HE210 Test 4

LEGISLATIVE INITIATIVES

In addition to the federal, private, and private- public efforts just discussed, state legislatures have become involved in quality health care issues. For example, several states have passed or have pending legislation that mandates hospitals to disclose their infection rates to the public. The rationale behind these initiatives is that hospitals will improve their infection control programs if threatened by the loss of patients or purchasers to competitors who seem to have better infection control performance than their own. (As the old saying goes, "sunlight is the best disinfectant.") Pennsylvania and Illinois were leaders in this area. Following widely publicized investigative series on preventable deaths attributable to nosocomial infection in the Chicago Tribune and the Pittsburgh Tribune-Review , Illinois and Pennsylvania instituted policies requiring hospitals to report data on nosocomial infections to oversight agencies and adopted plans to make comparative data on infection rates available to the public. These states were the first to require systematic, ongoing reporting on nosocomial infection data. The Illinois and Pennsylvania initiatives fall within a clear consumer choice model for addressing nosocomial infections. Rather than compelling hospitals to adopt new infection control practices, the legislation works by publicly disclosing infection rates, which proponents assert will better enable consumers to make appropriate health care decisions as well as provide a market incentive for health care providers to improve infection control in their facilities. Both the Illinois legislation (Hospital Report Card Act) and the new reporting rules promulgated by the Pennsylvania Health Care Cost Containment Council went into effect on January 1, 2004. After the Illinois and Pennsylvania programs were adopted, Missouri and Florida also passed laws instituting nosocomial infection reporting requirements. Finally, a piece of federal legislation titled "The Patient Safety and Quality Improvement Act" was enacted in 2005 (White House, 2005). This legislation created a voluntary, confidential medical errors reporting database and had widespread support from representatives of the health care industry at the time of signing. Whereas consumer advocates support programs that require public disclosure of quality information such as infection rates, the hospital industry regularly opposes such programs, expressing concern that publicizing quality data will lead to increased tort litigation against providers. It is unclear as of the writing of this book what effects these legislative initiatives will have on the quality of health care. Also, another problem with the "consumer choice" approach is that, in most cases, consumers do not have a choice. Their doctor tells them what hospital they are going to, or there is only one hospital that is accessible anyway. Furthermore, most people on their way to a hospital are sick enough that they do not want to stop to evaluate their choices and could not do much with the information anyway. They just want to be admitted and taken care of.

SOME POLICY ISSUES IN MC

In the mid-1990s, a longtime observer of the MC scene laid out a list of what he thought would and should happen under MC over the next 10 years (Dennis L. Kodner, personal communication with Jonas, autumn 1996): An increase in the practice of population-based care An increase in the use of physician/nonphysician team care The development of highly sophisticated medical, health, and management informa4. tion systems The return of physician control Increased public sector enrollment: Medicare/Medicaid "Carve-outs" (health services sectors set outside the MC system), for example, mental health, substance abuse, and high-cost subspecialty care Increased insurance company ownership of MCOs and decline in insurance company involvement in indemnity insurance. Decline of both group and staff-model plans with a concomitant rise in other forms, such as the integrated delivery system Competition among MCOs on the basis of quality Going from managed cost to MC A similar list was developed by Barton (1999, p. 31), who also added rationalization of resource use, greater accountability, more disease prevention and health maintenance, and improved quality. The list by Shortell, Gillies, Anderson, Erickson, & Mitchell (1999) is also similar. However, 17 years later, we see that the emphasis on quality and population health has not occurred as completely as predicted. Luft (2003) has described the problem of defining MC and, therefore, of evaluating MCOs on quality, access, and cost: The collection of health plans commonly referred to as "managed care" has come to include an astonishing variety of forms. Although a few are tightly integrated prepaid group practices, a much larger number reflect the complex mixes of associations of clinicians and institutions into provider groups and insurers that face myriad, sometimes conflicting, incentives and employ widely disparate information systems. Managed care plans also differ in the mix of prepaid and fee-for-service patients they enroll and the associated payor sources with which they must interact. Given this heterogeneity, it is difficult to meaningfully compare the quality of managed care plans as a group to fee-for-service plans or to assess the relative performance among types of managed care plans. (p. 1373) Therefore, the controversy that has followed the rise of MC regarding its ability to meet our health care goals continues today and opinion is mostly unfavorable. For example, we still question the effect of MC on the doctor- patient relationship. Does MC harm the relationship between physician and patient? There is evidence brought to bear on both sides of the argument (e.g., Alexander & Lantos, 2006; Light, 2006). Further research may resolve this issue and others related to the desirability of MC. However, the continual change of MCOs in response to critics— both consumers and providers— poses difficulties in obtaining convincing answers. MC has changed dramatically in response to its critics. Thus, for example, RAND (Marquis, Rogowski, & Escara, 2005) put forward two nearly polar opposite explanations for the failure of HMO enrollment to drop in the late 1990s and early 2000s following much reported consumer disfavor with MC: (a) Many consumers were more satisfied with their HMOs than had been thought; and (b) many HMOs relaxed their cost containment restrictions in order to avoid losing market share.

MANAGED CARE

Although health insurance has traditionally been a major payer of health care costs, the enactment of the HMO Act of 1973 brought about a major change in how health insurance pays for health care, called MC . Managed care plans are health insurance plans that contract with health care providers and medical facilities to provide care for members at reduced costs. These providers make up the plan's network. How much of your care the plan will pay for depends on the network's rules. Restrictive plans generally cost you less. More flexible plans cost more. There are three types of managed care plans: ■ ■ Health Maintenance Organizations (HMO) usually pay for care only within the network. You choose a primary care doctor who coordinates most of your care. ■ ■ Preferred Provider Organizations (PPO) usually pay more if you get care within the network, but they still pay a portion if you go outside. ■ ■ Point of Service (POS) plans let you choose between an HMO or a PPO each time you need care (MedlinePlus, 2011). MCOs enter into contracts with hospitals, physicians, and other providers to deliver health care to their enrollees (or beneficiaries) at what the MCO believes will be a favorable rate per enrollee for their care (capitated). Key attributes of MC plans are (a) selecting providers who will then deliver a comprehensive range of services to enrollees at the agreed upon rate; (b) giving economic incentives to providers to choose less costly care; and (c) reviewing providers' utilization and quality of care, formally and regularly, through data mining claims data and chart review. Typically, the primary care provider is the "gatekeeper" who must approve the use of specialists. There are controls on inpatient hospital care and length of stay; and disease management, case management, wellness incentives, and patient education are used to control costs and quality. This matter-of-fact description of MC disguises the transformational change that it brought about in the U.S. health care system. MC shifted the balance of power from providers to payers. Payers entered "the treatment room" with providers, influencing their treatment patterns through reimbursement rates that affect patient flow; through provider incentives that favor certain tests and procedures over others; and through utilization and quality reviews that further constrain provider autonomy in decision making. MC has been a very controversial practice from the start. Critics say it restricts needed access to health care and adversely affects health care quality. The use of economic incentives to providers for limiting certain kinds of health care and the restraint on their fees concern detractors. Proponents argue that MC reduces inefficiencies and, thereby, costs of the health care system without affecting quality or access. However, two factors make it difficult to evaluate the effects of MC on cost, quality, and access. First, MC is almost invisible now because it is so pervasive. All payers— for-profit, nonprofit, and government— have adopted MC principles and practices to some extent. As an example, the health care reform legislation passed under President Obama in 2010— the Affordable Care Act— put MC principles and practices into place by its focus on effectiveness and efficiency. Second, MC plans are so varied that it is difficult to generalize about their effects on cost, quality, and access. The criteria for selection of providers, the limitations on covered services, the reimbursement rates negotiated with providers, and the ways that utilization and quality reviews are used differ widely across plans. Thus, we should expect that the actual quality of care received and the costs of that care will differ, as well. These factors— reimbursement rates, favored services, and utilization review criteria— may be more predictive of quality and cost of health care than whether or not the care was "managed." Nevertheless, we refer to MC because of its singular influence on the way health care is delivered today in the United States, although its influence on costs, quality, and access appears not to be uniform.

PATEINT SAFETY

Another aspect of health care quality is patient safety. The patient safety movement of the 1990s led to a great deal of interest in improving the quality of health care delivery through the application of methods borrowed from other industries and pioneered by W. Edwards Deming. Deming was an American statistician, considered the father of the modern quality assurance movement. He developed his system following the end of World War II. Unable to get a hearing in this country, he went to Japan. His methods, designated Statistical Process Control (SPC) and Total Quality Management (TQM), strongly influenced the rebirth and eventual massive expansion of Japanese industry post- World War II. Patient safety has been defined by the Institute of Medicine (2000) as "freedom from accidental injury; ensuring patient safety involves the establishment of operational systems and processes that minimize the likelihood of errors and maximizes the likelihood of intercepting them when they occur" (p. 211). Therefore, patient safety encompasses all events and situations that result in accidental harm to patients, including medication errors, surgical mistakes, falls, improper use of medical devices, and nosocomial infection. The Institute of Medicine report, To Err Is Human (2000), has played a major role in bringing national attention to the issue of patient safety. The Report converted an issue of gradually growing professional awareness over a great deal of time to one of substantial public concern in a manner and pace unprecedented in modern experience with matters of healthcare quality. The epidemiologic finding that more than one million injuries and nearly 100,000 deaths occur in the United States annually as a result of mistakes in medical care came from studies nearly a decade old. But this was new information for the public, and it resonated strongly. (Leape, Berwick, & Bates, 2002, p. 501) To Err Is Human brought a new perspective to health care quality assurance by supporting the importation of industrial quality-improvement practices into health care settings. Using Charles Perrow's analysis of the Three Mile Island accident (Perrow, 1984) as a model, the report advocates a systems approach to health care improvement in order to understand and modify the conditions that contribute to errors. The authors conclude (Institute of Medicine, 2000): The application of human factors in other industries has successfully reduced errors. Health care has to look at medical error not as a special case of medicine, but as a special case of error, and to apply the theory and approaches already used in other fields to reduce errors and improve reliability. (p. 66) There are many excellent books on the application of health improvement methods to health care, including the classic by Berwick, Gladfrey, and Roessner (1990) and the more recent by Dlugacz, Restifo, and Greenwood (2004). A number of organizations provide training in quality-improvement methods. Hospitals that have applied these quality- improvement methods have reported significant success in improving safety (e.g., Van den Heuvel, Bogers, Does, van Dijk, & Berg, 2006).

