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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Secretarial Review and Publication of the Annual Report to Congress Submitted by the Contracted Consensus-Based Entity Regarding Performance Measurement

AGENCY: Office of the Secretary of Health and Human Services, HHS.

ACTION: Notice.

SUMMARY: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) and section 3014 of the Affordable Care Act of 2010. The statute requires the Secretary to publish the report in theFederal Registertogether with any comments of the Secretary on the report not later than six months after receiving the report. This notice fulfills those requirements.

FOR FURTHER INFORMATION CONTACT:Stephanie Mika (202) 260-6366.

I. Background

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:

Formulation of a National Strategy and Priorities for Health Care Performance--NQF shall synthesize evidence and convene key stakeholders on the formulation of an integrated national strategy and priorities for health care performance measurement in all applicable settings. NQF shall give priority to measures that: Address the health care provided to patients with prevalent, high-cost chronic diseases; provide the greatest potential for improving quality, efficiency and patient-centered health care and may be implemented rapidly due to existing evidence, standards of care or other reasons. NQF shall consider measures that assist consumers and patients in making informed health care decision; address health disparities across groups and areas; and address the continuum of care across multiple providers, practitioners and settings.

Implementation of a Consensus Process for Endorsement of Health Care Quality Measures--NQF shall implement a consensus process for endorsement of standardized health care performance measures which shall consider whether measures are evidence-based, reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible to collect and report, and responsive to variations in patient characteristics such as health status, language capabilities, race or ethnicity, and income level and is consistent across types of providers including hospitals and physicians.

Maintenance of Consensus Endorsed Measures--NQF shall establish and implement a maintenance process to ensure that endorsed measures are updated (or retired if obsolete) as new evidence is developed.

Promotion of Electronic Health Records--NQF shall promote the development and use of electronic health records that contain the functionality for automated collection, aggregation, and transmission of performance measurement information.

Focused Measure Development, Harmonization and Endorsement Efforts to Fill Critical Gaps in Performance Measurement--NQF shall complete targeted tasks to support performance measurement development, harmonization, endorsement and/or gap analysis.

Development of a Public Web site for Project Documents--NQF shall develop a public Web site to provide access to project documents and processes. The HHS contract work is found at:http://www.qualityforum.org/projects/ongoing/hhs/.

Annual Report to Congress and the Secretary--Under section 1890(b)(5)(A) of the Act, by not later than March 1 of each year (beginning with 2009, NQF shall submit to Congress and the Secretary of HHS an annual report. The report shall contain a description of the implementation of quality measurement initiatives under the Act and the coordination of such initiatives with quality initiatives implemented by other payers; a summary of activities and recommendations from the national strategy and priorities for health care performance measurement task; and a discussion of performance by NQF of the duties required under the HHS contract. Section 1890(b)(5)(B) of the Social Security Act requires the Secretarial review of the annual report to Congress upon receipt and the publication of the report in theFederal Registertogether with any Secretarial comments not later than 6 months after receiving the report.

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 theFederal Registerin compliance with the statutory mandate for review and publication of the annual report on September 10, 2009 (74 FR 46594).

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 theFederal Registeron October 22, 2010 (75 FR 65340) to comply with the statutorily required Secretarial review and publication.

In March 2011, NQF submitted the third annual report to Congress and 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 January 14, 2010 through January 13, 2011. The third annual report was published in theFederal Registeron September 7, 2011 (76 FR 55474).

Affordable Care Act was signed into law on March 23, 2010. 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 inHealthcare. The NQF convened the National Priorities Partnership and developed a consensus report on input to HHS on the development of the National Quality Strategy.

Section 3014 of the Affordable Care Act also required NQF to: convene multi-stakeholder groups to provide input on the selection of quality measures, such as for use in reporting performance information to the public; and transmit multi-stakeholder input to the Secretary. It also amended the requirements for the Annual Report to include identifying gaps in quality measures, including measures in the priority areas identified by the Secretary under the national strategy and areas in which evidence is insufficient to support evidence of quality measures in priority areas. Activities required by the Affordable Care Act will be carried out from 2010 throughout 2014.

In March 2012, NQF submitted its fourth annual report to the Congress and the Secretary. The report covers the period of performance of January 14, 2011 through January 13, 2012. This notice complies with the statutory requirement for Secretarial review and publication of the fourth NQF annual report.

II. March 2012--NQF Report to Congress and the HHS Secretary

Submitted in March 2012, the fourth annual report to Congress and the Secretary spans the period of January 14, 2011 through January 13, 2012.

A copy of NQF's submission of the March 2012 annual report to Congress and the Secretary of HHS can be found at:http://www.qualityforum.org/Publications/2012/03/2012_NQF_Report_to_Congress.aspx.

The 2012 NQF annual report is reproduced in section III of this notice. This year's annual report has two sections. The first is entitled2012 NQF Report to Congress Changing Healthcare by the Numbers.The second section is entitledNQF Report on Measure Gaps and Inadequacies.Both sections were reviewed by the Secretary.

III. NQF March 2012 Annual Report2012 NQF Report to Congress Changing Healthcare by the NumbersReport to the Congress and the Secretary of the U.S. Department of Health and Human Services, Covering the Period of January 14, 2011, to January 13, 2012 Pursuant to Public Law 110-275 and Contract #HHSM-500-2009-00010CContentsLetter From William Roper and Janet Corrigan

Over the last decade, Members of Congress from both parties, as well as federal and private-sector leaders, have increasingly supported the use of standardized quality measures as part and parcel of a larger healthcare value agenda. Agreed-upon strategies for improving value--healthier individuals and communities, as well as better, lower-cost care--include public reporting of standardized performance measures and linking measures to payment.

