Measurements for Improved Quality in Healthcare

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Measurements for Improved Quality in Healthcare

The American healthcare system is complex and fragmented, and is currently the most expensive system in the world. This report is focused on systematic healthcare improvements based on clinical outcomes indicators and disease registries in the United States. It is part of the Swedish Agency for Growth Policy Analysis’

Health Measurement Project in which quality measurements in

USA

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Reg. no. 2013/012

Swedish Agency for Growth Policy Analysis Studentplan 3, SE-831 40 Östersund, Sweden Telephone: +46 (0)10 447 44 00

Fax: +46 (0)10 447 44 01 E-mail: info@growthanalysis.se www.growthanalysis.se

For further information, please contact Martin Wikström Telephone: 010 447 44 73

E-mail: martin.wikstrom@tillvaxtanalys.se

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Foreword

This country report is focused on systematic healthcare improvements based on measurements within the healthcare system, including clinical outcome indicators and disease registries in the United States of America. It is part of the Swedish Agency for Growth Policy Analysis’ Health Measurement Project in which quality measurements in healthcare have been studied in a number of countries. The Swedish Ministry of Health and Social Affairs commissioned the project.

The report was written by Sofie Björling at Growth Analysis office in Washington DC.

Martin Wikström was the project leader for the multinational study.

Stockholm, April 2013

Enrico Deiaco, Director and Head of Division, Innovation and Global Meeting Places

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Summary

The American healthcare system is complex, fragmented and currently the most expensive in the world. High-quality care has traditionally not been emphasized, which seems to be partly due to the payment system which is predominantly fee-for-service with the absence of a single payer. The country does not have a central agency responsible for ensuring the quality of the healthcare services delivered to patients, although the Department of Health and Human Services (HHS) is the principal federal ministry. The Center for Medicare and Medicaid Services (CMS), an agency under HHS, is the largest payer of healthcare services in the country and has significant influence on how the quality of care is measured and evaluated and what is paid for, even in the private sector.

The ongoing healthcare reform is still politically controversial, but includes many initiatives with the objective of making healthcare more cost-efficient and of higher quality than before. It is believed that paying for quality will lower costs as well. There is more interest in patient-centered care now than before and a more holistic view of care is emerging.

Many different types of quality measures are collected by a variety of stakeholders, such as measure developers, entities involved in endorsement, certification, or accreditation, federal agencies, and a wide range of measure end-users, including health plans, hospital and medical systems, and other providers of health services, local and state agencies, and multi-stakeholder alliances. This is problematic and can be a big burden for the providers, because it has resulted in multiple reporting requirements since health plans have not developed similar approaches to quality reporting.

CMS runs several programs wherein healthcare providers are reimbursed for reporting quality measures as well as delivering care that meets certain quality standards. There is an ongoing shift when paying for healthcare services, from paying for volume (fee-for- service), to paying for results (pay-for-performance), both in the public and private insurance sector.

There are numerous registries in the country with many different owners, such as professional organizations, insurance companies, healthcare providers, researchers, and others, but relatively few initiatives that span the entire country. There is currently no list of all registries in the United States, although a new project by the Agency for Healthcare Research and Quality (AHRQ) is trying to change this. There is an emerging interest in using disease registries to monitor and improve healthcare quality and political initiatives on mandating participation in registries exist. CMS has several such requirements in place when paying for care.

The federal government has invested a considerable amount of money into the implementation of Electronic Health Records (EHR) in the healthcare system. Incentives are paid to eligible hospitals and professionals that adopt, implement, upgrade or demonstrate

“meaningful use” of certified EHRs. Submission of data to a clinical data registry will be one of the criteria that eligible professionals and hospitals must meet in order to continue to participate in EHR incentive programs in the future.

Three examples of healthcare providers that deliver high-quality care are presented in this report: the Veterans Health Administration, Kaiser Permanente and Intermountain Healthcare. They were chosen on the basis that they all rely heavily on quality measurements and use EHRs and registries in their work.

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Sammanfattning

Det amerikanska sjukvårdssystemet är komplext, fragmenterat och för närvarande det mest kostnadskrävande i världen. Man har traditionellt inte lagt tonvikten på högkvalitativ vård, något som delvis tycks bero på betalningssystemet som övervägande är en lösning med volymbaserad ersättning utan enhetlig finansiering. Det finns ingen central myndighet som ansvarar för att säkerställa kvaliteten på patientvården, även om Department of Health och Human Services (HHS) är det i sammanhanget viktigaste federala departement. Center for Medicare and Medicaid Services (CMS), en del av HHS, är den största köparen av sjuk- vård och har stort inflytande på hur vårdkvaliteten mäts och utvärderas och vad man betalar för, även inom den privata sektorn. Vårdreformen är fortfarande politiskt kontro- versiell, men innehåller många initiativ som syftar till att göra vården kostnadseffektivare och höja kvaliteten. Man anser att om man i framtiden skiftar till att betala för kvalitet så kommer kostnaderna att sjunka. Intresset för patientorienterad vård har ökat och en mer holistisk syn på vården håller på att växa fram.

Många olika typer av kvalitetsmått samlas in av en rad olika aktörer, däribland utvecklare av mätmetoder, organ med uppgift att godkänna, certifiera eller ackreditera, federala myndigheter samt ett stort antal slutanvändare där kvalitetsmåtten används – sjukvårdsförsäk- ringar, sjukhus och medicinska system, andra leverantörer av vårdtjänster, lokala och stat- liga myndigheter samt allianser av flera intressenter. Detta är ett problem i sig och kan medföra en stor belastning för vårdleverantörerna. Detta då försäkringsgivarna inte utvecklat liknande system för rapportering och kvalitetsredovisning.

CMS driver flera program där vårdgivare får ersättning för att rapportera kvalitetsmått och för att erbjuda vård som uppfyller vissa kvalitetsstandarder. Det pågår en förskjutning från volymersättning (fee-for-service) till målbaserad ersättning (pay-for-performance), både inom den offentliga och den privata försäkringssektorn.