Employer-Based Health Insurance

During the first decades of the 20th century, the value of medical care was becoming evident in vaccines and antitoxins, which prevented childhood illnesses; medicines, such as insulin, which saved and extended life; and surgery, which could cure dozens of conditions, aided by effective anesthesia and the protection of aseptic techniques. It was at that point that reformers sought to extend the reach of professional medical attention to the entire population for the first time. International comparisons in rates of illness and death, which became possible with the standardization of vital statistics reporting, again emphasized the dramatic differences in both overall death rates and in deaths from specific causes as a result of public health improvements and medical care (Center for Medical Humanities, Compassionate Care, and Bioethics, 2012). In response, the United States created a system of employer-based health insurance for nonmilitary workers and their families. In 1910, early forerunners of health insurance plans (HIP) appeared as "prepaid" group practices. Plan members paid a monthly premium and received a wide range of medical services through an exclusive group of providers. The American system of health insurance developed from there. In 1929, Blue Cross Plans were established to provide "prepaid" hospital care to workers in the Dallas public school system: An official at Baylor University Hospital in Dallas noticed that Americans, on average, were spending more on cosmetics than on medical care. "We spend a dollar or so at a time for cosmetics and do not notice the high cost," he said. "The ribbon-counter clerk can pay 50 cents, 75 cents, or $1 a month, yet it would take about 20 years to set aside [money for] a large hospital bill. The Baylor hospital started looking for a way to get regular folks in Dallas to pay for health care the same way they paid for lipstick— a tiny bit each month. Hospital officials started small, offering a deal to a group of public school teachers in Dallas. They offered a plan for the teachers to pay 50 cents each month in exchange for Baylor picking up the tab on hospital visits. (Blumberg & Davidson, 2009) In 1930, Blue Shield Plans began providing reimbursement for physician services. In 1955, the spread of health insurance coverage— from less than 10% of the population having coverage in 1940— grew to nearly 70%. The Blue Cross and Blue Shield logos become ubiquitous icons in both homes and medical offices across America (Lichtenstein, 2015). Employer-based insurance was fostered by World War II caps on wages that led employers to lure workers with benefits such as health insurance. At the same time that employer-based insurance was being developed, the United States continued to build a military health care system for members of the armed forces, their dependents, and veterans, which was begun in the 19th century when the federal government authorized, in 1811, the first home and medical facility for veterans. Later in the 19th century, the nation's veterans' assistance was expanded to include benefits and pensions for veterans as well as their widows and dependents. The system continued to grow and develop and is a major provider of health care today (U.S. Department of Veterans Affairs [VA], 2015). very small employers (3- 9 workers) and 73% of small employers (10- 24 workers) did so (Kaiser Family Foundation, 2006). It is noteworthy that the overall insured rate dropped from 69% in 2000 to 61% in 2006, because of a decline in the number of the smallest firms to offer health insurance to their employees. Additionally, whereas more than 29% of the "jumbo" firms (5,000 + workers) offered a choice of plans, fewer than 10% of small employers (3- 199 workers) did so (Kaiser Family Foundation, 2006). Also of note is that the percentage of jumbo firms offering only one plan increased from 7% in 2000 to 29% in 2006.

EFFICIENCY OF HEALTH CARE

Efficiency is the third criterion for judging a health care system. "Efficiency requires that we produce the combination of goods and services with the highest attainable total value, given our limited resources and technology" (Aday et al., 1993, p. 73). Efficiency is either allocative or production. Allocative efficiency concerns attaining the most valued mix of health care services. Production efficiency refers to producing a given level of health care services at minimum cost. As an example, an allocative efficiency issue is how much to invest in preventive versus curative medical services, whereas a production efficiency issue might concern whether and when to substitute relatively low-cost nurses for higher cost physicians in the provision of health care services. At the microlevel of physician practices, hospitals, and other health care settings, efficiency is assessed using (a) production functions and (b) cost-effectiveness, cost-benefit, and related cost-utility analysis (Aday et al., 1993). These analyses are used to determine, for example, which of two equally effective treatments should be recommended to clinicians. If both are effective, the goal of efficiency suggests that the less expensive treatment is preferable. These kinds of decisions are increasingly made by health care payers. For example, the Commonwealth Fund newsletter (March 2006, p. 1) reports: Washington State's Health Care Authority, which coordinates the Prescription Drug Program for the state's Medicaid, public employee, and worker c ompensation programs, is using an integrated approach to value-based pharmaceutical purchasing. The evidence-based drug review process involves a thorough a nalysis of quality and effectiveness before applying cost considerations. The p rocess, which includes an evidence-based preferred drug list and supplemental rebates from pharmaceutical manufacturers, is producing savings of about $20 million each year to the state— over 5 percent of its Medicaid fee-for-service drug spending—and about $40 million in combined state- federal spending. At the macrolevel, efficiency analysis is based on comparisons between regions, states, and nations. Often, we use international comparisons of health care systems (Aday et al., 1993). We can use WHO statistics and the Commonwealth Fund to contrast the United States with peer nations, including Australia, Canada, France, Germany, Japan, New Zealand, Norway, the Netherlands, Switzerland, Sweden, and the United Kingdom on numerous indicators of cost and available health care resources. In 2014, the United States was ranked first in proportion of its gross domestic product spent on health services (17.7%) and ranked first in per capita total expenditures on health care. At the average exchange rate in U.S. dollars, per capita expenditure was $8,508 in the United States, compared to $3,405 in the United Kingdom, the country ranked first in overall health system performance (Davis, Schoen, & Stremikis, 2010; Davis, Schoen, Stremikis, & Squires, 2014). The United States was ranked second to last in physicians per 1,000 population, and last in number of physician visits per capita. The United States ranked in the bottom of the percentage of those who believe, if they became seriously ill, they would be confident they could afford the care they needed. Overall, the United States ranks last on mortality amenable to health care, last on infant mortality, and second to last on health life expectancy at age 60. Primary care physician survey data also suggests the United States is lagging in adoption of national policies that promote primary care, quality improvement, and information technology. The United States is spending more per capita on health care and providing fewer basic health care resources relative to other countries. Further, the U.S. rankings on various measures of mortality discussed previously in this chapter (see "Population Health Outcomes") suggest that the U.S. health care system is not efficient, because our rankings on life expectancy, quality-of-life adjusted life expectancy, infant mortality, and other mortality rates are consistently lower than those of peer nations spending less on health care.

PUBLIC/PRIVATE PARTNERSHIPS AND PRIVATE INITATIVES

There are also a number of private initiative or private- public partnerships providing health care performance information to consumers and purchasers. Both the consumers and the purchasers of hospital services, such as insurance companies and the Medicare program, have a vital interest in the quality of those services. However, until fairly recently, consumers and purchasers had very limited ability to evaluate the quality of a hospital's performance in any aspect of care. Now, two organizations— the National Quality Forum (NQF) and the Leapfrog Group— are attempting to rectify this problem by developing standard measures of hospital quality and disseminating information about hospital performance to purchasers and consumers. The effectiveness of providing consumers and payers with information about health care quality is controversial and untested, as yet. National Quality Forum. The NQF is a nonprofit organization created to improve the quality of American health care by building consensus on national priorities and goals for performance improvement, endorsing national consensus standards for measuring and publicly reporting on performance, and promoting the attainment of national goals through education and outreach programs (National Quality Forum, 2012). Established in 1999 as a partnership between public and private stakeholders, the NQF aims to promote health care quality improvement by developing the intellectual framework for nationally standardized performance measures and quality data reporting so that individual hospitals and health systems can be compared. The NQF encourages the use of standardized measures by consumers and stakeholders within the health care system. However, it should be noted that the NQF has no authority to implement its standards, although payers of hospital services, such as insurance companies and the Medicare program can demand compliance with their standards. The NQF enjoys broad participation from health care consumer advocacy groups, public and private purchasers, health care professionals, employers, provider organizations, health plans, accrediting bodies, organized labor, and organizations involved in health care research and quality improvement. The organization is governed by a 27-member board of directors representing consumers, purchasers, providers, insurers, health services experts, and representatives from the CMS and the AHRQ. Currently, there are more than 200 member organizations active in the NQF. The NQF seeks not only to promote new guidelines, standards, and quality measures to rectify serious and pervasive quality deficiencies, but also to reconcile the redundant and often incompatible guidelines, standards, and reporting measures offered by various organizations and agencies dedicated to health care quality improvement. The NQF consensus process was developed pursuant to and in accordance with the National Technology Transfer Act of 1995 (U.S. Office of Management and Budget Circular A-119). This means that NQF endorsement of hospital performance measures and standards confers on them the special legal status of voluntary consensus standards . This status makes NQF-endorsed recommendations more easily adopted for use by Medicare, Medicaid, and other federally funded health care programs; that is, federal health care programs can require hospitals to adopt NQF recommendations in order to qualify for federal insurance programs. The NQF has issued reports endorsing a set of quality measures and endorsing patient safety practices. The measures are designed to provide consumers, providers, purchasers, and quality-improvement professionals the tools to evaluate and compare the quality of care in hospitals across the nation using a standard set of measures. The goal is to make data on these performance measures publicly available, and thus, enable performance-based decisions about hospital selection, create incentives for hospital performance improvement, enhance value-based purchasing, and generally stimulate the improvement of health care. The Leapfrog Group. The Leapfrog Group (2012) is a member-supported program aimed at mobilizing employer purchasing power to alert America's health industry that big leaps in health care safety, quality, and customer value will be recognized and rewarded. It was established in 2000 to: reward hospitals for advances in patient safety and quality and to educate employees, retirees, and families about the importance of hospitals' efforts in this area. Leapfrog purchasers provide health benefits to more than 34 million Americans and spend billions on healthcare annually. (Leapfrog Group, 2012, p. 1) Leapfrog was founded by the Business Roundtable, and its funding comes from its members. Leapfrog aims to give consumers information on hospital quality so that they are able to make more informed hospital choices and to mobilize employer health care purchasing power to improve patient safety. Focusing on quality of care issues relevant to urban area hospitals, the group works with medical quality-improvement experts to identify problems and propose solutions believed to improve hospital patient care. The Leapfrog Group's strategy is to recommend a set of safety practices, and then survey hospitals regarding the practice areas targeted. For each recommended practice, the hospital is rated on the following scale: fully implemented recommended practice, good progress in implementation, good early stage in implementation, willing to report but does not meet criteria for good early stage, and did not disclose. Leapfrog collects and makes publicly available comparative hospital ratings based on implementation of the recommended practices. This information is available through the HealthGrades website and through the Leapfrog Group website (www.leapfroggroup.org/cp). The Leapfrog Group encourages health care purchasers to provide incentives to hospitals that implement and report on the recommended practices. Incentives, such as increased patient volume, price variation based on performance, and public recognition are expected to encourage hospitals to adopt Leapfrog's recommendations. The Leapfrog Group further encourages corporate purchasers who utilize health plans as intermediaries to hold the health plans accountable for ensuring application of Leapfrog standards. The Leapfrog Group Safe Practices Score was based initially on the NQF's Safe Practices for Better Healthcare: A Consensus Report. Since that initial report, Leapfrog has utilized NQF updated reports to keep current. The most recent version of the report endorsed 34 practices that should be universally used in applicable clinical care settings to reduce the risk of harm to patients. There are practices aimed at: leadership and teamwork; preventing illness and infections; creating and sustaining a culture of safety; matching care needs to service capability; improving information transfer and communication; improving medication management, health care-associated infections, and specific care processes. Included in the 34 practices are two of the original three Leapfrog Leaps: computerized physician order entry and ICU physician staffing. After completion of the Leapfrog hospital survey, each hospital's relative ranking, compared with other hospitals, is displayed on the Leapfrog website, along with their results for the initial three Leaps and other measurement areas. In the 2011 Hospital Survey, Leapfrog scored hospitals' progress on 17 of the 34 NQF Safe Practice areas for a total of 737 points. Each practice area was assigned an individual weight, which was factored into the overall score. Hospitals were then ranked by quartiles. Institute for Healthcare Improvement. A number of private organizations provide expertise and leadership to hospitals that voluntarily aim to improve their quality of health care. Foremost among these organizations is the IHI. The IHI is a not-for-profit organization with a mission to improve health by focusing on a set of goals adapted from the Institute of Medicine's six improvement aims for the health care system: safety, effectiveness, patient centeredness, timeliness, efficiency, and equity (IHI, 2012). IHI attempts to bring change by identifying gaps; helping the public to understand and demand the improvement that is needed and possible; spreading improvement knowledge across the globe; and providing methods, tools, and other supports, largely through partnerships, for thousands of health care organizations to turn knowledge into improved results. IHI initiates and supports innovation efforts, so as to discover, cultivate, and demonstrate the feasibility of new, more capable designs. In terms of health care quality improvement, the IHI orientation is the Deming model of continuous quality improvement. The IHI focus is on innovation, research and development, and the creation of new solutions to old problems. In recent years, their research has been directed at transforming entire systems through redesign of all major care processes. This work was ultimately manifested in the 100,000 Lives Campaign and 5 Million Lives Campaign, in which IHI spread best practice changes to thousands of hospitals through the United States, and created a national network for improvement focused on reducing needless deaths and preventing harm from care.

