The Role of Policy in Quality Improvement Lisa A. Simpson, MB, BCh, MPH; Gerry Fairbrother, PhD From AcademyHealth, Washington, DC The views expressed in this report are those of the authors and do not necessarily represent those of the US Department of Health and Human Services, the Agency for Healthcare Research and Quality or the American Board of Pediatrics Foundation. The authors declare that they have no conflict of interest. Publication of this article was supported by the Agency for Healthcare Research and Quality and the American Board of Pediatrics Foundation. Address correspondence to Lisa A. Simpson, MB, BCh, MPH, FAAP, 1150 17th Street NW, Suite 600, Washington, DC 20036 (e-mail: Lisa. [email protected]). Received for publication February 22, 2013; accepted March 25, 2013.

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Johnson Aligning Forces for Quality (AF4Q) program,8 the Office of the National Coordinator (ONC) Beacon Communities Program,9,10 and, for children, the National Improvement Partnership Network (NIPN).11 The measurement of quality has also followed this evolution, although at a slower pace: in addition to disease-specific indicators, measurement efforts now address patient experiences of care, composite indicators12,13 and indicators of a highfunctioning health system.14 It is not coincidental that key provisions in the ACA were informed by these trends and put the focus firmly on system-level change and on the triple aim of improved health care, lower cost, and improved population health.15

IN THE AFTERMATH of the 2012 US presidential election and the implementation of the Patient Protection and Affordable Care Act (ACA), the role of policy strategies in improving quality has assumed heightened importance.1 The survival of the insurance mandate together with the urgent need to address health care cost growth has created the political and public oxygen for the policy conversation to turn from solely coverage to a major focus on system transformation. Thus, the United States is entering a period of dramatic change in both health care and policy, including a significant infusion of funds to develop and test new models to improve care. At this time of unprecedented opportunity, it bears remembering that although “not all change is improvement, all improvement is change.”2 As we individually and collectively engage in this transformation phase, academic pediatricians and others engaged in child health services research need to be ready to capitalize on this dynamic environment to identify and foster change that results in improvement for children.

EVOLUTION OF THE USE OF POLICY TO DRIVE IMPROVEMENT Ever since the publication of the Institute of Medicine’s Crossing the Quality Chasm report, the quality community has talked about improvement using the 4-level framework for change summarized by Berwick.16 In this framework, level 4 is that of the health care environment where policies, regulations, financing, accreditation, litigation, professional education, and other factors come together to hinder or support improvements in quality. Despite over a decade of work debating these environment factors and the funding of several initiatives in the public and private sectors to address them,17 we only now have a range of policy levers to really support improvement. The policy levers in the ACA for bringing about improvement include provisions requiring measuring and reporting on quality,18,19 financial and payment reforms to align quality and payment, a focus on prevention and population health, and encouraging health services research on a wide variety of topics, including effective delivery system models and strategies to reduce health disparities.

EVOLUTION OF THE QUALITY IMPROVEMENT MOVEMENT It has been at least 15 years since quality improvement (QI) began emerging as distinct approach to making health care better.3 During this time, improvement efforts have evolved from passive dissemination of clinical practice guidelines, to more active education, to collaborative improvement, on to system redesign, and most recently to questions of spread and sustainability. The latter is where policy strategies are critical. Some in the QI field are recognizing that disease- or issue-specific collaboratives have variable evidence of effectiveness,4–6 are resource intensive, and may be contributing to a phenomenon we call improvement fatigue among the participating clinicians and practices who tend to be the usual suspects and early adopters. There is growing recognition that a focus on one disease or issue at a time will not bring about the broad and sustainable transformation in care that is needed.7 The shift in focus from a single disease to broader system or community improvement is evident in major transformation initiatives such as the Robert Wood ACADEMIC PEDIATRICS Copyright ª 2013 by Academic Pediatric Association

IMPLICATIONS OF POLICY CHANGES FOR CHILD HEALTH SERVICES RESEARCH The Children’s Health Insurance Program Reauthorization Act (CHIPRA) put new and enormous emphasis on quality through provisions to measure and report quality20 and through demonstration projects to test new QI

