Implementation of NCCARE360, a Digital Statewide Closed-Loop Referral Platform to Improve Health and Social Care Coordination: Evidence from the North Carolina COVID-19 Support Services Program.

Introduction: Efforts to improve population health by being responsive to patients' social and economic conditions will benefit from care models and technologies that assess and address unmet social needs. In 2019, NCCARE360 launched in North Carolina as the first state-wide digital care coordination network to "close the loop" on referrals between community-based organizations (CBOs), health service providers, and social service agencies. The platform creates a shared network for sending and receiving electronic referrals and track client outcomes. Methods: As a case study, we compare NCCARE360 resolution rates for community resource referrals originating from a large integrated health system primarily in Durham County from September 1, 2020, through February 28, 2021. In the first year, COVID-19 Support Ser-vices Program (COVID-SSP) funding was available to reimburse associated CBOs for providing food assistance and case management services. We compared this with the same period the following year after funds had been exhausted. We present frontline implementation experiences and highlight opportunities, challenges, and recommendations for NCCARE360 implementation. Results: Multi-level considerations for individual end users, organizations adopting the platform, and policymakers are presented. Addi-tionally, we find that when COVID-SSP funding was available, more referrals were placed (3,220 cases) and referrals were more likely to be resolved (88% resolution rate) when compared to the same time frame when funds were no longer available (860 cases; 30% resolution rate). These results underscore the importance of reimbursement mechanisms and funding. Limitations: The examination of referral rates is observational and may not generalize to other contexts. Conclusion: The shift to value-based care is an opportunity to embrace structural solutions to health and social care fragmentation. There is also an opportunity to realize the potential of NCCARE360 and efforts like it to contain costs and improve health outcomes and equity.

Association of ACO Shared Savings Success and Serious Illness Spending.

EXECUTIVE SUMMARY: Accountable care organizations (ACOs) need confidence in their return on investment to implement changes in care delivery that prioritize seriously ill and high-cost Medicare beneficiaries. The objective of this study was to characterize spending on seriously ill beneficiaries in ACOs with Medicare Shared Savings Program (MSSP) contracts and the association of spending with ACO shared savings. The population included Medicare fee-for-service beneficiaries identified with serious illness (N = 2,109,573) using the Medicare Master Beneficiary Summary File for 100% of ACO-attributed beneficiaries linked to MSSP beneficiary files (2014-2016). Lower spending for seriously ill Medicare beneficiaries and risk-bearing contracts in ACOs were associated with achieving ACO shared savings in the MSSP. For most ACOs, the seriously ill contribute approximately half of the spending and constitute 8%-13% of the attributed population. Patient and geographic (county) factors explained $2,329 of the observed difference in per beneficiary per year spending on seriously ill beneficiaries between high- and low-spending ACOs. The remaining $12,536 may indicate variation as a result of potentially modifiable factors. Consequently, if 10% of attributed beneficiaries were seriously ill, an ACO that moved from the worst to the best quartile of per capita serious illness spending could realize a reduction of $1,200 per beneficiary per year for the ACO population overall. Though the prevalence and case mix of seriously ill populations vary across ACOs, this association suggests that care provided for seriously ill patients is an important consideration for ACOs to achieve MSSP shared savings.

The Past Decade of Paying for Value : From the Affordable Care Act to COVID-19.

The Affordable Care Act played a major role in transitioning American health care away from fee-for-service payment. We explore the spread of payment reforms since the implementation of the ACA, both nationally and in North Carolina; the corresponding effects on health care costs and quality; and further steps needed to achieve greater transformation.

Reports of self-rated health by citizenship and homeownership, United States 2000-2010.

Citizenship facilitates home ownership, which promotes access to additional resources and structures social context, factors that improve the health of individuals and communities. The objective of this study was to examine whether citizenship moderated the association between homeownership and self-rated health. We used multivariate logistic regression models and propensity score matching techniques to examine this association using pooled years 2000-2010 of the Medical Expenditure Panel Survey data linked with the National Health Interview Survey to examine U.S. adults aged 18 and older (N=170,429). Rates of fair/poor health among homeowners vs. non-homeowners were comparable for foreign-born non-citizens. However, native- and foreign-born citizen non-homeowners showed significantly higher rates of reporting fair/poor health, with native-born citizens having the highest rates of poor health. While homeownership is protective for self-rated health, not meeting the "American Dream" of home ownership may be embodied more in the health of native-born citizens as "failure" and translate into poorer self-rated health. However, the economic privileges of homeownership and its association with better self-rated health are limited to citizens. Non-citizens may be disadvantaged despite socioeconomic position, particularly wealth as considered by homeownership, placing citizenship at the forefront as the most proximate and important burden besides socioeconomic status that needs further investigation as a fundamental health determinant.