Det finns en mängd register i landet vilka kan vara ägda av branschorganisationer, försäk- ringsbolag, vårdgivare, forskare eller andra. Få register är landsomfattande. För närvarande finns ingen lista över alla kliniska register i USA, även om ett nytt projekt i regi av Agency for Healthcare Research and Quality (AHRQ) försöker skapa en sådan. Det finns ett väx- ande intresse för att använda sjukdomsregister i syfte att övervaka och förbättra vårdkvali- teten, och det kommer krav från politiskt håll att göra registeranvändningen obligatorisk.

CMS tillämpar flera sådana krav när vårdtjänster upphandlas.

Den federala regeringen har investerat avsevärda summor i att införa elektroniska patientjournaler i sjukvården. Man betalar ut ersättningar till sjukhus och yrkesutövare som implementerar, uppgraderar till, eller uppvisar ”meningsfull användning” av godkända elektroniska patientjournaler. Rapportering av uppgifter till kliniska dataregister kommer att bli ett av de kriterier som yrkesutövare och sjukhus måste uppfylla för att få fortsätta delta i incitamentsprogram för elektroniska patientjournaler i framtiden.

Tre exempel på vårdgivare som levererar högkvalitativ vård presenteras i denna rapport:

Veterans Health Administration, Kaiser Permanente och Intermountain Healthcare. De valdes ut eftersom de alla tillämpar kvalitetsmått i stor utsträckning och använder elektroniska patientjournaler och register i sina verksamheter.

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1 Introduction to the healthcare system

1.1 The System

The healthcare system in the United States is complex and is based on different kinds of federal, state, and private health insurance coverage. 56 percent of the residents received primary care coverage from private health insurance companies in 2010, of which 51 percent received it via their employers. Almost 50 million residents were uninsured, which is 16 percent of the population. Medicare is a federal insurance program for the elderly, some disabled and patients with end-stage renal disease, and is financed through premiums, pay- roll taxes, and federal general revenues. Medicaid is a joint federal-state program for certain low-income populations. It is administered by the states within broad federal guidelines and is a tax-funded, joint federal–state health insurance program. The federal government gives states matching funds for Medicaid. The State Children’s Health Insur- ance Program (CHIP) offers coverage for children in low-income families. The Centers for Medicare and Medicaid Services (CMS) is a federal agency that administers Medicare, Medicaid and CHIP.¹

In 2011, the federal government financed 28 percent of total health spending, which was an increase from 23 percent in 2007. The households financed 28 percent and businesses, state and local governments, and other private revenues financed 21, 17 and 7 percent, respectively.²

A broad mix of organizations and programs provide care for uninsured, low-income, and vulnerable patients. These include public hospitals, community health centers, local health departments and free clinics.³ Hospitals providing care to a disproportionate number of low-income and uninsured patients receive federal Disproportionate Share (DSH). States receive an annual DSH amount to cover the costs of DSH hospitals that provide care to low-income patients who are not paid by other payers, such as Medicare, Medicaid, CHIP or other health insurance.⁴ The federal government funds community health centers, which provide a major source of primary care for underserved and uninsured populations. Private providers are a significant source of charity and uncompensated care. Among those who were insured in 2010, 29 million were underinsured.⁵

The type of healthcare benefits a person receives in the United States varies according to the type of insurance he or she has. Primary care doctors account for roughly 40 percent of all U.S. doctors.⁶ The majority of primary care doctors operate in small practices with fewer than five full-time–equivalent physicians. Depending on the insurance plan, a patient generally has a free choice of doctor and is usually not required to register with a primary

1 S. Thomson, R. Osborn, D. Squires, and M. Jun, International Profiles of Health Care Systems, 2012, The Commonwealth Fund, November 2012. http://www.commonwealthfund.org/Publications/Fund-

Reports/2012/Nov/International-Profiles-of-Health-Care-Systems-2012.aspx , accessed February 18, 2013.

2 http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and- Reports/NationalHealthExpendData/downloads/highlights.pdf, accessed April 5, 2013.

Reports/2012/Nov/International-Profiles-of-Health-Care-Systems-2012.aspx, accessed February 18, 2013.

4 http://www.hhs.gov/recovery/cms/dsh.html, accessed February 19, 2013.

6 http://www.hschange.com/CONTENT/1078, accessed March 25, 2013.

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care practice. Primary care doctors have no formal gatekeeper function, except within some managed care plans.⁷ Most healthcare services in the United States are paid via fee- for-service and primary care has traditionally been underfunded. The country has less primary care physicians than other countries, which contributes to the system being more expensive. Several actors are now trying to reinvigorate primary care into the system.⁸ The Department of Health and Human Services (HHS) is a key stakeholder working to ensure an adequate primary care workforce^.9 According to the OECD, the shortage of primary care services not only contributes to the healthcare system being more expensive, but also contributes to some lower outcomes of care. “The United States stands out as performing very well in the area of cancer care, achieving higher rates of screening and survival from different types of cancer than most other developed countries. The United States does not do well in preventing costly hospital admissions for chronic conditions, such as asthma or chronic obstructive pulmonary disease, which should normally be managed through proper primary care.”¹⁰

The U.S. Department of Veteran Affairs has the largest healthcare system in the country based on revenue and is both a payer and a provider. It operates 153 medical centers. It also operates what it describes as more than 1,400 sites of care, including 909 ambulatory care and community-based outpatient clinics, 135 nursing homes, 47 residential rehabilita- tion treatment programs, 232 Veterans Centers, and 108 comprehensive home-care programs.¹¹ The largest hospital group in the country is the Hospital Corporation of America (HCA)¹² with 163 hospitals.

1.2 Healthcare Reform

For almost a century, presidents and members of Congress have tried and failed to provide universal health benefits to Americans. On March 23, 2010, following many debates be- tween Republicans and Democrats and after passage in Congress without one single Republican vote, President Obama signed legislation into law that would remake the nation’s healthcare system, the Patient Protection and Affordable Care Act (ACA).¹³ Obamacare, as the reform was provocatively named by opponents and a name the Presi- dent reportedly now likes, has been the subject of much debate even after its passage.