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strategies.21–23 In addition, there are numerous opportunities and potential challenges for QI in children’s health care brought about by the ACA, which established the Centers for Medicare and Medicaid Innovation (CMMI) within the Centers for Medicare and Medicaid Services, the Patient Centered Outcomes Research Institute (PCORI), and contains numerous provisions to promote prevention and population health and to address disparities in health and health care (Table). Finally, the ACA came on the heels of the 2009 HITECH Act, legislation included in the American Recovery and Reinvestment Act, that spurred dramatic investments in the adoption of electronic health records and health information exchange. These 3 pieces of legislation demand a refocusing of our QI implementation and research efforts in children’s health care to emphasize the measurement of system level change34,35 and a need to generate new frameworks, designs, and methods for evaluating new models of care and other system-level improvement strategies for their impact on children’s health care and health, including disparities.36 We are entering the adolescence of child health services research (CHSR) and have a responsibility to help our field navigate some challenging developmental transitions37 in the context of these new opportunities and challenges. First among these challenges is the need for academic pediatricians and the CHSR community more broadly to go beyond thinking of QI as solely disease- or conditionfocused clinical practice-based enterprise. Many of the policy changes being implemented under ACA and elsewhere (eg, PCMH, accountable care organizations,38 public reporting,39,40 pay for performance,41 nonpay for poor performance42) may not be designed along childfriendly principles, and assessing their impact on children may be an afterthought. The CHSR community needs to engage in evaluations from the perspective of children and their families and communities (including communities of children’s health care providers). Taking this approach will likely require collaborations across research settings of policy makers and front-line practitioners. A second set of challenges is the dramatic imbalance in research funding for new biomedical discoveries versus translation into practice and for children versus adults. It was recently estimated that 98% of federal plus private funding is for basic science and T1 research.43 Glasgow et al, and Woolf before them, pointed out that the return on investment for implementation and dissemination research that would help move T1 findings into practice dwarfs the return on investment on T1 research.44 No estimates are available, but it is likely that a small portion of current spending on dissemination, implementation, and improvement science is dedicated to children. Hay et al noted that although pediatric research enjoyed significant benefits during the National Institutes of Health (NIH) doubling era, the proportion of the NIH budget devoted to the pediatric-research portfolio has declined overall.45 Although the Agency for Healthcare Research Quality (AHRQ) supports research on QI, including in children’s

services, and it is more likely than NIH to support the testing of non-disease-specific improvement innovations in health care (eg, patient-centered medical home; health information technology, prevention and management of health care–associated infections, facilitation of primary care improvements), AHRQ’s overall budget is small— even smaller than the eventual budget of PCORI. Only a few of the innovations in payment and delivery being tested with support from CMMI include children: only 9 of the Health Care Innovation Awards (HCIA) focus exclusively on children’s care.46 This is despite the fact that recent reports document the rapid growth in the costs of care for children, noting that prices for children’s outpatient visits rose the fastest of any service category, increasing at nearly 6 times the rate of general inflation, and that care for teens had the highest increases in costs.47 The recent CMMI State Innovation Model awards could prove to be an especially important set of demonstrations to watch if any of them incorporate a focus on child health in their broader strategy, given the large role that states play in children’s health care and health.48 Third, assessing the effectiveness of innovations to improve quality, assess sustainability, and evaluate the impacts of spread bring with them a need to learn and apply research techniques that have not been traditional in clinical and health services research. Health services research needs to go beyond the identification of problems in quality (eg, using secondary data sources) to intervention-focused research focused on QI.49 QI research cannot use research methods used to test clinical interventions in patients (eg, new drugs, surgical techniques, counseling strategies).50 Yet if health care quality is to improve through the spread of generalizable knowledge, research into the effectiveness of interventions must be rigorous and attentive to the impact of context.51 This need has led to an increasing emphasis on rapid cycle evaluation,52 realist evaluation methods,35 improvement science methods,53 and implementation and dissemination research.54,55 The academic pediatric community has responded well to this call to use rigorous but relevant methods through participation in Pediatric Quality Improvement Methods Conferences sponsored by the Academic Pediatric Association (APA) and other conferences on QI research methods and the publication of this special issue. Fourth, the emergence of prospective electronic clinical data and policy incentives for adoption under HITECH provide us with a game-changing opportunity to conduct research across multiple settings that builds on data collection at the point of care, is clinically rich and specific, and is conducted in near real time.56 In child health, several notable efforts are underway thanks to efforts by leading children’s hospitals, consortia that combine research and QI, and the American Board of Pediatrics.57 Technology advances go well beyond electronic health records and include numerous innovations in health information exchange, patient-reported data, mobile health technology (mHealth), and an explosion of new apps for smart devices (recently estimated at over 40,000 health apps) to inform systems and practice choices and could contribute to health