Evidence of support for this agenda includes the fact that approximately 85 percent of measures currently used in public programs are endorsed by the National Quality Forum (NQF),1as well as the significant use of NQF-endorsed measures by private health plans and employers. In addition, recent statutes--the 2008 Medicare Improvements for Patients and Providers Act (MIPPA) and the 2010 Affordable Care Act (ACA)--reinforce preferential use of NQF-endorsed measures on federal healthcare Compare Web sites, and linkage of endorsed measures to payment for clinicians, hospitals, nursing homes, health plans, and other entities.

In 2011, this commitment to a value agenda was significantly accelerated. Under the auspices of NQF, and in a historic first, private-sector organizations voluntarily worked in a more coordinated and collaborative fashion with each other and with the public sector to forge consensus about how to further this accountability environment. Specifically, innovations in convening and rulemaking facilitated the private sector bringing its real-world experience to inform guidance to the Department of Health and Human Services (HHS) on implementing the first-ever National Quality Strategy (NQS), and provided advice on selecting the best measures for use across an array of federal health programs. Forward-thinking leaders--including those on Capitol Hill and within HHS--understand that the public and private sectors working independently will not yield improvements quickly or comprehensively enough in our unorganized and complex healthcare system.

We are grateful to Congress, HHS, and private-sector leaders for their vision and tenacity in designing and advancing this ambitious value agenda, and for the progress we collectively are making against it each and every day. These advancements are made possible because of the ever-expanding number of organizations and individuals who are committing themselves to work in partnership, including our colleagues at HHS; the more than 450 institutional members of NQF; the hundreds of experts who volunteer to serve on NQF committees; the NQF staff; and the many, many organizations that constitute the quality movement. We are privileged to work at the intersection of so many committed and diverse organizations that are increasingly rowing in the same direction to improve both our nation's health and healthcare for the benefit of the American public.

We are changing healthcare by the numbers.

Executive Summary

The U.S. healthcare system is among the most innovative in the world and patients with very serious and/or unusual conditions are particularly appreciative of the range of therapies, interventions, and clinical talent it offers to treat them and restore them to health. That said, it is also one of the most fragmented, unorganized, and uncoordinated systems as compared to its counterparts in the industrialized world--which contributes to less-than-optimal quality outcomes, serious patient safety problems, and very high per-capita costs.2, 3, 4Consequently, Members of Congress, business leaders from small and large companies, patients, physicians, nurses, and many others have come to the conclusion that Americans are not deriving enough value for the substantial dollars they spend.

Important strides have been made toward improving this value proposition over the last decade, starting with thesine qua nonof using standardized performance measures to assess "how we are doing" on an array of healthcare quality and cost dimensions, making the measure results public, and then linking those results to provider payment. And while establishing this accountability environment is critical foundational work, it is not sufficient for achieving the kind of substantial improvements that the National Quality Strategy (NQS) envisions. Released by the Department of Health and Human Services (HHS) in March 2011 and supported by public- and private-sector healthcare leaders, the NQS is built around three compelling aims focused on healthy people and communities, better care, and more affordable care. To achieve these ambitious aims also will take fundamental reform of care delivery and payment, which, while underway, will still require time, effort, and perseverance to realize.

That said, the accountability environment's basic infrastructure is moving into place. A key lesson learned in constructing it is that neither the public nor private sectors, nor any single stakeholder, can meaningfully shape it on their own. Healthcare is too large and complex, with too many interrelated parts, for a go-it-alone strategy to be fully effective. Recent actions of healthcare leaders demonstrate that they understand that sustainable solutions to our nation's healthcare challenges are ones that all stakeholders embrace. Over the last year, significant progress has been made toward forging a shared sense of priorities for improvement; an agreed-upon way to set, continuously enhance, and implement strategies to achieve these priorities; and standardized methods for measuring progress along the way. Without such agreements, competing strategies and a plethora of near-identical measures run the risk of whipsawing providers and overburdening them with redundant and sometimes conflicting reporting requirements. In addition, such an environment can confuse consumers who increasingly seek to better inform themselves as they play a more active role in healthcare decision-making.

Congress, wisely understanding this need for a quality infrastructure and more public-private collaboration, passed two statutes that included this notion, and directed HHS to work with a consensus-based entity to act as a key convener and measurement standard setter. These statutes include the 2008 Medicare Improvements for Patients and Providers Act (MIPPA) (Pub. L. 110-275) and the 2010 Patient Protection and Affordable Care Act (ACA) (Pub. L. 111-148). HHS awarded contracts related to the consensus-based entity to the National Quality Forum (NQF).

NQF has prepared this third Annual Report to Congress which covers highlights of work related to these statutes conducted under federal contract between January 14, 2011 and January 13, 2012. See appendix A for a complete listing of deliverables worked on and completed during the contract year.

Building Consensus About What and How To Improve

In the fall of 2010, as HHS was developing the first-ever NQS, the National Priorities Partnership (NPP), convened by NQF, was asked to provide initial input on the overarching aims and priority areas and published a report. Subsequently, in response to a second request from HHS, NPP identified three goals for each of the NQS six priorities in a second report, along with appropriate performance measures, and "strategic opportunities" to accelerate progress. These opportunities require leveraging the reach of the many public and private stakeholder groups participating in NPP, which balances the interests of consumers, purchasers, health plans, clinicians, providers, federal agency leaders, community alliances, states, quality organizations, and suppliers. In 2011, NPP focused further on enhancing patient safety, one of the six NQS priorities and a very important focus for HHS. More specifically, NPP worked collaboratively with HHS on its Partnership for Patients initiative, through hosting quarterly meetings and an interactive webinar series, which brought tools and ideas for reducing patient harm to nearly 10,000 front-line clinicians, hospitals, and other stakeholders across the country. Moving forward in 2012, NPP will draw on the real-world experience of its partners to develop implementation strategies, likely targeting patient safety in maternity care and readmissions.