THE JOINT COMMISSION AND OTHER HEALTH CARE ACCREDITING ORGANIZATIONS

Though they are private entities, the accrediting organizations have a great deal of direct and indirect influence on quality assurance and improvement in health care. This is particularly true because of the relationship between the CMS certification process and accreditation by a CMS-approved accrediting organization: In order for a healthcare organization to participate in and receive payment from the Medicare or Medicaid programs, it must be certified as complying with the Conditions of Participation (CoP), or standards, set forth in federal regulations. This certification is based on a survey conducted by a state agency on behalf of the Centers for Medicare & Medicaid Services (CMS). However, if a national accrediting organization, such as The Joint Commission, has and enforces standards that meet the federal Conditions of Participation, CMS may grant the accrediting organization "deeming" authority and "deem" each accredited health care organization as meeting the Medicare and Medicaid certification requirements. The healthcare organization would have "deemed status" and would not be subject to the Medicare survey and certification process. (American Society for Healthcare Engineering [ASHE], 2012, p. 1) The CoPs and Conditions for Coverage (CfCs) set by CMS are standards that CMS considers essential for improving quality and protecting the health and safety of Medicare and Medicaid beneficiaries. Through its approval process, CMS tries to ensure that the standards of approved accrediting organizations meet or exceed the Medicare standards set forth in the CoPs and the CfCs (CMS, 2012). The Joint Commission (2012) is the oldest and largest health care accrediting organization in the country, accrediting nearly 19,000 health care organizations in the United States, including general, psychiatric, children's, and rehabilitation hospitals; critical access hospitals; home care organizations; nursing homes and other long-term care facilities; behavioral health care organizations; ambulatory care providers; and independent or freestanding clinical laboratories. The Joint Commission aims to provide standards for high-quality care that will ensure both patient and staff safety. Accreditation is designed to ensure quality care, maintain infection control, and help reduce the occurrence of medical errors. The performance measurement tools used by The Joint Commission have developed over the years. For example, in 1986, The Joint Commission (then JCAHO) developed the Indicator Measurement System (IMS). It had six sets of performance measures, for perioperative care, obstetrical care, trauma care, oncology care, infection control, and medication use. This system was not implemented, but it set the stage for the current ORYX initiative, which is based on multiple measurement systems. As described by The Joint Commission (2012, p. 1), the ORYX system Integrates outcomes and other performance measurement data into the accreditation process. ORYX measurement requirements are intended to support Joint Commission accredited organizations in their quality improvement efforts. Performance measures are essential to the credibility of any modern evaluation activity for health care organizations. In 2010, The Joint Commission categorized its performance measures into accountability and non-accountability measures. This approach places more emphasis on an organization's performance on accountability measures— quality measures that meet four criteria designed to identify measures that produce the greatest positive impact on patient outcomes when hospitals demonstrate improvement: research, proximity, accuracy and adverse effects. Non-accountability measures (for example, providing smoking cessation advice) are more suitable for secondary uses, such as exploration or learning within individual health care organizations, and are good advice in terms of appropriate patient care. Going forward, The Joint Commission will only adopt accountability measures for its ORYX program. The principal objective of measurement activities, including ORYX, is to create the technical infrastructures within health care organizations and also The Joint Commission to support performance measurement and improvement in the health care system (The Joint Commission, 2012). Other CMS-approved, but much smaller, accrediting bodies for hospitals are the American Osteopathic Association's Healthcare Facilities Accreditation Program and DNV Healthcare, which were approved in 2008. The Accreditation Association for Ambulatory Health Care, the American Association for Accreditation of Ambulatory Surgery Facilities, and the Accreditation Commission for Health Care are CMS-approved for nonhospital health care settings, including ambulatory surgery centers and hospices (CMS, 2012).

Other "Fixes" for Problems of Access

"Major tinkering" occurred in the 1960s when the federal government created the Medicare and Medicaid programs. However, in most eras of dissatisfaction with health care, "minor tinkering" with the system prevailed. Three examples of this type of incremental change are the Hill- Burton Act, Emergency Medical Treatment and Labor Act (EMTALA), and Health Insurance Portability and Accountability Act (HIPAA) The 1946 Hill- Burton Act funded hospital construction in underserved areas. It was actually aimed at preventing government from taking a larger role in the provision of medical care for the general population: Supported by the medical establishment and guided through the Senate by Senator Robert Taft, [the Hill- Burton Act] deflected President Truman's proposal for a comprehensive health plan by limiting the government's role to the subsidy of voluntary nonprofit hospitals. The Hill- Burton Act eventually helped to finance 9,200 new hospitals and other facilities, assisting in financing almost one-third of all hospital projects in the nation. (Lipscomb, 2002, p. 109) Another "fix" was the EMTALA of 1986, which required hospitals participating in Medicare that operated active emergency rooms to provide appropriate medical screening and stabilizing treatments. EMTALA was passed after several highly publicized reports of "dumping" ("the denial of or limitation in the provision of medical services to a patient for economic reasons and the referral of that patient elsewhere") despite Joint Commission on Accreditation of Healthcare Organizations (JCAHO, now The Joint Commission) and American College of Emergency Physician prohibitions, as well as the 1946 Hill- Burton Act. It is now considered one of the most comprehensive laws guaranteeing nondiscriminatory access to emergency medical care and thus to the health care system and, through interpretations by the Centers for Medicare & Medicaid Services and the courts, potentially applies to virtually all aspects of patient care in the hospital setting (Zibulewsky, 2001). The HIPAA of 1996 brought about a number of significant improvements in access to health care. HIPAA provided for improving continuity or "portability" of coverage in the large group, small group, and individual health insurance markets. It also mandated that insurance cover at least a 2-day hospital stay for women who give birth and 4 days for C-sections and that mental health have the same status as physical health. Related, but less directly, to health care access are the privacy standards established under HIPAA. The Act established that the data within the medical record belongs to the patient, whereas the physical form the data takes belongs to the entity responsible for maintaining the record. Patients have the right to ensure that the information contained in their record is accurate, and can petition their health care provider to amend factually incorrect information in their records. Finally, HIPAA created national standards for certain electronic health care transactions to improve efficiency (U.S. Department of Health and Human Services [DHHS], 2013).

