Office of the Secretary of Health and Human Services, HHS.
Notice.
This notice acknowledges the Secretary of the Department of Health and Human Services' (HHS) receipt and review of the annual report submitted to the Secretary and Congress by the contracted consensus-based entity as mandated by section 1890(b)(5) of the Social Security Act, as added by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The statute requires the Secretary to publish the report in the
Kate Goodrich (202) 690–7213.
Rising health care costs coupled with the growing concern over the level and variation in quality and efficiency in the provision of health care raise important challenges for the United States. Section 183 of MIPPA also required the Secretary of the Department of Health and Human Services (HHS) to contract with a consensus-based entity to perform various duties with respect to health care performance measurement. These activities support HHS's efforts to achieve value as a purchaser of high-quality, patient-centered, and financially sustainable health care. The statute mandates that the contract be competitively awarded for a period of four years and may be renewed under a subsequent competitive contracting process.
In January, 2009, a competitive contract was awarded by HHS to the National Quality Forum (NQF) for a four-year period. The contract specified that NQF should conduct its business in an open and transparent manner, provide the opportunity for public comment and ensure that membership fees do not pose a barrier to participation in the scope of HHS's contract activities, if applicable.
The HHS four-year contract with NQF includes the following major tasks:
The first annual report covered the performance period of January 14, 2009 to February 28, 2009 or the first six weeks post contract award. Given the short timeframe between award and the statutory requirement for the submission of the first annual report, this first report provided a brief summary of future plans. In March 2009, NQF submitted the first annual report to Congress and the Secretary of HHS. The Secretary published a notice in the
In March 2010, NQF submitted to Congress and the Secretary the second annual report covering the period of performance of March 1, 2009 through February 28, 2010. The second annual report was published in the
In March 2011, NQF submitted the third annual report to Congress and the Secretary of HHS. This notice complies with the statutory requirement for Secretarial review and publication of the third annual report covering the period of performance of March 1, 2010 through February 28, 2011.
The Patient Protection and Affordable Care Act of 2010 (ACA) was signed into law on March 23, 2011. Section 3014 of this Act included a time-sensitive requirement for NQF to provide input into the national priorities for consideration under for the National Strategy for Quality for Improvement in Healthcare. As a result, one additional activity was added to the contract to fulfill this requirement within the contract year. The NQF convened the National Priorities Partnership and
Submitted in March 2011, the third annual report to Congress and the Secretary spans the period of January 14, 2010 through January 13, 2011.
A copy of NQF's submission of the March 2011 annual report to Congress and the Secretary of HHS can be found at:
The 2011 NQF annual report is reproduced in section III of this notice.
The National Quality Forum (NQF) operates under a three-part mission to improve the quality of American healthcare by:
• Building consensus on national priorities and goals for performance improvement and working in partnership to achieve them;
• Endorsing national consensus standards for measuring and publicly reporting on performance; and
• Promoting the attainment of national goals through education and outreach programs.
As a private-sector standard-setting body recognized under the National Technology Transfer and Advancement Act (Pub. L. 104–113), NQF endorses standardized performance measures, serious reportable events, and safe practices. NQF also serves as the convener of two multi-stakeholder partnerships: the National Priorities Partnership, which provides guidance on setting national priorities, goals, and strategic improvement opportunities; and the Measure Applications Partnership, which recommends measures for use in various public reporting, payment, and other programs.
In 2008, Congress passed the Medicare Improvements for Patients and Providers Act (Pub. L. 110–275),
On January 14, 2009, the National Quality Forum (NQF) was awarded a contract that addresses the Act's Section 183, which calls for the Department of Health and Human Services (HHS) “to contract with a consensus-based entity, such as the National Quality Forum,” to achieve many of these quality improvement goals. This contract subsequently was modified to accommodate specific work called for under the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111–148).
The first year of the contract was devoted to building infrastructure to support healthcare quality. We are pleased to report that in the second year of the contract, NQF has leveraged that infrastructure to demonstrate real achievements in the areas of the identification of priorities and gaps in available performance measures; adaptation of more than 100 measures for use in electronic health records; and endorsement of 62 new measures. These are concrete, measurable, and sustainable accomplishments in the nation's quality infrastructure that will translate into more effective performance improvement, public reporting, and value-based payment programs. We are grateful to the Congress and HHS for their continued support of NQF and, more broadly, of the quality enterprise in the United States. Their commitment to healthcare quality improvement is thoughtful, clear, and unquestioned. We also thank the more than 430 institutional members of NQF, the hundreds of experts who volunteer to participate in NQF expert panels, and NQF staff, whose efforts have contributed to a healthcare system that is becoming, as the Institute of Medicine (IOM) envisioned in its “call to action” a decade ago, safe, effective, patient-centered, timely, efficient, and equitable.
1. U.S. Congress, Medicare Improvements for Patients and Providers Act (Pub. L. 110–275), Washington, DC: U.S. Government Printing Office: 2008. Available at
2. U.S. Congress, Patient Protection and Affordable Care Act of 2010 (Pub. L. 111–148), Washington, DC: U.S. Government Printing Office; 2010. Available at
Key strategies for reforming healthcare include: Publicly reporting performance results to support informed consumer decision-making; aligning payments with value; rewarding providers for investing in health information technology (health IT) and using it to improve patient care; and providing knowledge and tools to healthcare providers and professionals to help them improve their performance. Foundational to the success of all of these efforts is a robust “quality measurement enterprise” that includes priorities and goals for improvement; standardized performance measures; an electronic data platform that supports measurement and improvement; use of measures in payment, public reporting, health IT investment programs, and other areas; and performance improvement initiatives in all healthcare settings. Many public- and private-sector organizations have important responsibilities in the quality
Recognizing the widespread and systemic nature of the nation's healthcare quality and cost challenges and the need to build the nation's quality measurement enterprise, Congress passed the Medicare Improvements for Patients and Providers Act (Pub. L. 110–275) in 2008. On January 14, 2009, NQF was awarded a contract that addresses the Act's Section 183, which calls for the Department of Health and Human Services (HHS) “to contract with a consensus-based entity, such as the National Quality Forum,” to carry out work related to its quality improvement goals. On September 20, 2010, this contract was modified to accommodate specific work called for under the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111–148).
During the contract period, NQF made important contributions to the following quality enterprise functions: setting priorities and goals, endorsing performance measures, building an infrastructure to support performance measurement using an electronic data platform, and providing input to the selection of measures for determining “meaningful use” of health IT.
