Milbank Quarterly最新文献

Policy Points With increasing public attention to cases of inaccurate and misleading laboratory-developed tests, there have been calls for regulatory reform. To protect patients from faulty laboratory tests, we need a framework that balances comprehensive test review with laboratory flexibility. The Verifying Accurate Leading-edge IVCT [In Vitro Clinical Test] Development (VALID) Act would have helped ensure laboratory test safety and validity through a much-needed expansion of Food and Drug Administration (FDA) oversight. However, Congress did not pass the VALID Act in 2022, forcing the FDA to start the regulatory reform process on its own.

Policy Points The adoption of Medicaid institutions for mental disease (IMD) exclusion waivers increases the likelihood of substance abuse treatment facilities offering mental health and substance abuse treatment for co-occurring disorders, especially in residential facilities. There are differential responses to IMD waivers based on facility ownership. For-profit substance abuse treatment facilities are responsive to the adoption of IMD substance use disorder waivers, whereas private not-for-profit and public entities are not. The response of for-profit facilities suggests that integration of substance abuse and mental health treatment for individuals in residential facilities may be cost-effective.

Context: Access to integrated care for those with co-occurring mental health (MH) and substance use disorders (SUDs) has been limited because of an exclusion in Medicaid on paying for SUD care for those in institutions for mental disease (IMDs). Starting in 2015, the federal government encouraged states to pursue waivers of this exclusion, and by the end of 2020, 28 states had done so. It is unclear what impact these waivers have had on the availability of care for co-occurring disorders and the characteristics of any facilities that expanded care because of them.

Methods: Using data from the National Survey of Substance Abuse Treatment Services, we estimate a two-stage residual inclusion model including time- and state-fixed effects to examine the effect of state IMD SUD waivers on the percentage of facilities offering co-occurring MH and SUD treatment, overall and for residential facilities specifically. Separate analyses are conducted by facility ownership type.

Findings: Results show that the adoption of an IMD SUD waiver is associated with 1.068 greater odds of that state having facilities offering co-occurring MH and substance abuse (SA) treatment a year or more later. The adoption of a waiver increases the odds of a state's residential treatment facility offering co-occurring MH and SA treatment by 1.129 a year or more later. Additionally, the results suggest 1.163 higher odds of offering co-occurring MH/SA treatment in private for-profit SA facilities in states that adopt an IMD SUD waiver while suggesting no significant impact on offered services by private not-for-profit or public facilities.

Conclusions: Our study findings suggest that Medicaid IMD waivers are at least somewhat effective at impacting the population targeted by the policy. Importantly, we find that there are differential responses to these IMD waivers based on facility ownership, providing new evidence for the literature on the role of ownership in the provision of health care.

Policy Points We examined the effect of the Paid Family Leave policy (PFL) and Paid Sick Leave policy (PSL) on care provision to older parents. We found that PSL adoption led to an increase in care provision, an effect mainly attributable to respondents in states/periods when PSL and PFL were concurrently offered. Some of the strongest effects were found among women and unpartnered adult children. PFL adoption by itself was not associated with care provision to parents except when PFL also offered job protection. Paid leave policies have heterogeneous effects on eldercare and their design and implementation should be carefully considered.

Context: Family caregivers play a critical role in the American long-term care system. However, care responsibilities are known to potentially conflict with paid work, as about half of family caregivers are employed. The federal Family and Medical Leave Act passed by the US Congress in 1993 provides a nonuniversal, unpaid work benefit. In response, several states and localities have adopted the Paid Family Leave policy (PFL) and Paid Sick Leave policy (PSL) over the last two decades. Our objective is to examine the effect of these policies on the probability of personal care provision to older parents.

Methods: This study used longitudinal data from the Health and Retirement Study (1998-2020). Difference-in-differences regression models were estimated to examine associations between state- and local-level PFL and PSL mandates and personal care provision to older parents. We analyzed heterogeneous effects by the type of paid leave exposure (provision of job protection with PFL and availability of both PSL and PFL [with or without job protection] concurrently). We also examined results for different population subgroups.

Findings: PSL implementation was associated with a four- to five-percentage point increase in the probability of personal care provision. These effects were mainly attributable to respondents in states/periods when PSL and PFL were concurrently offered. The strongest effects were found among adult children who were employed at baseline, women, younger, unpartnered, and college educated. PFL implementation by itself was not associated with care provision to parents except when the policy also offered job protection.

Conclusions: Paid leave policies have heterogeneous impacts on personal care provision, potentially owing to differences in program features, variation in caregiving needs, and respondent characteristics. Overall, the results indicate that offering paid sick leave and paid family leave, when combined with job protection, could support potential family caregivers.