Healthcare was the second most important topic during the midterm election of 2010 and the newly elected Republican majority in the House of Representatives made as one of its first pledges 2011 to “repeal and replace Obamacare”. This turned out not to be possible, however, and the constitutionality of parts of the law, most specifically the individual mandate which requires people to buy health insurance, was instead brought to the Supreme Court by a majority of the states in the country. In a much publicized ruling in June 2012, the court ruled that the individual mandate is not against the Constitution, but

8 Interview December 11, 2012 with Ann O´Malley, Senior Fellow at Center for Studying Health System Change.

9 Interview January 16, 2013 with Donald Moulds, Acting Assistant Secretary of Planning and Evaluation and Pierre Yong, Division of Quality at the Department of Health and Human Services.

10 http://www.oecd.org/els/healthpoliciesanddata/49084319.pdf accessed January 19, 2013.

11 http://www.darkdaily.com/nations-list-of-top-ten-largest-healthcare-systems-include-some-surprises- 113#axzz2EMph4sZI, accessed February 19, 2013.

12 http://hcahealthcare.com/home/index.dot,accessed February 19, 2013

13 http://www.nytimes.com/interactive/2009/07/19/us/politics/20090717_HEALTH_TIMELINE.html, accessed February 19, 2013.

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did make the Medicaid expansion optional for the states, which the law expands signifi- cantly.¹⁴

The main reasons for the healthcare debate are the high cost of healthcare in the country and the large number of persons without healthcare insurance. The annual per-capita health expenditure in the country is the highest in the world – US$8,233 in 2010. Total national health expenditures have been increasing at rates well above the increase in national income, reaching 17.6 percent of GDP in 2010 and expected to reach 19.6 percent by 2021, if current trends continue.¹⁵ Over 62 percent of all personal bankruptcies in 2007 were due to medical bills.¹⁶ Many believe that one reason for the high costs is the fee-for-service system, in which providers are reimbursed for all services performed, regardless of their impact on patient health. There is very little pressure to discourage the delivery of unnecessary services in the system. Most patients are shielded from the direct cost of care, because they are covered by private or public insurance, while the fear of lawsuits encour- ages doctors to order a large number of tests and other procedures (“defensive medicine”).¹⁷ It has been estimated that $750 billion was spent on unnecessary health-related costs in 2009.¹⁸ As with many things in the United States, care and treatment quality varies considerably across the country, but since the country is below the OECD average in many health indicators, such as life expectancy at birth¹⁹ and infant mortality²⁰, the discussions concern how the costs can be decreased without simultaneously lowering, but actually increasing, the quality of the care.

The ACA is mostly known for regulating health insurance by expanding health coverage to 30 million more Americans within a decade, predominantly by instituting a fee on individuals choosing not to purchase health insurance and by expanding Medicaid. It also offers subsidies to people whose income is below 400 percent of the federal poverty level to help them afford private coverage. The majority of the 905 pages of the law contains changes in the business model for medicine in the country, however, something that is not discussed much in public. The law includes 45 changes to how doctors deliver healthcare and how patients pay for it. The objective is to move the country’s health system away from one that pays for volume toward one that pays for value. The law aims at rewarding healthcare providers that can deliver care that is both less costly and more effective. There are already providers in the country that use this model, called integrated delivery systems. In some integrated delivery systems, such as staff model HMOs, hospitals and insurers work together to deliver the most cost-effective treatments and doctors are often paid a flat salary.

14 http://www.nytimes.com/2012/06/29/us/supreme-court-lets-health-law-largely-stand.html?pagewanted=all, accessed February 19, 2013.

16 http://www.amjmed.com/article/S0002-9343(09)00404-5/abstract, accessed February 18, 2013.

17 http://www.theatlantic.com/health/archive/2012/05/moving-away-from-fee-for-service/256755/, accessed January 19, 2013.

18 National Research Council. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington, DC: The National Academies Press, 2012.

19 http://www.oecd-ilibrary.org/sites/health_glance-2011-en/01/01/g1-01- 01.html?contentType=&itemId=/content/chapter/health_glance-2011-4-

en&containerItemId=/content/serial/19991312&accessItemIds=/content/book/health_glance-2011- en&mimeType=text/html, accessed January 19, 2013.

20 http://www.oecd-ilibrary.org/sites/health_glance-2011-en/01/07/g1-07- 01.html?contentType=&itemId=/content/chapter/health_glance-2011-10-

en&containerItemId=/content/serial/19991312&accessItemIds=/content/book/health_glance-2011- en&mimeType=text/html, accessed January 19, 2013.

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Instead of doctors charging for each procedure they perform, they often receive incentive payments for reaching certain quality metrics.²¹ Since CMS is by far the largest single payer of healthcare in the country it is believed that by changing the way CMS will pay for health services, it will bring the rest of the healthcare sector with it.

21 http://innovation.cms.gov/initiatives/ACO/index.html, accessed January 20, 2013 and

http://www.washingtonpost.com/blogs/wonkblog/post/health-reform-at-2-why-american-health-care-will- never-be-the-same/2012/03/22/gIQA7ssUVS_print.html, accessed January 20, 2013.

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2 Discussions on and initiatives for increased quality and follow-up in HC

2.1 Quality of Healthcare

Even though the United States is among the wealthiest countries in the world and spends the most on healthcare, is it far from the healthiest. Americans live shorter lives and suffer more injuries and illnesses than people in many other high-income countries, according to a recent study by the National Research Council and the Institute of Medicine (IOM). Even highly advantaged Americans, i.e. those that are covered by health insurance and are white, educated or belong to upper-income groups, appear to be in worse health than similar groups in 17 peer countries. In most age groups, however, the report shows that Americans feel healthier than people from the other countries. Americans have higher survival rates after age 75 than people do in the peer countries and the population of recent immigrants generally has better health than native-born Americans.²² This is interesting, since one of the few population groups in the country that are covered by a single payer system is retirees, who are covered by Medicare. Reports such as these certainly affect the way policy-makers look upon American healthcare, but the well-to-do part of the population generally seems to think that they are receiving the best possible care.