Setting national priorities is a critical first step to addressing our country's serious safety, quality, and cost challenges. Providers cannot measure and improve in all areas at once. Priorities focus attention on those areas most likely to produce the greatest return on investment in terms of better health and healthcare. National priorities, especially when established with input from multiple stakeholders, also serve as a starting point for alignment of public- and private-sector efforts to improve performance. In 2010, NQF made three contributions to national priority-setting initiatives: providing guidance to HHS on the proposed National Health Care Quality Strategy, identifying a prioritized list of high-impact conditions for Medicare beneficiaries, and specifying an agenda for measure development and endorsement to fill gaps in available measures.
The Affordable Care Act calls for HHS to establish a National Health Care Quality Strategy and to consult with a consensus-based entity to convene a multi-stakeholder group to provide input on national priorities for improvement in population health and the delivery of healthcare services. When asked to perform this role, NQF convened the National Priorities Partnership (NPP), a collaborative that now includes 48 leading organizations. In October 2010, NPP submitted its report to HHS, recommending eight priority areas for national action. These include the original six priorities NPP identified in a priority-setting effort in 2008: (1) Patient and family engagement, (2) population health, (3) safety, (4) care coordination, (5) palliative and end-of-life care, and (6) overuse. They also include the addition of two areas of focus: (1) Equitable access to ensure that all patients have access to affordable, timely, and high-quality care; and (2) infrastructure supports (
Source: National Quality Forum (NQF),
Complementing NPP's work, which focused on “cross-cutting” areas (
*As determined by NQF Measure Prioritization Advisory Committee under contract to HHS.
Source: NQF,
Taken together, cross-cutting areas and the prioritized conditions provide a two-dimensional framework for performance measurement. The current portfolio of NQF-endorsed measures includes many measures applicable to these cross-cutting areas and leading conditions, but there are important gaps. To advise HHS on how best to focus measure development resources on filling these gaps, NQF was asked to construct an agenda for measure development and endorsement. In constructing this agenda, the NQF Measure Prioritization Advisory Committee also considered child health measurement needs and the needs of the broader population health community. The final report,
The NQF portfolio of endorsed measures includes more than 625 measures that support the needs of both public- and private-sector stakeholders and are appropriate for use in accountability and quality improvement programs. The measures fall into the following major categories: Measures of patient outcomes (
During the contract period, the HHS contract provided support for measure endorsement projects in the following areas: Patient outcomes for the 20 high-impact Medicare conditions; patient safety, including medication safety and healthcare-associated infections; nursing homes; child health; and efficiency and resource use. NQF's endorsement process, which includes evaluation by technical experts and a multi-stakeholder panel, as well as extensive public input, requires up to a year to complete depending on the volume and complexity of measures. On occasion, a project also may be temporarily halted to allow time for the measure developers to change measures in response to NQF requests (for example, two measures of overuse of neck imaging in trauma combined). There were 62 newly endorsed measures resulting from the work conducted during the contract period—14 endorsed prior to the close of the contract period and another 48 awaiting final ratification by the NQF Board (which occurred shortly after the close of the reporting period). See Appendix B for a complete list of newly endorsed measures.
In addition to endorsing new measures, NQF also oversees the updating and maintenance of currently endorsed measures. As a condition of maintaining endorsement, measure developers are required to update their measures to reflect changes in the evidence base. NQF-endorsed measures undergo a comprehensive re-evaluation every three years and must recompete “head-to-head” with any new or existing measures for “best-in-class” determination. During the contract period, NQF began maintenance of the 47 cardiovascular measures and 44 surgical measures in its portfolio.
NQF also analyzed the implications of the transition from the International Classification of Disease, Ninth Revision, Clinical Modification (ICD–9–CM) to the International Classification of Diseases, Tenth Revision, Clinical Modification and Procedure Coding System (ICD–10–CM/PCS) for quality measurement. As explained in the final report
The American Recovery and Reinvestment Act of 2009 provides $20 billion for investment in health IT and use of that technology to improve patient care. Health IT has the potential to lead to care that is safer, more effective, more affordable, and better coordinated. But to get there, electronic health records (EHRs) and other tools must capture the right data to support performance measurement, and performance measures must be specified to run on an electronic platform. NQF contributions in this area fall into four categories: (1) Development of a Quality Data Model (QDM) that defines the data that must be captured in EHRs and personal health records to support quality measurement and improvement; (2) development of a standard form and an automated tool for measure developers to create eMeasures that can readily be incorporated into vendors' health IT systems; (3) re-specification of 113 performance measures for use with EHRs (
The QDM classifies and describes the information needed for quality measurement in a way that health IT vendors understand what data elements to capture (including the most reliable source of the data and the point in time in the care process when it should be recorded), and measure developers know how to specify eMeasures so they will pull the correct information from the EHR. Although the QDM was created in 2009, NQF's Health Information Technology Advisory Committee made important enhancements covered under this contract, such as the development of a comprehensive framework for evolving the model that will accommodate the data needs of new types of measures (
To facilitate the specification of eMeasures in a standardized fashion concordant with the QDM, NQF developed a standardized eMeasure format to be used by the more than 50 measure developers. The QDM and eMeasure format taken together will yield important benefits in future years, such as:
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The eMeasure format now is being converted into a software tool known as the Measure Authoring Tool, which will be tested in 2011. NQF will provide training on using the tool to measure developers and others.