CLINICAL EFFECTIVENESS

A major concept used in defining the quality of health care in the present era is the evaluation of its effectiveness , that is, whether the care produces the desired or intended result. This term is synonymous with efficacy . Assessing the effectiveness, or efficacy, of health care at the microlevel of physician practices, hospitals, and other health care settings is becoming increasingly evidence based, that is, based on scientifically valid, empirical research. One of the best and most well-known definitions of evidence-based medicine is from an article in the British Medical Journal (Sackett, Rosenberg, Gray, Haynes, & Richardson, 1996): Evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. (p. 71) Thus, the standards against which quality is measured are based on clinical research. Clinical outcomes research is the foundation of quality-improvement efforts at the microlevel. Beginning in the last decade of the 20th century, and funded by the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and other organizations, researchers have continually generated, updated, and published the results of clinical outcomes studies. These studies have then been synthesized by experts in the field, and the synthesized results are translated into clinical practice guidelines (or alternatively, clinical practice protocols). A standard definition of clinical practice guidelines was developed by Field and Lohr (1992): "systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances." Clinical practice guidelines are published by government agencies, such as the Preventive Services Task Force, and voluntary agencies, such as the medical specialty societies and the disease-specific advocacy organizations such as the American Cancer Society. Each set of practice guidelines or protocols is the result of the distillation of the evidence provided by hundreds of studies. Performance assessment and the development of evidence-based "best practices" focus on the quality of care in clinical settings, such as hospitals, ambulatory care centers, and nursing homes, for categories of disease conditions, such as heart disease, infectious diseases, diabetes, or asthma. The following abstract from a study by Carson, McDonagh, and Peterson (2006) is an example of a clinical outcomes study. It compares the effectiveness of different atypical antipsychotic drugs for people with dementia: Although the Food and Drug Administration (FDA) has not approved atypical antipsychotics for use in patients with dementia, they are commonly prescribed in this population. Recent concerns about increased risk of cerebrovascular events and mortality have led to warnings. A systematic review was conducted to assess the benefits and harms of atypical antipsychotics when used in patients with behavioral and psychological symptoms of dementia. Electronic searches (through March 2005) of the Cochrane Library, Medline, Embase, and PsycINFO were supplemented with hand searches of reference lists, dossiers submitted by pharmaceutical companies, and a review of the FDA Website and i ndustry-sponsored results database. Using predetermined criteria, each study was assessed for inclusion, and data about study design, population, interventions, and outcomes were abstracted. An overall quality rating (good, fair, or poor) was assigned based on internal validity. The evidence for olanzapine and risperidone supports their effectiveness compared with placebo. Short-term adverse events were similar to placebo. Risperidone had no advantage over haloperidol on efficacy measures in the better-quality studies. Risperidone had an advantage over haloperidol on some measures of extrapyramidal symptoms. Evidence for the other atypical antipsychotics is too limited to assess efficacy and safety. Trials were short term and conducted in highly selected populations. The potential for increased risk of cerebrovascular adverse events and mortality is a serious concern. To make judgments about when the benefits of atypical antipsychotics outweigh the potential harms, clinicians need more information. Additional data from existing trials and more complete reporting of trial results could provide this information. (p. 354) The study used as an example here is typical of evidence-based research, where the results are suggestive but inconclusive, and therefore, the implications for clinical guidelines are not certain. However, evidence-based medicine uses the results of many such studies to determine the clinical efficacy of a set of clinical practices (i.e., clinical guidelines or protocols) in order to overcome the limitations of a single study. Although clinical practice guidelines are sometimes deridingly referred to as "cookbook medicine," they are proliferating and increasingly used by insurers and other payers to evaluate the quality of medical care provided to patients.

BIG DATA AND HEALTH INFORMATION

Access to more and better data, with the ability to manage and analyze it, will continue to transform the health care system: ■ ■ Complete, longitudinal electronic health records will allow a previously inconceivable level of data mining, enabling new levels of understanding about how genomics/biome, environment, and behavior affect health and medical care. ■ ■ Access to data will increase the emphasis on quality reporting and pay for performance, which will bring about improvements in quality of care, some improvements in costs, and eventually improvements in outcomes. ■ ■ Evaluations of medical procedure effectiveness, and resulting protocols, will continue to improve as a result of new data systems.

FUTURE OF THE OBAMA HEALTH PLAN

Increase in public-sector involvement in the health care system under the ACA has been strongly challenged. The rhetoric of Americans who wish to limit government has been perhaps more explicit and strident than at any time in memory, and antigovernment sentiment appears more widespread and powerful. The rise of the Tea Party as the most influential representative of conservative America has been a hallmark of this period. The mission and core principles of the Tea Party movement, in its own words, are: The Tea Party Patriots' mission is to restore America's founding principles of Fiscal Responsibility, Constitutionally Limited Government, and Free Markets. (Tea Party Patriots, 2012) Thus, it is not surprising that, since the ACA was passed, the Republicans in Congress have repeatedly attempted to repeal the legislation. They explain themselves on the Republican website GOP.gov by saying that: "Because the new health care law kills jobs, raises taxes, and increases the cost of health care, we will immediately take action to repeal this law" (GOP.gov, 2012). As the eighth edition of this book was being written, Republicans were still attempting to repeal the legislation, and Congress found bipartisan support to delay important provisions of the ACA, including the tax on generous health plans and a separate tax on health insurance providers. The excise tax on manufacturers of medical devices, which took effect in 2013, was suspended through 2017. The White House and many economists have defended the "Cadillac tax" on high-cost employer-sponsored health plans as a way to reduce health costs and make the health care system more efficient (Herszenhorn & Pear, 2015). The Commonwealth Fund explains: A last-minute deal in Congress delayed or suspended some of the taxes included in the ACA— one on medical devices, one on health insurers, and one on high-cost health plans. Estimated cost: $35.8 billion in lost revenue. To be clear, most of the ACA's funding comes from general revenue, and so isn't directly impacted by these taxes. (Blumenthal & Squires, 2015) In addition, many states have still rejected the Medicaid expansion, which is a feature of the ACA whereby the income eligibility criteria are expanded to include more people and the costs of adding health care for a greater number of people is paid by the federal government at first. This is a blow for the goal of attaining full health care coverage. Another disappointment concerning the ACA has been the performance of the Consumer Operated and Oriented Plan Program (CO-OP). "The Affordable Care Act calls for the establishment of the Consumer Operated and Oriented Plan (CO-OP) Program, which will foster the creation of qualified nonprofit health insurance issuers to offer competitive health plans in the individual and small group markets" (Centers for Medicare & Medicaid Services [CMS], 2015). However, the Commonwealth Fund assessment is that this will not be a major defeat: Underfunding for risk corridor programs designed to stabilize premiums, unmanageable deadlines, restrictions on marketing, the difficulty of setting up brand new insurance companies— there are many culprits behind the collapse of 12 of the 23 ACA-funded CO-OPs (Consumer Operated and Oriented Plans). But evidence that the folding CO-OPs are a harbinger of a broader collapse of the ACA exchanges remains scant. Rather, the CO-OPs' struggles have highlighted the substantial barriers to injecting competition into insurance markets— and how both economics and politics can get in the way. (Blumenthal & Squires, 2015). The future of the ACA is still in doubt as Republicans have promised to overturn it if a Republican president is elected in 2016. However, even if the ACA is overturned, many of its policies will remain, as they represent trends that were underway before passage of the bill and have much support in all sectors of the health care system.

EQUITY AND ACCESS TO HEALTH CARE

Is access to health care equitable in the United States? Here, the evidence is quite clear. People without health insurance (or with poor health insurance) have much reduced access to health care. As we have discussed, the United States finances health care through a mixed system, based largely on employer-based health insurance and the public insurance programs for the elderly and disabled (Medicare) and the poor (Medicaid). This patchwork system leaves 41 million people without health insurance (Kaiser Family Foundation, 2015). Millions more are underinsured, that is, they do not have comprehensive coverage. This can mean high deductibles and copays and limited coverage for a variety of health care services, including mental health services, medical equipment, and preventive care (Lee & Tollen, 2002). The health care access problems of the uninsured are well documented. The uninsured are much less likely to have a "usual place to go" for medical care. If they have a usual place for health care, they are less likely than insured persons to have a physician's office as their site of care. Uninsured adults are more likely to use "safety net" providers, such as community health centers, emergency rooms, and public health or free clinics as their usual place for health care. They are less likely than the insured person to see the same health care provider each time they obtain health care. They are more likely to report that they do not get needed health care, and they have fewer ambulatory care visits. Research has shown that uninsured persons are significantly more likely to delay seeking health care. Lack of health insurance has been found to be significantly related to the failure to fill a recommended prescription, and it is found that medications, even when filled, are not taken as directed, but saved or spread out over a longer than prescribed period of time to save money (Kaiser Family Foundation, 2002). Not all Americans have the same probability of being uninsured. National surveys have consistently found that age, SES, race, and ethnicity are predictors of being uninsured or underinsured. The majority of the uninsured and underinsured are employed. Until the Affordable Care Act, typically, 18to 34-year-olds were the least likely to have health insurance, either because they could not afford it or because they chose not to be insured, preferring to spend that money on something else. People who have had only a high school education or less schooling are more likely to be uninsured. A higher percentage of Hispanics and African Americans are uninsured compared to non-Hispanic Whites. Foreign-born noncitizens rank the highest of all in rate of being uninsured (Jonas & Kovner, 2005; Kaiser Family Foundation, 2006, 2015). Another factor leading to inequities in access to health care is geographic location. People who live in rural America and those who live in inner cities have reduced access to health care, even if they have health insurance. These areas often lack health care resources, including physicians and other health care providers and facilities, particularly easy-to-reach, comprehensive hospitals. Rural residents generally face a greater financial burden for obtaining care than do urban and suburban residents, and mental health services can be scarce (Reschovsky & Staiti, 2005). Rural areas tend to attract fewer doctors than urban areas. Even though 20% of Americans live in rural areas, only 9% of U.S. physicians practice in rural areas (AHRQ, 2005). The problem of equity, in both access to and quality of health care, is well known, and there have been efforts to remedy the problem starting early in the 20th century when reformers began to focus on securing universal health care coverage in the United States. The history of the efforts to correct the inequities in the U.S. health care system is described at length in Chapter 8—"History of Change From 1990 to the Present: Piecemeal Reform."

COST OF PRESCRIPTION DRUGS COME UNDER SCRUTINY

The "correct pricing" of pharmaceuticals will become a bigger issue in order to control cost, including inpatient care, resulting from, for example, coronary events (e.g., Lipitor) and liver failure (e.g., new hepatitis cures, although expensive, are cheaper than transplants).