A 2001 report by the Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century²³, formed the core of the movement towards higher quality within the healthcare sector in the United States.²⁴ The report states that healthcare should be safe, effective, patient-centered, timely, efficient, and equitable. These six priorities are commonly referred to as the “six aims for healthcare”.

In order to get the US system to reach these goals during the 21st century, several sugges- tions for action were made in the report, such as: redesign of care processes based on best practices; use of information technologies to improve access to clinical information and support clinical decision-making, knowledge and skills management; coordination of care across patient conditions, services, and settings over time; incorporation of performance and outcome measurements for improvement and accountability; alignment of payment policies with quality improvement.

2.2 Department of Health and Human Services (HHS)

The United States does not have a central agency responsible for ensuring the quality of the healthcare services delivered to patients. However, with the passage of the ACA, Congress called on the Department of Health and Human Services (HHS), the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help them- selves, to create a National Quality Strategy to “improve the delivery of health care

22 National Research Council. U.S. Health in International Perspective: Shorter Lives, Poorer Health.

Washington, DC: The National Academies Press, 2013.

http://sites.nationalacademies.org/DBASSE/CPOP/US_Health_in_International_Perspective/index.htm, accessed February 19, 2013.

23Committee on Quality of Health Care in America, Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: The National Academies Press, 2001.

http://www.nap.edu/catalog.php?record_id=10027, accessed January 24, 2013.

24 Interview January 24, 2013 with Robin Weinick, associate director of RAND Health.

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services, patient health outcomes, and population health.”²⁵ It was published in March 2011 by HHS as a report to Congress, the National Strategy for Quality Improvement in Health Care²⁶ and was followed by an annual progress report to Congress in April 2012.²⁷It is meant to serve as a framework for quality measurements, measure development and analysis of where more can be done, both in the public and private sectors.It also puts pressure on CMS to keep costs down.

The strategy presents three aims for the health care system:

Better Care: Improve the overall quality of care by making health care more patient- centered, reliable, accessible, and safe.

Healthy People and Communities: Improve the health of the U.S. population by sup- porting proven interventions to address behavioral, social, and environmental determinants of health in addition to delivering higher-quality care.

Affordable Care: Reduce the cost of quality health care for individuals, families, employ- ers, and government.

With the passage of the ACA, certain aspects of the private health insurance industry are starting to be regulated by HHS and one of the goals of the strategy is to reach consensus on how quality should be measured in order for stakeholders to align their efforts.²⁸ This is significant because HHS has traditionally not regulated private health insurance and there- fore has not implemented healthcare initiatives for the entire populations of the country.

Prior to the development of the National Quality Strategy, different federal healthcare quality programs used different measures, requiring healthcare providers to collect and report the same information in different ways. One of the goals of the National Quality Strategy is to streamline data collection and reporting²⁹ and there are strong movements towards streamlining what is measured in publically and privately financed healthcare.³⁰ According to HHS, the strategy has already led to alignment of different measurement approaches, in order to reduce the burden on providers that are working to improve quality.

In the progress report of 2012, key measures to track national progress were established, some that include targets. States are adopting the priorities of the strategy and use them to drive higher quality from private health insurers and Medicaid beneficiaries.³¹

A provision of the ACA has created a formal process to ensure that CMS receives annual public review and comment on the measures it proposes. The act required HHS to institute

25 http://www.hhs.gov/, accessed January 11, 2013.

26 US Department of Health and Human Services. National Strategy for Quality Improvement in Health Care, Report to Congress, March 2011. http://www.healthcare.gov/news/reports/quality03212011a.html accessed February 20, 2013.

27 US Department of Health and Human Services, National Strategy for Quality Improvement in Health Care, Annual Progress Report to Congress April 2012,

http://www.ahrq.gov/workingforquality/nqs/nqs2012annlrpt.pdf, accessed February 20, 2013.

28 US Department of Health and Human Services. National Strategy for Quality Improvement in Health Care, Report to Congress, March 2011. http://www.healthcare.gov/news/reports/quality03212011a.html accessed February 20, 2013.

29 http://www.healthcare.gov/news/factsheets/2012/04/national-quality-strategy04302012a.html, accessed February 20, 2013.

31 US Department of Health and Human Services, National Strategy for Quality Improvement in Health Care, Annual Progress Report to Congress April 2012,

http://www.ahrq.gov/workingforquality/nqs/nqs2012annlrpt.pdf, accessed February 20, 2013.

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a federal process for selecting quality and efficiency measures for its qualifying programs.

Under the new process, HHS must:

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Make publicly available, by December 1 each year, a list of measures it is considering for its qualifying programs, including measures suggested by the public.

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Provide the opportunity for multi‐stakeholder groups to review and provide input by February 1 every year.

The review and input process is being conducted by the Measure Applications Partnership, or MAP, a public-private partnership convened by the National Quality Forum (NQF, described below). During 2011, MAP convened several meetings open to the public to review the measures list. Should HHS have selected for its programs any quality or efficiency measure that is not endorsed by the NQF it must publish its rationale for doing so. It must also publish an assessment of the measures’ impact every three years at minimum.³² There are many other federal actors involved in discussions and measurements of care and treatment quality. Some are described below:

CMS, which is an agency under the auspices of HHS, is the biggest payer of health care services in the country and has a big influence on how the quality of the care is measured and evaluated and what is paid for. Historically, CMS focused on the provision of healthcare services to beneficiaries while private healthcare insurers have been more focused on benefits and costs. In spite of this, the costs have historically been kept relatively low by CMS.³³

The Agency for Healthcare Research and Quality (AHRQ) is an agency under HHS with a mission to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. The central goal of the research it supports is to reach measurable improvements in healthcare in the country.

The overall focus is:

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Safety and quality: Reduce the risk of harm by promoting delivery of the best possible health care.

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Effectiveness: Improve health care outcomes by encouraging the use of evidence to make informed health care decisions.