The foundational work on the QDM and the eMeasure format conducted in 2009 and 2010 under the contract was critical to the accomplishment of another important objective—the re-specification of 113 measures from paper-based format to eMeasure format. In response to an HHS request to develop eSpecifications for measures currently being used by HHS for public reporting, payment, quality improvement, or other purposes, NQF worked in coordination with the 18 developers of these measures to convert the measures from their current format into the eMeasure format. These eMeasures, along with detailed specifications, can be found on the NQF Web site at
The fourth and final area of NQF's health IT work focused on answering the question, “How will we know if health IT is being properly used by clinicians to provide better care?” To achieve the full potential of health IT to enhance the safety, effectiveness, and affordability of care, clinicians must use the technology as intended. For example, reductions in medication errors will be achieved only if clinicians do not disable or ignore alerts for potential drug interactions. In the report
Setting National Priorities and Goals serves as an important starting point for selecting measures, but for most applications there are additional considerations. In response to a request from the Office of the National Coordinator for Health IT (ONC), NQF prepared a “quick turnaround” report in the summer of 2010 to assist HHS leadership and the Health IT Policy Committee in identifying a parsimonious set of measures that might be used in 2013 to assess meaningful use of health IT. The NQF report
This is an extraordinary period of challenges and opportunities for our country's healthcare system. Reforming the healthcare delivery system to provide care that is safe, effective, and affordable necessitates changes in the environment of care. As the Institute of Medicine noted a decade ago in its landmark report
Fundamental building blocks for all of these efforts are a vigorous quality measurement enterprise including national priorities that focus our efforts on high-leverage areas with the greatest potential to produce better health and healthcare; the ability to measure, report, and reward performance results; and the ability to share best practices. Building such an enterprise is a shared responsibility of many stakeholders in the public and private sector. NQF is thankful for the opportunity to contribute.
1. U.S. Congress,
NQF was created in 1999 as a national standard-setting organization for healthcare performance measures. NQF is governed by a Board of Directors that includes healthcare leaders from the public and private sectors, with a majority of its at-large seats held by consumers and those who purchase services on consumers' behalf. A multi-stakeholder organization, NQF's more than 430 members are organized into eight councils—consumers; purchasers; healthcare professionals; health plans; provider organizations; public/community health agencies; quality measurement, research, and quality improvement organizations; and suppliers and industry—thus drawing on the expertise and insight of every sector of the healthcare field.
In establishing national consensus standards, NQF adheres to the National Technology Transfer and Advancement Act of 1995 (Pub. L. 104–113)
The NQF portfolio of voluntary consensus standards includes performance measures, serious reportable events, and preferred practices (
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•
Approximately one-third of the measures in NQF's portfolio are measures of patient outcomes (
The measures included in the NQF portfolio are owned or sponsored by 53 different stewards, which include: Public agencies (
In recent years, NQF has worked closely with the Department of Health and Human Services (HHS) and measure stewards to re-specify performance measures for use with interoperable electronic health records (EHRs) and personal health records. To date, more than 110 measures have been “retooled.” HHS currently uses these retooled measures for activities including “meaningful use” measurement in the Electronic Health Records Incentive Programs, the Medicare Hospital Compare public reporting program, and in various value-based payment programs. NQF has encouraged measure stewards to adopt common conventions in specifying eMeasures and in identifying the types of data that must be captured in electronic health records to support quality measurement and improvement.
In addition to its role as a standard-setting body, NQF also serves as the neutral convener of two national multi-stakeholder partnerships. The National Priorities Partnership (NPP) was established in 2007 to set national priorities and goals for performance improvement and released its first report shortly thereafter identifying six original major priority areas: (1) Patient and family engagement, (2) population health, (3) patient safety, (4) care coordination, (5) palliative and end-of-life care, and (6) overuse. NPP currently consists of 42 leading private-sector organizations—including consumers, purchasers, health plans, providers, health professionals, accreditation/certification bodies—and six Federal agencies. These NPP leaders have worked closely over the past three years
In recent years, NQF also has enhanced its health information technology portfolio to contribute to the creation of an interoperable electronic infrastructure that supports quality measurement and improvement. This began with NQF's construction of the Quality Data Model (QDM), a classification system that describes clinical and other information used for quality measurement and provides a standardized terminology to be used in constructing eMeasures. NQF also is working on a Measure Authoring Tool to help measure developers build eMeasures.
1. U.S. Congress, National Technology Transfer and Advancement Act of 1995 (PL 104–113), Washington, DC: U.S. Government Printing Office, 1995. Available at
2. The White House,
3. National Quality Forum (NQF),
4. National Priorities Partnership.
The Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110–275) is a wide-ranging law that addresses many aspects of Medicare and Medicaid, including the addition of new benefits for Medicare beneficiaries. Among other things, the Act directs the Secretary of HHS to contract with a consensus-based entity for certain activities relating to healthcare performance measurement.
On January 14, 2009, NQF was awarded a contract, HHSM–500–2009–00010C, under the Act's Section 183. This contract is administered by HHS's Office of the Assistant Secretary for Planning and Evaluation (ASPE), which provides strategic leadership and technical and management oversight for the contract, and by CMS, which provides technical input and operational support. The contract provided up to $10 million for the first year after award, with the option for three $10 million annual renewals through 2012. It calls for NQF to:
• Develop a prioritized list of conditions that impose a heavy health burden on beneficiaries and account for significant costs;
• Identify and endorse measures that various stakeholders can use to assess and improve the care provided to beneficiaries with these conditions, and the performance of providers in various healthcare settings;
• Identify programs to track and disseminate measures;
• Ensure performance measures are regularly and appropriately updated and remain relevant for public reporting and improvement;
• Promote the use of EHRs for performance measurement, reporting, and improvement; and
• Report annually to Congress on the status of the project and progress to date.
This contract had the effect of providing a mandate and stable funding to NQF, granting the organization a source of core funding to pursue this important work in a coordinated, strategic manner. While the work conducted under the contract is intended specifically to benefit all those served by HHS programs, it will have the salutary additional benefit of improving care for all Americans. The work being conducted under this contract directly relates to NQF's core competencies in three areas:
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Under the contract, HHS asked that performance measures focus on “outcomes and efficiencies that matter to patients, align with electronic collection at the front end of care, encompass episodes of care when possible, and will be attributable to providers where possible.”
The work under this contract is divided into 13 tasks. Six of the tasks are procedural—involving an opening meeting, the development of a work plan, the development and implementation of a quality assurance Internal Evaluation Plan, weekly conference calls, monthly progress reports, and the creation of this annual report. The remaining seven call for specific deliverables and are the focus of this report.
Task 6 is the formulation of a national strategy and priorities for healthcare performance measurement. Task 7 is the implementation of a consensus process for endorsing healthcare quality measures. This task includes an evaluation of NQF's consensus development process and the conduct of endorsement projects focusing on known measure gap areas. Task 8 is the maintenance of previously endorsed NQF measures. Task 9 is the promotion of EHRs. Task 11 is the development of a public Web site for project documents. Task 12 calls for measure development, harmonization, and endorsement efforts to fill critical gaps in performance measurement. In 2010, Congress passed the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111–148), which directed HHS to contract with a consensus-based entity to provide multi-stakeholder input into the National Quality Strategy, as well as the
Details of work performed under the HHS contract in each of these tasks are found in Section IV of this report.
