1.3: Quality, Safety, Cost and Value

Improve health care quality, safety, cost and value.

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In the future, American health care will be shaped into a system in which doctors and hospitals succeed by providing the best value for their patients. Value in health care means delivering the right health care to the right person, at the right time, for the right price. Providing reliable health care cost and quality information can empower consumer choice at all levels. Systemwide improvements can occur as providers and payers can track how their practice, service, or plan compares to others. As value in health care becomes transparent to consumers and providers alike, HHS anticipates the following benefits: Costs will stabilize; more people will acquire insurance; more people will get access to better health care; and economic competitiveness will be preserved. Ultimately, this is a prescription for a value-driven system—a prescription of good medicine that works for everyone. HHS will work to achieve this value-based system over the next 5 years. Several HHS operating and staff divisions contribute to this goal of improving the quality, safety, cost and, ultimately, the value of health care, including AHRQ, AoA, CMS, FDA, HRSA, IHS, NIH, ONC, OPHS, and SAMHSA. The performance indicators for this strategic objective, listed in full at the end of this chapter, measure: * Adoption of electronic health care records, which affect the long-term quality, value, and safety of health care; * Quality of care that residents receive in nursing home facilities; and * Number of States implementing specific approaches to improve the quality of Medicaid funded health care, on which many low-income people depend. Health Care Transparency: Health care transparency may restrain the growth of health care costs because consumers will know the comparative costs and quality of their health care—and they will have a financial incentive to seek out quality care at the lowest cost. Consumers will gain control of their health care and have the knowledge to make informed decisions. Health care transparency is built on four interconnected cornerstones: * Connect the System. Every medical provider has a system for keeping health records. Increasingly, those systems are electronic. Standards need to be identified so that all health information systems can quickly and securely communicate and exchange data. * Measure and Publish Data on Quality. Every case, every procedure, has an outcome. Some outcomes are better than others are. To measure quality, HHS must work with doctors and hospitals to define benchmarks for what constitutes quality care. * Measure and Publish Data on Price. Price information is useless unless cost is calculated for identical services. Agreement is needed on what procedures and services are covered in each “episode of care.” * Create Positive Incentives. All parties—providers, patients, insurance companies, and payers— should participate in arrangements that reward both those who offer and those who purchase high-quality, competitively priced health care. Employers committing to these cornerstones would agree to collect quality and price information through its health plan or benefit administrator, using the consensus standards. Employers committing to the goals also would be encouraged to share quality and price information with regional collaboratives, where information from many sources could be aggregated, thus producing the most broad-based and reliable information possible. The employer or its health plan would share quality information with enrollees and would provide specific costs the enrollee would expect to pay under the plan. Six pilot programs to demonstrate how transparency can promote improvements in health care are underway, with support from CMS and AHRQ. These pilot programs are being coordinated under the Better Quality Information Data Aggregation and Reporting project, through a contract with the Maryland Medicare Quality Improvement Organization. The communities were selected using a set of criteria by a representative committee of the public/private entity Ambulatory Care Quality Alliance, which consists of 135 physician organizations, consumers, employers, and health plan representatives. The Alliance makes available quality information about physician care. The purpose is to measure and report on physician practice in a meaningful and transparent way for consumers and purchasers of health care. Personalized Health Care: The future of health care in America is one in which care will be personalized, predictive, preemptive, and participatory. Advances in basic research have positioned us to begin to harness new and increasingly affordable potential in medical and scientific technology. With clinical tools that are increasingly targeted to the individual, our health care system can give consumers and providers the means to make more informed, individualized, and effective choices. Emphasis on personalized health care could make health care safer and more effective for every patient, especially when we are able to use the power of genetic information and health information technology to better understand each patient’s needs and more precisely target therapies. This may mean that the same medical condition requires different treatment for men and women, or for older persons, or for others whose inherited traits may put them at particular risk. Ongoing activities across HHS are working toward the long-term goals of personalized health care, and the convergence of these efforts will act as a powerful force to educate both the patient and the health care provider to improve clinical outcomes. Basic research at NIH is improving the foundational knowledge of diseases; FDA’s Critical Path Initiative is improving the speed and safety of product development; and CDC will use population data to understand the genetic basis of diseases. FDA has initiated the Critical Path to Personalized Medicine, a program designed to modernize and ensure more efficient development and clinical use of medical products. Under the Critical Path Initiative, HHS anticipates being able to dramatically increase the success rate in providing patients with innovative solutions that strike an optimal balance of high benefit and low risk