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Efficiency: Transform research into practice to facilitate wider access to effective health care services and reduce unnecessary costs.³⁴

AHRQ is not supposed to publish medical guidelines, which is a result of criticism of its predecessor, the Agency for Health Care Policy and Research (AHCPR) in the 1990s.

After thorough research a panel at AHCPR published recommendations in 1994 regarding the treatment of low back pain and concluded that there was little evidence to support sur- gery before nonsurgical interventions as the initial treatment for low back pain. This upset back surgeons, who started a campaign against AHCPR in Congress, which resulted in

32 http://journal.ahima.org/2011/12/12/public-review-for-quality-measures-selection/

34 http://www.ahrq.gov/, accessed January 10, 2013.

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changes of the agency’s mandate and a considerable cut in its budget. The agency was not supposed to practice policy anymore, as illustrated by the change of its name.³⁵

Every year, AHRQ publishes the National Health Care Quality Reports and the National Healthcare Disparities Reports, which measure trends in effectiveness of care, patient safety, timeliness of care, patient centeredness, and efficiency of care. Examples of quality measures used in these reports are the percentage of children who received recommended vaccinations or the percentage of heart attack patients who received recommended care when they reached the hospital.³⁶ The latest report, from 2011, states that “Quality is improving; access and disparities are not improving.”³⁷

The National Quality Measures Clearinghouse (NQMC) is a database and website for in- formation on specific evidence-based healthcare quality measures and measure sets. The NQMC is sponsored by AHRQ to encourage access to quality measures by the healthcare community and other interested individuals. The NQMC’s mission is to provide practition- ers, healthcare providers, health plans, integrated delivery systems, purchasers and others an accessible mechanism for obtaining detailed information on quality measures, and to further their dissemination, implementation, and use in order to make informed healthcare decisions

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³⁸ Measures represented on the NQMC Websites are submitted by measure developers and must meet the NQMC’s inclusion criteria.39 Many health professionals elect to use this beneficial resource. NQMC measures are developed on a range of topics, such as different diseases/conditions (for example the cardiovascular system), treatment/intervention (such as chemicals and drugs) and health services administration (such as psychiatry and psychology).40 In some of the measurements presented, a module containing 30 indicators that reflect the quality of care inside hospitals is used. This mo- dule was tested on data from the AHRQ Healthcare Cost and Utilization Project (HCUP).41 HCUP is a family of healthcare databases sponsored by AHRQ which brings together data collection efforts of state data organizations, hospital associations, private data organization and the federal government, in order to create a national information resource of patient-level healthcare data. HCUP includes the largest collection of longi- tudinal hospital care data in the country, with information dating back to 1988. It enables research on health policy issues at the national, state and local market levels, such as cost and quality of health services, medical practice patterns, access to healthcare programs and outcomes of treatments

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⁴²

The Centers for Disease Control and Prevention (CDC) is another agency under the auspices of HHS. CDC monitors health, detects and investigates health problems and con- ducts research to enhance prevention, among other things.⁴³ CDC runs the National Center for Health Statistics, which hosts the Health Indicators Warehouse. On the CDC website the public can retrieve health indicators on a range of topics, such as specific diseases,

35 Interview January 28, 2013 with Ann O´Malley, Senior Fellow at Center for Studying Health System Change and http://www.washingtonmonthly.com/features/2007/0710.brownlee.html, accessed April 5, 2013.

36 http://www.ahrq.gov/qual/qrdr11.htm, accessed January 10, 2013.

37 http://www.ahrq.gov/qual/nhdr11/key.htm, accessed January 10, 2013.

38 http://www.qualitymeasures.ahrq.gov/about/index.aspx, accessed January 10, 2013.

39 http://www.qualitymeasures.ahrq.gov/about/inclusion-criteria.aspx., accessed April 5, 2013.

40 http://www.qualitymeasures.ahrq.gov/browse/by-topic.aspx, accessed January 10, 2013.

41http://www.qualityindicators.ahrq.gov/Downloads/Software/SAS/V42/iqi_sas_documentation_v42.pdf

42 http://www.hcup-us.ahrq.gov/overview.jsp accessed March 14, 2013.

43 http://www.cdc.gov/about/organization/mission.htm, accessed March 14, 2013.

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conditions, age groups or socio-demographic characteristics. Data may often be presented by state, country and hospital referral regions.⁴⁴

2.3 Patient-Centered Outcomes Research Institute (PCORI) According to the RAND Corporation, an independent nonprofit research organization, a key source of inefficiency in the U.S. healthcare system is the lack of evidence regarding the effectiveness of medical treatments. Variation in the use of diagnostic tests and treatments for patients with similar symptoms or conditions has been attributed to clinical un- certainty. The federal government has made large investments in comparative effectiveness research (CER), with the expectation that CER will influence clinical practice and improve the efficiency of healthcare delivery.⁴⁵ The American Recovery and Reinvestment Act made available $1.1 billion in federal funding for comparative effectiveness research in 2009, and as part of the Affordable Care Act the Patient-Centered Outcomes Research Institute (PCORI) was established. PCORI is authorized by Congress to conduct research to provide information about the best available evidence to help patients and their health care providers make more informed decisions. PCORI will use its endowment of $150 million and revenue from a fee on health insurers to identify which treatments work best for which patients, resulting in improved outcomes and reduced waste. The research is intended to give a better understanding of the prevention, treatment and care options available. The program is scheduled to end in 2019.⁴⁶ PCORI’s aim is to make healthcare centered around the patient and to investigate what gives patients the best outcomes. PCORI has awarded grants for research projects, mostly to academic institutions. It is not authorized to fund cost-effectiveness research⁴⁷

During the ACA debate, there was considerable criticism of the suggested creation of PCORI from opponents to the law. The arguments were that PCORI would have the function of rationing care, some opponents warned that it would function as a “death panel”.⁴⁸ As a result, CMS may not use the results from PCORI to make payment determinations, that is, specify by how much a certain procedure should be reimbursed, but they may be applied to health policy.⁴⁹

2.4 Examples of Non-Governmental Organizations Involved in Healthcare Quality Measurements

In addition to these federal agencies, there are several non-governmental organizations involved in measuring healthcare quality. Some examples are given below.