This section describes details of work performed under each task according to the HHS contract in 2010. Appendix A is a summary of the accomplishments under the contract. Appendix C is a list of all final reports produced with links to where they can be found on the NQF Web site.
Forming a strategy and setting priorities for performance improvement is crucial to focusing resources on areas that will produce the greatest improvements in terms of better health and healthcare. In 2007, NQF convened NPP, co-chaired by Margaret O'Kane, president of the National Committee for Quality Assurance, and Bernard Rosof, MD, chair of the Physician Consortium for Performance Improvement convened by the American Medical Association. In work predating this contract, NPP identified six priorities as those with the greatest potential to eradicate disparities, reduce harm, and remove waste from the American healthcare system. In its recent report to the Secretary, NPP added two additional priorities.
Building upon this foundation, in work funded under this contract, NQF undertook the following projects:
• Prioritizing high-impact Medicare conditions and associated measure gaps (Task 6.0);
• Setting a national measure development and endorsement agenda (Task 6.2);
• Analyzing measures targeted under the Meaningful Use portion of the Medicare Electronic Health Record Incentive Program, specifically examining how health IT tools can improve the efficiency, quality, and safety of healthcare delivery (Task 6.4);
• Investigating the use of NQF-endorsed measures (Task 6.1); and
• Analyzing measures being used to gauge quality of care for people with multiple chronic conditions (Task 6.3).
In May 2010, NQF published
* As determined by NQF Measure Prioritization Advisory Committee under contract to HHS.
The work on prioritization of conditions fed directly into a related project under this task—the creation of a measure development and endorsement agenda. This prioritization project provides guidance on how best to invest measure development resources and will assist NQF in helping the portfolio of endorsed measures evolve to be most useful for public reporting, performance-based payment, and quality improvement.
The Measure Prioritization Advisory Committee considered the performance measure needs of Medicare, child health, and population health. Key objectives included alignment with the measures needed for new approaches to public reporting and payment in the Affordable Care Act and for the meaningful use provisions in the American Recovery and Reinvestment Act of 2009 (Pub. L. 111–5). The Measure Prioritization Advisory Committee considered the following: priorities for improvement previously identified by NPP; priorities identified by measure developers; key areas identified during health information technology meaningful use deliberations; disparities-sensitive measure gaps; and gaps identified during previous NQF endorsement activities. The final report,
• Resource use/overuse,
• Care coordination and management,
• Health status,
• Safety processes and outcomes,
• Patient and family engagement,
• System infrastructure supports,
• Population health, and
• Palliative care.
In spring 2010, HHS's Office of the National Coordinator for Health Information Technology (ONC) requested a rapid analysis of the types of measures that might be selected to assess meaningful use of health information technology (health IT) in 2013 and a preliminary scan of whether such measures currently are available or could be developed, tested, and endorsed within the requisite timeframe. This project, which became Task 6.4 under the HHS contract, provided a framework for considering various types of measures and an inventory of available EHR-based measures from leading sources. A report,
NQF also began two projects under this task order that are currently in process: measure use evaluation (Task 6.1) and the development of an endorsed performance measurement framework for patients with multiple chronic conditions (Task 6.3). For evaluating uses of NQF-endorsed measures, NQF has engaged RAND to conduct an independent, third-party assessment on uptake of endorsed measures for such purposes as payment, public reporting, quality improvement, and accreditation/certification, as well as to examine success factors and implementation barriers. To support the development of a performance measurement framework for patients with multiple chronic conditions, NQF is in the process of engaging researchers to draft a white paper highlighting key measurement-related issues for these patients. A multi-stakeholder committee will consider that input and recommend a measurement framework. The framework will inform future work pertaining to the endorsement of measures of performance for patients with multiple chronic conditions.
Valid, meaningful measures of performance make it possible to gauge the quality of healthcare and focus quality improvement efforts by helping identify what is working and what needs additional improvement. Stakeholder-based endorsement of performance measures via a formal endorsement process has long been NQF's stock in trade. This task involves both a formal evaluation of the endorsement process and a set of consensus projects focused on known measure gap areas.
In the past year, NQF has engaged in several HHS-funded measure endorsement projects and related projects. These have included:
• Measures of performance on healthcare outcomes (Task 7.1);
• Measures of patient safety and other projects specifically related to patient safety (Task 7.3);
• Measures of performance on palliative care (Task 7.4);
• Measures of performance in nursing homes (Task 7.5);
• An evaluation of NQF's consensus development process, with an eye toward making the process more efficient and user friendly (Task 7.6); and
• Measures of performance of care delivered to children (Task 7.8).
NQF's outcome measures project focused on areas with the greatest potential impact, including common conditions, gaps in measurement of patient-focused outcomes, and transitions across care settings. The first two cycles of this three-cycle project concentrated on the Medicare 20 high-impact conditions list, while the third cycle focused on child and mental health. A significant amount of this work has been completed, resulting in the endorsement of 35 outcome measures
Under the HHS contract in 2010–2011, NQF engaged in four significant patient safety activities:
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Hospice and palliative care services offer physical, emotional, and spiritual care to patients coping with severe or end-of life-illnesses. These programs also help coordinate care of multiple specialists to ensure pain is alleviated and help patients and their families make difficult decisions regarding treatment goals. Unfortunately, more than 1 million people die each year without ever having access to these important services. Many of those lacking adequate access will endure
In 2006, NQF endorsed a framework and preferred practices for palliative and hospice care quality.
NQF was an early pioneer in advancing measures of nursing home care quality, endorsing an initial set of performance measures in this area in 2004.
NQF uses its formal endorsement process to evaluate and endorse consensus standards, including performance measures, preferred practices, frameworks, and reporting guidelines. The process is designed to call for input and carefully consider the interests of stakeholder groups from across the healthcare industry.