Endorsing Measures for Use in Accountability and Performance Improvement

NQF completed 11 endorsement projects during the course of the contract year--using both the NQS priorities that cross conditions and leading health conditions with respect to prevalence and cost as a way to prioritize its efforts. In total, NQF committees evaluated 353 submitted measures and endorsed 170 new measures--or 48 percent of those submitted. While the number of measures endorsed is considerably higher than in previous years, the endorsement rate is lower due to the enhanced rigor of the review criteria. At the same time, NQF placed emphasis on reducing providers' reporting burden by harmonizing specifications related to similar measures.

Currently, the portfolio of NQF-endorsed measures includes more than 700 measures, of which 30 percent assess patient outcomes and experience with care. Considerable progress also has been made in specifying measures for use with electronic health records. NQF worked with 18 measure developers to create eMeasure specifications for 113 existing endorsed measures, and released an initial and updated Measure Authoring Tool (MAT). The re-tooled measures and MAT are innovations that enable the field to get substantially closer to having electronic health records with the capacity to capture and report performance information during routine care.

Aligning Payment and Public Reporting Programs That Reward Value

A significant proportion--about 85 percent--of the measures used in federal programs are NQF-endorsed. Further, NQF-endorsed measures are used extensively by private health plans, state governments, and others. Such alignment can simultaneously reduce reporting burdens for providers and accelerate improvement because of the common signals that payers send. The NQF-convened Measure Applications Partnership (MAP), launched in the spring of 2011, fostered further alignment with its series of three performance measurement coordination strategy reports:Clinician Performance Measurement, Dual-Eligible Beneficiaries,andHealthcare-Acquired Conditions and Readmissions Across Public and Private Payers.As a part of these reports, MAP also developed a framework and criteria to guide the selection of the best measures for use in numerous payment and public reportingprograms. Building on these reports, MAP then provided pre-rulemaking guidance to HHS, including input on measure sets pertaining to 17 HHS programs, as well as strategies for enhancing consistency and minimizing reporting burden across federal programs and between public- and private-sector efforts. Leaders from nine different HHS agencies are actively participating in MAP.

This advice from MAP--provided many months in advance of relevant rules--represents a true innovation in rulemaking, with the public and private sectors now having forums for substantive back-and-forth dialogue that cuts across program silos, and a unique opportunity to build a shared perspective and consensus about measure selection. Measures related to care coordination--essential to making care more patient centered--are an object lesson for what is possible with pre-rulemaking convening and endorsement. More specifically, MAP recommended that an existing care transitions measure focused on hospitals also be used in other settings, and suggested a broadening of a readmission measure to include all ages and applicability to additional kinds of providers. MAP also advised the Center for Medicare & Medicaid Services (CMS) to require reporting of medication reconciliation measures at the time of transition between settings. As it turns out, NQF has already endorsed measures for medication reconciliation, readmission, and care transitions that apply to additional settings and populations so these measures can move right into other federal programs.

Taken together, the reports are important stepping stones for MAP as the Partnership works on a comprehensive measurement strategy it will recommend to guide HHS measure selection for federal programs in the coming years. This strategy will be informed by the Partnership's in-depth understanding of current measures and their use in relevant programs, opportunities for potential coordination and integration, growing collaboration across the public and private sectors, and a vision for the future.

Numbers are an essential guidepost for gauging healthcare performance, and measures may be a powerful motivator of change when paired with public reporting and payment. But alone, they cannot drive achievement of the value agenda. Rather, implementation of innovative measures needs to go hand-in-glove with fundamental redesign of delivery and payment systems to achieve the NQS' three, interconnected aims. And while local communities are changing the way care is organized and paid for to break down existing silos, facilitate integration and coordination of care, and connect healthcare to other sectors (e.g., employment, education), such innovations have not yet swept the country. When they do, and are coupled with accountability strategies embraced by the public and private sectors, we will be able to achieve our goals of healthier people and communities, and better, less-costly patient care. We will have then changed healthcare by design and by the numbers.

1National Quality Forum: Background

More than a decade after their publication, the Institute of Medicine's (IOM's) landmarkQuality ChasmandTo Err is Humanreports still resonate: Our healthcare system continues to fall short on quality, safety, and affordability. That said, recent years have seen a re-energized commitment to improving care and constraining healthcare costs. HHS, NQF, and the increasing number of private-sector organizations that constitute the quality movement are at the center of that resurgence.

Established in 1999 as the standard-setting organization for healthcare performance measures, NQF today has a much-broadened mission to:

* Build consensus on national priorities and goals for performance improvement, and work in partnership with the public and private sectors to achieve them.

* Endorse and maintain best-in-class standards for measuring and publicly reporting on healthcare performance quality.

* Promote the attainment of national goals and the use of standardized measures through education and outreach programs.

NQF is governed by a 27-member Board of Directors (see Appendix B) from a diverse array of public- and private-sector organizations. A majority of seats on the board is held by consumers, employers, and other organizations that purchase healthcare services on consumers' behalf. In 2011, NQF convened hundreds of experts across every stakeholder group on its priority-setting, measure-review, and measure-selection committees--individuals who volunteered their time, talents, experience, and insights (see Appendix F). NQF also directly reached some 10,000 frontline clinicians, hospitals, and others with educational programming via webinars. And its endorsed performance standards touched the care delivered to millions of patients every day.

In recent years, the number and variety of NQF-endorsed measures has greatly expanded. More than 700 NQF-endorsed measures now address most settings of care, conditions, and types of providers. The measures portfolio includes clinical process measures, patient experience of care, the actual outcomes of care, the costs and resources that go into providing care, as well as select structural measures. The portfolio is being enhanced with advanced measures, such as functional outcome and crosscutting care-coordination measures. At the same time, the NQF portfolio is being carefully culled to retire measures that no longer meet the more rigorous criteria. In the last year alone, 353 measures were submitted to NQF and 170, or nearly half, were endorsed. This endorsement rate--or ratio of submitted-to-endorsed measures--reflects NQF's efforts to systematically raise the bar on performance measurement, even as it seeks to reduce the burden on providers by eliminating duplicative measures.

