Health affairs scholar最新文献_第9页

Use of real-world evidence in the Medicare Drug Price Negotiation Program: A checklist for the Centers for Medicare and Medicaid Services and manufacturers. 在医疗保险药品价格谈判计划中使用真实证据：医疗保险和医疗补助服务中心和制造商的清单。

Health affairs scholar Pub Date : 2025-03-21 eCollection Date: 2025-03-01 DOI: 10.1093/haschl/qxaf030

Sean R Tunis, Jason Shafrin, Kyi-Sin Than, Melanie D Whittington, Richard J Willke, Murtuza Bharmal

{"title":"Use of real-world evidence in the Medicare Drug Price Negotiation Program: A checklist for the Centers for Medicare and Medicaid Services and manufacturers.","authors":"Sean R Tunis, Jason Shafrin, Kyi-Sin Than, Melanie D Whittington, Richard J Willke, Murtuza Bharmal","doi":"10.1093/haschl/qxaf030","DOIUrl":"10.1093/haschl/qxaf030","url":null,"abstract":"Under the Inflation Reduction Act's (IRA's) - Medicare Drug Price Negotiation Program, the Centers for Medicare & Medicaid Services' (CMS's) \"maximum fair price\" must be informed by evidence on factors such as therapeutic advance of the selected drug compared with its alternative, comparative effectiveness across clinical and patient-reported outcomes, the impact on specific populations, and the ability to address unmet medical needs. This paper describes how real-world evidence could improve CMS decision-making and creates a best practices checklist to help CMS evaluate the quality of any manufacturer-submitted evidence. The checklist was developed in four steps: (i) identification of the IRA requirements for determining the maximum fair price through a review of official guidance from CMS, (ii) assessment of provisions that could be supported by real-world evidence (RWE) in addition to clinical trial evidence, (iii) literature review on existing best-practice guidelines relevant to RWE, and (iv) consolidation of these RWE guidelines into a checklist through a series of web conference discussions among experts. The checklist aims to improve the quality of the information available to CMS during the drug price negotiation process.","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 3","pages":"qxaf030"},"PeriodicalIF":0.0,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11926674/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143694948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Correction to: Medicaid-covered health care visits during the postpartum year: Variation by enrollee characteristics and state. 更正：产后一年医疗补助覆盖的医疗保健访问：参保者特征和州的变化。

Health affairs scholar Pub Date : 2025-03-21 eCollection Date: 2025-03-01 DOI: 10.1093/haschl/qxaf055

引用次数: 0

Trends in providers participating in Medicare oncology value-based care models. 医疗服务提供者参与医疗肿瘤学价值护理模式的趋势。

Health affairs scholar Pub Date : 2025-03-20 eCollection Date: 2025-04-01 DOI: 10.1093/haschl/qxaf058

Arthur S Hong, Sofia Babool, Lesi He, Ethan A Halm

引用次数: 0

Correction to: What happens behind closed doors? Investigating care practices in nursing home and assisted living memory care units. 更正：关起门来发生了什么？调查养老院和辅助生活记忆护理单位的护理实践。

Health affairs scholar Pub Date : 2025-03-19 eCollection Date: 2025-03-01 DOI: 10.1093/haschl/qxaf053

引用次数: 0

Evidence available and used by the Food and Drug Administration for the approval of orphan and nonorphan drugs. 食品和药物管理局批准孤儿药和非孤儿药时可用的证据。

Health affairs scholar Pub Date : 2025-03-18 eCollection Date: 2025-04-01 DOI: 10.1093/haschl/qxaf057

Amanda J Koong, Veronica L Irvin, Aditya Narayan, Sujin Song, Robert M Kaplan

{"title":"Evidence available and used by the Food and Drug Administration for the approval of orphan and nonorphan drugs.","authors":"Amanda J Koong, Veronica L Irvin, Aditya Narayan, Sujin Song, Robert M Kaplan","doi":"10.1093/haschl/qxaf057","DOIUrl":"10.1093/haschl/qxaf057","url":null,"abstract":"There are substantial financial incentives to develop orphan drugs for rare diseases, but concerns about the quality and volume of supporting evidence have emerged. We compare evidence used to evaluate orphan and nonorphan drugs approved by the Food and Drug Administration (FDA) between 2016 and 2023. This retrospective cross-sectional analysis utilizes FDA data on approvals and study information from ClinicalTrials.gov to compare characteristics of studies relevant to orphan and nonorphan drugs approved between 2016 and 2023. Of the 368 total drugs approved, 50% were orphan drugs. The FDA-approved drugs based on significantly fewer studies for orphan (1.5 studies/drug) compared to nonorphan (2.4 studies/drug). Additionally, a significantly lower proportion of studies were completed before FDA approval for orphan drugs (25% vs 41%). Orphan drugs were significantly less likely to be evaluated in randomized clinical trials (RCTs) (34% vs 63%). Of these RCTs, there were significantly fewer completed before approval (40% vs 54%) and that had results posted (35% vs 53%). There was a significant difference in the available evidence for orphan and nonorphan drugs. As new legislation like Cures 2.0 is developed, it is critical to examine the balance between an expedited approval timeline and the standard of clinical evidence.","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 4","pages":"qxaf057"},"PeriodicalIF":0.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11970248/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143797462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Trends in hospital discharge outcomes among high-risk Medicare beneficiaries before and during the COVID-19 pandemic. COVID-19大流行之前和期间高危医疗保险受益人出院结果的趋势

Health affairs scholar Pub Date : 2025-03-18 eCollection Date: 2025-04-01 DOI: 10.1093/haschl/qxaf056