Just as NQF asks the healthcare system to measure, report, monitor, and constantly improve, the organization expects constant improvement of its own systems, policies, and processes. Thus, under the HHS contract in 2010, NQF engaged subcontractor Mathematica Policy Research, Inc., to evaluate its consensus process. This comprehensive analysis included a technical process analysis, stakeholder analysis, and scan of comparative alternatives. The reviewers found that the NQF consensus process is generally well regarded among its stakeholders; nevertheless, they did suggest specific refinements of the process's timeliness, efficiency, and effectiveness. The final report,
Child health quality is an important, underemphasized area of measure development and endorsement. To date, NQF has endorsed more than 70 pediatric and perinatal measures, with emphasis in the areas of perinatal and neonatal care, chronic illness care, and care for hospitalized children. However, the need for child health quality measures has outpaced the number of available endorsed measures. The recent release of an initial core set of measures for Medicaid and CHIP (Children's Health Insurance Program) voluntary use provides an important step in assessing child health quality by state programs. The Agency for Healthcare Research and Quality National Advisory Council Subcommittee on Children's Healthcare Quality Measures for Medicaid and CHIP Programs (AHRQ SNAC) has identified a number of child health priority areas without adequate measures, including mental health and substance abuse services, other specialty services, and inpatient care.
To assist in these efforts, NQF has embarked on a consensus project to endorse additional measures of child health quality in a project that will complement the AHRQ SNAC collaboration with CMS, CHIP, and Survey and Certification. While the initial core set of Children's Health Insurance Program Reauthorization Act (CHIPRA) measures will be specified by the Secretary of HHS, there may be other appropriate measures that could enhance the portfolio of child health quality measures and could be used in the future for the pediatric quality measurement program as required by CHIPRA. NQF's current project in this area targets measures that could be used in public reporting at the population level (
NQF endorsed its first performance measures in 2001. Since then, much has changed about healthcare, performance measurement, the technologies supporting patient care and documentation (which enable performance measurement and reporting), and the NQF endorsement process itself. The science supporting quality measurement and medicine itself is rapidly evolving, and, of particular note, the science and technology of care delivery have changed. It is critically important that NQF keep pace with these changes. Simply put, it is unreasonable and counterproductive to all parties to gauge performance based on anything other than the most up-to-date, best-in-class measures.
NQF has endorsed more than 625 measures. Ensuring these measures remain up to date—a process known as “measure maintenance”—is a time-consuming and resource-intensive task, but a necessary one. Endorsed measures must be re-evaluated against NQF's measure evaluation criteria
Under the HHS contract in 2010, NQF finalized a process for the systematic, complete maintenance of all of its endorsed measures. This process involves reviewing all endorsed measures across 22 topic areas every three years. The numbers of topic areas and measures are subject to change in the future depending on the type and volume of new measures received in upcoming projects. NQF also began work using this new endorsement maintenance process on two major areas for measure maintenance: Cardiovascular and surgery measures. These projects are scheduled for completion later in 2011.
The opportunity to improve healthcare through health IT has never been greater. The American Recovery and Reinvestment Act of 2009 provides a $20 billion mandate to ensure health IT plays a central role in transforming care through the EHR Incentive Program and its meaningful use provisions, while the Affordable Care Act ensures that performance measures, supported by an electronic infrastructure, drive a national strategy for quality improvement. Health IT will help ensure care is safer, more affordable, and better coordinated. But to get there, a common language among systems is necessary, and EHRs and other tools must capture the right data to support performance measurement. This will give actionable data to providers, patients, and others working to improve quality.
To understand NQF's accomplishments in health IT in 2010–2011, it is important to understand two projects that NQF previously completed in this area:
1.
2.
NQF's health IT portfolio supports the creation of this electronic infrastructure. In 2010–2011 under the HHS contract, NQF undertook several projects in health IT, including:
• The development of a measure authoring tool (Task 9.1);
• The convening of a Clinical Decision Support Expert Panel (Task 9.2);
• Maintenance of its previously developed Quality Data Model (Task 9.5);
• The convening of a Health IT Utilization Expert Panel (Task 9.6);
• Measure retooling for EHRs (Task 9.7); and
• The convening of an eMeasure Format Review Panel (Task 9.8).
Under the HHS contract, NQF is sponsoring the development of a software tool that measure developers will use to create the eMeasure. The tool will be Web based, easy to use, and maintained over time for use in NQF's measure submission process. It will allow a measure developer, knowing clinical concepts, to enter information into the tool and come out with a standard healthcare quality measure format in what is known as Extensible Markup Language, or XML, that any EHR can implement. NQF has engaged a subcontractor, the Iowa Foundation for Medical Care, to develop this tool. It is anticipated that the measure authoring tool will be available for public use by late 2011.
Properly positioned within an EHR system, clinical decision support (CDS) tools can play an important role in matching patient information with relevant clinical knowledge, thereby helping clinicians incorporate that knowledge into decision-making. CDS is an essential capability of health IT systems; however, a common classification or taxonomy is necessary to enable system developers, system implementers, and the quality improvement community to develop tools, content, and policies that are compatible and support CDS features and functions. In 2010, under the HHS contract, NQF convened an Expert Panel with expertise in CDS and performance measurement. The members of the panel assisted in identifying best practices and reducing duplicative or uncoordinated efforts. In December, the panel published the report
The QDM is a model of presenting information that allows measure developers to express what they want to say, or what information they want to pull from a health record, in a way that EHRs can understand. To ensure the value and use of the QDM, NQF will enhance it periodically in response to evolving needs for performance measurement. While the QDM was created under a separate contract, its maintenance and revision is covered
Proper use of health IT (
At the request of HHS, NQF in 2010 managed the conversion, or “retooling,” of a set of 113 measures from their paper-based format to the eMeasure format, working in coordination with their original 18 developers. These NQF-endorsed quality measures needed to be converted so that the data elements are defined using the eMeasure format and in the context of EHR usage. The goal is to measure quality directly out of EHRs. These measures, a mix of inpatient and ambulatory measures, were chosen by HHS for retooling for potential inclusion in the CMS EHR Incentive Program. The 113 measures, along with detailed eSpecifications, eMeasure code list descriptors, and a guide to how to view and interpret an electronic measure, can be found on the NQF Web site at
The first 44 measures produced were included in the July 2010 Meaningful Use Stage 1 measures. The project included a complete review of efforts required to convert paper-based measures to eMeasure format, including use of the QDM and guidance on how to present logic and timing for each element in a standard manner. NQF incorporated feedback from a large number of public comments in the model used for the final product delivered to HHS. The information learned also was incorporated into the measure authoring tool software development effort. This project was completed under the HHS contract in 2010.