To be NQF endorsed, a measure must be a process or outcome that is important to measure and report, be scientifically acceptable, be feasible to collect, and provide useful results. NQF conducts an eight-step, consensus-based process that has been continually improved over a decade (see Appendix C). Review committees are comprised of multiple stakeholders; consumer organizations are equal partners with clinicians and other stakeholders throughout the process. There is a strong commitment to transparency and NQF invites public participation at every step, ranging from nominations for committees, to decisions on specific measures. Endorsed measures are re-evaluated every three years to ensure their actual use and usefulness in the field and their continuing relevance with current science, and to determine whether they continue to represent the best in class.

Measures included in the NQF portfolio are developed and maintained by about 65 different organizations. The following gives a sense of the range of organizations NQF works with: CMS, the National Committee on Quality Assurance (NCQA), the American Medical Association-Physician Consortium for Performance Improvement (AMA PCPI), Ingenix, the Joint Commission, American College of Surgeons (ACS), Bridges to Excellence, Cleveland Clinic, Minnesota Community Measurement, and Pharmacy Quality Alliance.

In recognition of its skill in building consensus across multiple stakeholders in the measure-endorsement realm, NQFhas been asked to convene diverse committees to advise the public and private sectors on priorities for improvement, related implementation strategies, and selection of measures to both drive these strategies and gauge results. The NQF-convened NPP and MAP and their published reports are tangible outcomes of this work. An equally important outcome of these partnerships is the ongoing alignment across stakeholder groups and across public- and private-sector leaders about what levers to use to both improve healthcare performance and move the delivery system to be more patient centered.

NQF has been fortunate to have received support from the federal government for over 10 years, with more substantial support starting in 2008 when federal leaders strongly committed themselves to designing and implementing a value agenda. More specifically:

* MIPPA has provided NQF with $10 million annually over a four-year period starting in 2009. These funds--awarded to NQF through a competitive process--are supporting the organization's efforts to identify priority areas for improvement, endorse and update related performance measures, foster the transition to an electronic environment, and report annually to Congress on the status and progress to date of this effort.

* ACA has provided NQF with support of about $10 million, starting in 2011. Under section 3014, Congress directed HHS to contract with "the consensus-based entity under contract" to provide multi-stakeholder input into the NQS, as well as advice to the Secretary of HHS on the selection of measures for use in various quality programs that utilize the federal rulemaking process for measure selection. With federal leadership and support, as well as the support of foundations and over 450 NQF member organizations, much has been collectively accomplished since NQF's founding in 1999. With more substantial and predictable support from the federal government over the last three years, and an enhanced commitment on the part of the public and private sectors to work together, the basic infrastructure for performance measurement is moving into place and our ability to shape and further an environment of accountability has grown. NQF's accomplishments during 2011 will be described against that backdrop.

Sidebar 1--Working With NQF Helped Spur Rapid Evolution of Ophthalmology Measures

There are many intangible benefits from the endorsement activities supported under the HHS contract. One of these is that it provides valuable input to measure developers which helps focus measure development resources on important gap areas. The efforts of the American Academy of Ophthalmology (AAO) are a case in point.

As early as the 1980s, and before many other specialty societies, AAO developed "preferred practice patterns" to provide practice guidance for ophthalmologists. These guidelines proved to be a solid foundation to draw from when, in 2006, AAO began developing related quality measures for quality improvement feedback and public reporting purposes. Over the last five years, AAO has developed ever more sophisticated performance measures--evolving from process, to outcome, to functional status--and credits involvement with the NQF review process as an important catalyst in this evolution.

More specifically:

* AAO--in collaboration with the AMA-PCPI--first worked to develop process measures focused on eye-care issues such as diabetic retinopathy (damage to the eye's retina as a result of long-term diabetes), and performance of optic nerve exams in primary open-angle glaucoma (chronic, progressive optic-nerve damage) patients.

* Recognizing that measures that evaluate actual results of care are more critical to improving quality, NQF encouraged AAO to shift its focus to developing clinical outcome measures. As a result, NQF later endorsed a measure focused on reducing glaucoma patients' eye pressure (which can lead to optic-nerve damage or blindness) by 15 percent.

* More outcome measures were later developed and endorsed under the HHS-funded outcomes project, focusing on issues such as complications within 30 days following cataract surgery, as well as 20/40 or better visual acuity within 90 days of cataract surgery.

* Recently, the NQF board has approved measures related to patient functional status, attempting to measure improvement in patients' visual functional status and their overall satisfaction within 90 days following cataract surgery. These measures are currently under NQF review, and have been included in the 2012 Physician Quality Reporting System (PQRS) measure set.

Dr. Flora Lum, executive director of AAO's H. Dunbar Hoskins Jr., MD Center for Quality Eye Care, noted that NQF's ability to bring patient and consumer perspectives to the Steering Committee responsible for evaluating measures has been invaluable over the years. AAO's efforts to advance healthcare quality continue, with the organization now striving to develop appropriateness-of-care measures.

The evolution of AAO's measures over a short time period is noteworthy and the information that results from the measures provides physicians with multi-faceted feedback about the care they deliver. Ideally, such information is available in rapid-response reports, with educational interventions to help facilitate improvements at the practice level, and over time, so that ophthalmologists and patients can gauge progress. As AAO has gone on this journey to develop ever-increasingly sophisticated and meaningful measures, NQF has been pleased to be a part of it. [End of Sidebar 1]

Sidebar 2--Resource-Use Measures: Critical to the Value Agenda

U.S. healthcare per-capita spending is greater than that in any other country, yet it has not resulted in better health for Americans. With costs increasing beyond annual inflation, spending is largely focused on treating acute and chronic illnesses rather than prevention and health promotion.