Racial/Ethnic Disparities in Influenza Vaccination of Chronically Ill US Adults: The Mediating Role of Perceived Discrimination in Health Care.

BACKGROUND: Despite well-established programs, influenza vaccination rates in US adults are well below federal benchmarks and exhibit well-documented, persistent racial and ethnic disparities. The causes of these disparities are multifactorial and complex, though perceived racial/ethnic discrimination in health care is 1 hypothesized mechanism. OBJECTIVES: To assess the role of perceived discrimination in health care in mediating influenza vaccination RACIAL/ETHNIC disparities in chronically ill US adults (at high risk for influenza-related complications). RESEARCH DESIGN: We utilized 2011-2012 data from the Aligning Forces for Quality Consumer Survey on health and health care (n=8127), nationally representative of chronically ill US adults. Logistic regression marginal effects examined the relationship between race/ethnicity and influenza vaccination, both unadjusted and in multivariate models adjusted for determinants of health service use. We then used binary mediation analysis to calculate and test the significance of the percentage of this relationship mediated by perceived discrimination in health care. RESULTS: Respondents reporting perceived discrimination in health care had half the uptake as those without discrimination (32% vs. 60%, P=0.009). The change in predicted probability of vaccination given perceived discrimination experiences (vs. none) was large but not significant in the fully adjusted model (-0.185; 95% CI, -0.385, 0.014). Perceived discrimination significantly mediated 16% of the unadjusted association between race/ethnicity and influenza vaccination, though this dropped to 6% and lost statistical significance in multivariate models. CONCLUSIONS: The causes of persistent racial/ethnic disparities are complex and a single explanation is unlikely to be sufficient. We suggest reevaluation in a larger cohort as well as potential directions for future research.

Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis.

BACKGROUND: The influenza A (H1N1) 2009 monovalent vaccination programme was the largest mass vaccination initiative in recent US history. Commensurate with the size and scope of the vaccination programme, a project to monitor vaccine adverse events was undertaken, the most comprehensive safety surveillance agenda in the USA to date. The adverse event monitoring project identified an increased risk of Guillain-Barré syndrome after vaccination; however, some individual variability in results was noted. Guillain-Barré syndrome is a rare but serious health disorder in which a person's own immune system damages their nerve cells, causing muscle weakness, sometimes paralysis, and infrequently death. We did a meta-analysis of data from the adverse event monitoring project to ascertain whether influenza A (H1N1) 2009 monovalent inactivated vaccines used in the USA increased the risk of Guillain-Barré syndrome. METHODS: Data were obtained from six adverse event monitoring systems. About 23 million vaccinated people were included in the analysis. The primary analysis entailed calculation of incidence rate ratios and attributable risks of excess cases of Guillain-Barré syndrome per million vaccinations. We used a self-controlled risk-interval design. FINDINGS: Influenza A (H1N1) 2009 monovalent inactivated vaccines were associated with a small increased risk of Guillain-Barré syndrome (incidence rate ratio 2·35, 95% CI 1·42-4·01, p=0·0003). This finding translated to about 1·6 excess cases of Guillain-Barré syndrome per million people vaccinated. INTERPRETATION: The modest risk of Guillain-Barré syndrome attributed to vaccination is consistent with previous estimates of the disorder after seasonal influenza vaccination. A risk of this small magnitude would be difficult to capture during routine seasonal influenza vaccine programmes, which have extensive, but comparatively less, safety monitoring. In view of the morbidity and mortality caused by 2009 H1N1 influenza and the effectiveness of the vaccine, clinicians, policy makers, and those eligible for vaccination should be assured that the benefits of inactivated pandemic vaccines greatly outweigh the risks. FUNDING: US Federal Government.

Strategies for achieving whole-practice engagement and buy-in to the patient-centered medical home.