Closely related to the measure retooling project, NQF in 2010 under the HHS contract convened a body of experts to participate in a panel to conduct a transparent and thorough review of the retooled measures. This panel will oversee an eMeasure review process to evaluate the specifications (structure) and intent (content) of retooled measures. This evaluation ensures that a measure's intent remains intact for continued NQF endorsement. The review panel's work is ongoing.
The HHS contract provided funding for NQF to revamp and maintain its Web site,
Under the HHS contract, NQF in 2010 substantially overhauled its Web site, developing and maintaining content and supporting materials for numerous HHS-supported consensus development projects and other tasks, and adding web analytics to make it easier to determine the actual needs of public consumers seeking information about NQF projects. To facilitate access to endorsed measures, NQF has established a measures database that will be considerably enhanced in 2011 with more advanced search capabilities. NQF also has streamlined its web submission forms to reduce time to process items, created a new health IT content area to reflect the health IT work conducted under this contract, and created commenting tools that allow for open-ended or guided public comments. The Web site now features a content management system with an online measure submission form, an online public and member comment capability, and online voting platform for members. Important pages on the Web site include:
• A page containing all MIPPA-funded consensus development activity,
• A home for all of its health IT activity,
• An online measure submission form, which can be accessed through
Further enhancements planned for 2011 include integrating the Measure Authoring Tool to allow seamless access to measure developers needing to develop eMeasures.
The HHS contract provides for measure development and related activities to fill immediate areas of need that HHS has identified. In 2010, HHS requested work in four areas:
• Efficiency and resource use (Task 12.1);
• Measure harmonization (Task 12.2);
• ICD–10 conversion guidance (Task 12.3); and
• Emergency regionalization (Task 12.5).
Under the HHS contract, NQF in 2010 conducted in two projects related to efficiency. The first focuses on endorsing measures of imaging efficiency, noting that Medicare spends approximately $14 billion annually on outpatient imaging studies.
The current quality landscape includes many quality reporting initiatives and measure developers, as well as a proliferation of measures. Separate quality initiatives—focusing on different settings and patient
In 2010, under the HHS contract, NQF convened a Steering Committee to develop operational guidance for achieving harmonization within future NQF consensus development projects. The final project report,
In 2013, one of the code sets that HHS uses to classify healthcare will be upgraded. This transition from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD–9–CM) codes to the International Classification of Diseases, Tenth Revision, Clinical Modification and Procedure Coding System (ICD–10–CM/PCS) has implications for quality measurement because a majority of the diagnoses used to define NQF-endorsed measures are specified using ICD–9–CM codes.
To prepare for this major transition, NQF examined the implications for its measure maintenance procedures and analyzed the impact of code transitions for the measurement community, particularly measure developers, as the healthcare field begins to shape processes to accommodate the necessary measure updates. In October 2010, NQF published a report,
Regionalizing emergency medical care services—i.e., directing patients to emergency facilities with optimal capabilities for a given type of illness or injury in order to coordinate emergency care across a region—is one policy option for improving care while making more efficient use of medical resources. Under the HHS contract, NQF has undertaken a project to identify quality measures already in place and identify gaps in the measurement of regionalized emergency medical care services that must be filled if one is to provide a detailed picture of the utilization and quality of emergency services at the national, state, and regional levels. The first phase of this work, conducting an environmental scan of existing projects and performance measures and developing a framework to guide measure development and identify gaps as well as points of leverage for regionalization of emergency medical services, was begun in late 2010 and is expected to be completed in early 2012.
The Affordable Care Act, which became law March 23, 2010, calls for HHS to establish a National Health Care Quality Strategy that will integrate multiple public- and private-sector quality improvement initiatives. This strategy will ultimately include a comprehensive strategic plan and the identification of priorities to improve the delivery of healthcare services, patient health outcomes, and population health. In September 2010, the HHS–NQF contract was modified to comply with Section 3014 of the Affordable Care Act, which requires the Secretary of HHS to consult with a consensus-based entity to convene a multi-stakeholder group to provide input on national priorities for improvement in population health and in the delivery of health care services for consideration under the National Quality Strategy. NQF convened the National Priorities Partnership to accomplish this project, which became Task 13 under the HHS contract.
In October 2010, the NPP submitted its report to HHS, identifying eight priority areas for national action. These include the original six priorities that the NPP identified in 2008—patient and family engagement, population health, safety, care coordination, palliative and end-of-life care, and overuse—and the addition of two areas of focus: Equitable access to ensure that all patients have access to affordable, timely, and high-quality care; and infrastructure supports (
1. NQF,
2. The list of the top 20 high-impact Medicare conditions was provided to NQF by HHS, as those conditions that account for 95 percent of Medicare costs based on an analysis of claims in CMS's
3. NQF,
4. NQF,
5. NQF's Measure Evaluation Criteria can be found at
6. US Government Accountability Office (GAO),
It now has been just over two years since NQF began its work with HHS under the contract following the Medicare Improvements for Patients and Providers Act. This contract has led to specific, measurable results.
Accomplishments have included:
• The presentation of multi-stakeholder input on the Secretary's National Quality Strategy, with the foundation being laid for a strong public-private partnership focused on achieving the aims of that strategy;
• The endorsement of performance measures in key gap areas, including measures of care transitions for acute myocardial infarction, heart failure, and pneumonia; inpatient psychiatric hospital measures; and measures addressing population health and care coordination; and
• The migration of performance measures to an electronic platform and the development of a process by which measures can be more easily adapted to an electronic format.
Much work remains to be done on these and other initiatives central to improving the quality of American healthcare. But the work performed in the past two years comprises an important foundation upon which the nation's healthcare quality enterprise can continue to build.
In 2011, NQF will continue to convene multiple stakeholders to provide input to HHS on its priority- and goal-setting efforts, endorse and maintain an even greater number of performance measures, and facilitate the integration of performance measurement into electronic health records. Additionally, NQF is just beginning to implement work called for under the Affordable Care Act. This will be centered on the establishment of the Measure Applications Partnership, a multi-stakeholder group that will provide input to the HHS Secretary on the selection of quality measures for public reporting and payment programs.
The nation's quality infrastructure, of which NQF is a part, is still being built—but its foundations are strong. NQF remains committed to working with HHS and its agencies to refashion the American healthcare system into one that is, as the IOM envisioned, safe, timely, effective, efficient, equitable, and patient centered.