Policy Points Improving health systems requires the pursuit of both patient-centered care and a supportive environment for health professionals. This Quadruple Aim includes improving the experience of care, improving the health of populations, reducing per capita costs of care, and improving the work life of the care providers. We propose expanding a recently defined Fifth Aim of health equity to include health democracy, ensuring that that the health and health care wants, needs, and responsibilities of populations are being met, and also propose adding a Sixth Aim of preserving and improving the health of the environment to create the best health possible. As social tension and environmental changes continue to impact the structure of our society, this "Hexagonal Aim" might provide additional ethical guiderails as we set our health care goals to foster sustainable and improved population health.

Policy Points Opioid treatment agreements (OTAs) are controversial because of the lack of evidence that their use reduces opioid-related harms and the potential risks they pose of stigmatizing patients and undermining the clinician-patient relationship. Even so, their use is now required in most jurisdictions, and their use is influencing the outcomes of civil and criminal lawsuits. More research is needed to evaluate how OTAs are implemented given existing requirements. If additional research does not resolve the current level of uncertainty regarding OTA benefits, then policymakers in jurisdictions where they are required should consider eliminating OTA mandates or providing flexibility in the legal requirements to make room for clinicians and health care institutions to implement best practices.

Context: Opioid treatment agreements (OTAs) are documents that clinicians present to patients when prescribing opioids that describe the risks of opioids and specify requirements that patients must meet to receive their medication. Notwithstanding a lack of evidence that OTAs effectively mitigate opioids' risks, professional organizations recommend that they be implemented, and jurisdictions increasingly require them. We sought to identify the jurisdictions that require OTAs, how OTAs might affect the outcomes of lawsuits that arise when things go wrong, and instances in which the law permits flexibility for clinicians and health care institutions to adopt best practices.

Methods: We surveyed the laws and regulations of all 50 states and the District of Columbia to identify which jurisdictions require the use of OTAs, the circumstances in which OTA use is mandatory, and the terms OTAs must include (if any). We also surveyed criminal and civil judicial decisions in which OTAs were discussed as evidence on which a court relied to make its decision to determine how OTA use influences litigation outcomes.

Findings: Results show that a slight majority (27) of jurisdictions now require OTAs. With one exception, the jurisdictions' requirements for OTA use are triggered at least in part by long-term prescribing. There is otherwise substantial variation and flexibility within OTA requirements. Results also show that even in jurisdictions where OTA use is not required by statute or regulation, OTA use can inform courts' reasoning in lawsuits involving patients or clinicians. Sometimes, but not always, OTA use legally protects clinicians from liability.

Conclusions: Our results show that OTA use is entwined with legal obligations in various ways. Clinicians and health care institutions should identify ways for OTAs to enhance clinician-patient relationships and patient care within the bounds of relevant legal requirements and risks.

Policy Points State Medicaid experience with value-based payment (VBP) arrangements for medical products is still relatively limited, and states face a number of challenges in designing and implementing such arrangements, particularly because of the resource-intensive nature of arrangements and data needed to support measurement of desired outcomes. A number of success factors and opportunities to support VBP arrangement efforts were identified through this study, including leveraging established venues or processes for collaboration with manufacturers, engaging external and internal partners in VBP efforts to bolster capabilities, acquiring access to new data sources, and utilizing annual renegotiation of contracts to allow for adjustments.

Context: To date, uptake of value-based payment (VBP) arrangements for medical products and knowledge of their design and impact have been mainly concentrated among private payers. Interest and activity are expanding to Medicaid; however, their experiences and approaches to VBP arrangements for medical products are not well characterized.

Methods: This study sought to characterize the use of VBP arrangements for medical products among state Medicaid agencies through the use of a two-staged, mixed-methods approach. A survey and semistructured interviews were conducted to gain an understanding of state experiences with VBP arrangements for medical products. The survey and interviews were directed at senior leaders from nine states through the survey, with respondents from seven of these states additionally participating in the semistructured interviews.

Findings: Although experience with VBP arrangements for medical products among states varied, there were similarities across their motivations and general processes or phases employed in their design and implementation. States collectively identified a number of significant challenges to VBP arrangements, such as manufacturer engagement, outcomes measurement, and the time, expertise, and resources required to design and implement them. We outline a range of strategies to help address these gaps and make it easier for states to pursue VBP arrangements, including more direct engagement from the Center for Medicare and Medicaid Services, state-to-state peer learning and collaboration, data infrastructure and sharing, and additional research to inform fit-for-purpose VBP arrangement approaches.