PURPOSE: The current model of primary care in the United States limits physicians' ability to offer high-quality care. The patient-centered medical home (PCMH) shows promise in addressing provision of high-quality care, but achieving a PCMH practice model often requires comprehensive organizational change. Guided by Solberg's conceptual framework for practice improvement, which argues for shared prioritization of improvement and change, we describe strategies for obtaining organizational buy-in to and whole-staff engagement of PCMH transformation and practice improvement. METHODS: Semistructured interviews with 136 individuals and 7 focus groups involving 48 individuals were conducted in 20 small- to mid-sized medical practices in Pennsylvania during the first regional rollout of a statewide PCMH initiative. For this study, we analyzed interview transcripts, monthly narrative reports, and observer notes from site visits to identify discourse pertaining to organizational buy-in and strategies for securing buy-in from personnel. Using a consensual qualitative research approach, data were reduced, synthesized, and managed using qualitative data management and analysis software. RESULTS: We identified 13 distinct strategies used to obtain practice buy-in, reflecting 3 overarching lessons that facilitate practice buy-in: (1) effective communication and internal PCMH campaigns, (2) effective resource utilization, and (3) creation of a team environment. CONCLUSION: Our study provides a list of strategies useful for facilitating PCMH transformation in primary care. These strategies can be investigated empirically in future research, used to guide medical practices undergoing or considering PCMH transformation, and used to inform health care policy makers. Our study findings also extend Solberg's conceptual framework for practice improvement to include buy-in as a necessary condition across all elements of the change process.

Addressing Housing-Related Social Needs Through Medicaid: Lessons From North Carolina's Healthy Opportunities Pilots Program.

North Carolina Medicaid's Healthy Opportunities Pilots program is the country's first comprehensive program to evaluate the impact of paying community-based organizations to provide eligible Medicaid enrollees with an array of evidence-based services to address four domains of health-related social needs, one of which is housing. Using a mixed-methods approach, we mapped the distribution of severe housing problems and then examined the design and implementation of Healthy Opportunities Pilots housing services in the three program regions. Four cross-cutting implementation and policy themes emerged: accounting for variation in housing resources and needs to address housing insecurity, defining and pricing housing services in Medicaid, engaging diverse stakeholders across sectors to facilitate successful implementation, and developing sustainable financial models for delivery. The lessons learned and actionable insights can help inform the efforts of stakeholders elsewhere, particularly other state Medicaid programs, to design and implement cross-sectoral programs that address housing-related social needs by leveraging multiple policy-based resources. These lessons can also be useful for federal policy makers developing guidance on addressing housing-related needs in Medicaid.

Overcoming Barriers to the Implementation of Integrated Musculoskeletal Pain Management Programs: A Multi-Stakeholder Qualitative Study.

Integrated pain management (IPM) programs can help to reduce the substantial population health burden of musculoskeletal pain, but are poorly implemented. Lessons learned from existing programs can inform efforts to expand IPM implementation. This qualitative study describes how health care systems, payers, providers, health policy researchers, and other stakeholders are overcoming barriers to developing and sustaining IPM programs in real-world settings. Primary data were collected February 2020 through September 2021 from a multi-sector expert panel of 25 stakeholders, 53 expert interviews representing 30 distinct IPM programs across the United States, and 4 original case studies of exemplar IPM programs. We use a consensual team-based approach to systematically analyze qualitative findings. We identified 4 major themes around challenges and potential solutions for implementing IPM programs: navigating coverage, payment, and reimbursement; enacting organizational change; making a business case to stakeholders; and overcoming regulatory hurdles. Strategies to address payment challenges included use of group visits, linked visits between billable and nonbillable providers, and development of value-based payment models. Organizational change strategies included engagement of clinical and administrative champions and co-location of services. Business case strategies involved demonstrating the ability to initially break even and potential to reduce downstream costs, while improving nonfinancial outcomes like patient satisfaction and provider burnout. Regulatory hurdles were overcome with innovative credentialing methods by leveraging available waivers and managed care contracting to expand access to IPM services. Lessons from existing programs provide direction on to grow and support such IPM delivery models across a variety of settings. PERSPECTIVE: Integrated pain management (IPM) programs face numerous implementation challenges related to payment, organizational change, care coordination, and regulatory requirements. Drawing on real-world experiences of existing programs and from diverse IPM stakeholders, we outline actionable strategies that health care systems, providers, and payers can use to expand implementation of these programs.

Analysis of North Carolina Medicaid Claims Data to Simulate a Pediatric Accountable Care Organization.