Includes 62 newly endorsed resulting from the work conducted during the contract period, 14 endorsed prior to the close of the contract period, and another 48 awaiting final ratification by the NQF Board of Directors (which occurred shortly after the close of the contract period).
William L. Roper, MD, MPH (Chair), Dean, School of Medicine, Vice Chancellor for Medical Affairs and Chief Executive Officer, UNC Health Care System, University of North Carolina at Chapel Hill.
Andrew Webber (Vice Chair), President and CEO, National Business Coalition on Health.
Gerald M. Shea (Treasurer), Assistant to the President for External Affairs, AFL–CIO.
Richard J. Baron, MD, FACP, President and Founder, Greenhouse Internists.
Lawrence M. Becker, Director, HR Strategic Partnerships, Xerox Corporation.
JudyAnn Bigby, MD, Secretary, Executive Office of Health & Human Services, Commonwealth of Massachusetts.
Janet M. Corrigan, PhD, MBA, President and CEO, National Quality Forum.
Maureen Corry, Executive Director, Childbirth Connection.
Helen Darling, MA, President, National Business Group on Health.
Robert Galvin, MD, MBA, Chief Executive Officer, Equity Healthcare, The Blackstone Group.
Wade Henderson,
Ardis Dee Hoven, MD, Chair, American Medical Association Board of Trustees and Medical Director, Bluegrass Care Clinic, Affiliated with the University of Kentucky School of Medicine.
Karen Ignagni, MBA, President and CEO, America's Health Insurance Plans (AHIP).
Chris Jennings, President, Jennings Policy Strategies, Inc.
Charles N. Kahn III, MPH, President, Federation of American Hospitals.
Mark B. McClellan, MD, PhD, Senior Fellow and Director, Engelberg Center for Health Care Reform and Leonard D. Schaeffer Chair in Health Policy Studies, The Brookings Institution.
Sheri S. McCoy, Worldwide Chairman of the Pharmaceuticals Group, Johnson & Johnson.
Harold D. Miller, President and CEO, Network for Regional Healthcare Improvement.
Dolores L. Mitchell, Executive Director, Commonwealth of Massachusetts Group Insurance Commission.
Mary Naylor, PhD, RN, FAAN, Director, New Courtland Center for Transitions & Health and Marian S. Ware Professor in Gerontology, University of Pennsylvania School of Nursing.
Debra L. Ness, President, National Partnership for Women & Families.
Samuel R. Nussbaum, MD, Executive Vice President and Chief Medical Officer, WellPoint, Inc.
J. Marc Overhage, MD, PhD, Director, Regenstrief Institute and President and CEO, Health Information Exchange.
John C. Rother, JD, Executive Vice President for Policy and Strategy, AARP.
Bernard M. Rosof, MD, Chair, Board of Directors, Huntington Hospital and Chair, Physician Consortium for Performance Improvement convened by the American Medical Association.
Joseph R. Swedish, FACHE, President and CEO, Trinity Health.
John Tooker, MD, MBA, FACP, Associate Executive Vice President, American College of Physicians.
Richard J. Umbdenstock, President and CEO, American Hospital Association.
Donald M. Berwick, Administrator.
Designee: Barry Straube, MD, Chief Medical Officer and Director, Office of Clinical Standards and Quality.
Carolyn M. Clancy, MD, Director.
Francis S. Collins, MD, PhD, Director, National Institutes of Health.
Designee: Barry Portnoy, PhD, Senior Advisor for Disease Prevention.
Mary Wakefield, PhD, RN, Administrator.
Designee: Kyu Rhee, MD.
Thomas R. Frieden, MD, MPH, Director.
Designee: Peter A. Briss, MD, MPH, Captain, U.S. Public Health Service, Medical Director.
Arthur Levin, MPH, (Chair, Consensus Standards Approval Committee), Director, Center for Medical Consumers.
Curt Selquist, (Chair, Leadership Network), Johnson & Johnson Health Care System, Inc. (retired).
Paul C. Tang, MD, MS, Vice President and Chief Medical Information Officer, Palo Alto Medical Foundation and Chair, Health Information Technology Advisory Committee.
Janet M. Corrigan, President and Chief Executive Officer.
Karen Adams, Vice President, National Priorities.
Helen Burstin, Senior Vice President, Performance Measures.
Floyd Eisenberg, Senior Vice President, Health Information Technology.
Marybeth Farquhar, Vice President for Performance Measures.
Larry Gorban, Vice President, Operations.
Ann Hammersmith, General Counsel.
Lisa Hines, Vice President, Member Services and Education.
Laura Miller, Senior Vice President and Chief Operating Officer.
Nicole Silverman, Vice President, Federal Program Management.
Mary Shaffran, Vice President, Health Information Technology.
Diane Stollenwerk, Vice President, Community Alliances.
Thomas Valuck, Senior Vice President, Strategic Partnerships.
Kyle Vickers, Chief Information Officer.
NQF uses its formal Consensus Development Process (CDP) to evaluate and endorse consensus standards, including performance measures, best practices, frameworks, and reporting guidelines. The CDP is designed to call for input and carefully consider the interests of stakeholder groups from across the healthcare industry.
Because NQF uses this formal CDP, it is recognized as a voluntary consensus standards-setting organization as defined by the National Technology Transfer and Advancement Act of 1995
NQF's CDP involves nine principal steps. Each contains several substeps and is associated with specific actions. The steps are:
1. U.S. Congress,
2. The White House,
The National Quality Forum wishes to acknowledge the invaluable editorial services of Philip Dunn and the design expertise of Corporate Visions, Inc. This report was printed by MOSAIC Print.
The Secretary is pleased with the scope and vision of NQF's March 2011 annual report to Congress (the “annual report”). An internal multidisciplinary HHS team is working collaboratively with NQF to provide a clear multi-year vision to ensure the most efficient and effective utilization of the HHS contract. The contract with NQF provides a unique opportunity to further enhance HHS' efforts to foster a collaborative, multi-stakeholder approach to increase the availability of national voluntary consensus standards for quality and efficiency measures that can help to ensure broad transparency in achieving value in health care delivery.