Anthony I Roberts, Christopher M Santostefano, Zihan Chen, Brian E McGarry, Elizabeth M White, Linda J Resnik, Fangli Geng, David C Grabowski, Momotazur Rahman

{"title":"Trends in hospital discharge outcomes among high-risk Medicare beneficiaries before and during the COVID-19 pandemic.","authors":"Anthony I Roberts, Christopher M Santostefano, Zihan Chen, Brian E McGarry, Elizabeth M White, Linda J Resnik, Fangli Geng, David C Grabowski, Momotazur Rahman","doi":"10.1093/haschl/qxaf056","DOIUrl":"10.1093/haschl/qxaf056","url":null,"abstract":"Introduction: Medicare beneficiaries face significant health risks and care disruptions during public health emergencies, but little is known about how care patterns evolved throughout the COVID-19 pandemic or differed between traditional Medicare (TM) and Medicare Advantage (MA).Methods: Using Medicare claims data for over 20 million hospital discharges during 2018-2022, we examined trends in hospital length of stay, discharge disposition, and mortality among beneficiaries with 5 major comorbidities (dementia, diabetes, congestive heart failure, hip fracture, and stroke), stratified by COVID status and payer type.Results: We found that COVID patients initially experienced substantially longer hospital stays (8.3 vs 4.6 days) and higher 30-day mortality (34% vs 5%) compared to patients without COVID. MA beneficiaries showed consistently higher home health utilization but similar mortality patterns to TM enrollees. By mid-2022, most outcome differences had converged between COVID and non-COVID patients, suggesting health system adaptation to the pandemic.Conclusion: Our findings highlight how the pandemic was associated with shifts toward home-based post-acute care, emphasizing the need for policies supporting home-based care infrastructure and flexible care delivery models that could help health systems better adapt during future public health emergencies.","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 4","pages":"qxaf056"},"PeriodicalIF":0.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11970246/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143797507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Centering marginalized care: Home care cooperatives and system change. 以边缘照护为中心：家庭照护合作社与制度变迁。

Health affairs scholar Pub Date : 2025-03-17 eCollection Date: 2025-03-01 DOI: 10.1093/haschl/qxae184

Geoffrey M Gusoff, Lina Stepick, Aquilina Soriano-Versoza, Katrina Kazda

{"title":"Centering marginalized care: Home care cooperatives and system change.","authors":"Geoffrey M Gusoff, Lina Stepick, Aquilina Soriano-Versoza, Katrina Kazda","doi":"10.1093/haschl/qxae184","DOIUrl":"10.1093/haschl/qxae184","url":null,"abstract":"Home care workers (HCWs), who provide paid in-home support for daily activities, are at the center of the care received by millions of Americans. However, HCWs are profoundly marginalized professionally and economically within our political-economic system, which devalues care work, public goods, and the labor of women, immigrants, and workers of color. This systemic marginalization has contributed to the impoverishment of millions of HCWs and massive workforce shortages, which prevent millions of Americans from accessing the consistent care they need. Home care cooperatives-businesses co-owned and controlled by HCWs-represent an alternative approach that places HCWs at the center. By providing greater compensation, training opportunities, and control over workplace decisions, home care cooperatives have achieved greater continuity of care and half the turnover rates compared with traditional agencies. They demonstrate what is possible when HCWs are centered at an organizational level and what could be achieved if HCWs were centered at a system level. This latter possibility requires the following: (1) reclaiming care work as a public good and investing in it accordingly; (2) structurally empowering HCWs within the care team and broader economy; and (3) new narratives about HCWs that recognize their skills, value, and centrality in providing quality care.","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 3","pages":"qxae184"},"PeriodicalIF":0.0,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11909589/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143652882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Reviving public provisioning in US health care. 恢复美国医疗保健的公共供给。

Health affairs scholar Pub Date : 2025-03-17 eCollection Date: 2025-03-01 DOI: 10.1093/haschl/qxaf013

Hayden Rooke-Ley, Dana Brown, Colleen Grogan

引用次数: 0

The fundamental importance of social insurance for health equity. 社会保险对健康公平的根本重要性。

Health affairs scholar Pub Date : 2025-03-17 eCollection Date: 2025-03-01 DOI: 10.1093/haschl/qxae170

Seth A Berkowitz

引用次数: 0

Advancing a political economy approach to health using lessons from US antitrust and climate policy. 借鉴美国反垄断和气候政策的经验，推进健康问题的政治经济学方法。

Health affairs scholar Pub Date : 2025-03-17 eCollection Date: 2025-03-01 DOI: 10.1093/haschl/qxaf008

Elizabeth Popp Berman

{"title":"Advancing a political economy approach to health using lessons from US antitrust and climate policy.","authors":"Elizabeth Popp Berman","doi":"10.1093/haschl/qxaf008","DOIUrl":"10.1093/haschl/qxaf008","url":null,"abstract":"Advocates of a political economy approach to US health policy center an analysis of power and the broad political, social, and economic landscape that enables or harms health. They must contend, however, with a dominant policy orientation focused on ensuring individual access to the existing healthcare system. This Policy Inquiry reviews the recent history of US antitrust and climate/industrial policy, both domains where policy movements taking a political economy approach have had significant and unexpected recent success, to draw lessons for health policy, in which a \"care economy\" movement aligned with political economy has had some momentum, but not produced major policy change. Advocates of a political economy approach to US health policy should continue to build on the momentum of the care economy movement while also looking for ways to tie healthcare market reform into the shifts in industrial policy and antitrust. Across both spaces, advocates should center the building of issue networks, make connections to historically resonant political themes, and, where possible, find ways to tap into the energy of youth organizers-all strategies shared across antitrust and climate policy.","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 3","pages":"qxaf008"},"PeriodicalIF":0.0,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11909588/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143652878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0