Importance: Despite momentum for pediatric value-based payment models, little is known about tailoring design elements to account for the unique needs and utilization patterns of children and young adults. Objective: To simulate attribution to a hypothetical pediatric accountable care organization (ACO) and describe baseline demographic characteristics, expenditures, and utilization patterns over the subsequent year. Design, Setting, and Participants: This retrospective cohort study used Medicaid claims data for children and young adults aged 1 to 20 years enrolled in North Carolina Medicaid at any time during 2017. Children and young adults receiving at least 50% of their primary care at a large academic medical center (AMC) in 2017 were attributed to the ACO. Data were analyzed from April 2020 to March 2021. Main Outcomes and Measures: Primary outcomes were total cost of care and care utilization during the 2018 performance year. Results: Among 930 266 children and young adults (377 233 children [40.6%] aged 6-12 years; 470 612 [50.6%] female) enrolled in Medicare in North Carolina in 2017, 27 290 children and young adults were attributed to the ACO. A total of 12 306 Black non-Hispanic children and young adults (45.1%), 6308 Hispanic or Latinx children and young adults (23.1%), and 6531 White non-Hispanic children and young adults (23.9%) were included. Most attributed individuals (23 133 individuals [84.7%]) had at least 1 claim in the performance year. The median (IQR) total cost of care in 2018 was $347 ($107-$1123); 272 individuals (1.0%) accounted for nearly half of total costs. Compared with children and young adults in the lowest-cost quartile, those in the highest-cost quartile were more likely to have complex medical conditions (399 individuals [6.9%] vs 3442 individuals [59.5%]) and to live farther from the AMC (median [IQR distance, 6.0 [4.6-20.3] miles vs 13.9 [4.6-30.9] miles). Total cost of care was accrued in home (43%), outpatient specialty (19%), inpatient (14%) and primary (8%) care. More than half of attributed children and young adults received care outside of the ACO; the median (IQR) cost for leaked care was $349 ($130-$1326). The costliest leaked encounters included inpatient, ancillary, and home health care, while the most frequently leaked encounters included behavioral health, emergency, and primary care. Conclusions and Relevance: This cohort study found that while most children attributed to the hypothetical Medicaid pediatric ACO lived locally with few health care encounters, a small group of children with medical complexity traveled long distances for care and used frequent and costly home-based and outpatient specialty care. Leaked care was substantial for all attributed children, with the cost of leaked care being higher than the total cost of care. These pediatric-specific clinical and utilization profiles have implications for future pediatric ACO design choices related to attribution, accounting for children with high costs, and strategies to address leaked care.

A hidden vulnerable population: Young children up-to-date on vaccine series recommendations except influenza vaccines.

Very young children (under 2 years old) have high risk for influenza-related complications. Children 6 months or older in the US are recommended to receive influenza vaccination annually, yet uptake is substantially lower than other routinely-recommended vaccines. Existing nationally-representative studies on very young child influenza vaccine uptake has several limitations: few examine provider-verified influenza vaccination (relying on parental report), few contain parental vaccine attitudes variables (known to be crucial to vaccine uptake), and none to our knowledge consider intersectionality of social disadvantage nor how influenza vaccine determinants differ from those of other recommended vaccines. This nationally-representative study examines provider-verified data on 7,246 children aged 6-23 months from the most recent (2011) National Immunization Survey to include the restricted Parental Concerns module, focusing on children up-to-date on a series of vaccines (the 4:3:1:3:3:1:4 series) but not influenza vaccines ("hidden vulnerability to influenza"). About 71% of children were up-to-date on the series yet only 33% on influenza vaccine recommendations by their second birthday; 44% had hidden vulnerability to influenza. Independent of parental history of vaccine refusal and a myriad of health services use factors, no parental history of delaying vaccination was associated with 7.5% (2.6-12.5) higher probability of hidden vulnerability to influenza despite being associated with 15.5% (10.8-20.2) lower probability of being up-to-date on neither the series nor influenza vaccines. Thus, parental compliance with broad child vaccine recommendations and lack of vaccine hesitancy may not indicate choice to vaccinate children against influenza. Examination of intersectionality suggests that maternal college education may not confer improved vaccination among non-Hispanic Black and Hispanic children despite that it does for non-Hispanic White children. Policymakers and researchers from public health, sociology, and other sectors need to collaborate to further examine how vaccine hesitancy and intersectional social disadvantage interact to affect influenza vaccine uptake in young US children.