Over the past year NQF continued work on tasks outlined in the Statement of Work, including: development of a national strategy for performance measurement and prioritization of measures for development and endorsement; evaluation of NQF's consensus development process; conduct of measure endorsement projects focused on areas where there are gaps in measures, such as outcomes measures and patient safety measures; maintenance of current NQF-endorsed measures; and promotion of Electronic Health Records through such activities as developing a measure authoring software tool, initiation of a taxonomy and rules for clinical decision support that are in accord with the Quality Data Model, retooling of a subset of existing NQF-endorsed measures into electronic measure format, development of a public Web site to make available current NQF activities, and development of evaluation criteria for the endorsement of efficiency and resource use measures. In response to a time-sensitive Affordable Care Act requirement, a new short-term task was added for NQF to provide input into the national priorities for consideration under for the National Strategy Quality for Improvement in Healthcare. The NQF convened the National Priorities Partnership (NPP) and delivered a report that provided actionable input for improvement in population health and in the delivery of health care services.
The Secretary has reviewed the annual report and has the following comments. First, the Secretary notes an inadvertent statement in the annual report that appears at the end of the second paragraph in the section entitled “II. About the National Quality Forum”. It refers to the Consensus Development Process (CDP) and states that “strict adherence to this CDP qualifies NQF as a voluntary consensus standards-setting organization, granting its endorsed measures special legal standing”. The CDP qualifies the NQF as a voluntary consensus standards-setting organization, and therefore, the endorsed measures are granted standing as voluntary consensus standards. The endorsed measures are not granted special legal standing. This same issue also arises in the section entitled “III. About the Contract” in the second bullet following the third paragraph. The sentence includes the statement that the CDP grants the “measures and practices special legal standing as voluntary consensus standards”. The CDP grants the measures and practices standing as voluntary consensus standards, but does not grant the measures special legal standing.
Second, the Secretary wishes to clarify a statement that has the potential to be misleading. This statement is included in the annual report's section entitled “II. About the National Quality Forum”. It appears in the third sentence of the sixth paragraph. This sentence mischaracterizes the quality programs described. In particular, CMS is not “measuring” meaningful use for purposes of the EHR program. Rather, if eligible professionals and hospitals are able to demonstrate that they meet the requisite meaningful use criteria, they will receive an incentive payment. In addition,
Third, the Secretary wishes to clarify a statement in the subsection entitled “Implementation of a Consensus Process for the Endorsement of Quality Measures (Task 7)” in the section entitled “IV. HHS–Funded Work”. The fourth sentence in the first bullet point under the heading “Patient Safety” within that subsection could be misleading. It states: “
Fourth, a sentence in the subsection entitled “Technical Infrastructure to Support Measurement Using an Electronic Platform” within the section entitled “I. Executive Summary” states that the American Recovery and Reinvestment Act of 2009 (ARRA) “provides $20 billion for investment in health IT and use of that technology to improve patient care.” Similarly, a sentence in the subsection entitled “Promotion of Electronic Health Records (Task 9)” within the section entitled “IV. HHS–Funded Work” states that ARRA “provides a $20 billion mandate to ensure health IT plays a central role in transforming the EHR Incentive Program and its meaningful use provisions * * *.” ARRA does not specify an amount of funding for the EHR Incentive Program. The final amount will depend on the numbers of providers and professionals that participate in the program and their specific years of participation. ARRA also appropriated $2 billion for the Office of the National Coordinator for Health Information Technology (ONC).
Finally, the information describing Task 9.7 (Measure retooling for EHRs) in Appendix A; Summary of Accomplishments Under the Contract: Jan. 14, 2010 to Jan. 12, 2011 warrants further clarification. During the reporting period, the specifications for 113 measures were drafted and updated. They are undergoing review and public comment and will be further updated by December 2011. The Web site where the measures and eSpecifications were posted for public comment is included in Appendix A.
The Secretary is pleased with the progress and timeliness of the work outlined in the Annual Report.
The consensus-based contract with NQF is a four year contract. During this second full performance year of the contract, NQF completed deliverables for each task required by MIPPA and for the short-term requirements of section 3014 in ACA. HHS will continue to task NQF with single year and multi-year projects.
During March 2010 to February 2011, NQF recommended eight priority areas for national action to the Department for the National Health Care Quality
The NQF Prioritization Measure Advisory Committee continued to explore priorities for health care performance measurement and developed a list of 20 prioritized high-impact Medicare conditions and measurement gaps. These conditions account for more than 90 percent of Medicare costs. This work complemented the NPP's additional focus on “cross-cutting” areas which affect all or most patients, such as care coordination.
The NQF portfolio includes 625 measures organized into five major categories of quality health care: Patient outcomes; care processes; patient experience; resource use; and composite measures. The measures are used in a variety of provider settings, such as ambulatory care settings, emergency service settings and nursing homes, which operate with different data reporting platforms. To meet the various platform needs, measures need to accommodate paper records, and administrative and claims data. During the year, additional work focused on the endorsement of measures of the 20 high-impact Medicare conditions as well as measures for patient safety, nursing homes and child health. Simultaneously, the NQF conducted reviews for potential endorsement of 62 measures that fit into the five categories above.
During March 2010 to February 2011, NQF maintained endorsed measures relevant to HHS-wide programs and will continue to maintain consensus-based endorsed measures as developed under the priority process.
During March 2010 to February 2011, NQF continued to support the promotion of electronic health records as part of HHS-wide efforts. NQF's contributions during the year focused on four areas: (1) Enhancement of the Quality Data Model, which specifies the necessary data for electronic and personal health records; (2) standardization of eMeasure format for use by more than 50 measure developers; (3) re-specification of a subset of performance measures into eMeasures for use with electronic health records; and (4) identification of types of measures for use in determining whether clinicians are properly using electronic health records as well as to detect any unintended consequences. Initial work was undertaken during the year to incorporate the eMeasure format into a Measure Authoring Tool.
During March 2010 to February 2011, NQF continued to support a variety of performance measurement efforts focused on efficiency, harmonization, the ICD–10 and regionalized emergency care services. Both harmonization and ICD–10 activities that were specified for work were complete within the year. NQF made progress in the area of efficiency with two tasks nearing completion and another undertaken during the year. NQF also initiated work on regionalized emergency care services mid-way through the year and progress in that area continues.
During the next contract year, NQF will focus its work on fulfilling the requirements of ACA section 3014 in addition to the continuation of work as required under MIPPA. NQF will also undertake work to provide further input into the annual National Quality Strategy and selection of quality measures for use in public and private reporting programs and value-based purchasing programs. This work will be included in subsequent annual reports.
This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the paperwork Reduction Act of 1995 (44 U.S.C. 35)