Deriving more value from health spending is predicated on having both quality and cost (or resource use) information. To date, limited information about resource use exists. CMS and many measure developers are working to change that, and in 2009, NQF was tasked with further defining resource-use measures and identifying important attributes to consider when evaluating them. NQF also endorsed its first-ever resource-use measures during the 2011 contract year.

As defined by NQF, resource-use measures are comparable measures of actual dollars or standardized units of resources applied to the care given to a specific population or event--such as a specific diagnosis, procedure, or type of medical encounter. The endorsed measures:

* Relative Resource Use for People with Diabetes* Relative Resource Use for People with Cardiovascular Conditions* Total Resource Use Population-Based Per-Member Per-Month (PMPM) Index* Total Cost of Care Population-Based PMPM Index"The endorsement of standardized measures of healthcare resource use and cost fills a huge void that has kept the nation from measuring the value of healthcare in a consistent way," said Steering Committee member Dolores Yanagihara, director, pay for performance, at the Integrated Healthcare Association. "That said, it is a complex process, both technically and from an accountability standpoint. The measures recommended for endorsement give us a broader picture of healthcare--overall and related to specific conditions."[End of Sidebar 2] 2Bridging Consensus About Improvement Priorities and Approaches

Released by HHS in March 2011, the country's NQS focuses the public and private sectors on an inspiring set of three, interconnected aims--better care, more affordable care, and healthier people and communities--as well as six related priority areas (see Figure 1). While the field has long targeted improving clinical care, the NQS gives significant, equal heft to the notion of health/wellbeing and affordability.

The NQS provides a critical framework for the efforts of the multiple-stakeholder committees convened by NQF. These efforts range from discussions at the highest, most conceptual levels about a three-to-five-year measurement strategy to undergird the evolving value agenda; to committees working in a new measurement area and developing consensus about what and how to measure; to those simultaneously enhancing and culling a set of measures in an established area, while considering their larger context within the NQF-endorsed measurement portfolio.

National Priorities Partnership

Development of the landmark NQS was informed by the collective input of the NQF-convened National Priorities Partnership (NPP), a collaboration of 51 public- and private-sector organizations uniquely qualified to represent the array of stakeholders needed to improve the nation's healthcare system. As the NQS was being formulated, HHS sought multi-stakeholder input from NPP on its aims and priorities. After publication of the NQS in March 2011, HHS again reached out to NQF to convene NPP to provide input on further specifying goals, measures, and implementation pathways to move the national strategy and related priorities forward, drawing upon the real-world experience of its stakeholder participants.

The NPP recommendations are captured in a follow-up report to the HHS Secretary,Priorities for the National Quality Strategy,published in September 2011. This second report identifies goals and measure concepts that address the three NQS aims and six priorities simultaneously. For example, there are suggestions for goals and measurement areas related to care coordination that cut across clinical conditions. This would encourage better, more integrated care delivery, enhanced health outcomes, and fewer wasted resources. The NPP report also acknowledges that successful implementation of NQS-related goals and measures are predicated on strategic and technical measure alignment--or agreement--across various levels of accountability in our healthcare system. This starts at the most granular level--the patient and physician--and moves in a linked chain across a family of measures and levels of increasing aggregation. Without agreement about strategic direction and concordance on measure selection, a predictable cacophony results, frustrating clinicians and confusing consumers. The cholesterol-control example (Figure 2) provides an illustration of a family of measures with linkages across levels and illustrates this crucial strategy of alignment. Further, these NQF-endorsed measures are included in HHS's newly launched and broad-based MillionHearts Campaign--a public-private initiative that aims to prevent one million heart attacks and strokes in five years.

In addition to NPP's consultative role as it relates to the NQS, NPP has served as a catalyst in developing implementation strategies--working across diverse stakeholder groups to spur collective action--focused on improving patient safety and reducing patient harm. Such a focus also can reduce costs, with the IOM estimating that decreasing healthcare-associated infections (HAIs), complications, and unnecessary readmissions by 10 to 20 percent could result in $2.4 billion to $4.9 billion annual savings for the U.S. healthcare system.5

NQF's Focus on Safety

In 2011, NQF's work in the safety realm spanned updating of measures and serious reportable events (SREs), a recommended approach for further aligning public- and private-sector patient-safety measurement strategies, and development of implementation strategies in support of HHS's Partnership for Patients Initiative.

Partnership for Patients is engaging stakeholders from the private and public sectors to reduce all-cause harm (i.e., all forms of harm that can affect patients) and hospital readmissions. More specifically, NPP partnered with the Partnership for Patients to host 11 webinars that attracted about 10,000 frontline clinicians, hospitals, and others across the country and provided education, tools, resources, and insight on key safety issues. These webinars ranged from big-picture interventions (e.g., how to get your Board on board when it comes to improving patient safety), to those with a more laser focus on clinical teams (e.g., reducing surgical-site infections [SSIs]). Nearly 90 percent of webinar participants, who came from every region of the country, reported that they would be able to implement something new in their institutions as a result of this novel public-private programming. Moving forward in 2012, NPP is developing two action pathways, which its multiple partners can implement and spread. These pathways are focused on the health of mothers and babies by reducing elective deliveries before 39 weeks, and reducing avoidable admissions and re-admissions across all settings of care. These represent 2 of the 10 areas Partnership for Patients is pursuing to achieve its global safety and harm-reduction goals. Reaching these goals also will substantially reduce costs.

