Welcome to Value-Based Care, Regulatory Environment. This is lecture a, this lecture will provide you with an overview of some of the problems facing US healthcare today. Much of the focus will be on describing concerns with healthcare quality and healthcare spending. In addition, the lecture will outline policy recommendations that seek to improve quality and reduce spending. The objectives for this lecture, rationale for reform, are to describe the state of healthcare quality in the United States. Describe reasons for growth in healthcare spending, and describe policy recommendations to improve healthcare quality and reduce spending. The Institute of Medicine now known as the National Academy of Medicine which is a part the National Academy of Sciences, established the quality of healthcare in America project in June 1998. The project and it's working committee were charged with reviewing and synthesizing findings in the literature on the quality of care in the United States, and developing a policy framework to guide develop strategies to improve care. The quality of healthcare committee delivered to landmark reports. The first report produced in 1999 called to err is human reviewed the evidence of safety issues and quality concerns that had been produced at that point in time. Crossing the quality chasm, the second report, provides a road map for system redesign. The focus on healthcare system redesign really began with these two reports. The quote on the screen from the chasm report very nicely summarizes the quality concerns that efforts and system redesign and the new models of care delivery are intended to address. The crossing the quality chasm report, was spurred on in part by prior reports. The first report, mentioned earlier, called to err is human provided substantive evidence of quality problems. An oft quoted number from this report is that at least 44,000 Americans die in hospitals each year because of preventable medical errors, and that this number could be as high as 98,000. A report produced by the president's advisory commission on consumer protection and quality in the healthcare industry, noted that there are several kinds of errors. This report summarized the research literature from around the 1990s and concluded that, at that time, there was no guarantee that patients would receive high quality care. And report noted that there are four kinds of errors. Avoidable errors include missed or delayed diagnosis perhaps due to mistakes and interpreting laboratory reports, it also includes medication errors. Under utilization of services occurs when the patient did not receive a service or the benefits likely exceed the risks. Underuse can lead to limitations in functioning and quality of life, or perhaps even lead to death. Overuse of services happens when a service is provided to a patient that poses significantly greater risks than the benefit to a patient. Finally, research documents wide variation in healthcare practice across regions, within smaller areas in a specific region, and across subgroups of individuals. Aside from the harm that can come to patients, medical errors and poor quality care have significant financial implications. The to err is human report estimated that at the time, national costs of adverse events were around $38 billion and preventable adverse events, or about $17 billion. This was about 4% of national health expenditures in 1996. The recognition of the amount of money being spent, all quality was still sub-optimal, lead to more interest in new models of care that could address both quality and cost. In 2011, the Commonwealth Fund surveyed 18,000 adults, 18 years and older, in 11 countries including the United States. Adults were considered sicker if they rated their health as fair or poor. Reported receiving medical care for serious chronic illness, injury, or disability, had surgery or had been hospitalized in the past two years. The 11 countries are considered high income, that is, they look a lot economically like the United States. As this slide shows, sicker adults in the U.S. are more likely to report a medical error compared to adults in the other countries. The quality chasm report provides some underlying reasons for poor quality of care. Healthcare is a complex, highly technical industry. Medicines knowledge-based as well as the number of drugs, medical devices and other technologies has grown exponentially. No nurse, doctor, pharmacist or other healthcare professional can acquire or retain all the knowledge and evidence necessary for sound decision making. We are also living longer and living longer with chronic long-term conditions. Treating chronic conditions can require collaborations across a variety of healthcare professionals and healthcare organizations, and this brings us to the third bullet on the slide. Our healthcare delivery system is not well organized to work with individuals with chronic disease. Episodic care systems are designed to cater to acute conditions rather than long-term chronic diseases. The delivery system is comprised of a variety of public and private care organizations and financing and insurance mechanisms. A patient with a chronic condition may see multiple providers who do not interact with each other. The fragmented system also results in a lack of accountability for patients and their outcomes. In addition, in the late 1990s the U.S. lagged behind other countries in the use of information technology, such as, electronic medical records. One problem is that the EMR systems, even today, have difficulty exchanging information across providers because of the lack of interoperability. This means that similar systems from different vendors, or sometimes different systems from the same vendor, cannot communicate with each other. For example, a 2010 article by O'Malley and colleagues. In the journal of general internal medicine noted that primary care physicians, reported that EMRs are not able to support coordination between clinicians and practice locations, because there was a lack of standardization of key data elements across the various systems. As reported by the Commonwealth Fund in 2011, the percent of primary care providers in the US who reported using electronic medical