Frontiers of Upstream Stroke Prevention and Reduced Stroke Inequity Through Predicting, Preventing, and Managing Hypertension and Atrial Fibrillation: A Call to Action From the Value in Healthcare Initiative's Predict & Prevent Learning Collaborative.

Stroke is one of the leading causes of morbidity and mortality in the United States. While age-adjusted stroke mortality was falling, it has leveled off in recent years due in part to advances in medical technology, health care options, and population health interventions. In addition to adverse trends in stroke-related morbidity and mortality across the broader population, there are sociodemographic inequities in stroke risk. These challenges can be addressed by focusing on predicting and preventing modifiable upstream risk factors associated with stroke, but there is a need to develop a practical framework that health care organizations can use to accomplish this task across diverse settings. Accordingly, this article describes the efforts and vision of the multi-stakeholder Predict & Prevent Learning Collaborative of the Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University. This article presents a framework of a potential upstream stroke prevention program with evidence-based implementation strategies for predicting, preventing, and managing stroke risk factors. It is meant to complement existing primary stroke prevention guidelines by identifying frontier strategies that can address gaps in knowledge or implementation. After considering a variety of upstream medical or behavioral risk factors, the group identified 2 risk factors with substantial direct links to stroke for focusing the framework: hypertension and atrial fibrillation. This article also highlights barriers to implementing program components into clinical practice and presents implementation strategies to overcome those barriers. A particular focus was identifying those strategies that could be implemented across many settings, especially lower-resource practices and community-based enterprises representing broad social, economic, and geographic diversity. The practical framework is designed to provide clinicians and health systems with effective upstream stroke prevention strategies that encourage scalability while allowing customization for their local context.

Streamlining and Reimagining Prior Authorization Under Value-Based Contracts: A Call to Action From the Value in Healthcare Initiative's Prior Authorization Learning Collaborative.

Utilization management strategies, including prior authorization, are commonly used to facilitate safe and guideline-adherent provision of new, individualized, and potentially costly cardiovascular therapies. However, as currently deployed, these approaches encumber multiple stakeholders. Patients are discouraged by barriers to appropriate access; clinicians are frustrated by the time, money, and resources required for prior authorizations, the frequent rejections, and the perception of being excluded from the decision-making process; and payers are weary of the intensive effort to design and administer increasingly complex prior authorization systems to balance value and appropriate use of these treatments. These issues highlight an opportunity to collectively reimagine utilization management as a transparent and collaborative system. This would benefit the entire healthcare ecosystem, especially in light of the shift to value-based payment. This article describes the efforts and vision of the multistakeholder Prior Authorization Learning Collaborative of the Value in Healthcare Initiative, a partnership between the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University. We outline how healthcare organizations can take greater utilization management responsibility under value-based contracting, especially under different state policies and local contexts. Even with reduced payer-mandated prior authorization in these arrangements, payers and healthcare organizations will have a continued shared need for utilization management. We present options for streamlining these programs, such as gold carding and electronic and automated prior authorization processes. Throughout the article, we weave in examples from cardiovascular care when possible. Although reimagining prior authorization requires collective action by all stakeholders, it may significantly reduce administrative burden for clinicians and payers while improving outcomes for patients.

Value in Healthcare Initiative: Summary and Key Recommendations.

In spring 2018, the American Heart Association convened the Value in Healthcare Summit to begin an important conversation about the challenges patients with cardiovascular disease face in accessing and deriving quality and value from the healthcare system. Following the summit and recognizing the collective momentum it created, the American Heart Association, in collaboration with the Robert J. Margolis Center for Health Policy at Duke University, launched the Value in Healthcare Initiative-Transforming Cardiovascular Care. Four areas of focus were identified, and learning collaboratives were established and proceeded to conduct concrete, actionable problem solving in 4 high-impact areas in cardiovascular care: Value-Based Models, Partnering with Regulators, Predict and Prevent, and Prior Authorization. The deliverables from these groups are being disseminated in 4 stand-alone articles, and their publication will initiate further work to test and evaluate each of these promising areas of reform. This article provides an overview of the initiative's findings and highlights key cross-cutting themes for consideration as the initiative moves forward.

Prospective or retrospective ACO attribution matters for seriously ill patients.