In addition, MAP released a report,Coordination Strategy for Healthcare-Acquired Conditions and Readmissions Across Public and Private Payers,in October 2011, detailing the ways in which public and private healthcare providers can align performance measurement to enhance patient safety. Specifically, the report makes three recommendations: (1) There needs to be a national set of core safety measures applicable to all patients; (2) Data need to be collected on all patients to inform these national core safety measures; and (3) Public and private entities need to coordinate their efforts to make care safer. MAP's recent pre-rulemaking report further emphasizes the importance of safety measures by supporting their inclusion in federal public reporting and performance-based payment programs, and MAP will focus on alignment of core safety measures across programs in 2012. With respect to measure review, NQF endorsed numerous patient-safety measures, including healthcare-associated infections (HAIs), which now address long-term, acute-care and rehabilitation hospitals, and radiation-safety measures, to name a few.

NQF also updated its list of SREs, a compilation of serious, harmful, and largely--if not entirely--preventable patient-safety events, designed to help the healthcare field assess, measure, and report performance in providing safe care. In the 2011 update, the events were broadened in focus to explicitly include hospitals, office-based practices, ambulatory surgery centers, and skilled nursing facilities to reflect the various settings in which patients receive care and could experience harm. Based on input from users, the implementation guidance for each event was expanded, and a glossary was added to facilitateuniformity in reporting of the events. The list includes wrong-site surgery; death or serious injury associated with medication errors or unsafe blood products; and failure to follow up on lab, pathology, or radiology test results. Public and private purchasers have drawn heavily from the SRE list in identifying healthcare-associated conditions for use in payment and reporting programs. (See Sidebar 3.)

Sidebar 3--NQF and Patient SafetyPatient-Safety Measures

NQF's inventory of endorsed measures includes more than 100 patient-safety measures, with several focused specifically on healthcare-associated infections or HAIs. Preventing HAIs has become a national priority for public health and patient safety. To date, 27 states are requiring public reporting of certain HAIs. Further, the NQS has identified safer care as one of its primary aims and, in 2013, hospitals' annual Medicare payment updates will be tied to submission of infection data, including central line-associated bloodstream infections and surgical-site infections (SSIs).

In this past year, NQF endorsed four additional patient-safety measures focused on HAIs, including a successfully harmonized measure from the American College of Surgeons and the Centers for Disease Control and Prevention focused on SSIs, and updates of existing HAIs addressing urinary tract infections and bloodstream infections. These efforts were completed under federal contract.

Serious Reportable Events

Preventing adverse events in healthcare is also central to NQF's patient-safety efforts. To ensure that all patients are protected from injury while receiving care, NQF has developed and endorsed a set of serious reportable events (SREs). This set is a compilation of serious, harmful, and largely--if not entirely preventable--patient safety events, designed to help the healthcare field assess, measure, and report performance in providing safe care. The SREs focus on the following areas:

* Surgical or invasive-procedure events* Product or device events* Patient-protection events* Care-management events* Environmental events* Radiologic events* Potential criminal events

Originally envisioned as a set of events that would form the basis for a national state-based reporting system, the SREs continue to serve that purpose. To date, 26 states and the District of Columbia have enacted reporting systems to help stakeholders identify and learn from SREs. The majority of those states incorporate at least some portion of NQF's list to help align reporting efforts and encourage learning across healthcare systems.[End of Sidebar 3]

Finally, NQF launched a project in 2011 that will leverage health IT data to address patient safety and quality concerns associated with medical devices, such as pumps used to deliver intravenous medications at home. This project, which continues in 2012, will determine what data needs to be collected and shared to improve quality and safety related to devices. It also will focus on ways to identify and report adverse events associated with the use of such devices.

3Endorsing Measures and Developing Related Tools

With its extensive evaluation (see Sidebar 4) and multi-stakeholder input, NQF is recognized as a voluntary consensus standards-setting organization under the National Technology Transfer and Advancement Act of 1995. In addition, NQF adheres to the Office of Management and Budget's formal definition of consensus.6Consequently, NQF-endorsed measures have special legal standing allowing federal agencies to readily adopt them into their programs, which they have done at a striking rate. About 85 percent of measures in federal health programs are currently NQF-endorsed, including those that apply to hospitals, clinicians, nursing homes, patient-centered medical homes, and many other settings.

In 2011, NQF completed 11 endorsement projects--reviewing 353 submitted measures and endorsing 170, or 48 percent. Enhancements to the endorsement process over the last year included strengthening its rigor by requiring testing of measures prior to measure review, initiation of a project to reduce endorsement cycle time, integration of review of existing measures with new measures to ensure harmonization and best-in-class assessment, and creation of an expedited review process to respond to important regulatory or legislative requests. In addition, NQF worked with 18 measure developers to update 113 electronic measures, or eMeasures, so they could be more readily collected through EHRs, and introduced and updated tools to respectively facilitate development and collection of eMeasures.

Sidebar 4--What does it take for a measure to get endorsed?

With the enhanced rigor of NQF's endorsement criteria, only about 50 percent of submitted measures were endorsed this past year.

The leading reason that measures do not pass the grade is failure to meet the "must pass" importance-to-measure-and-report criterion. This includes being able to demonstrate that the proposed measure or related data is focused on a high-impact health goal or priority; there is less-than-optimal performance; and there is strong scientific evidence for the measure, with respect to quality, quantity, and consistency. NQF expert committees rate the evidence based on specific guidance.

The second "must pass" criterion is scientific acceptability of measure properties. In other words, do the data from testing the measure show that it is reliable and valid and precisely specified? Expert committees look for moderate-to-high ratings so they are confident the measure results are reliably consistent and can be compared across providers and analyzed longitudinally. Other important criteria include usability and feasibility--assessing whether intended audiences can understand the results and find them helpful for decision-making and quality improvement. The criteria also consider whether providers can collect data without undue burden. See Appendix C for more detail.[End of Sidebar 4]

NQF Endorsement in 2011

The overall framework used to guide the NQF measures portfolio is multi-dimensional. It includes the NQS crosscutting priorities, as well as leading health conditions with respect to prevalence and cost that affect an array of populations. Figure 3 provides a snapshot of how the current NQF-endorsed measures portfolio stacks up against the NQS, with the percentages reflecting the proportion of NQF-endorsed measures against the six priorities. Some measures are counted in multiple priority areas. The chart shows gaps in emerging measurement areas, including patient-family centered care, measures related to community health and wellbeing, and affordability. These gaps require significant foundational work to understand what to focus on for measurement and how to best overcome technical barriers. NQF has undertaken this foundational work over the last year, and has started to bring in measures in all of these areas for endorsement review.