The National Quality Forum (NQF) is an independent nonprofit organization with a 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

44 http://healthindicators.gov/, accessed March 14, 2013.

45 Schneider, Eric C., Justin W. Timbie, D. Steven Fox, Kristin R. Van Busum and John Caloyeras.

Dissemination and Adoption of Comparative Effectiveness Research Findings When Findings Challenge Current Practices. Santa Monica, CA: RAND Corporation, 2011.

http://www.rand.org/pubs/technical_reports/TR924.

46 http://www.pcori.org/about/, accessed February 24, 2013.

48 http://www.kaiserhealthnews.org/Stories/2011/August/03/pcori-panel-treatment-information-health- law.aspx, accessed March 26, 2013.

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performance, and promoting the attainment of national goals through education and out- reach programs. NQF's membership includes a wide variety of healthcare stakeholders, including consumer organizations, public and private purchasers, physicians, nurses, hospitals, accrediting and certifying bodies, supporting industries, and healthcare research and quality improvement organizations.⁵⁰ NQF is one of the key partners of the National Quality Strategy. HHS enlisted NQF in this work to recommend goals and key measures for each of the priorities in the strategy.⁵¹

NQF has a rigorous process to evaluate, endorse, and update quality measures using a set of standard criteria and multi-stakeholder input. CMS uses NQF-endorsed measures for reporting and payment.⁵² NQF is highly trusted as a neutral third party, which is important in the United States.

Another neutral third party in the health care evaluation regime is the Institute of Medicine (IOM), which is the health arm of the National Academy of Sciences and as such an independent, nonprofit organization that⁵³ works outside of government. Its aim is to help those in government and the private sector make informed health decisions by providing evidence upon which they can rely. Congress often mandates that the IOM should undertake many of the studies performed and others are requested by federal agencies and independent organizations.⁵⁴

National Center for Quality Assurance (NCQA) is an independent organization per- forming accreditation, certification, recognition and performance measurement programs for different types of organizations, medical groups, and individual physicians. NCQA gathers quality information in certain areas and makes it available to consumers, employers, health plans and doctors. Practices are able to get NCQA recognition after meeting specific quality measurement criteria and paying a fee.⁵⁵ Insurance companies will evaluate the care provided by physicians that are in the programs which are offered to employers.

The employers, in turn, will likely check that a health plan is accredited by NCQA before their employees are able to enlist in that plan. A physician’s contract might also depend on his/her participation in follow-ups and measurements. ⁵⁶

The Healthcare Effectiveness Data and Information Set (HEDIS) is a tool at NCQA used by more than 90 percent of America's health plans to measure performance on important dimensions of care and service. Altogether, HEDIS consists of 75 measures across eight domains of care. Relative Resource Use (RRU) is a measure that indicates how intensively plans use physicians’ visits, hospital stays and other resources for patients having certain specified chronic diseases. When evaluated alongside quality measures, RRU measures make it possible to consider quality and spending simultaneously. According to NCQA, RRU measures give indications of the value of services that health plans offer and how effectively resources are used.⁵⁷

50 http://www.qualityforum.org/Home.aspx accessed March 14, 2013.

51 http://www.ahrq.gov/workingforquality/nqs/nqs2012annlrpt.pdf, accessed February 24, 2013.

53

http://resources.iom.edu/widgets/timeline/index.html?keepThis=true&TB_iframe=true&height=710&width=1 000;

54 http://www.iom.edu/About-IOM.aspx, accessed January 20, 2013.

55 http://www.ncqa.org/, accessed January 10, 2013.

57 http://www.ncqa.org/, accessed January 10, 2013.

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The Joint Commission (TJC) (formerly the Joint Commission on Accreditation of Healthcare Organizations, JCAHO) is an independent, not-for-profit organization which accredits and certifies more than 19,000 healthcare organizations, hospitals and programs in the United States. Accreditation and certification by the Joint Commission is widely used as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.⁵⁸

The Dartmouth Atlas of Healthcare has documented variations in how medical resources are distributed and used in the United States, using Medicare data. It is based at the Dart- mouth Institute for Health Policy and Clinical Practice at Dartmouth College in New Hampshire and is supported by a coalition of funders led by the Robert Wood Johnson Foundation. It will release reports with comparative data by region and hospital in the entire country on topics such as care of chronic illness in the last two years of life, Medicare reimbursements, hospital use, surgical procedures and post-acute care.⁵⁹

The Robert Wood Johnson Foundation (RWJF) is a philanthropy devoted to the health of the public, with the mission of improving the health and healthcare of all Americans. It provides research funding in the areas of childhood obesity, healthcare coverage, human capital, innovations, public health, quality and equality of healthcare, and vulnerable pop- ulations. RWJF publishes the County Health Rankings & Roadmaps, where health factors in different counties are measured and compared, such as high school graduation rates, obesity, smoking, family and social support. It also offers communities policy tools and expert assistance aimed at improving health.⁶⁰ It runs the Aligning Forces for Quality (AF4Q), with the objectives of raising the quality of healthcare in targeted communities, reducing racial and ethnic disparities, and providing models for national reform.⁶¹

The Leapfrog Group is an independent not-for-profit organization that is promoting transparency and value-based hospital incentives. It measures and publically reports on hospital performance through the annual Leapfrog Hospital Survey⁶², which is a transpar- ent and evidence-based national tool in which more than 1,100 hospitals participate, free of charge.⁶³

Measurements are also performed by private companies, such as health insurance or phar- maceutical companies, professional organizations, e.g. the American College of Cardiology (ACC), and by researchers. Many providers will have taken steps to improve the quality of the care they provide through measurement and other mechanisms. For example, many hospitals employ quality officers as part of their management team.⁶⁴

58 http://www.jointcommission.org/, accessed January 10, 2013.