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Table. Summary of Provisions in ACA That Support Quality Improvement Program or Component Name National Strategy to Improve Health Care Quality (National Quality Strategy)25

Medicaid Quality Measurement Program National Impact Assessment of Federal Quality Measures26

Physician Quality Reporting Initiative Provider-level outcome measures for hospitals and physicians and other HHS/AHRQ/ CMS developed measures Quality Measures Reporting System Support for Payment Reform and Innovation

Center for Medicare and Medicaid Improvement24,27 State Innovation Model28

Shared savings program models Accountable care organizations29 Bundled payment program models

National Prevention Strategy; Prevention and Public Health Fund (PPHF); Benefit Designs to Promote Wellness; Encourage Employer Wellness Programs; Community Transformation grants

HSR related

PCORI (§6301, corrections §10602), Delivery system research (§3501), Research on optimizing the Delivery of Public Health Services (§4301), Understanding Health Disparities: Data Collection and Analysis (§4302), National Healthcare Workforce Commission and Assessment (§5101 and §5103)

ACA ¼ Patient Protection and Affordable Care Act; HHS ¼ US Health and Human Services; NQF ¼ National Quality Forum; AHRQ ¼ Agency for Healthcare Research Quality; CMS ¼ Centers for Medicaid and Medicare Services; HSR ¼ health services research.

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Population Health30–33

Details To improve health outcomes and efficiency, identify areas for improvement, address gaps in comparative effectiveness information and data gathering, and improve research and dissemination of best practices. Includes public reporting of performance information through health care quality Web sites. State Medicaid plans must report on state-specific health quality measures and requires the HHS secretary to test, validate, and develop the quality measures. HHS conducts an assessment of the quality and efficiency impact of NQF-endorsed quality and efficiency measures for use in certain specific health care programs and measures for use in reporting performance information to the public. Incentive payments to physicians who report quality measures data to Medicare. Included 10 outcome measurements for acute and chronic diseases by March 2012 and 10 outcome measurements for primary and preventive care by March 2013. Intended for long-term care hospitals, inpatient rehabilitation facilities, cancer hospitals, and hospice programs. Tests and evaluates payment and service delivery models that reduce costs and maintain or improve quality of care. Tests whether new payment and service delivery models will produce greater results when implemented in the context of a state-sponsored State Health Care Innovation Plan. For states planning, designing, testing, and supporting evaluation of new payment and service delivery models in the context of larger health system transformation. Health groups meeting benchmarks share Medicare savings. A group of providers willing and able to improve: Health care experience (better care); Overall health status (better health); Care efficiency (lower costs). CMS partnership with providers allowing both retrospective and prospective bundling where the episode of care is: inpatient stay in the general acute care hospital; inpatient stay and post–acute care 30–90 d after discharge; starts at discharge from the inpatient stay and ends >30 d after discharge; inpatient stay only, but single prospective payment for all services. Addresses need for systematic approach to definition, funding, evidence base, communication, and need for cooperation. The introduction of a reliable, steady stream of funding for public health research. Encourages development and use of common metrics to measure effectiveness. Promotes prevention in the health care system. Investment in HSR to improve health care decision making and the health care system.

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care QI studies in pediatrics.58 However, for this treasure trove of data to optimally advance child health care and health, it will need to include 2 types of data that to date are not included to any significant degree or in any standardized way: patient/family reported data and outcomes and data on social/environmental factors, including practice context.59 To turn this tsunami of new data into useful information for research and QI will require considerable effort on the part of the academic pediatrics and related child health research communities as well as the development of new analytic methods. The field of QI in child health was dramatically enhanced by CHIPRA and can be enhanced through ACA.60 It will be important for those focused on children’s health care and health to build on that progress in this postACA era by actively contributing to the debate on what actually works to improve quality in the coming years and keeping children on the national improvement agenda.