FEDERAL AGENCIES

The major federal government agencies that focus on ensuring and improving the quality of health care are described next. Each of these agencies has been discussed previously in Chapters 5 and 6, but the following discussion focuses on their role in ensuring quality and evaluating health systems performance. Centers for Medicare & Medicaid Services. The CMS is a federal agency within the U.S. Department of Health and Human Services. (Until 2001 it was known as the Health Care Financing Administration or HCFA.) CMS has several offices and initiatives that focus on improving the quality of health care, including the Office of Clinical Standards and Quality, the Quality Initiatives (QIs), and the Medicare Health Outcomes Survey (HOS). Because Medicare and Medicaid pay for so much health care in the United States, their ability to influence quality throughout the health care system is enormous. The Office of Clinical Standards and Quality (OCSQ) serves as the focal point for all quality, clinical and medical science issues and policies for CMS programs . . . . It coordinates quality-related activities with outside organizations. OCSQ also monitors the quality of Medicare and Medicaid programs and evaluates the success of interventions. (CMS, 2007a, p. 1) The overall goal of the QI is to improve the quality of services for Medicare and Medicaid recipients through methods of provider accountability and public disclosure. The QI was launched nationally in 2002 with the Nursing Home QI (NHQI) and expanded in 2003 with the Home Health QI (HHQI) and the Hospital QI (HQI). In 2004, the Physician Focused QI, which includes the Doctor's Office Quality Project, was developed. In 2004, the QI was expanded to officially include kidney dialysis facilities. The End Stage Renal Disease (ESRD) QI promotes ongoing CMS strategies to improve the quality of care provided to ESRD patients. In 2006, CMS launched the Physician Voluntary Reporting Program (CMS, 2007b). In 2009, CMS estimated that almost all settings covered by Medicare were covered by quality measures (CMS, 2009). CMS, in collaboration with the National Committee for Quality Assurance (NCQA), launched the Medicare HOS in 1998 to study the outcomes of Medicare-managed care. The Medicare HOS is being used as part of the effectiveness of care component of the Health Plan Employer Data and Information Set (now called the Healthcare Effectiveness Data and Information Set (HEDIS)]. The HOS measure includes physical and mental health outcomes and risk adjustment techniques. In addition to health outcomes measures, the HOS is used to collect the Urinary Incontinence in Older Adults and Physical Activity in Older Adults HEDIS measures (CMS, 2007c). Agency for Healthcare Research and Quality. The AHRQ is the division of the U.S. Department of Health and Human Services charged with coordinating, conducting, and supporting research, demonstrations, and evaluations related to the measurement and improvement of health care quality. The AHRQ mission is "to improve the quality, safety, efficiency, and effectiveness of health care for all Americans" (AHRQ, 2007a, p. 1). AHRQ is charged with disseminating scientific findings about clinical practice guidelines and facilitating public access to information on the quality of health care. AHRQ research provides evidence-based information on health care outcomes; quality; and health care cost, use, and access. The information helps health care decision makers— patients and clinicians, health system leaders, purchasers, and policymakers— make more informed decisions and improves the quality of health care services. Beginning in 2005, AHRQ's "research agenda reflected a shift to emphasize the translation of research into practice" (AHRQ, 2007b, p. 1). Nearly 80% of AHRQ's annual budget of approximately $300 million is awarded as grants and contracts to researchers at universities and other research institutions across the country through its evidence-based practice centers and the National Quality Measures Clearinghouse (AHRQ, 2007c, 2007d). Researchers are funded to conduct systematic, comprehensive analyses, and syntheses of the scientific literature and to develop reports and technology assessments based on the research-supported evidence (i.e., clinical practice guidelines). To ensure that report findings are translated into improvements in clinical practice, AHRQ enlists partners, such as specialty societies and health systems, which use the findings of evidence-based practice centers to develop tools and materials that will improve the quality of care. Centers for Disease Control and Prevention. The CDC is the nation's primary government agency for developing disease prevention and control initiatives and health-promotion and educational activities. In terms of health care quality, it has a particularly important role in the control of nosocomial infection. The DHQP undertakes initiatives in conjunction with other CDC divisions, such as the National Center for Infectious Diseases, when appropriate. The DHQP is charged with protecting patients and health care personnel and promoting safety, quality, and value in the health care delivery system (CDC, 2005a, 2012a). Among the DHQP priorities are the following: ■ ■ Measuring, validating, interpreting, and responding to data relevant to health care outcomes; health care-associated infections/antimicrobial resistance; related adverse events; and medical errors among patients and health care personnel (This priority is addressed primarily through the NNIS system discussed previously in this chapter.) ■ ■ Investigating and responding to outbreaks and emerging antimicrobial-resistant pathogens and infections among patients or associated with the health care environment ■ ■ Identifying and evaluating the efficacy of interventions designed to prevent health care-associated infections or antimicrobial resistance, related adverse events, and medical errors ■ ■ Promoting clinical microbiology laboratory quality. The CDC provides extensive information on infection control guidelines, infectious disease outbreak management, antimicrobial resistance, laboratory practice, sterilization and disinfection, and surveillance. The CDC further offers advice and consultation to health care providers or regional health departments on matters relating to infection control. It also operates a free rapid notification system through which time-sensitive e-mail messages about important health care events (e.g., outbreaks, product recalls) and publications (e.g., new health care guidelines) are sent to persons active in the prevention of health care-acquired infections and antimicrobial resistance. The CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC) is a federal advisory committee made up of 14 external infection control experts who provide advice and guidance to the CDC regarding the practice of health care infection control, strategies for surveillance, and prevention and control of health care associated infections in U.S. health care facilities. One of the primary functions of the committee is to issue recommendations for preventing and controlling health care-associated infections in the form of guidelines, resolutions, and informal communications. HICPAC has issued practice guidelines on the following subjects: environmental infection control in health care settings; hand hygiene in health care settings; intravascular device-related infections; surgical site infections; isolation precautions; nosocomial pneumonia; and CAUTI. Along with the Get Smart for Healthcare: Know When Antibiotics Work Campaign, the CDC has an interagency task force on antimicrobial resistance, which partners with hospitals, state and local health departments, medical and professional associations, health insurers, private industry, continuing medical education organizations, and other health agencies to promote universal adoption of several practice recommendations concerning infection prevention, effective diagnosis and treatment, wise antimicrobial use, and transmission prevention designed to prevent antimicrobial resistance among patients. As part of this campaign, the CDC provides clinicians with information for preventing antimicrobial resistance among specific patient populations (e.g., surgical, children), including fact sheets listing the particular steps that should be taken to prevent resistant infections in targeted populations and materials for distribution to patients with tips on infection prevention. National Institutes of Health. The NIH is a primary source of funding for medical and behavioral research in the United States. An agency under the federal Department of Health and Human Services, the NIH funds a broad array of extramural projects, grants, contracts, and cooperative agreements conducted primarily by universities, hospitals, and other research institutions. Much of the patient-oriented research includes studies into the development of new technologies, human disease mechanisms, therapeutic interventions, and clinical trials. Other clinical research includes epidemiological and behavioral studies, outcomes research, and health services research. The NIH is the source of much funding for clinical outcomes studies that are used for evidence-based medicine and clinical practice guidelines.

APPENDIX B: TIMELINE OF EVENTS IN DEVELOPMENT OF THE U.S. HEALTH CARE SYSTEM, 1763-2015

Timeline of Events in Development of the U.S. Health Care System, 1763- 2015 1763: Physicians petition to allow doctors to found societies with licensing powers. 1798: Edward Jenner publishes his work on developing a vaccine against smallpox. 1813: U.S. Vaccine Agency is established and the U.S. Post Office is required to carry smallpox vaccine material for free. 1847: The American Medical Association is founded. 1854: President Franklin Pierce vetoed a national mental health bill on the basis that it would be unconstitutional to regard health as anything but a private matter in which government should not become involved. 1861- 1865: U.S. Civil War mobilizes a "support army" to care for the wounded, advancing the practice of surgery, nursing, and emergency medicine while establishing new legitimacy for physicians. 1877: Louis Pasteur proposed The Germ Theory of Disease. 1895: X-rays are discovered and almost immediately put into use for medical research and diagnostics. 1900: About six to nine women died per 100 live births and the infant mortality rate averaged around 100 while reaching up to 300 in some U.S. cities. 1900: Bertillon or International List of Causes of Death is adopted (predecessor of International Classification of Diseases [ICD]). 1902: The Biologics Control Act is passed to ensure purity and safety of serums, vaccines, and similar products used to prevent or treat diseases in humans. 1906: Pure Food and Drug Act is passed prohibiting interstate commerce in adulterated and misbranded food and drugs, establishing the forerunner of the Food and Drug Administration. 1910: Flexner Report facilitates new standards for medical schools essentially endorsing AMA standards and practices as standards for medicine. 1920: AMA opposed compulsory health insurance through a resolution by house of delegates. 1929: Blue Cross Plans are established to provide "pre-paid" hospital care. 1930: Blue Shield Plans begin providing reimbursement for physician services. 1930: NIH is established for purpose of discovering the causes, prevention, and cure of disease. 1935: Social Security Act is approved. It does not include compulsory health insurance as a result of AMA influence. 1938: The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 establishes the FDA to oversee the safety of food, drugs, and cosmetics. 1943: Penicillin is mass produced for the first time. 1940- 1944: U.S. businesses begin to offer health benefits as they compete for workers, giving rise to the employer-based systems in place today. 1948: AMA launches a campaign against President Truman's plan for national health insurance; the plan is subsequently defeated. 1951: Durham- Humphrey Amendment establishes a system prohibiting sales of many drugs except under prescription from a physician. 1955: Health insurance coverage grows to nearly 70% from 10% in 1940. 1962: Kefauver- Harris Drug Amendments require drug manufacturers to prove scientifically that a medication is not only safe, but effective prior to marketing. 1965: Medicaid and Medicare are created to ensure access to health care for the poor and elderly. 1973: The Health Maintenance Organization Act is signed into law to encourage the development of competition in the health care market. 1983: Medicare Prospective Payment System replaces the generally "cost-plus" reimbursement model that threatened Medicare's solvency. 1986: Emergency Medical Treatment and Labor Act requires hospitals to provide appropriate medical screening and stabilizing treatment to anyone who presents for care. 1989: New Medicare physician fee schedule replaces previous "customary and usual" rate schedules while Stark Law limits self-referrals. 1996: Health Insurance Portability and Accountability Act establishes that the data within the medical record belongs to the patient, provides for continuity or "portability" of coverage during changes in insurance, and gives mental health the same status as physical health. 2000: U.S. infant mortality rate is 6.89 per 1,000 live births, a nearly 95% decrease since 1900. 2001: The Human Genome Project consortium publishes a 90% complete sequence of all 3 billion base pairs in the human genome, understood to be the blueprint for life. 2006: Massachusetts implements laws to provide health care coverage for nearly all state residents. 2010: Passage of the Patient Protection and Affordable Care Act, which aims to (a) increase access; (b) increase quality; and (c) decrease cost of health care through new regulations and taxes on physicians, hospitals, insurers/payors, drug and medical device companies, and establishes national and state-based health insurance marketplaces modeled after Massachusetts' program. 2015: International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) is implemented (approximately 21 years after WHO developed ICD-10 and 18 years after the National Center for Health Statistics began the first round of testing). 2015: The Medicare Access and Children's Health Insurance Program Reauthorization Act will shift physicians to alternative payment models designed to encourage quality and efficiency.

PREVENTION AND MENTAL HEALTH

■ ■ Mental health, behavioral health, and physical health will be more tightly linked in diagnosis and treatment. ■ ■ There will be continuing interest in prevention in order to control health care costs. This trend also links primary care and public health, in order to foster prevention and to diagnose early. ■ ■ The health care systems will become more oriented toward promoting health in populations (population health).

