JAMA Health Forum最新文献

{"title":"JAMA Health Forum.","authors":"","doi":"10.1001/jamahealthforum.2024.0536","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2024.0536","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e240536"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medical Devices Applying for Outpatient Medicare Supplemental Payments.","authors":"Osman Moneer, James L Johnston, Vinay K Rathi, Joseph S Ross, Sanket S Dhruva","doi":"10.1001/jamahealthforum.2024.4016","DOIUrl":"10.1001/jamahealthforum.2024.4016","url":null,"abstract":"<p><strong>Importance: </strong>Medicare transitional pass-through payments (TPTPs) provide supplemental reimbursement that is intended to facilitate adoption of new devices in the outpatient setting. The US Centers for Medicare & Medicaid Services (CMS) have historically evaluated manufacturer applications for TPTPs based on newness, cost, and evidence of substantial clinical improvement, ie, the traditional pathway. In 2020, CMS introduced an alternative pathway to allow US Food and Drug Administration (FDA)-designated breakthrough devices to qualify for supplemental reimbursement without demonstrating substantial clinical improvement.</p><p><strong>Objective: </strong>To characterize CMS TPTP approval rates and the premarket evidence used by FDA to support authorization of new outpatient medical devices considered for CMS TPTP.</p><p><strong>Design and setting: </strong>This was a cross-sectional study of TPTP applications for new outpatient medical devices from 2017 to 2023. Using the Federal Register, CMS Outpatient Prospective Payment System final rules for fiscal years 2017 through 2023 were obtained, from which all manufacturer applications for TPTPs were identified. For each application, the CMS TPTP review pathway (traditional/alternative), CMS final decision (award/deny), and FDA authorization pathway were assessed.</p><p><strong>Main outcomes and measures: </strong>Characteristics of devices considered for CMS TPTPs and design, effectiveness end points, and patient demographic characteristics of premarket clinical studies used to support FDA authorization.</p><p><strong>Results: </strong>CMS approved 17 of 43 (40%) applications for TPTPs, including all 8 (100%) alternative pathway applications for breakthrough devices and 9 of 35 applications (26%) using the traditional pathway. Devices approved for TPTPs were more likely to have been assessed in premarket clinical studies than devices denied TPTPs (12/17 [71%] vs 2/26 [8%]). Among the 14 premarket studies of TPTP-approved devices, 8 (57%) used surrogate markers as primary effectiveness end points and 5 (42%) did not meet all primary end points. The median (IQR) percentage of female, Black, and Hispanic patients among the trials that reported demographic data was 26% (17%-36%), 6% (2%-17%), and 4% (3%-5%), respectively.</p><p><strong>Conclusions and relevance: </strong>The findings of this cross-sectional analysis indicated that CMS more commonly awarded supplemental outpatient payment through TPTPs for devices assessed in premarket clinical studies to support FDA authorization. However, these studies often lacked generalizability to Medicare beneficiaries, used surrogate markers of effectiveness, or did not meet all primary end points. As more breakthrough devices receive FDA authorization and effectively qualify for automatic supplemental payments, strengthening premarket clinical evidence requirements for CMS TPTP approvals would provide better information to guide clinical decisio","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e244016"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568453/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142640364","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}

{"title":"Errors in Conflict of Interest Disclosures.","authors":"","doi":"10.1001/jamahealthforum.2024.4268","DOIUrl":"10.1001/jamahealthforum.2024.4268","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e244268"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11530933/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559434","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}

