Health affairs scholar最新文献

Introduction: Most states mandate clinicians to review prescription drug monitoring program (PDMP) databases before prescribing opioids, but the association with perioperative outcomes is unknown.

Methods: We analyzed 2016-2019 Medicare claims for patients ≥65 undergoing surgery in 21 states that enacted PDMP use mandates in 2017-2018 vs states without mandates during 2016-2019. Procedure-level, difference-in-differences models adjusted for patient demographics, prior opioid use, mental health, prior substance use disorders, comorbidities, surgeon specialty, and procedure type. Outcomes included discharge opioid prescriptions, days supplied, total and daily morphine milligram equivalents, high-risk prescribing (≥7-day supply or opioid-benzodiazepine overlap), and 30-day post-discharge adverse events (overdose, emergency department visit, hospitalization, or death).

Results: Among 597 455 procedures for 462 290 patients (mean age 73.3 years; 54.5% female), mandates were not associated with changes in opioid prescribing, high-risk prescribing, or adverse events (difference-in-differences estimate: -0.03% points, 95% CI: -1.0, 0.9). Findings were consistent among patients with prior substance use or in states with stringent mandates.

Conclusion: PDMP use mandates were not associated with changes in perioperative opioid prescribing or post-surgical adverse events, suggesting that policymakers should consider pairing mandates with evidence-based, procedure-specific prescribing guidelines.

We reflect on how Medicare Part D formulary design could facilitate access to biosimilars, create cost-savings, and motivate investment in biosimilar development. We evaluated adalimumab, a self-administered biologic for inflammatory conditions with the most approved biosimilars, including interchangeable as a case study. We found that formulary access in Part D for adalimumab biosimilars is lower relative to the innovator. Moreover, when adalimumab biosimilars are on the formulary, beneficiaries typically pay coinsurance, a cost higher than a fixed copay. This is unlike generic drugs, whose coverage in most Part D formularies typically has a co-pay of $5 or less (Dusetzina SB, Cubanski J, Nshuti L, et al. Medicare Part D plans rarely cover brand-name drugs when generics are available. Health Aff [Millwood]. 2020;39[8]:1326-1333. https://doi.org/10.1377/hlthaff.2019.01694). The US biosimilar market has been slow to grow, limiting potential cost-savings. The investment required to develop and manufacture a biosimilar is larger than that for a generic and requires a greater return for investment, and many off-patent biologics lack a biosimilar competitor (Arad N, Staton E, Hamilton M, et al. Realizing the Benefits of Biosimilars: Overcoming Rebate Walls. Duke Margolis Center for Health Policy; 2022). The Food and Drug Administration's October 2025 effort to simplify evidence requirements for biosimilarity may reduce development costs, but without market access financial returns from development are limited (Food and Drug Administration. FDA moves to accelerate biosimilar development and lower drug costs [press release]. October 29, 2025. https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs). Policies to encourage formularies to expand access to biosimilars in programs such as Medicare could motivate investment.

Recent policy shifts at the U.S. Patent and Trademark Office (USPTO) have sharply limited the use of two administrative pathways for patent reviews, inter partes review (IPR) and post-grant review (PGR). Congress created these administrative pathways to provide a faster and less costly way to challenge weak patents. Recently, the USPTO has expanded the use of "discretionary denials," invoking a new "settled expectations" rationale that blocks IPR petitions for patents more than about six years old. From May to September 2025, 60% of 506 requests for discretionary denial were granted, triple historical levels, including one-third involving drug patents. These changes are especially consequential for biologic drugs, where large "patent thickets" can delay biosimilar entry and sustain high drug prices. Additional procedural reforms, such as reducing allowable brief length by 60% and consolidating all institution decisions under the Director, further constrain challengers and reduces transparency. Together, these policies undermine the congressional purpose of ensuring that invalid patents do not block competition. Congress should clarify when discretionary denials are appropriate and prohibit non-merits-based rationales like "settled expectations" to preserve effective patent oversight and timely access to affordable medicines.

Introduction: High administrative costs are a notable feature and frustration of the American health care system. Administrative complexity drives excess health care spending and clinician burnout. There is growing interest in patient administrative burden: the nonclinical, administrative work a patient must do to use the health care system.

Methods: Following the PRISMA-ScR framework, we conducted a scoping review to synthesize empirical evidence characterizing patient administrative burden in US health care delivery from 2002-2024 using a systematic search across 4 indexed databases. To conduct this search in the absence of standard MeSH (Medical Subject Heading) terms, we first developed a conceptual model of "patient administrative burden" to define inclusion and exclusion criteria.

Results: Sixty-three studies were identified across the patient journey: seeking care, receiving care, and following up to resolve care issues. Insurance selection, as part of care seeking, had the most mature evidence base, whereas patients' roles in identifying and solving health system problems are especially understudied.

Conclusion: Measurement of health care administrative costs focus on clinicians and health care organizations and likely understate total costs given the in-kind work performed by patients. Improving systematic data collection and incorporating measures of patient-facing administrative work would provide a more complete accounting of administration costs.

Introduction: Natural disasters and climate-related extreme weather events are increasing in frequency and severity, magnifying health inequities and exposing systemic weaknesses in health and social infrastructure.