because they are “personalized.” Once both the disease and the person are understood at the molecular level, physicians will be able to provide treatment options uniquely suited to a patient’s particular needs. Electronic Health Records: Patients cannot receive appropriate and efficient care unless clinical information about them is available at the point of care. When patients’ health information is not accessible to providers as they transition through the continuum of care, clinical decisions often must be made without full knowledge of patients’ history and health status. The absence of needed clinical information can lead to a requirement to duplicate tests that not only increase the costs of health care, but also subject patients to unneeded clinical interventions that always carry a degree of risk. Similarly, the absence of needed information could lead to incorrect decisions or medical errors that could result in adverse clinical outcomes. Over time, more advanced electronic health records will have integrated clinical decision support with the latest scientific evidence guiding clinical interventions at the point of care along with environmental data that should also influence many treatment decisions. Increasing the adoption of interoperable electronic health records will decrease these risks to both the efficiency and efficacy of care. Through the collaborative activities of the American Health Information Community, chaired by the Secretary of HHS, much work is underway to identify the functionality and standards that will support the development and adoption of interoperable electronic health records to achieve the President’s vision of making electronic health records available to most Americans by 2014. More information about this effort can be found later in this chapter in In the Spotlight: Advancing the Development and Use of Health Information Technology. Value-Based Purchasing: Value-based purchasing is the use of payment methods and other incentives to encourage substantive improvement for patient-focused, high-value care. At HHS, value-based purchasing is in its early stages of development. The Tax Relief and Health Care Act of 2006 (H.R. 6111) lays the groundwork for CMS to establish many models for financial and nonfinancial incentives used in value-based purchasing programs or strategies. Programs such as Medicare Hospital Pay for Performance, Medicare Demonstration Project to Permit Gainsharing, and the Premier demonstration are viewed as one component of a broader strategy of promoting health care quality. At least 12 States throughout the country have already implemented a wide range of value-based purchasing initiatives under Medicaid. States are using both payment differentials and nonfinancial incentives, such as auto-enrollment and public reporting, to reward performance. CMS will provide technical assistance to those States that voluntarily elect to implement value-based programs. CMS also will encourage States to include an evaluation component to provide evidence of the effectiveness of this methodology. Quality Improvement Efforts: Medicare Quality Improvement Efforts. Improving quality of care and reducing medical errors are important goals in modernizing Medicare. The Medicare Web site will continue to display quality data that allow consumers to make informed choices by comparing the performance of hospitals, nursing homes, home health agencies, and dialysis facilities. Medicaid Quality Improvement Efforts. States continue to advance efforts to improve overall quality of care as they seek new approaches to improve and expand insurance coverage. In many instances, State Medicaid programs have led the way in quality initiatives that have the potential to shape activities of other public and private payers across the country. Several States have implemented value based purchasing programs with the objective of redesigning the payment structures to promote and reward the provision of high-quality care. At least 13 States now publicly report performance measurement data that can be used by State agencies, beneficiaries, policymakers, and others to promote transparency and personal responsibility in the care provided. CMS also has launched a Neonatal Care Outcomes Improvement project with an objective of decreasing infant morbidity and mortality. Nursing Home Quality Initiatives. The CMS Nursing Home Quality Initiative is a broad-based effort that includes continuing regulatory and enforcement systems. New and improved consumer information is available through the 1–800–MEDICARE (1-800-633- 42273) line and at the Medicare Web site. In addition, community-based nursing home quality improvement programs, and partnerships and collaborative efforts to promote awareness and support, are underway. The first goal of the initiative is to provide consumers with an additional source of information about the quality of nursing home care by establishing quality measures based on the Minimum Data Set and by publishing information on Medicare’s Nursing Home Compare Web site. The second goal is to help providers improve the quality of care for their residents by giving them complementary clinical resources, quality improvement materials, and assistance from the Quality Improvement Organizations in every State. Collaborative Quality Improvement Initiatives. Two joint planning efforts focus on quality and improvement initiatives. With representation from CMS, CDC, AHRQ, and a number of non-Federal organizations, one effort experiments with approaches to create incentives for hospitals and physicians to provide both high-quality and efficient care (e.g., Gainsharing, Hospital Compare, Surgical Care Improvement Project, and others). The second effort, the Quality Workgroup, consists of CMS, AHRQ, IHS, ONC, the Office of Personnel Management, and a variety of non-Federal organizations representing labor, insurers, hospitals, and other stakeholders. The Quality Workgroup makes recommendations to the American Health Information Community (AHIC) so that health information technology can provide the data needed for the development of quality measures that are useful to patients and others in the health care industry. The Quality Workgroup seeks to automate the measurement and reporting of a comprehensive current and future set of quality measures and to