17. Simpson LA. That was then; this is now. Am J Manage Care. 2012;18: S109–S111. 18. Cronin C, Riedel A. State-of-the-art of hospital and physician/ physician group public reports. Commissioned by the Agency for Healthcare Research and Quality (AHRQ) for the National Summit on Public Reporting for Consumers. Available at: http://www. informedpatientinstitute.org/pdf/AHRQ%20Report%20Card%20Paper %208-10-11.pdf. 2011. Accessed March 2013. 19. Hoo E, Lansky D, Roski J, et al. Health Plan Quality Improvement Strategy Reporting Under the Affordable Care Act: Implementation Considerations. . New York, NY: Commonwealth Fund; 2012. 20. Agency for Healthcare Research and Quality. Children’s Health Insurance Program Reauthorization Act (CHIPRA). Available at: http://www.ahrq.gov/legacy/chipra/. Accessed March 21, 2013. 21. Simpson LA, Fairbrother G, Touschner J, et al. How federal implementation choices can maximize the impact of CHIPRA on health care of children with developmental and behavioral needs. J Dev Behav Pediatr. 2010;31:238–243. 22. Simpson LA, Fairbrother G, Touschner J, et al. Implementation Choices for the Children’s Health Insurance Program Reauthorization Act of 2009. New York, NY: Commonwealth Fund; 2009. 23. Simpson LA, Fairbrother G. How health policy influences quality of care in pediatrics. Pediatr Clin North Am. 2009;56:1009–1021. 24. Institutes of Medicine. ACA provisions with implications for a learning healthcare system (IOM Summary). Available at: http://www. iom.edu/w/media/Files/Activity%20Files/Quality/VSRT/summary %20of%20ACA%20impact%20on%20the%20learning%20healthcare %20system.pdf. Accessed May 21, 2013. 25. HealthAffairs. Public reporting on quality and costs. HealthAffairs Health Policy Brief, March 8, 2012. Available at: http://www. healthaffairs.org/healthpolicybriefs/brief.php?brief_id¼65. Accessed May 21, 2013. 26. Centers for Medicare and Medicaid Services. National impact assessment of Medicare quality measures. March 2012. Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/QualityMeasures/Downloads/NationalImpactAssessment ofQualityMeasuresFINAL.PDF. Accessed May 21, 2013. 27. Centers for Medicare and Medicaid Services. Innovation challenge. Available at: http://innovation.cms.gov. Accessed May 21, 2013. 28. Social Security Act, §1115A. Available at: http://www.ssa.gov/OP_ Home/ssact/title11/1115A.htm. Accessed May 21, 2013. 29. Devore S, Champion RW. Driving population health through accountable care organizations. Health Aff (Millwood). 2011;30:41–50. 30. Bovbjerg RR, Ormond BA, Waidmann TA; Urban Institute Health Policy Center. What directions for public health under the Affordable Care Act? November 2011. Available at: http:// www.urban.org/UploadedPDF/412441-Directions-for-Public-HealthUnder-the-Affordable-Care-Act.pdf. Accessed May 21, 2013. 31. Trust for America’s Health. Prevention and health/Affordable Care Act. Available at: http://tfah.org/health-issues/index.php. Accessed May 21, 2013. 32. Department of Health and Human Services. Report to Congress: national strategy for quality improvement in health care, March 2011. Available at: http://www.healthcare.gov/news/reports/national qualitystrategy032011.pdf. Accessed May 21, 2013. 33. National Prevention Strategy. Available at: http://www.healthcare. gov/prevention/nphpphc/strategy/report.pdf. Accessed May 21, 2013. 34. Best A, Greenhalgh T, Lewis S, et al. Large-system transformation in health care: a realist review. Milbank Q. 2012;90:421–456. 35. Pawson R. The Science of Evaluation: A Realist Manifesto. Thousand Oaks, Calif: Sage; 2013. 36. Fisher ES, Shortell SM, Kreindler SA, et al. A framework for evaluating the formation, implementation, and performance of accountable care organizations. Health Aff (Millwood). 2012;31:2368–2378. 37. Simpson LA. The adolescence of child health services research. JAMA Pediatr In press. 38. Chesney ML, Lindeke LL. Accountable care organizations: advocating for children and PNPs within new models of care. J Pediatr Health Care. 2012;26:312–316.

ACKNOWLEDGMENTS We thank Rebecca Singer Cohen for her assistance in document preparation and Denise Dougherty for her helpful comments.

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