Methods: This umbrella review synthesized findings from 33 systematic reviews and meta-analyses published between 2005 and 2025 to assess the physical or mental health outcomes or healthcare access impacts of disasters on populations experiencing health disparities.

Results: Mental health effects, especially post-traumatic stress, depression, and anxiety, were consistently elevated across disaster types. Geophysical events such as earthquakes and tsunamis produced sustained psychological distress and service disruptions among displaced and low-income populations. Hydrological and meteorological disasters, including floods and hurricanes, increased infectious-disease incidence and maternal and geriatric morbidity. Climatological hazards such as heatwaves, droughts, and wildfires were associated with cardiovascular, respiratory, and metabolic impacts, particularly among older adults and outdoor workers. Reviews addressing multiple hazards emphasized persistent inequities in healthcare access and long-term recovery. Few studies analyzed intersectional determinants, limiting understanding of compounding risk.

Conclusion: Policy responses should embed social vulnerability assessments into preparedness and recovery planning, invest in behavioral health and primary care surge capacity, and ensure income, housing, and transportation supports for disproportionately affected communities.

Introduction: Massachusetts Medicaid (MassHealth) transitioned a Section 1115 waiver-based housing support program to a permanent program in 2025, implementing new eligibility restrictions.

Methods: We projected the potential impact of these new eligibility restrictions using linked administrative claims and programmatic data.

Results: Among individuals enrolled from 2021 to 2024, 68% would no longer qualify under updated 2025 criteria. Those projected to remain eligible were older and had more chronic conditions and higher healthcare utilization than those projected to be ineligible, but similar prevalence of opioid use disorder and mental illness.

Conclusion: These findings highlight the potential for unintended consequences in eligibility prioritization stemming from operational shifts in Medicaid waiver-based programs.

Introduction: Artificial intelligence-enabled medical devices (AIMDs) are increasing in use, but this growth has raised concerns about inequities in access across well-resourced and under-resourced settings. Little is known about industry-clinician partnerships in the AIMD ecosystem.

Methods: We examined the value, specialty distribution, market concentration, and institutional profile of payments made by industry to clinicians for Food and Drug Administration-approved AIMDs using the Open Payments Database. We linked payments to the affiliated hospital of the clinician using the Medicare Provider Data catalog. We performed a regression to explain the association of payments with hospital and county-level factors.

Results: We found $59.3 million was spent on payments to 46 315 clinicians for AIMDs between 2017 and 2023, representing an increasing share of total medical device payments over time. We saw high payment concentration in technologically intensive medical specialties and among clinicians affiliated with large, urban teaching hospitals.

Conclusion: Industry payments for AIMDs are increasing and concentrated among technology-intensive specialties. Payments are more likely to flow to clinicians affiliated with teaching hospitals that are larger and in non-rural areas. This may reflect or mediate increased AI utilization in these settings. Continued monitoring of payments, transparent reporting, and targeted resource support may be needed to promote equitable access to AIMDs.

Introduction: Cannabis legalization enables greater access to commercial cannabis among adults. Little is known about the extent to which demand for cannabis is met by licit or illicit markets among states with medical-only or recreational cannabis laws, or no legalization.

Methods: Annual sales values of medical and recreational tetrahydrocannabinol (THC), illicit THC, hemp-derived cannabidiol (CBD) and hemp-derived THC were estimated for 2024 in 12 US states by combining and triangulating data from national- and state-level public sources, Euromonitor's Passport database, in-store audits (n = 142), retailer interviews (n = 78), and expert interviews (n = 10) of cannabis industry stakeholders. States were classified into three types of cannabis legalization status.

Results: State-level THC market size was substantial, accounting for ≥90% of the combined cannabis market value of THC and CBD, regardless of legalization status. However, the composition of THC markets-across legal recreational, medical, illicit, and hemp-derived segments-varied considerably, even among states with the same legalization status.

Conclusions: The emergence of hemp-derived THC in both legal and non-legal markets alongside the persistence of illicit THC sales in legal markets highlight regulatory gaps and challenges in market oversight. These findings underscore the need for integrated policy approaches that align enforcement strategies with public health objectives and consumer education.

Introduction: US lockdowns and school closures implemented during the COVID-19 pandemic were intended to mitigate viral transmission and protect public health. However, the broader health effects of these interventions remain unclear.

Methods: We conducted a systematic review of peer-reviewed studies that assessed the impact of US lockdowns and school closures on health-related outcomes excluding COVID-19 transmission and mortality.

Results: A total of 132 studies met inclusion criteria, yielding 454 unique outcomes. Lockdowns and school closures were associated with detrimental health effects in the majority of outcomes analyzed, including over 90% of mental health, obesity-related, and health-related social need outcomes (child development/education, employment, access to food, and economic/financial stability). Analyses focused on vulnerable populations, such as racial and ethnic minorities, low-income groups, and individuals with disabilities, were significantly more likely to report detrimental outcomes than the general population.

Conclusion: Given how lockdowns and school closures may affect population well-being, policymakers should carefully weigh both the benefits and harms of these interventions, including how they may affect vulnerable populations. We conclude with policy recommendations to mitigate ongoing harms and inform more evidence-based decision-making.