59 http://www.dartmouthatlas.org/data/topic/, accessed March 6, 2013.

60 http://www.rwjf.org/en/about-rwjf.html, accessed March 26, 2013.

61 http://forces4quality.org/about-us, accessed March 26, 2013.

62 https://leapfroghospitalsurvey.org/,and www.hospitalsafetyscore.org, accessed March 6, 2013.

63 http://www.hospitalsafetyscore.org/about-the-score/about-the-leapfrog-group, accessed March 6, 2013.

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3 Information systems and registries

As discussed above, many different types of quality measures are collected by a variety of stakeholders, such as measure developers, entities involved in endorsement, certification, or accreditation, federal agencies, and a wide range of measure end-users including health plans, hospital and medical systems, and other providers of health services, local and state agencies, and multi-stakeholder alliances.⁶⁵When measuring hospital care, structural, efficiency and process measures are collected, as well as care outcomes and patient experi- ences. As described by Carrier and Cross, structural measures involve the presence of staff or infrastructure associated with improved outcomes in research studies, process measures investigate actions that have led to improved outcomes, while efficiency measures evaluate if there is an absence of processes that are deemed unnecessary or potentially harmful.

Care outcomes have direct relevance to patients and payers, but are difficult to evaluate.

Patient experience measures generally capture patients’ perception of the providers treating and may be considered a part of outcomes measures.⁶⁶

There are numerous registries in the country with many different owners, such as professional organizations, insurance companies, healthcare providers, researchers, and others, but relatively few national initiatives. It has not been possible for this author to even attempt to describe the different types. In this chapter some registries are presented, but they are not meant to illustrate the immense breadth that exists. The three healthcare providers described in detail in this report, the Veterans Health Administration, Kaiser Perma- nente and Intermountain Healthcare, all use registries, and are described in detail below.

3.1 AHRQ and Registries

There is currently no list of all registries in the United States, not even of AHRQ-supported registries. AHRQ has initiated the project Registry of Patient Registries (RoPR), which will include information about many registries that exist in the world. Submitting information to the RoPR is at the discretion of the registry owners and is open equally to the American and the international community. Many international registries have already registered. The ambition is that the format of data that constitute the registries will eventually be standardized, so that the different registries will be compatible. AHRQ is not ex- pecting the RoPR to contain a complete list of all registries in the world, but as many as possible.⁶⁷ One goal of the RoPR is that it will be compatible with ClinicalTrials.gov, which is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.⁶⁸ The RoPR has the following objectives: 1) provide a searchable database of existing patient registries in the United States; 2) facilitate the use of common data fields and definitions in similar health conditions to improve opportunities for sharing, comparing, and linkage; 3) provide a public repository of searchable summary results, including results from registries that have not yet been published in the peer-reviewed literature; 4) offer a search tool to locate existing data that

65 http://www.qualityforum.org/Projects/i-

m/Measure_Registry_Needs_Assessment/Measure_Registry_Needs_Assessment.aspx, accessed March 27, 2013.

66 Carrier, E. and Cross, D. Hospital Quality Measurement and Active Purchasing, in preparation.

67 Interview January 25, 2013 with Jean R. Slutsky, Director, Center for Outcomes and Evidence and Task Order Officer Elise Berliner at AHRQ.

68 http://clinicaltrials.gov/, accessed March 6, 2013.

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researchers can request for use in new studies; and 5) serve as a recruitment tool for researchers and patients interested in participating in patient registries.⁶⁹

AHRQ has stated that registries have the potential to provide unique scientific information about the effectiveness, safety, and quality of the health-care service or intervention that is being studied. AHRQ has published a user’s guide for creating them, Registries for Evalu- ating Patient Outcomes: A User’s Guide, in which practical, scientific advice on the de- sign, operation, analysis, and evaluation of patient registries is presented.⁷⁰

AHRQ sees a potential of future development and implementation of registries in the con- text of health information exchange (HIE), which refers to reliable and interoperable electronic health-related information sharing, a cornerstone of the HITECH act. There are only a few regional health information organizations (RHIOs) that have computerized disease registries and AHRQ has invested in projects that are evaluating the impact of these.

Some of the projects implementing these registries are listed below:⁷¹

1. Santa Cruz County Diabetes Registry^:Expands an established Web-based, interactive Diabetes Mellitus Registry that provides patient histories and needed tests at the point of care among public, private, and not-for-profit health care providers. It also tracks the diabetes population to identify trends in key indicators of care.

2. Rural Virginia eHealth Collaborative:Examines automation of the continuity of care record for use in patient referrals, hospital admission, and hospital discharge; e- prescribing in physician practices, hospital discharge medications, and long-term care facilities with links to community pharmacies; and disease registries for managing preventive care interventions and chronic diseases.

3. Evaluation of a Computerized Clinical Decision Support System and EHR-Linked Registry to Improve Management of Hypertension in Community Based Health Centers:Creates a computerized disease registry and seeks to address the need for more empirical outcome data on effective information technology strategies for improving control of hypertension among low-income immigrant populations.

4. Feedback of Treatment Intensification Data to Reduce Cardiovascular Disease Risk:

Utilizing the PHASE registry to assess whether the use of systematic feedback on need for treatment intensification in patients with poor control of CVD risk factors improves risk factor control.

5. Colorado Associated Community Health Information Exchange (CACHIE):Uses computerized disease registries as data sources in its interoperable quality. information system developed for a collaborative network of community health centers that permits real-time and synchronous quality reporting to inform patient care and quality interventions.

6. Using Precision Performance Measurement to Conduct Focused Quality Improvement:

Creating systems, including developing codes to update disease registries, which

69 http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and- reports/?productid=690&pageaction=displayproduct, accessed March 6, 2013.

70 Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User's Guide. (Prepared by Outcome DEcIDE Center [Outcome Sciences, Inc. dba Outcome] under Contract No. HHSA29020050035I TO1.)AHRQ Publication No. 07-EHC001-1. Rockville, MD: Agency for Healthcare Research and Quality.

