5. Recognizing the need to strengthen its food safety regulatory op- erations, FDA recently developed a Food Protection Plan, an in- tegrated strategy to protect the food supply through prevention, intervention, and response (FDA, 2007b). The IOM committee understands that transferring FSIS functions to the department is likely to be difficult and that similar proposals in the past have been met with resistance: â¢ It would be a large move, in both budgetary and personnel terms. â¢ Major revisions to authorizing legislation for FSIS would be needed. â¢ It would weaken the voice of public health within USDAâ obviating the need for the position of USDA undersecretary for food safety, who is currently required by law to have food safety or public health credentials. â¢ Without additional action, it would sever the food regulatory re- sponsibility from its research base. For the unification to be effective, it therefore would have to include provisions for (1) ongoing collaboration or relocation of USDA food safety research programs to HHS, and (2) maintaining relationships with USDA programs that work to prevent food contaminations on farms.
FOSTER ADAPTABILITY AND ALIGNMENT 83 Bringing FSISâand closer ties to USDAâs science programsâinto HHS would strengthen U.S. food safety efforts overall. Finally, because drug regulation so dominates the current FDA, 10 the committee was not persuaded that the unified food safety function should be lodged automatically within that agency. Creation of a new, focused food safety entity might be preferable. In any case, the advantages to the public of unifying food safety regulatory authority within a health- focused department far exceed the disadvantages. The nation no longer should have to rely on excessively compartmentalized, fragmented, and inconsistent regulatory procedures to ensure that the food Americans eat is safe for human consumption. Related Recommendation i. To address the growing threat of food-borne ill- nesses, Congress should unify the USDAâs Food Safety and Inspection Service and the food safety activities of FDA within HHS and ensure provi- sion of adequate resources for high-quality in- spection, enforcement, and research. REFERENCES Bhattacharjee, Y., J. Kaiser, E. Kintisch, A. Lawler, and J. Mervis. 2008. U.S. science faces a flat 2009. ScienceNOW September 29. Boufford, J., and P. Lee. 2001. Health policies for the 21st century: Challenges and recommendations for the U.S. Department of Health and Human Ser- vices. New York: Milbank Memorial Fund. Bridges, A. 2007. Food safety. Associated Press Archive February 26. Catlin, A., C. Cowan, M. Hartman, S. Heffler, and the National Health Expendi- ture Accounts Team. 2008. National health spending in 2006: A year of change for prescription drugs. Health Affairs 27(1):14-29. CDC (Centers for Disease Control and Prevention). 1993. Perspectives in dis- ease prevention and health promotion final results: Medicare influenza vac- 10 Internally, the ratio of FDAâs budget spent on food, compared to that spent on human drugs, has shrunk markedlyâfrom 0.89:1 in 2000 to 0.73:1 in 2009 (FDA, 2008). (That is, in 2000, for every dollar spent on human drugs, the agency spent 89 cents on food safety; in 2009, though budgets for both activities have increased, it spent only 73 cents on food safety for every dollar spent on drugs.)
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