OBJECTIVES: Since 2019, the Medicare Shared Savings Program (MSSP) has allowed accountable care organizations (ACOs) to choose either retrospectively or prospectively attributed ACO populations. To understand how ACOs' choice of attribution method affects incentives for care among seriously ill Medicare beneficiaries, this study compares beneficiary characteristics and Medicare per capita expenditures between prospective and retrospective ACO populations. STUDY DESIGN: This retrospective, cross-sectional analysis describes survival, patient characteristics, and Medicare spending for Medicare fee-for-service beneficiaries identified with serious illness (n = 1,600,629) using 100% Medicare Master Beneficiary Summary and MSSP beneficiary files (2014-2016). METHODS: We used generalized linear models with ACO and year fixed effects to estimate the average within-ACO difference between potential retrospective and prospective ACO populations. RESULTS: Dying in the first 90 days of the performance year was associated with reduced odds of retrospective ACO attribution (odds ratio [OR], 0.24; 95% CI, 0.24-0.25) relative to beneficiaries surviving 270 days or longer. Similarly, hospice use was associated with reduced odds of retrospective assignment (OR, 0.80; 95% CI, 0.79-0.80). Among ACOs that did not achieve shared savings, average per capita Medicare expenditures (after truncation) were $2459 (95% CI, $2192-$2725) higher for prospective vs retrospective ACO populations. The difference was $834 (95% CI, $402-$1266) greater per capita among ACOs that achieved shared savings. CONCLUSIONS: The difference in survival and spending for ACO populations captured by prospective vs retrospective attribution methods means that ACOs may need to employ different care management strategies to improve performance depending on their attribution method.

Advancing Value-Based Models for Heart Failure: A Call to Action From the Value in Healthcare Initiative's Value-Based Models Learning Collaborative.

Heart failure (HF) is a leading cause of hospitalizations and readmissions in the United States. Particularly among the elderly, its prevalence and costs continue to rise, making it a significant population health issue. Despite tremendous progress in improving HF care and examples of innovation in care redesign, the quality of HF care varies greatly across the country. One major challenge underpinning these issues is the current payment system, which is largely based on fee-for-service reimbursement, leads to uncoordinated, fragmented, and low-quality HF care. While the payment landscape is changing, with an increasing proportion of all healthcare dollars flowing through value-based payment models, no longitudinal models currently focus on chronic HF care. Episode-based payment models for HF hospitalization have yielded limited success and have little ability to prevent early chronic disease from progressing to later stages. The available literature suggests that primary care-based longitudinal payment models have indirectly improved HF care quality and cardiovascular care costs, but these models are not focused on addressing patients' longitudinal chronic disease needs. This article describes the efforts and vision of the multi-stakeholder Value-Based Models Learning Collaborative of The Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University. The Learning Collaborative developed a framework for a HF value-based payment model with a longitudinal focus on disease management (to reduce adverse clinical outcomes and disease progression among patients with stage C HF) and prevention (an optional track to prevent high-risk stage B pre-HF from progressing to stage C). The model is designed to be compatible with prevalent payment models and reforms being implemented today. Barriers to success and strategies for implementation to aid payers, regulators, clinicians, and others in developing a pilot are discussed.

Improving Cardiovascular Drug and Device Development and Evidence Through Patient-Centered Research and Clinical Trials: A Call to Action From the Value in Healthcare Initiative's Partnering With Regulators Learning Collaborative.

The pipeline of new cardiovascular drugs is relatively limited compared with many other clinical areas. Challenges causing lagging drug innovation include the duration and expense of cardiovascular clinical trials needed for regulatory evaluation and approvals, which generally must demonstrate noninferiority to existing standards of care and measure longer-term outcomes. By comparison, there has been substantial progress in cardiovascular device innovation. There has also been progress in cardiovascular trial participation equity in recent years, especially among women, due in part to important efforts by Food and Drug Administration, National Institutes of Health, American Heart Association, and others. Yet women and especially racial and ethnic minority populations remain underrepresented in cardiovascular trials, indicating much work ahead to continue recent success. Given these challenges and opportunities, the multistakeholder Partnering with Regulators Learning Collaborative of the Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University, identified how to improve the evidence generation process for cardiovascular drugs and devices. Drawing on a series of meetings, literature reviews, and analyses of regulatory options, the Collaborative makes recommendations across four identified areas for improvement. First, we offer strategies to enhance patient engagement in trial design, convenient participation, and meaningful end points and outcomes to improve patient recruitment and retention (major expenses in clinical trials). Second, new digital technologies expand the potential for real-world evidence to streamline data collection and reduce cost and time of trials. However, technical challenges must be overcome to routinely leverage real-world data, including standardizing data, managing data quality, understanding data comparability, and ensuring real-world evidence does not worsen inequities. Third, as trials are driven by evidence needs of regulators and payers, we recommend ways to improve their collaboration in trial design to streamline and standardize efficient and innovative trials, reducing costs and delays. Finally, we discuss creative ways to expand the minuscule proportion of sites involved in cardiovascular evidence generation and medical product development. These actions, paired with continued policy research into better ways to pay for and equitably develop therapies, will help reduce the cost and complexity of drug and device research, development, and trials.