PARTICIPATION

A major benefit of the proposed system will be the collection of data that essentially have been unavailable, as CDC surveillance systems have been focused on a limited number of facilities and procedures. In the current NNIS system, membership is restricted to only approximately 315 hospitals. Participating hospitals must also meet certain thresholds of bed number and size of infection control staff. Under the NHSN, all bonafide health care delivery entities (participants in the CMSs, members of the American Hospital Association, and Veterans Administration stations) whose practice generates relevant data will be encouraged to participate. Nationwide implementation of the system will be phased in, first being available to existing CDC surveillance participants, then to their affiliates, and finally to all health care entities. Nationwide availability of the system was expected sometime in 2006.

INFORMING CLINICANS

Although using EHRs promotes quality and efficiency in health care settings, few health care organizations and practices in the United States have computerized their medical records as of the writing of this book. Acceptance is growing, and many hospitals, in particular, have or are obtaining EMR systems. However, most small practices still use paper records exclusively. The ONC has identified several reasons for the slow adoption of EHRs among health care organizations and practices, including the cost of hardware, software, and training and disruption of the present workflow. Therefore, one goal of the ONC is to arrange for the investment in EHRs to be shared between clinicians and others in the health care system. The office is exploring financial and nonfinancial incentives for investors. Second, the ONC will certify EHR software vendors to help clinicians choose vendors with standard products. Third, the ONC will develop a strategy to provide access to EHRs in rural and underserved areas.

CONSOLIDATION WITHIN THE HEALTH CARE SYSTEM

Consolidation will be an ongoing theme, continuing the trend of the past 20 years. As the Commonwealth Fund report notes: It seemed like every week in 2015 brought news of a mega-merger between two drug companies, hospital systems, or health insurers. This arms race in market size has attracted scrutiny from regulators and calls for greater antitrust enforcement. Such calls are likely to grow louder in light of new evidence linking high regional private health spending to market concentration, and indications that competition in insurance markets lowers premiums. (Blumenthal & Squires, 2015) Consolidation will take place across three dimensions: ■ ■ Vertical with payers and providers ■ ■ Horizontal with the creation of larger systems ■ ■ Continuum of care from primary care through post acute care

EQUITY AND THE QUALITY OF HEALTH CARE

Is the distribution of quality health care equitable in the United States? An examination of disparities in quality of care suggests that it is not (Fiscella, Franks, Gold, & Clancy, 2000). For example, lower SES is associated with receiving fewer Papanicolaou tests, mammograms, childhood and adult influenza immunizations, and diabetic eye exams. Lower SES is also associated with late enrollment in prenatal care and lower quality ambulatory and hospital care. Racial and ethnic status is linked to quality of care received. Elderly African Americans receive fewer preventive medicine procedures when compared with elderly Whites. African Americans, in general, receive less intensive hospital care, and Hispanic women receive fewer medical procedures and preventive measures as compared to Whites. African Americans have also been found to have higher rates of end-stage diabetic conditions, such as amputations, indicating poor-quality ambulatory care. However, a recent study by the RAND Corporation (Asch et al., 2006) suggests that inequities in health care quality may not be as important as deficiencies in the overall level of quality in the United States. In the RAND study, health care quality differed little between people in different socioeconomic, racial, ethnic, and geographic groups. Rather, the researchers found that health care was mediocre for all groups, equally. The study suggests that disparities in quality of care may be closing, but the overall quality of health care for all Americans needs much improvement. The discrepancy between the RAND study findings and those of previous research had not been resolved at the time this book was written, but it is an important issue that should generate a great deal of research in the future.

QUALITY OF HEALTH CARE

Using the model originally developed by Avedis Donabedian, health care quality is assessed in terms of structure, process, and outcomes (Donabedian, 1980- 1985). "Structure . . . is meant to designate the conditions under which care is provided" (Donabedian, 2003, p. 46). It includes material resources, such as facilities and equipment; human resources, such as number and qualities of professional and support personnel providing health care; and organizational characteristics, such as (for individual facilities such as hospitals) nonprofit status, academic affiliation, and governing structure. Examples of structure-oriented questions are: What is the nurse-to-patient ratio on a hospital floor? What is the age of the facility? What proportion of a hospital's patients do not have insurance, are receiving Medicaid, or are covered by Medicare? Are the physicians in a practice salaried employees or paid on a fee-for-service basis? Process "is taken to mean the activities that constitute health care— including diagnosis, treatment, rehabilitation, prevention, and patient education— usually carried out by professional personnel, but also including other contributions to care, particularly by patients and their families" (Donabedian, 2003, p. 46). For example, a study of health care process might ask the following questions: Is infection control policy followed by the hospital staff? How long does it take for the primary care physician to receive the test results needed for diagnosis? How does the treating physician transmit information about a drug's side effects to the patient? What is the waiting time in the emergency room? How much time does a physician spend with a patient, on average, for an annual physical? What is the standard practice among the physician staff for treating a particular health condition, such as acute myocardial infarction or stroke? Structure and process influence the outcomes, or effectiveness, of health care. For example, each of the structure and process-oriented issues just mentioned may lead to poor health care outcomes, but they are not outcomes in themselves. Outcomes "are taken to mean changes (desirable or undesirable) in the health of individuals and populations that can be attributed to health care" (Donabedian, 2003, p. 46). Generally speaking, there are two types of outcomes used to assess the quality of health care systems: (a) the outcomes of persons who have received care, that is, patients; and (b) population health outcomes, that is, the outcomes of both people who have and people who have not received health care. We begin with population health outcomes and then consider the health outcomes of patients.

SUMMARY

We have discussed health care system performance from the perspective of three recognized criteria: (a) quality of health care, (b) equity of health care, and (c) efficiency of health care. Of the three, we have spent the most time on the quality of health care, mainly because over the past 20 years an increasingly large effort has developed to measure and improve quality at the microlevel. Evaluations of clinical effectiveness and patient safety are based on empirical studies that provide evidence about best practices and are the foundation of clinical practice guidelines. These studies have been well funded, and the practice guidelines that have resulted are increasingly used to evaluate the performance of health care providers— individual providers and organizations. Public as well as private organizations are involved in this effort. Equity in access to and quality of health care, although not a major focus of this chapter, is a major concern to policy makers in the United States. Our history is replete with attempts to make our system equitable by extending health care coverage to all Americans. This history is detailed in the final chapter, but no attempts have been completely successful. The efficiency of the health care system is another area that, although important, has received less attention in this chapter. However, many of the QIs are driven by an equal interest: making our system more efficient. Finally, we have briefly touched on the importance of data for evaluating health care performance. In the area of health information, there is tremendous activity, partially driven by improvements in the technological capability to computerize information. The EMR will be the standard very shortly for all health care providers— individual and institutional—and the digitizing of this information and other information about patients will follow. Again, this development will have a significant impact on the way care is delivered and how easily it is able to be evaluated. Thus, health information systems, too, will affect the work and future of all health professionals.

OBAMA HEALTH PLAN FROM THE CONSUMER PERSPECTIVE

With enactment of the Patient Protection and Affordable Care Act (ACA) of 2010 under President Obama, we have seen comprehensive reform in the U.S. health care system for the first time. Yet, consistent with the American context discussed in Chapter 7, the overhaul of the health care system maintains the mixed public and private system. All previous private-sector participants in health care delivery are present, even though governmental involvement has been expanded through mandates on individuals, employers, health insurance companies, health care providers, including physicians, hospitals, and long-term care facilities, as well as pharmaceutical companies. An example of the reach of the bill's mandates is the overall approach to expanding access to health care coverage: Require most U.S. citizens and legal residents to have health insurance. Create state-based American Health Benefit Exchanges through which individuals can purchase coverage, with premium and cost sharing credits available to individuals/families with income between 133- 400% of the federal poverty level (the poverty level is $18,310 for a family of three in 2009) and create separate Exchanges through which small businesses can purchase coverage. Require employers to pay penalties for employees who receive tax credits for health insurance through an Exchange, with exceptions for small employers. Impose new regulations on health plans in the Exchanges and in the individual and small group markets. Expand Medicaid to 133% of the federal poverty level. (Kaiser Family Foundation, 2011, p. 1) In addition, there has been an expansion of the public programs— Medicaid and SCHIP— under the ACA, as well as creation of state-based health insurance exchanges— American Health Benefit Exchanges and Small Business Health Options Program (SHOP) Exchanges— that will be "administered by a government agency or nonprofit organization through which individuals and small businesses with up to 100 employees can purchase qualified coverage" (Kaiser Family Foundation, 2011). Therefore, we can say that today public-sector involvement in the health care delivery system is substantial, although the private sector is as well.

COMPLEMENTARY MEDICINE

A tremendous amount of out-of-pocket money is being spent by Americans each year on complementary or alternative medical care, that is, nonallopathic medicine. A growing trend in hospitals is to add complementary medical therapies to their offerings. These include acupuncture, massage therapy, guided imagery for stress reduction, pet therapy, and music/art therapy. As hospitals elbow one another to attract patients, increasingly they're hoping to tap into Americans' interest in— and willingness to spend money on— complementary and alternative therapies such as acupuncture and massage. According to a recent survey by the American Hospital Assn. and the Samueli Institute, a nonprofit research group focusing on complementary medicine, 42% of the 714 hospitals that responded offered at least one such therapy in 2010; five years earlier, only 27% of hospitals offered such treatments. Experts say hospitals are embracing these therapies for many reasons, including a growing recognition that some integrative therapies, as they're also called, are very effective in certain instances. In addition, hospitals aren't blind to the opportunity these therapies present to attract patients and perhaps make some money. According to the most recent report from the National Center for Health Statistics, Americans spent $33.9 billion on integrative therapies in 2007— with most of the money coming out of their own pockets, since the majority of these treatments aren't covered by insurance. That figure includes fees for about 354 million visits to complementary and alternative medical practitioners, and it represents about 11% of total out-of-pocket expenditures on health care. (Andrews, 2011)

HOSPITAL VERSUS AMBULATORY CARE

AHA Environmental Scan 2011 , projects that in the future: There will be widespread use of ambulatory, home and community care in place of traditional inpatient services and expanded use of new communication and monitoring techniques. Medical devices have become more portable and sophisticated, making it possible to treat and monitor chronic conditions outside the hospital. A significant number of devices including infusion pumps, ventilators and wound care therapies are now being used for home care. Given the growing number of home medical devices, the Food and Drug Administration plans on developing procedures for makers of home-care equipment. Procedures will include post- marketing follow-up and other things that will encourage the safe use of these devices. (AHA, 2011)

EQUITY OF HEALTH CARE

Equity is the second criterion used to evaluate the performance of health care systems. Equity or distributive justice is concerned with the fair allocation of benefits and burdens among those who are deserving of care and those who are in a position to pay for it— the two groups may or may not be the same (Aday et al., 1993, p. 120). We are concerned about inequities in access to health care as well as inequities in the quality of health care— as measured and evaluated by standards established for structure, process, and outcomes. We use disparities in access and quality of health care to indicate inequity. The factors that are consistently associated with inequities in health care access and quality are socioeconomic status (SES), race and ethnicity, and geographic location. We find in study after study that people with low income, low education, and low-status occupations; people belonging to minority racial and ethnic groups, particularly African American and Hispanic; and people who live in rural areas or inner cities are more likely to have poor access to care and poor-quality health care (Institute of Medicine, 2003).