accelerate the use of clinical decision support that can improve performance on those quality measures. In addition, this workgroup makes recommendations on how performance indicators should align with the capabilities and limitations of health information technology. More information about the AHIC’s work is included in the Meeting External Challenges section of this chapter. Medical Home Quality Improvement Initiative. A medical home is primary care that is accessible, continuous, comprehensive, family centered, coordinated, compassionate, and culturally effective. In a medical home, a pediatric clinician works in partnership with the patient and his or her family to assure that all the medical and nonmedical needs of the patient are met. Through this partnership, the pediatric clinician can help the patient and family access and coordinate specialty care, educational services, out-of-home care, family support, and other public and private community services that are important to the overall health of the child or youth and family. A HRSA initiative will identify effective strategies currently being used in collaboration with Title V Children with Special Needs programs in the States and will implement quality improvement activities within their medical home activities. The purpose is to enhance infrastructure development, provide quality care, and foster exchange of strategies among families, communities, and State and Federal leaders. Medical Product Safety: FDA is responsible for addressing concerns regarding the safety of medical products, in particular, drugs. As the science of drug development continues to evolve, FDA will continually improve the approach to drug regulation to ensure that care providers and patients can make optimal decisions about the medicines they use to improve their health. FDA’s reform effort will include developing new tools for communicating information to patients and improving the management of the process for how FDA uncovers and communicates important drug safety issues. For example, FDA will focus on improving the safety of drugs on the market in part through its plans to modernize the Adverse Event Reporting System (AERS) and establish “AERS II” as the primary source for drug product adverse event data. These resources also will allow FDA to augment AERS data and further its efforts with CMS to obtain access to valuable drug safety information housed in CMS population-based databases. This collaboration with CMS will be integrated with the Sentinel System, a seamless platform for gathering and evaluating information about adverse events related to the use of medical products. This integration will enable FDA to gather more information from the point of care about potential safety problems and will provide a framework for turning these raw data into useful knowledge about the safe use of medical products. In order to improve current processes and systems for collection of adverse events and errors, FDA is developing MedWatch Plus. This program will provide a single internet portal for anyone needing to report an adverse event resulting from an FDA regulated product, including product complaint reporting. This initiative will improve the collection and processing of adverse event information for all FDA regulated products. The user-friendly electronic submission capability will facilitate submission of adverse events reports to better allow FDA to efficiently and effectively use the information to promote and protect public health. Through these modernization efforts, FDA will continue to ensure that the medical products it regulates are the safest in the world. OPHS coordinates vaccine safety activities among HHS agencies which conduct a broad range of activities aimed at ensuring the safety of vaccines. NIH conducts and funds basic research that leads to the development of vaccines with a major emphasis on safety. FDA has statutory responsibility for licensing vaccines. Additionally, the FDA coadministers the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system, with CDC. CDC also conducts active surveillance of vaccine associated adverse events through the Brighton Collaboration, and examines vaccine adverse events on the practice level through Clinical Immunization Safety Assessment (CISA) centers. HRSA compensates individuals who may have been injured by vaccines through the Vaccine Injury Compensation Program (VICP). The Federal government has a heightened responsibility to ensure that vaccines are optimally safe as vaccines are recommended for nearly ever child in the U.S. and children are required by state laws to receive vaccines in order to enter school. OPHS is coordinating an interagency strategic plan to enhance HHS vaccine safety activities. Vaccine safety activities will be enhanced in the areas of research and development, post-licensure surveillance, and risk communication. Generic Drugs. Part of FDA’s mission is to make sure that the generic drugs approved for use in the United States are just as safe and effective as the brand-name versions of the drugs. Generic drugs can be very helpful for patients because their price is typically much lower: For the average price of a brand-name prescription drug that is $72, the average price of a generic version is about $17.xiii This is an especially important source of drug savings at this time, because a growing number of important brand-name medications—more than 200 in the next few years—are coming off patent, paving the way for the development of generic versions. FDA’s new final regulation to improve how and when generic drugs can compete with brand-name drugs will lead to saving billions of dollars in drug costs each year. Health Disparities: The Racial and Ethnic Health Disparities Outreach joint planning effort focuses on outreach to raise awareness among minority communities about major health risks prevalent in their specific populations and to provide access to information on how to reduce these risks. AoA, CDC, IHS, NIH, OCR, and OPHS partner with media, State and local health departments, State and area agencies on aging, and tribal governments on this effort. Additional information on HHS’s efforts on this topic can be found later in this chapter in In the Spotlight: Reducing Health Disparities.

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