The 170 measures newly endorsed by NQF in 2011 include many outcome measures; measures that focus on populations previously under-represented, including pregnant women and children; a number of patient-safety measures--given the importance of reducing patient harm; measures in new areas that fill important gaps, such as cost (resource use); as well as the updating of measures related to highly prevalent conditions, (e.g., cardiac and surgical care). More specifically:

Outcome Measures

NQF has made great strides over the past year to endorse measures that evaluate results of care, particularly in the patient-safety, nursing-home, and surgical-care areas. Outcome measures are considered most relevant to patients and providers looking for improved quality and patient experience, as opposed to measures that assess process or structure. Examples of outcome measures endorsed in 2011 include potentially avoidable complications for select conditions (i.e., stroke, pneumonia), remission of symptoms in patients with depression, and patient experience in nursing homes and dialysis facilities.

Patient-Safety Measures

Long a focus of NQF, these new patient-safety measures span settings and types of conditions. They include measures focused on HAIs (urinary tract, central-line-associated bloodstream, and SSIs), and measures focused on issues such as standardized data collection and reporting of radiation doses.

Maternal and Child-Health Measures

These populations have been underrepresented in performance measurement. NQF has worked to fill these gaps through two endorsement projects over the past year--child health, and perinatal and reproductive health. Child-health measures focus on important screenings and access to care, including immunizations, hearing assessments, and well-child visits. Other measures address population health outcomes, including the number of school days missed due to illness and birth outcomes. Proposed perinatal measures (this project is still underway) address procedures such as cesarean sections and elective delivery prior to 39 weeks.

New and Existing Measurement Areas

NQF reviewed measures related to resource use, both those related to conditions (e.g., diabetes and cardiovascular disease), and those related more to global resource use. Endorsement projects in 2011 also focused on reviewing existing measurement areas for high-prevalence conditions or areas (palliative care and end-of-life care, cardiovascular disease and kidney disease), adding new measures, and retiring others as the expert committees saw fit. More specifically, NQF endorsed or maintained measures focused on optimal vascular care, complications or death for specific surgical procedures, and assessment of post-dialysis weight by nephrologists for kidney disease patients. Although NQF has made considerable progress in endorsing outcome measures--which constitute about 30 percent of the portfolio--differences exist with respect to outcome and process measures across conditions, which is illustrated in Figure 4. For example, there are more outcome measures for surgery and perinatal care than for mental health and cancer care. Also, HAIs are reflected under surgery, not infectious disease.

When NQF begins to address a new measurement area, the relevant expert committee will often start by developing a framework report to guide its future measurement review. These reports may include a scan of existing measures, a discussion about where there are key opportunities for improvement, and consideration of potential technical barriers. For example, NQF is developing a population health-measurement framework aimed at aligning delivery system, public health, and community stakeholder efforts to improve health outcomes and the social determinants of health. Historically, there has been little coordination across these sectors. NQF is also developing a patient-centric measurement framework for assessing the efficiency of care provided to individuals with multiple chronic conditions. This report will inform NQF's future efforts to endorse measures that apply respectively to population health and care for people who have more than one chronic condition.

Culling the NQF Portfolio

A key part of NQF's review process is focusing on endorsing best-in-class measures and eliminating similar or even identical measures that create confusion and burden across clinical settings and providers. This alignment of very similar measures--or measure harmonization--can reduce reporting burden for providers and enhance comparability of results for patients and payers, thereby reducing confusion and enabling decision-making. The harmonization of the surgical site infection measures from the Centers for Disease Control and Prevention and the ACS is a case in point (see Sidebar 5). Further, NQF's maintenance process retires existing measures that no longer meet the higher endorsement bar, thereby further culling the portfolio.

Sidebar 5--Harmonizing Surgical-Site Infection Measures

As part of NQF's federally funded Patient-Safety Measures project, similar and competing surgical-site infection (SSI) measures from the Centers for Disease Control and Prevention (CDC) and the American College of Surgeons (ACS) were reviewed. The CDC SSI measure has been in use since 2005; the ACS measure since 2004.

As a result of NQF member and public comments, and requests by the Steering Committee, the developers worked with NQF support to harmonize these two competing approaches to measurement. The result is a newly harmonized SSI measure, which is currently focused on abdominal hysterectomies and colon surgeries. CDC and ACS will jointly maintain the measure. The two organizations have also committed to developing harmonized measures for other procedures and will incorporate them into the combined SSI measure.

Notably, CMS has selected this harmonized measure for inclusion in the 2012 final rule of the Inpatient Prospective Payment System (IPPS).

Dr. Clifford Ko, director of ACS's National Surgical Quality Improvement Program, was directly involved in this effort. Dr. Ko noted that the resulting measure--Harmonized Procedure-Specific Surgical-Site Infection Outcome Measure--will now be available to literally thousands of hospitals that want to measure and improve their surgical-site infection rates.

Dr. Daniel Pollock, surveillance branch chief in CDC's Division of Healthcare Quality Promotion, says CMS' decision to include this measure will significantly increase SSI reporting rates in hospitals throughout the country. With increased reporting, providers will have more opportunities to identify areas for improvement. In addition, patients and payers will have SSI rate information when they are choosing between hospitals in a community.