{"title":"Heat Waves and Adverse Health Events Among Dually Eligible Individuals 65 Years and Older.","authors":"Hyunjee Kim, Eun-Hye Yoo, Angela Senders, Clint Sergi, Hiroko H Dodge, Sue Anne Bell, Kyle D Hart","doi":"10.1001/jamahealthforum.2024.3884","DOIUrl":"10.1001/jamahealthforum.2024.3884","url":null,"abstract":"<p><strong>Importance: </strong>Extensive research has found the detrimental health effects of heat waves. However, a critical gap exists in understanding their association with adverse health events among older dually eligible individuals, who may be particularly susceptible to heat waves.</p><p><strong>Objective: </strong>To assess the association between heat waves and adverse health events among dually eligible individuals 65 years and older.</p><p><strong>Design, setting, and participants: </strong>This retrospective time-series study assessed the association between heat waves in warm months from 2016 to 2019 and zip code tabulation area (ZCTA)-day level adverse health events. Dually eligible individuals 65 years and older who were continuously enrolled in either a Medicare fee-for-service plan or a Medicare Advantage plan with full Medicaid benefits from May to September in any given year were identified. All ZCTAs in the US with at least 1 dually eligible individual in each study year were included. Data were analyzed from September 2023 to August 2024.</p><p><strong>Exposure: </strong>Heat waves, defined as 3 or more consecutive extreme heat days (ie, days with a maximum temperature of at least 90 °F [32.2 °C] and in the 97th percentile of daily maximum temperatures for each ZCTA during the study period).</p><p><strong>Main outcomes and measures: </strong>Daily counts of heat-related emergency department visits and heat-related hospitalizations for each ZCTA.</p><p><strong>Results: </strong>The study sample included 5 448 499 beneficiaries 65 years and older in 28 404 ZCTAs across 50 states and Washington, DC; the mean (SD) proportion of female beneficiaries and beneficiaries 85 years and older in each ZCTA was 66% (7%) and 20% (8%), respectively. The incidence rate for heat-related emergency department visits was 10% higher during heat wave days compared to non-heat wave days (incidence rate ratio [IRR], 1.10; 95% CI, 1.08-1.12), and the incidence rate of heat-related hospitalizations was 7% higher during heat wave days (IRR, 1.07; 95% CI, 1.04-1.09). There were similar patterns in other adverse health events, including a 4% higher incidence rate of death during heat wave days (IRR, 1.04; 95% CI, 1.01-1.07). The magnitude of these associations varied across some subgroups. For example, the association between heat waves and heat-related emergency department visits was statistically significant only for individuals in 3 of 9 US climate regions: the Northwest, Ohio Valley, and the West.</p><p><strong>Conclusions and relevance: </strong>In this time-series study, heat waves were associated with increased adverse health events among dually eligible individuals 65 years and older. Without adaptation strategies to address the health-related impacts of heat, dually eligible individuals are increasingly likely to face adverse outcomes.</p>","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243884"},"PeriodicalIF":11.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142607386","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}

{"title":"JAMA Health Forum Editorial Fellows-Call for Applicants.","authors":"Sandro Galea","doi":"10.1001/jamahealthforum.2024.4573","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2024.4573","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e244573"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Repeal of Subminimum Wages and Social Determinants of Health Among People With Disabilities.","authors":"Mihir Kakara, Elizabeth F Bair, Atheendar S Venkataramani","doi":"10.1001/jamahealthforum.2024.4034","DOIUrl":"10.1001/jamahealthforum.2024.4034","url":null,"abstract":"<p><strong>Importance: </strong>People with disabilities experience pervasive health disparities driven by adverse social determinants of health, such as unemployment. Section 14(c) of the 1938 Fair Labor Standards Act has been a controversial policy that allows people with disabilities to be paid below the prevailing minimum wage, but its impact on employment remains unknown despite ongoing national debates about its repeal.</p><p><strong>Objective: </strong>To estimate whether state-level repeal of Section 14(c) was associated with employment-related outcomes for people with cognitive disability.</p><p><strong>Design, setting, and participants: </strong>This quasi-experimental, synthetic difference-in-differences study used individual-level data from the 2010-2019 American Community Surveys. Outcomes before and after subminimum wage law repeal in 2 states (New Hampshire and Maryland) that repealed Section 14(c) were compared with a synthetic group of control states that did not implement repeal. Individuals aged 18 to 45 years who reported having a cognitive disability were included. Data were analyzed from May 2023 to May 2024.</p><p><strong>Exposure: </strong>Repeal of Section 14(c) in New Hampshire (2015) and Maryland (2016).</p><p><strong>Main outcomes and measures: </strong>Primary outcomes were labor force participation and employment rates. Secondary outcomes were annual wages, annual hours worked, hourly wages, and proportion earning above state minimum wage among employed individuals.</p><p><strong>Results: </strong>The sample included 450 838 individuals. Of these, 253 157 (55.7%) were male, and the mean (SD) age was 31.3 (8.4) years. In state-specific analyses, New Hampshire's labor force participation and employment had a statistically significant increase by 5.2 percentage points (β = 0.05; 95% CI, 0-0.10; P = .04) and 7 percentage points (β = 0.07; 95% CI, 0.01-0.13; P = .03), respectively, following Section 14(c) repeal. Labor force participation and employment both increased in Maryland, although estimates were not statistically significant. Pooling both states, Section 14(c) repeal was associated with a statistically significant 4.7-percentage point (β = 0.05; 95% CI, 0.01-0.08; P = .01) increase in labor force participation and a nonsignificant 4.3-percentage point (β = 0.04; 95% CI, 0-0.09; P = .07) increase in employment.</p><p><strong>Conclusions and relevance: </strong>In this study, repeal of Section 14(c), a policy allowing subminimum wages for people with disabilities, led to increases in labor force participation, though with heterogeneity at the state level. These findings suggest the importance of state-level factors in shaping program effects, especially as national-level Section 14(c) repeal is being debated.</p>","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e244034"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568457/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142640409","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}