records was behind that of doctors in other countries Although this is improving, these problems can lead to an increased likelihood of medical errors and poor quality of care. In addition to concerns about health care quality and patient safety, the US health care system is very expensive and sometimes very difficult to access. Let's discuss health care cost a bit. The Kaiser Family Foundation analyzed the national health expenditure data from the Centers for Medicare and Medicaid Services, or CMS. The Kaiser Family Foundation concluded that this graph shows that health spending totaled $74.9 billion in 1970. By 2000, when those quality reports from the IOM emerged, health expenditures had reached $1.4 trillion. And in 2013, the amount spent on health had doubled to $2.9 trillion. Total health expenditures represent the amount spent on health care and health related activities, such as administration of insurance, health research, and public health, including expenditures from both public and private funds. The Kaiser Family Foundation also produced this graph, that shows that the proportion of the economy that is devoted to health has also been increasing over time. As they said, in 1970, the US devoted 7% of its gross domestic product to total health spending, both through public and private funds. By 2001, this represented 13%. And in 2013, the amount spent on health had increased to 17% of GDP. There are numerous reasons for the increase in health care spending, including some of the issues we discussed earlier. Increasing use of technology and pharmaceutical therapies, the aging of the population. Along with the rise and the prevalence of chronic disease, medical errors and patient safety concerns. Suboptimal quality health care and a complicated delivery system hampered by waste and fragmentation. Another underlying problem with US health care is that many people have a difficult time getting access to health care. According to Healthy People 2020, the nation's set of objectives for improving the health of Americans, access to health services means the timely use of personal health services to achieve the best health outcomes. In order to have access, individuals must gain entry to the health care system. Find and locate a place where health care services are provided, and find a health care provider with whom the patient can communicate and trust. Healthy People notes that health care access is unreliable, and is so because not everyone has the financial means to pay for health care. The lack of availability of providers in certain areas and specialties, and not being able to get a timely appointment, or to obtain specific tests and treatment in a timely manner. One issue of concern is that only 77% of people have an identified usual primary care provider, or PCP. PCPs are important because they help patients integrate care across providers, and increase the likelihood that patients will receive appropriate care. Some of the new delivery models are designed to help improve health care access. We will now discuss the findings of the Crossing the Quality Chasm report. The IOM, in its Crossing the Quality Chasm report, provided six aims for transforming the US health care system. Health care should be safe. That is, it should avoid injuries to patients from care that is intended to help. Effective, and provide services based on scientific knowledge to all who can benefit, and avoid providing services to patients who will likely not benefit. Patient-centered, which means providing care that is respectful and responsive to individual patient preferences, needs, and values. Timely, that is, waits and harmful delays should be reduced for those who receive and give care. Efficient, reducing waste and unnecessary cost. Equitable, which means providing care that does not vary in quality because of personal characteristics such as ethnicity or socioeconomic status. The IOM was quite high reaching in its recommendations by calling all organizations in health care to adopt these aims, and to work toward reducing the burden of illness in the United States. In addition, the report called on Congress to authorize and appropriate funds to track and monitor national progress toward these aims. These six aims very clearly address the quality, cost, and access problems we discussed earlier. Donald Berwick, in a 2002 article for the journal Health Affairs, reviewed the Quality Chasm report, and summarized the aims for improvement and overarching recommendations into four levels of interest. The first two areas address patients and microsystems of care. According to Berwick, changes need to occur that will focus on patient experiences and need to be patient-centered. >> A good definition of patient-centered care comes from another article by Dr. Berwick. Where he defines such care as the experience, to the extent the informed individual patient desires it, of transparency, individualization, recognition, respect, dignity, and choice in all matters. Without exception related to one's person, circumstances, and relationships to health care. The next area for change is within health care organizations. According to Berwick, health care organizations must assure that they find and adopt best practices in clinical delivery. Information technology is use to improve access to information and data, and to aid in clinical decision making. Improvements are made in workforce knowledge and teamwork. There is better coordination among services and settings within and across settings of care, within and external to the organization. And sophisticated and valid approaches of measuring performance and outcomes of care are utilized. Berwick also addresses the health care environment, which includes health system financing, regulation, accreditation, litigation, education and social policy. The regulations and legislation leading to new models of care adopt these principles of improving patient experiences with care or focusing on patient-centered care. Reducing fragmentation, improving care coordination, and holding organizations accountable for the quality of care they deliver to patients And their outcomes of care. In 2007, the Institute for Healthcare Improvement, which was led by