While both Drs. Ko and Clifford noted that some characteristics of the original measures may be diminished or lost,they agreed that harmonized measures help eliminate the confusion non-comparable measures create and that, ultimately, providers, payers, and the public benefit.[End of Sidebar 5]

The recent Cardiovascular Project illustrates how NQF expert committees now consider new measures against existing endorsed measures. Using the measure evaluation criteria and guidance on evaluating related and competing measures, the Cardiovascular Committee reviewed proposed new measures and those undergoing maintenance, focusing on measures that address the broadest patient population or settings, while avoiding duplication whenever possible. Based on this rigorous vetting, 39 out of 65 measures (7 new and 32 undergoing maintenance) were endorsed (see Figure 5). When all is said and done, between 2010 and 2011 this represents approximately 13 percent fewer NQF-endorsed cardiovascular measures in this project.

Enhancing NQF Endorsement

As NQF's measures portfolio evolves, so too does its endorsement process. In 2011, NQF enhanced the rigor of its process by requiring that measures be tested before they are reviewed. This requirement now ensures that expert committees have crucial information about measure reliability and validity as they consider endorsement. In addition, NQF also established an approach that added greater consistency to review of the underlying evidence for measures, and created an expedited endorsement pathway to be responsive to key regulatory or legislative requests. Finally, NQF embarked upon a number of efforts to enhance effectiveness of the review process, including a lean effort to further reduce endorsement cycle time. This effort, which got underway in late 2011, maps each of the steps of the endorsement process to drive out redundancy, waste, and ultimately costs for measure developers, NQF, and HHS.

The Information Technology Accelerant

A future healthcare system that fully embraces health information technology (HIT) will allow for performance data to be collected in real time across settings, integrated, and regularly fed back to providers to inform practice and decision-making. It also will allow performance information to be made accessible in aggregated, de-identified, and timely public reports for payers and patients. Recent federal efforts--to simultaneously wire ambulatory practices and hospitals and assess providers' "meaningful use" of electronic health records (EHRs)--have been important steps on the path to a future HIT-enabled system.

Such milestones have been augmented by a number of NQF efforts that are helping the field move to a common electronic data platform that allows for the collection of more clinically relevant and actionable performance-measurement data. These HIT-enabled environments hold out the promise of reducing reporting burden for clinicians and other providers, and enhancing the precision and comparability of results.

In the past year, NQF has worked with measure developers to re-specify paper-based measures for EHRs, and developed tools that allow measure developers to marshal the building blocks necessary for their successful implementation. In both cases, these efforts broke new ground. To the best of NQF's knowledge, they have never been attempted--or accomplished--before. More specifically:

E-Measures

In 2010, at the request of HHS, NQF worked with 18 measure developers to re-tool 113 existing, endorsed measures for the electronic environment--that is,to develop electronic specifications that allow an EHR to calculate the measure--so they could be included in the Meaningful Use program. These eMeasures were further updated and enhanced in 2011. The measure stewards and NQF found that re-tooling measures for a new (electronic) platform was not a simple, straightforward matter; rather it involved the stewards re-conceptualizing each of the measures, with the support of NQF.

Quality Data Model (QDM)

This information model provides measure developers with a first-ever "grammar," which defines data elements. These data elements can then be efficiently assembled and re-assembled into performance measures to be read by EHRs. Work on the QDM began in 2007, with funding from the Agency for Healthcare Research and Quality (AHRQ). In 2011, the third version of the QDM was released, which includes data elements to enable development of measures in gap areas, including patient/consumer engagement and disparities, as well as new methods of data capture and use. In summary, this effort makes a substantial contribution toward being able to more readily leverage existing electronic health-record data to produce clinically relevant, advanced measures.

Measure Authoring Tool (MAT)

This non-proprietary, web-based tool makes it easier and more efficient for measure developers to specify, submit, and maintain electronic measures, or eMeasures. Introduced in 2011, there are now more than 35 organizations using this tool for eMeasure development.

Work that began in 2011 and carries over into 2012 includes a project focused on sharing data across settings, convening a forum for stakeholders to share best practices related to implementation of eMeasures, and a project that will leverage health IT data to address patient safety and quality concerns associated with medical devices, which was described previously. More specifically, with respect to the first two projects:

HIT Systems To Support Care Coordination Measurement: Data Sources and Readiness

This project is analyzing the current process for identifying and sharing data on significant patient factors, planned interventions, and expected outcomes (care goals) to support quality measurement related to transitions of care. It will recommend a critical path forward with specific action steps that the government can take to enable electronic measurement around care plans.

E-Measure Collaborative

The eMeasure Collaborative, a public forum convened by NQF, is bringing together stakeholders from across the quality enterprise. The eMeasure Collaborative's goal is to promote shared learning and advance knowledge and best practices related to the development and implementation of eMeasures.

4Aligning Accountability Programs To Enhance Value

At the request of HHS, NQF commissioned RAND Health to conduct an initial evaluation to better understand who is using NQF-endorsed measures and for what purposes. The RAND studies--coupled with NQF's own internal tracking efforts to understand measure use--have helped to provide some important context for HHS, NQF, and the NQF-convened MAP discussions.

Growing Use of NQF-Endorsed Measures

RAND interviews of key stakeholders using NQF-endorsed measures and online research across approximately 75 varied organizations found that nearly all used NQF-endorsed measures, although the extent varied as did the particular measures selected for use. Further, the study showed that most organizations used endorsed measures in quality-improvement efforts, followed closely by public reporting, then payment programs. The 2011 study also found that there is a strong preference to use NQF-endorsed measures where they exist because they are vetted, evidence-based, and seen as more credible within the provider community

NQF's additional research outside of the HHS contract indicates that about 90 percent of the portfolio of NQF-endorsed measures is being used in varied programs across the public and private sectors. Figure 6 is an estimation of the use of NQF-

Dated: August 27, 2012. Kathleen Sebelius, Secretary, Department of Health and Human Services.