DATA AND INFORMATION TECHNOLOGY

Every major organization with an interest in health care performance recognizes the need for better data in order to benchmark the current situation and then determine whether improvements have occurred in quality, access and equity, and cost and efficiency. These organizations include the payers for health care, such as the Medicaid and Medicare programs and private health insurance companies; providers of health care, including hospitals; private foundations, such as the Robert Wood Johnson Foundation, with a focus on health policy; the public- private partnerships such as the NQF and JCAHO; and many consumer groups such as Consumers Union, which has an interest in nosocomial infection control. It is generally agreed, as Hanrahan and his colleagues write, "Proper functioning of health care systems requires an advanced health information network that supports clinical care, personal health management, population health, and research. But this infrastructure does not yet exist in the United States" (Hanrahan, Foldy, Barthell, & Wood, 2006, p. 16). The health information systems needed to evaluate performance are both internal to health care organizations and external between health care organizations. The latter are called regional health information organizations or RHIOs. The electronic medical record (EMR) or electronic health record (EHR) is one of the basic sources of data for internal health information systems, as well as for RHIOs, but both types of systems will include other data as well. These systems will be used to (a) conduct clinical outcomes studies; (b) measure population health outcomes, such as morbidity and mortality rates for regions, states, and the nation; (c) design and evaluate interventions to improve clinical practice; and (d) increase access, equity, and efficiency.

POPULATION HEALTH OUTCOMES

Health outcomes can be measured at the population level and used to evaluate the quality of a health care system (Kindig, 1997). Population health indicators include population mortality and morbidity rates. These are used in macrolevel performance evaluations of regions, states, and nations. We assume the impact of health care on these rates even though we are not directly measuring use of health care among the population considered. If, for example, a disease-specific mortality rate is higher in one region than another, we assume that the health care system has not been optimal in the region with the higher mortality rate. Historically, population health indicators have been age-adjusted death rates, disease-specific death rates, life expectancy, premature death rate, time lost to prema ture death, and infant mortality rate (IMR). 1 The United Nations International Children's Emergency Fund (UNICEF) defines IMR as the probability of dying between birth and exactly 1 year of age (UNICEF, 2006). This rate is expressed per 1,000 live births per year. IMR is an important measure that indicates the well-being of infants, children, and pregnant women, as it is associated with maternal health, quality, and access to care, and public health in a given population. Life expectancy is defined by the World Health Organization (WHO) as the number of years of life that can be expected, on average, in a given population. Using life expectancy, the premature death rate can be calculated. The premature death rate is the death rate for persons who die before the expected age of death for that population. The time lost to premature death, also called years of potential life lost (YPLL), is based on the difference between the actual age at death and the expected age at death. Deaths at a younger age are weighted more heavily in the YPLL, providing an indicator of the severity of premature death's impact on the population (WHO, 2012a). A more recent concept of population health takes into account quality of life. Healthy life expectancy (HALE) at birth is defined by WHO as the "average number of years that a person can expect to live in 'full health' by taking into account years lived in less than full health due to disease and/or injury" (WHO, 2012c, p. 1). HALE is a measure that combines length and quality of life into a single estimate that indicates years of life that can be expected in a specified state of health (Kindig, 1997, p. 45). Other health-adjusted life expectancy measures are quality-adjusted life years (QALYs), which emphasizes the individual's perceived health status as the indicator of quality of life; disability-adjusted life years (DALYs), which combines mortality and disability measures; and years of healthy life (YHL), which combines perceived health and disability activity limitation measures from the National Health Interview Survey (Kindig, 1997). Health outcomes can be measured at the population level and used to evaluate the quality of a health care system (Kindig, 1997). Population health indicators include population mortality and morbidity rates. These are used in macrolevel performance evaluations of regions, states, and nations. We assume the impact of health care on these rates even though we are not directly measuring use of health care among the population considered. If, for example, a disease-specific mortality rate is higher in one region than another, we assume that the health care system has not been optimal in the region with the higher mortality rate. Historically, population health indicators have been age-adjusted death rates, disease-specific death rates, life expectancy, premature death rate, time lost to prema ture death, and infant mortality rate (IMR). 1 The United Nations International Children's Emergency Fund (UNICEF) defines IMR as the probability of dying between birth and exactly 1 year of age (UNICEF, 2006). This rate is expressed per 1,000 live births per year. IMR is an important measure that indicates the well-being of infants, children, and pregnant women, as it is associated with maternal health, quality, and access to care, and public health in a given population. Life expectancy is defined by the World Health Organization (WHO) as the number of years of life that can be expected, on average, in a given population. Using life expectancy, the premature death rate can be calculated. The premature death rate is the death rate for persons who die before the expected age of death for that population. The time lost to premature death, also called years of potential life lost (YPLL), is based on the difference between the actual age at death and the expected age at death. Deaths at a younger age are weighted more heavily in the YPLL, providing an indicator of the severity of premature death's impact on the population (WHO, 2012a). A more recent concept of population health takes into account quality of life. Healthy life expectancy (HALE) at birth is defined by WHO as the "average number of years that a person can expect to live in 'full health' by taking into account years lived in less than full health due to disease and/or injury" (WHO, 2012c, p. 1). HALE is a measure that combines length and quality of life into a single estimate that indicates years of life that can be expected in a specified state of health (Kindig, 1997, p. 45). Other health-adjusted life expectancy measures are quality-adjusted life years (QALYs), which emphasizes the individual's perceived health status as the indicator of quality of life; disability-adjusted life years (DALYs), which combines mortality and disability measures; and years of healthy life (YHL), which combines perceived health and disability activity limitation measures from the National Health Interview Survey (Kindig, 1997).

CLINICAL OUTCOMES

Health outcomes that are specific to the persons who receive care are often called clinical outcomes . We frequently use the following outcome measures in studies of health care quality among patients: readmission to the hospital after a surgical procedure; functional capacity after medical intervention; long-term pain and discomfort after medical treatment; infection acquired during a hospital stay (nosocomial); 5-year mortality rates among patients treated for cancer, heart disease, or other diseases; development of comorbidities after medical therapy; and satisfaction of the patient with the outcomes of health care treatment. Clinical outcomes research is the term given to studies that focus on the persons who receive care (patients) and the outcomes of their treatment. Following is a discussion of health care quality at the microlevel of clinical outcomes. We examine two aspects related to microlevel evaluation of health care quality: clinical effectiveness and patient safety.

FOR-PROFIT VERSUS NOT-FOR-PROFIT

Much of the controversy surrounding health care delivery reorganizations, such as introduction of MC, and the creation of large, integrated health systems concerns profit-making and its compatibility with the provision of quality, efficient, and accessible health care. For example, a prediction of the effects of MC as it has evolved made by health policy analyst Victor Fuchs (2002) was rather grim: The announcement that most of the nation's biggest insurers— Aetna, CIGNA, Humana, the United Health Group, and WellPoint Health Network— will be introducing a new kind of health plan during the next year or two signals the beginning of a new era in health insurance in the United States. These plans feature a complicated menu of premiums, co-payments, and deductibles that will add impetus to the trend of employers offering a defined [monetary] contribution for health benefits. . . . One of their major effects will be to shift the burden of health care costs from employees who use little care to those who use more. Thus, the new plans will be another nail in the coffin of health insurance as a form of social insurance. (p. 1822) As Randel, Pearson, Sabin, Hyams, and Emanual (2001) put it, in terms that still apply: The growth of managed care in the United States has been paralleled by a rising tide of anti- managed care sentiment. The "managed care problem" is understood generally as the need to protect individuals against large companies that care more about their bottom line than about people. (p. 44) As noted in the quote from Koop (1996; certainly no radical reformer) at the beginning of this chapter, it is the question of for-profit versus not-for-profit health care, not just MC. It is the question of whether having the health care delivery system become a major profit center for corporate America (the insurance industry) is healthy (in a variety of senses) for America and Americans. It is the issue at the center of virtually every other health care issue related not only to MC but to the future of the health care delivery system as a whole. The question is not a moral one. It is a functional one. Can a profit-making system and the so-called free market solve the myriad problems of the U.S. health care delivery system, as spelled out earlier in this chapter and elsewhere in this book? Because the focus of a for-profit system must be on profits, by definition, and because the solution of so many of the problems not only cannot generate profits but also would cost considerable sums of money, the answer would appear to be no. Therefore, we turn to a consideration of health care reform.

OFFICE OF THE NATIONAL CORRDINATOR FOR HEALTH INFORMATION TECHNOLOGY

Perhaps the most influential health information initiative is that of the Office of the National Coordinator for Health Information Technology (ONC) located in the U.S. Department of Health and Human Services. The ONC has four sequential goals: informing clinicians, interconnecting clinicians, personalizing health care, and improving population health (U.S. Department of Health and Human Services, 2006). The ONC initiative in health information includes a great deal of private-sector reliance on developing communication standards, software, hardware, and training for those who will use the system.

A HEALTH INFORMATION EXAMPLE: NATIONAL HEALTHCARE SAFETY NETWORK

The CDC developed an Internet-based data collection and information retrieval system called the National Healthcare Safety Network (NHSN) that became available in 2005. This network is an expansion and enhancement of current surveillance and monitoring capabilities, and once implemented will replace three existing CDC surveillance systems: NNIS, the National Surveillance System for Health Care Workers, and the Dialysis Surveillance Network (CDC, 2005b). The goal is to create a common interface web-based system for accumulating, exchanging, and integrating relevant information and resources among stake holders, in an effort to support local efforts to promote patient safety. The two main aspects of the network are reporting of adverse events— including nosocomial infections— and disseminating information on preventing such events. Ultimately, the CDC aims to work with other public health agencies to create a national system integrating data from a variety of surveillance systems into a national aggregate data repository through which health care providers and federal, state, and private stakeholders can exchange data and retrieve information. In the beginning, however, the system will be restricted to providers submitting data in the areas currently covered by the three systems identified earlier, with the CDC acting as the central repository.