April 2007. http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and- reports/?pageaction=displayproduct&productid=401, accessed March 6, 2013.

71 http://healthit.ahrq.gov/portal/server.pt?open=514&objID=5554&mode=2&holderDisplayURL=http://wci- pubcontent/publish/communities/k_o/knowledge_library/key_topics/health_briefing_11092009031502/compute rized_disease_registries.html, accessed March 17, 2013.

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improve quality data and seamlessly link this data to practice-level quality improvement programs and point of care interventions.

Below are a few examples of registries run by other stakeholders:

3.2 Cancer surveillance, databases and registries

The Surveillance, Epidemiology and End Results (SEER) Program of the National Cancer Institute (NCI), one of 27 institutes of the National Institutes of Health (NIH), collects and publishes cancer incidence and survival of approximately 28 percent of the American population. Its registries collect data on patient demographics, primary tumor site, tumor morphology and stage at diagnosis, first course of treatment, and follow-up for vital status. According to its website, the SEER Program is the only comprehensive source of population-based information in the country that includes stage of cancer at the time of diagnosis and patient-survival data.

The following population-based cancer registries are part of the SEER program:

Alaska Native Tumor Registry, Arizona Indians, Cherokee Nation, Connecticut, Detroit, Georgia Center for Cancer Statistics, Atlanta, Greater Georgia, Rural Georgia, Greater Bay Area Cancer Registry, San Francisco-Oakland, San Jose-Monterey, Greater California, Hawaii, Iowa, Kentucky, Los Angeles, Louisiana, New Jersey, New Mexico, Seattle-Puget Sound and Utah.⁷²

In 1992, Congress passed the Cancer Registries Amendment Act, by which state-based cancer registries collect, manage, and analyze data about cancer cases and cancer deaths. In each state, medical facilities report these data to a central cancer registry, called the National Program of Cancer Registries (NCPR). It is administered by CDC and feeds data into SEER.

State cancer registries are designed to:

•

Monitor cancer trends over time.

•

Determine cancer patterns in various populations.

•

Guide planning and evaluation of cancer control programs

•

Help set priorities for allocating health resources.

•

Advance clinical, epidemiologic, and health services research.

•

Provide information for a national database of cancer incidence.⁷³

The National Cancer Data Base (NCDB) is an outcomes database, in which data on all types of cancer are tracked and analyzed. Data are collected and submitted to NCDB from cancer program registries using nationally standardized format specifications, including patient characteristics, cancer staging and tumor histological characteristics, type of first course treatment administered, and outcomes information. The data are used to investigate trends in cancer care, create regional and state benchmarks and serve as a basis for quality

72 http://seer.cancer.gov/statistics/, accessed February 25, 2013.

73 http://www.cdc.gov/cancer/npcr/about.htm, accessed March 26, 2013.

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improvement. NCDB has a close relationship with several agencies and organizations, such as the American Cancer Society, NCPR and SEER.⁷⁴

3.3 The American Joint Replacement Registry (AJRR)

AJRR officially began operations in August 2011. Its goal is to foster a national center for data collection and research on total hip and knee replacement.⁷⁵ Caryn Etkin, Research Director, and Jeffrey Knezovich, Executive Director, at the American Joint Replacement Registry, explain that the aim is to become the first comprehensive national hip and knee orthopaedic implant registry in the United States with information from 90 percent of all joint replacements included in AJRR by the end of 2015. Currently, 130 out of the country’s 4,000 hospitals are enlisted. The primary goal is to track implants, look at failures, and improve the quality of the care of patients who have undergone a knee or hip replacement. Since 2011, AJRR has collected Level I data, which is procedural and demographic information. Level II data, such as patient comorbidities, Physicians Quality Reporting Initiative measures, surgical approaches, and prophylaxis, will be included in the registry soon, and eventually Level III data will be added, which include results from patient- reported outcomes on health-related quality of life and physical function. Participating hospitals will send Excel files with procedural information to AJRR, whose data teams will

“scrub” the data and enter it into the AJRR-database. The hospitals own the data collected and AJRR will own the aggregated report entered into the registry. Scientists may be able to use the data in order to perform research.⁷⁶

The AJRR is a not-for-profit organization supported by the American Academy of Ortho- paedic Surgeons (AAOS), the American Association of Hip and Knee Surgeons (AAHKS), the Hip Society, the Knee Society, hospitals, health insurers, and medical device manu- facturers.⁷⁷ AJRR is planning to start charging participating hospitals to be part of the registry and will make it possible for each physician or hospital to monitor the quality of their work by extracting reports from the registry. AJRR will not publish reports on how physicians and hospitals perform and will not publically compare different implants with each other.⁷⁸

3.4 The National Cardiovascular Data Registry (NCDR)

NCDR is the American College of Cardiology’s (ACCs) suite of data registries. It was developed in 1997 and comprises six hospital-based registries and one outpatient registry, making it the most comprehensive outcomes-based quality improvement program in the United States, according to its website. More than 2,400 hospitals and almost 1,000 outpatient providers participate in NCDR registries, which include 18 million patient records.

NCDR registries use standardized data elements and definitions for patient demographics, clinical variables, and outcomes to facilitate communication and allow for comparisons across disciplines and studies, such as practice patterns, demographics, and outcomes of diagnostic procedures and therapies with those from the national aggregate.⁷⁹

74 http://www.facs.org/cancer/ncdb/index.html, accessed March 26, 2013.

75 http://teamwork.aaos.org/ajrr/default.aspx accessed February 22, 2013

76 Interview February 21, 2013, with Caryn Etkin, Research Director and Jeffrey Knezovich, Executive Director, the American Joint Replacement Registry.

77 http://www.aaos.org/news/aaosnow/oct12/research2.asp, accessed February 22, 2013.

78 Interview February 21, 2013, with Caryn Etkin, Research Director and Jeffrey Knezovich, Executive Director, the American Joint Replacement Registry

79 https://www.ncdr.com/webncdr/home/about-the-ncdr, accessed March 15, 2013.

Measurements for Improved Quality in Healthcare