Conclusions: Findings from this study suggest that it may be easier for states to pursue VBP arrangements for medical products if there is greater clarity on processes employed that support design and implementation as well as effective strategies to address common challenges associated with contract negotiations. As states gain more experience, it will be important to monitor the design and implementation of common VBP arrangements to assess impact on the Medicaid program and th

Policy Points Artificial intelligence (AI) is disruptively innovating health care and surpassing our ability to define its boundaries and roles in health care and regulate its application in legal and ethical ways. Significant progress has been made in governance in the United States and the European Union. It is incumbent on developers, end users, the public, providers, health care systems, and policymakers to collaboratively ensure that we adopt a national AI health strategy that realizes the Quintuple Aim; minimizes race-based medicine; prioritizes transparency, equity, and algorithmic vigilance; and integrates the patient and community voices throughout all aspects of AI development and deployment.

Policy Points Maternal health is influenced by the quality and accessibility of care before, during, and after pregnancy. Nationwide, Medicaid covers nearly one in two births and uses managed care as a central means for carrying out these responsibilities. Thus, managed care plays a fundamental role in assuring timely, equitable, quality care and improving maternal health outcomes. A close review of managed care contracts makes evident that the absence of a national set of maternal health standards has caused challenges in setting expectations for managed care performance. State Medicaid agencies adopt a variety of approaches and underlying philosophies for contracting.

Context: Managed care is how Medicaid agencies principally furnish maternity care. For this reason, the contracts that Medicaid agencies enter into with managed care organizations have attracted strong interest as a means of improving maternal health access, quality, and equity. However, limited research has documented the extent to which states use these agreements to set binding expectations across the maternal health continuum and how states approach the task of maternal health contracting.

Methods: To explore maternal health contracting within Medicaid Managed Care, this study took a three-phase, sequential approach: (1) an extensive literature review to identify clinical guidelines and expert recommendations regarding maternal health "best practices" for people with elevated health and social needs, (2) a review of the managed care contracts in use across 40 states and Washington, DC, to determine the extent to which they incorporate these best practices, and (3) interviews conducted with four state Medicaid agencies to better understand how states approach maternal health when developing their contracts.

Findings: The evidence on maternal health best practices reveals nearly 60 "best practices," although the literature review also underscored the extent to which these recommendations are fragmented across numerous professional bodies and government agencies and are thus difficult for Medicaid agencies to ascertain. The contracts themselves reflect an approach to the maternal health continuum in a fragmented and incomplete way. Thematic analysis of interviews with state Medicaid agencies revealed three key approaches to contracting for maternity care: an "organic" approach, an "intentional" approach, and an approach "grounded" in state strategy.

Conclusions: The absence of comprehensive, integrated guidelines reflecting the full maternal health continuum likely complicates the contracting task and contributes to incomplete, ambiguous contracts. A major step would be the development of a "best practices tool" that helps state Medicaid agencies translate evidence into comprehensive, clear contracting expectations.

Policy Points Education-cognition research overlooks the role of education quality in shaping cognitive function at midlife and older ages, even though quality may be more responsive to federal and state investment in public schooling than attainment. For older US adults who attended school during the early to mid-20th century, the quality of US education improved considerably as federal and state investment increased. Ensuring access to high-quality primary and secondary education may protect against poor cognitive function at midlife and older ages, particularly among Black Americans and persons who complete less education. It may also play an important role in reducing health inequities.

Context: Although educational attainment is consistently associated with better cognitive function among older adults, we know little about how education quality is related to cognitive function. This is a key gap in the literature given that the quality of US education improved considerably during the early to mid-20th century as state and federal investment increased. We posit that growing up in states with higher-quality education systems may protect against poor cognitive function, particularly among Black adults and adults who completed fewer years of school.

Methods: We used prospective data on cognitive function from the Health and Retirement Study linked to historical data on state investment in public schools, restricting our sample to non-Hispanic White and Black adults born between 1914 and 1959 (19,096 White adults and 4,625 Black adults). Using race-stratified linear mixed models, we considered if state-level education quality was associated with level and decline in cognitive function and if these patterns differed by years of schooling and race.

Findings: Residing in states with higher-resourced education systems during childhood was associated with better cognitive function, particularly among those who completed less than 12 years of schooling, regardless of race. For White adults, higher-resourced state education systems were associated with higher scores of total cognitive function and episodic memory, but there were diminishing returns as resources increased to very high levels. For Black adults, the relationship between state education resources and cognitive function varied by age with positive associations in midlife and generally null or negative associations at the oldest ages.

Conclusions: Federal and state investment in public schools may provide students with opportunities to develop important cognitive resources during schooling that translate into better cognitive function in later life, especially among marginalized populations.