{"title":"Cannabis Use During Early Pregnancy Following Recreational Cannabis Legalization.","authors":"Kelly C Young-Wolff, Natalie E Slama, Lyndsay A Avalos, Alisa A Padon, Lynn D Silver, Sara R Adams, Monique B Does, Deborah Ansley, Carley Castellanos, Cynthia I Campbell, Stacey E Alexeeff","doi":"10.1001/jamahealthforum.2024.3656","DOIUrl":"10.1001/jamahealthforum.2024.3656","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;It is unknown whether state recreational cannabis legalization (RCL) is related to increased rates of prenatal cannabis use or whether RCL-related changes vary with cannabis screening methods or the local policy environment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To test whether RCL in California was associated with changes in prenatal cannabis use rates, whether changes were evident in both self-report and urine toxicology testing, and whether rates varied by local policies banning vs allowing adult-use retailers post-RCL.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This population-based time-series study used data from pregnancies in Kaiser Permanente Northern California universally screened for cannabis use during early pregnancy by self-report and toxicology testing from January 1, 2012, to December 31, 2019. Analyses were conducted from September 2022 to August 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Exposures: &lt;/strong&gt;California state RCL passage (November 9, 2016) and implementation of legal sales (January 1, 2018) were examined with a 1-month lag. Local policies allowing vs banning medical retailers pre-RCL and adult-use retailers post-RCL were also examined.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;Any prenatal cannabis use was based on screening at entrance to prenatal care (typically at 8-10 weeks' gestation) and defined as (1) a positive urine toxicology test result or self-report, (2) a positive urine toxicology test result, or (3) self-report. Interrupted time series models were fit using Poisson regression, adjusting for age, race and ethnicity, and neighborhood deprivation index.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The sample of 300 993 pregnancies (236 327 unique individuals) comprised 25.9% Asian individuals, 6.4% Black individuals, 26.0% Hispanic individuals, 37.7% White individuals, and 4.1% individuals of other, multiple, or unknown race, with a mean (SD) age of 30.3 (5.4) years. Before RCL implementation, rates of prenatal cannabis use rose steadily from 4.5% in January 2012 to 7.1% in January 2018. There was no change in use rates at the time of RCL passage (level change rate ratio [RR], 1.03; 95% CI, 0.96-1.11) and a statistically significant increase in rates in the first month after RCL implementation, increasing to 8.6% in February 2018 (level change RR, 1.10; 95% CI, 1.04-1.16). Results were similar when defining prenatal cannabis use by (1) a toxicology test or (2) self-report. In local policy analyses, the post-RCL implementation increase in use was only found among those in jurisdictions allowing adult-use cannabis retailers (allowed RR, 1.21; 95% CI, 1.10-1.33; banned RR, 1.01; 95% CI, 0.93-1.10).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;In this time-series study, RCL implementation in California was associated with an increase in rates of cannabis use during early pregnancy, defined by both self-report and toxicology testing, driven by individuals living in jurisdictions that a","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243656"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11530934/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559432","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}

{"title":"Surgeon Workforce in Underserved Communities.","authors":"Crystal D Taylor, Sara L Schaefer, Adrian Diaz, Nicholas Kunnath, John W Scott, Andrew M Ibrahim","doi":"10.1001/jamahealthforum.2024.3531","DOIUrl":"10.1001/jamahealthforum.2024.3531","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243531"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11581652/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559436","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}

{"title":"Considerations for Academic Medical Centers Moving AHEAD.","authors":"Anjali Bhatla, Scott A Berkowitz","doi":"10.1001/jamahealthforum.2024.3781","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2024.3781","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243781"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142640362","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characteristics of Health Systems Operating Medicare Advantage Plans.","authors":"Aaron Hedquist, Eric Yu, Pasha Hamed, E John Orav, Austin Frakt, Thomas C Tsai","doi":"10.1001/jamahealthforum.2024.3536","DOIUrl":"10.1001/jamahealthforum.2024.3536","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243536"},"PeriodicalIF":11.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549652/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142607385","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}