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Introduction: States have previously requested permission from the US Department of Agricultureto implement food item restrictions within the Supplemental Nutrition Assistance Program (SNAP), though these proposals were previously rejected. The current administration is encouraging states to submit waivers for restriction and has approved 12 states to restrict SNAP starting in January 2026.

Methods: This study analyzed states' waiver proposals and approval letters to describe the landscape of forthcoming restrictions, their justifications and proposed evaluations. Framework analysis was used to identify common terms and themes between states.

Results: Soda restrictions were common across all approved waiver states, with 8 states also implementing some form of restriction on candy. As justification for restriction, states cited the "intended purpose of SNAP" for nutrition (n = 9), Medicaid and healthcare costs (n = 8), promoting healthy eating (n = 8), stewardship of taxpayer dollars (n = 7) and high SNAP spending on unhealthy goods (n = 6). Evaluations using mixed-methods and pre-post analyses were most common (n = 7), with nearly all states proposing the use of retailer data and participant surveys. Key outcomes included purchasing patterns (n = 10), dietary patterns (n = 5) and health or disease outcomes (n = 5).

Conclusion: Substantial variation in restrictions and evaluation approaches warrants attention by policymakers and researchers.

Introduction: The Inflation Reduction Act (IRA) authorizes Medicare price negotiation but includes a "special rule" deferring negotiation for biologics with "imminent" biosimilar competition. This study examined the potential impact of this provision on Medicare spending.

Methods: We modeled Medicare savings under three hypothetical scenarios. In Scenario 1, we applied historical price reductions following biosimilar entry (2017-2024) for 10 reference products and 30 biosimilars to forecast savings for ustekinumab (Stelara) after biosimilar entry. Scenario 2 estimated savings from the IRA's negotiated maximum fair price for ustekinumab. Scenario 3 modeled a modified IRA implementation policy in which ustekinumab was excluded from negotiation and replaced by palbociclib (Ibrance), an eligible high spend drug that was not selected for the first round of Medicare price negotiation.

Results: Across all biologics in our sample, historic market-weighted prices declined to 40.3% of pre-entry levels within five years of biosimilar launch. Negotiating ustekinumab under the IRA yielded greater first-year savings, but cumulative savings were highest in the modified scenario-combining negotiated discounts for palbociclib with biosimilar-driven price declines for ustekinumab.

Conclusion: Selecting biologics with near-term biosimilar competition for IRA negotiation may produce short-term savings but forgo greater long-term savings achievable through competition.

The growing use of real-world data (RWD), particularly from electronic health records (EHRs), has heightened the need for careful attention to data privacy, utility, and transparency. We examine the complex processes involved in curating privacy-compliant EHR-derived RWD, highlighting key de-identification considerations and techniques. We emphasize the importance of aligning curation practices with privacy laws and regulations, with a particular focus on the comprehensive documentation of de-identification techniques. Such documentation should reflect intended data use, accessibility, availability, accuracy, and granularity. For researchers, greater transparency in these practices can improve compliance and lead to more robust and reliable real-world evidence. For policymakers, it provides a foundation to develop more specific and actionable guidelines and oversight mechanisms. Ultimately, highly transparent curation process enhances the reliability of RWD and supports rigorous, nuanced, and informed decision-making across the health care ecosystem.

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.