Child Influenza Vaccination and Adult Work Loss: Reduced Sick Leave Use Only in Adults With Paid Sick Leave.

INTRODUCTION: Children are a population of interest for influenza. They are at increased risk for severe influenza, comprise a substantial portion of influenza morbidity, and significantly contribute to its transmission in the household and subsequent parental work loss. The association between influenza vaccination and work loss prevention, however, has rarely been studied, and the sparse existing literature has very limited generalizability to U.S. adults, thus requiring better characterization. METHODS: Using pooled National Health Interview Survey data (2013-2015, analyses conducted in 2018) nationally representative of working U.S. adults with household children (n=23,014), zero-inflated negative binomial regression examined the association of child influenza vaccination (exposure) with sick days (outcome) stratified by paid sick leave (no: n=10,741, yes: n=12,273). RESULTS: Child influenza vaccination was associated with significantly lower sick day usage, but only among adults with paid sick leave (prevalence rate ratio=0.79, 95% CI=0.67, 0.93), equating to average annual sick days of 4.07 vs 3.29 in adults with unvaccinated versus vaccinated household children (difference=0.78 fewer days annually). CONCLUSIONS: Influenza vaccination of children is associated with reduced sick leave in household adults, helping to keep the workforce healthy and reduce influenza's costly annual economic burden. This only occurred among adults with paid sick leave, however, which is distributed inequitably by income, education, gender, occupation, and race/ethnicity. Health in All Policies considers downstream health effects of social and economic policy; the failure of federal policy to ensure paid sick leave likely contributes to propagating influenza and health inequities.

Why Do Accountable Care Organizations Leave The Medicare Shared Savings Program?

The ability of accountable care organizations (ACOs) to continue reducing costs and improving quality depends on understanding what affects their survival. We examined such factors for survival in the Medicare Shared Savings Program (MSSP) of 624 ACOs between performance years 2013 and 2017 (1,849 ACO-years). Overall, ACO exits from the MSSP decreased after ACOs' third year. Shared-savings bonus payment achievement, more care coordination, higher financial performance benchmarks, market-level Medicare cost growth, lower-risk patients, and contracts with upside-only risk were associated with longer survival. Quality scores, postacute care spending, organizational traits, and most market-context characteristics had no significant association with survival, which indicates that diverse organizations and markets can be successful. Put in context with the recently finalized MSSP rule from December 2018, our findings suggest that while new flexibilities for low-revenue ACOs likely reduce uncertainty for some, MSSP ACOs may need more than the new period of one to three years to prepare for downside risk. Policy makers should offer more support to ACOs (especially those with higher-risk patients) for building organizational competencies and should consider how benchmarking policy can fairly assess ACOs from regions with differing levels of cost growth.

Engaging Beneficiaries In Medicaid Programs That Incentivize Health-Promoting Behaviors.

Medicaid programs are increasingly adopting incentive programs to improve health behaviors among beneficiaries. There is limited evidence on what incentives are being offered to Medicaid beneficiaries, how programs are engaging beneficiaries, and how programs are evaluated. In 2017-18 we synthesized available information on these programs and interviewed eighty policy stakeholders to identify the rationale behind key program design decisions and stakeholders' recommendations for beneficiary engagement and program evaluation. Key underlying program rationales included improving the use of preventive services and promoting personal responsibility. Beneficiary engagement strategies emphasized meeting members where they are and offering prizes or services customized for certain groups. Stakeholders recommended collaborating with external evaluators to design and conduct robust evaluations of incentive programs. Finally, stakeholders recommended aligning beneficiary incentives with provider incentives and other payment reforms through the use of common meaningful measures to streamline program evaluation.