Dr. Berwick, proposed and promulgated The Triple Aim for improving the healthcare system. The Triple Aim refers to improvements in patient experiences with care including quality and satisfaction, improving the health of populations and reducing the per capita cost of care. Work on these three improvements needs to occur simultaneously and across organizations. The National Quality Strategy or NQS was mandated by the Patient Protection and Affordable Care Act, otherwise known as the ACA and is updated annually. The three aims for the NQS mirror those promulgated by the IHI Triple Aim. NQS has three broad aims that are used to guide local state and national efforts to improve quality. Better care, to improve overall quality by making healthcare more patient centered, reliable, and safe Healthy people, healthy communities. Improving the health of the US population by supporting proven interventions to address behavioral, social and environmental determinants of health, as well as high quality care. Affordable care to reduce the cost of quality health care for individuals, families, employers and government. The NQS is operationalized through a series of priorities and strategy levers. The priorities include making care safer by reducing harm caused in the delivery of care, insuring that each person and family is engaged as partners in their care. Promoting effective communication and coordination of care. Promoting the most effective prevention and treatment practices for the leading causes of mortality starting with cardiovascular disease. Working with communities to promote wide use of best practices to enable healthy living. Making quality care more affordable for individuals, families, employers and governments by developing and spreading new health care delivery models. Levers represent the core business functions organizations can use to pursue improvement. Recall the slide on Levels of Change that illustrated Don Berwick's suggestions for needed changes micro-systems and organizations work two of the levels of change. The levers, provide guidance for organizations and businesses who are working to align with the NQS. Organizations can provide performance feedback to plans and providers to improve care. Publicly compare treatment results, costs, and patients experience for consumers. Provide learning and technical assistance and foster learning environments that offer training, resources, tools and guidance to help organizations obtain quality improvement goals. Seek certification accreditation and regulation and in doing so adopt or adhere to approaches to meet safety and quality standards. Health consumers adopt healthy behaviors and make informed decisions through the use of consumer incentives and planned benefit designs. Reward and incentivize providers through payments to deliver high quality patient centered care. Improve communication, transparency and efficiency for a better coordinated health and healthcare through the use of health information technology. Foster innovation and diffusion in healthcare quality improvement and facilitate rapid adoption within and across organizations and communities. Invest in people to prepare the next generation of health care professionals, and support life long learning for providers. The NQS website includes more information on this national effort, including reports from federal agencies on how they are using these levers within these organizations to improve quality and outcomes. The NQS sets a framework for the nation to follow and encourages alignment of existing quality improvement strategies. For example, the existing quality improvement organization or QIO program. Has become an integral part of the NQS by seeking to improve the quality of care provided to Medicare beneficiaries. Ensuring that Medicare pays only for reasonable and necessary services and by addressing individual patient complaints. QIOs are comprised of a group of health and quality experts. In addition to ensuring alignment with existing systems, the NQS provides a road map for delivery system reports that support improvement in quality of care. This includes the development of new payment models that are designed to improve quality and reduce cost. The NQS also encourages the development and use of reliable and valid quality measures in order to track quality improvement activities. The US Department of Health and Human Services coordinates this process. And in 2015, convened a measurement policy council to evaluate current measures, create a consensus around the core group of measures for high priority areas, and foster future measurement development. In its 2015 report to Congress, the US Department of Health and Human Services reported that the measurement council had reviewed nine topics so far. Including some common and/or serious conditions, such as hypertension control, obesity BMI, smoking secession, depression screening, and HIV/AIDS. They also addressed care processes such as hospital acquired conditions and patient's safety, as well as perinatal care. Finally, they advocated the use of the survey known as HCAHPS, Hospital Consumer Assessment of Healthcare Providers and Systems. This concludes Lecture a of Regulatory Environment. By the beginning of the turn of the century, there was strong recognition that current ways in which the delivery system was organized were not sustainable. In this lecture, we provided an overview of the quality, cost and access issues associated with US health care, and noted that care can be sub-optimal and unsafe. Healthcare access can be unreliable, costs are high, and consuming a significant proportion of the GDP. And the delivery system is fragmented, information technology and the use of electronic health records can help reduce fragmentation. However, the country is just beginning to capitalize on this potential. We also described three frameworks or road maps for solving some of the problems facing US health care. The three frameworks are very similar and emphasize providing better care for individuals and populations while paying more attention to the cost of care. The National Quality Strategy, or NQS provides a guide for the nation's quality improvement activities both in the public and private sectors.