INTERCONNECTING CLINICANS

The ONC initiative is based on patient records, and the second goal of the initiative is to provide access to patient health information in any health care setting, any place in the United States: The current practice of using separate paper files for one patient in multiple clinical settings is limiting and can compromise the quality of health-care received. Conversion to an EHR system is necessary but not sufficient to solve the portability problem. That's because each clinician or medical practice may purchase an EHR system from different vendors, which may not be compatible with one another. Unless EHR systems can communicate, they are simply islands of data where patient information does not flow seamlessly from one clinical setting to the next. Without clinicians' ability to exchange information with one another electronically, whether it is across town or across the country, patients' information may not be readily available when and where it is needed. To remedy this, an interoperable system based upon a common architecture must be developed. Patient records would then be available electronically virtually anywhere in the country. (DHHS, 2006, p. 1) The ONC strategy to create a national health care information network that can be accessed by any health care provider is to foster the development of RHIOs; develop a common set of communication standards to be used by the RHIOs through a National Health Information Network (NHIN); and apply the same standards as developed for the private health care sector to government-run health care.

PERSONALIZING HEALTH CARE

The ONC's third goal is to equip patients to participate actively in their own health care and in health care decision making through the development of a national health information system. Innovations in technology are emerging to give patients electronic access to their health record and the ability to gather specific information tailored to their illnesses, chronic conditions and health characteristics. Widespread adoption of these innovations, via a concept known as a Personal Health Record (PHR), will revolutionize consumer health care decision-making. (DHHS, 2006, p. 1) The ONC's strategy for facilitating patient participation in their own health care involves promoting the use of PHRs, stimulating informed consumer choice, and encouraging the use of telehealth systems to improve the quality and cost-effectiveness of health care in rural and underserved areas. The PHR is an electronic application through which individuals can maintain and manage their health information (and that of others for whom they are authorized) in a private, secure, and confidential environment . . . . For example, a PHR can be used to effectively synthesize an abundance of health information and tailor it to a patient's specific needs. (DHHS, 2006, p. 1) In order to stimulate informed consumer choice, the ONC supports providing patients or potential patients with information about the quality of their health care providers and organizations and the clinical effectiveness of treatments. The ONC supports and will promote "efforts in the federal government and elsewhere to develop useful clinical performance measures in hospitals, nursing homes, home health agencies, and other settings of care."

POPULATION HEALTH

The ONC's third goal is to equip patients to participate actively in their own health care and in health care decision making through the development of a national health information system. Innovations in technology are emerging to give patients electronic access to their health record and the ability to gather specific information tailored to their illnesses, chronic conditions and health characteristics. Widespread adoption of these innovations, via a concept known as a Personal Health Record (PHR), will revolutionize consumer health care decision-making. (DHHS, 2006, p. 1) The ONC's strategy for facilitating patient participation in their own health care involves promoting the use of PHRs, stimulating informed consumer choice, and encouraging the use of telehealth systems to improve the quality and cost-effectiveness of health care in rural and underserved areas. The PHR is an electronic application through which individuals can maintain and manage their health information (and that of others for whom they are authorized) in a private, secure, and confidential environment . . . . For example, a PHR can be used to effectively synthesize an abundance of health information and tailor it to a patient's specific needs. (DHHS, 2006, p. 1) In order to stimulate informed consumer choice, the ONC supports providing patients or potential patients with information about the quality of their health care providers and organizations and the clinical effectiveness of treatments. The ONC supports and will promote "efforts in the federal government and elsewhere to develop useful clinical performance measures in hospitals, nursing homes, home health agencies, and other settings of care."

IMPACT OF NEW TECHNOLOGY

The continual pursuit of improved quality and efficiency in the health care system will drive application of technological innovations and policy changes. Technological improvements will continue to address cost or cost and quality. ■ ■ Automation will start to take hold— starting with eliminating lower level jobs like phlebotomists and coders while accelerating/supplementing higher level jobs like RN and physicians, for example, through computer-assisted diagnosis, computer-assisted documentation, and continuous patient assessments. ■ ■ Genomics and proteomics will lead to increasingly personalized treatments and protocols in the short term and begin to revolutionize the approach to medicine and health in general over longer time periods. ■ ■ We will start growing what we used to manufacture. This is already happening with knee implants. ■ ■ We will start injecting stem cells, nanobots, or other biologics to regrow new body parts and replace surgery. ■ ■ Medical devices and drugs will become so personalized that they will need to be evaluated like a medical procedure— effectiveness of an approach rather than a particular chemical compound or manufactured device. ■ ■ Shorter term new technology and understanding will allow more "site of service" optimization: hospital -> outpatient -> home care -> telemedicine.

ORGANIZATIONS WITH MAJOR INFLUENCE ON HEALTH CARE QUALITY

The following section describes the efforts of public and private organizations to improve the quality of health care in the United States. These efforts are increasingly collaborative. Many businesses that pay for the health care of their employees have banded together. Public initiatives are increasingly coordinated. And, private- public partnerships have developed. However, it is difficult to say which organizations are the most influential. Clearly, The Joint Commission and the Centers for Medicare & Medicaid Services (CMS), as one of the largest payers of health care services in the country, are extremely influential. However, private organizations and other public agencies have very important roles, as well. The impact of these significant efforts on the quality of U.S. health care is yet to be determined.

Major features of the Obama Health Plan

The main features of the bill include (Davis, 2010, pp. 5- 7): New federal insurance market rules that prohibit restricting coverage or varying premiums based on health, set limits on the share of private premiums going for nonmedical costs, and establish essential standard benefit packages that guarantee beneficiaries a comprehensive array of services with limits on levels of cost-sharing. New health insurance exchanges that will more efficiently pool risk, lower administrative costs, and provide eligible individuals and small businesses a choice of affordable health plans. Affordability provisions for lowand middle-income families , including an essential standard benefit package, premium assistance on a sliding scale up to four times poverty income (about $88,000 for a family of four), and expansion of Medicaid eligibility up to 133% of the federal poverty level (almost $30,000 for a family of four). A commitment to shared responsibility that preserves employer-sponsored insurance, provides health insurance tax credits to small businesses, assesses a contribution from larger businesses whose employees receive government-financed premium subsidies, and requires that individuals have coverage. Improvements to Medicare prescription drug benefits , including $250 rebates for seniors falling into the "doughnut hole" in 2010 and elimination of that coverage gap by 2020. Creation of a new long-term care financing program to support community living for the disabled. Investment in a stronger primary care foundation , one that includes increases in payment for primary care under Medicare and Medicaid, incentives for practices to organize as patient-centered medical homes providing more accessible and coordinated care, and investment in primary care training and expansion of community health centers and the National Health Service Corps. Establishment of an innovation center within the Centers for Medicare & Medicaid Services to rapidly test and spread effective payment methods that reward quality of care, rather than volume of services. Additional payment and system reform provisions encourage accountability for patient outcomes and use of medical resources, and provide incentives for productivity improvement. Creation of an Independent Payment Advisory Board with the authority to make recommendations for reducing cost growth and improving quality in both the Medicare program and the health system as a whole. Investment in the infrastructure required for a high-performance health system , including publicly reported information on quality, cost, and performance of providers and insurers; use of modern information technology in medical care and health insurance; and national strategies and policies on disease prevention, public health, quality, safety, and the health care workforce.

EFFICIENCY AND QUALITY OF HEALTH CARE

The organization of U.S. health care delivery evolved over the 20th century from solo practices and single hospitals to vertically and horizontally integrated health care delivery systems that may provide ambulatory, inpatient, long-term care, and home health care, as well as health insurance. The organizational changes described in this chapter have been prompted by the wish to improve the efficiency of health care delivery and the coordination of care. The form they have taken is again uniquely American in the mix of private and public involvement.

SURVEILLANCE AND DATA COLLECTION

The system will be divided into various adverse event modules, including d evice-associated adverse events, procedure-associated adverse events, and medication-associated adverse events. The infection data collected will be similar to that collected through the NNIS, but with important differences. Device-Associated Module. Currently, in the intensive care unit and high-risk nursery components of the NNIS system, data are collected on incidence rates and distributions for infections at all sites. In the NHSN system, infection data will initially be collected only for CLABSIs, catheter-associated urinary tract infections, ventilator- associated pneumonia, and infections related to dialysis treatments. Although data on fewer infection sites will be collected under the new system, surveillance will not be limited to the ICU and HRN only. Facilities may also choose to collect and report device-associated infection data for specialty care units, other wards, long-term care facilities, and home therapy. This will provide further flexibility in selecting the event and population under surveillance so that facilities may better tailor surveillance activities to their particular needs. Procedure-Associated Module. Data will be collected on inand outpatients undergoing NHSN-defined operative procedures. Under NHSN, seven more categories of procedure are covered than under NNIS, and whereas in the NNIS system information only on surgical site infections is collected, under the NHSN information on other surgical complications will also be collected. Further, the data collection protocols being designed for the NHSN will allow for more robust information on infections in surgical patients, including the ability to link bloodstream infections, pneumonia, and urinary tract infections occurring after an operative procedure to the procedure and the ability to monitor— by type of operation— procedure-associated pneumonia regardless of whether a ventilator is used. Medication-Associated Module. Antimicrobial resistance and antibiotic prescription monitoring will remain essentially unchanged in the transition from current surveillance activities to the NHSN.

DATA ANALYSIS AND FEEDBACK

The web-based system and central data repository being designed for the NSHN will allow participants to share data in a timely manner between users and public health agencies as well as among users (e.g., a multihospital system). The system will include data analysis wizards and statistical calculators, which will allow facilities (or groups of facilities) to generate custom reports, line lists, tables, graphs, and control charts easily. The ready availability of customizable internal and comparative analysis of infection rates is designed to facilitate the ability of health care providers to engage in continuous performance improvement. The system will also include a repository of prevention tools, lessons learned, and best practices. It is also designed to provide automatic feedback, including alerts for selected adverse events or near misses, identifying sentinel events that require an immediate response and need for root cause analysis, and identifying unusual events that might signal a preventable threat to patient safety.