JAMA Health Forum最新文献

{"title":"Populationwide Screening for Chronic Kidney Disease: A Cost-Effectiveness Analysis.","authors":"Marika M Cusick, Rebecca L Tisdale, Glenn M Chertow, Douglas K Owens, Jeremy D Goldhaber-Fiebert, Joshua A Salomon","doi":"10.1001/jamahealthforum.2024.3892","DOIUrl":"10.1001/jamahealthforum.2024.3892","url":null,"abstract":"<p><strong>Importance: </strong>Sodium-glucose cotransporter-2 (SGLT2) inhibitors have changed clinical management of chronic kidney disease (CKD) and made populationwide screening for CKD a viable strategy. Optimal age of screening initiation has yet to be evaluated.</p><p><strong>Objective: </strong>To compare the clinical benefits, costs, and cost-effectiveness of population-wide CKD screening at different initiation ages and screening frequencies.</p><p><strong>Design, setting, and participants: </strong>This cost-effectiveness study used a previously published decision-analytic Markov cohort model that simulated progression of CKD among US adults from age 35 years and older and was calibrated to population-level data from the National Health and Nutrition Examination Survey (NHANES). Effectiveness of SGLT2 inhibitors was derived from the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial. Mortality, quality-of-life weights, and cost estimates were obtained from published cohort studies, randomized clinical trials, and US Centers for Medicare & Medicaid Services data. Analyses were performed from June 2023 through September 2024.</p><p><strong>Exposures: </strong>One-time or periodic (every 10 or 5 years) screening for albuminuria, initiated at ages between 35 and 75 years, with and without addition of SGLT2 inhibitors to conventional CKD therapy (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers).</p><p><strong>Main outcomes and measures: </strong>Cumulative incidence of kidney failure requiring kidney replacement therapy (KRT); life years, quality-adjusted life years (QALYs), lifetime health care costs (2024 US currency), and incremental cost-effectiveness ratios discounted at 3% annually.</p><p><strong>Results: </strong>For those aged 35 years, starting screening at age 55 years, and continuing every 5 years through age 75 years, combined with SGLT2 inhibitors, decreased the cumulative incidence of kidney failure requiring KRT from 2.4% to 1.9%, increased life expectancy by 0.13 years, and cost $128 400 per QALY gained. Although initiation of screening every 5 years at age 35 or 45 years yielded greater gains in population-wide health benefits, these strategies cost more than $200 000 per additional QALY gained. The comparative values of starting screening at different ages were sensitive to the cost and effectiveness of SGLT2 inhibitors; if SGLT2 inhibitor prices drop due to patent expirations, screening at age 55 years continued to be cost-effective even if SGLT2 inhibitor effectiveness were 30% lower than in the base case.</p><p><strong>Conclusions and relevance: </strong>This study found that, based on conventional benchmarks for cost-effectiveness in medicine, initiating population-wide CKD screening with SGLT2 inhibitors at age 55 years would be cost-effective.</p>","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243892"},"PeriodicalIF":11.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549659/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142607388","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":"Change of Ownership and Quality of Home Health Agency Care.","authors":"Zhanji Zhang, Kun Li, Siyi Wang, Shekinah Fashaw-Walters, Yucheng Hou","doi":"10.1001/jamahealthforum.2024.3767","DOIUrl":"10.1001/jamahealthforum.2024.3767","url":null,"abstract":"<p><strong>Importance: </strong>The home health agency (HHA) market has seen increasingly more change in ownership transactions. Little is known about the organizational characteristics and quality of care of HHAs after ownership has changed.</p><p><strong>Objective: </strong>To examine whether an HHA change in ownership was associated with different quality-of-care outcomes, patient volume, and staffing levels.</p><p><strong>Design, setting, and participants: </strong>Using current HHA change of ownership files linked to publicly available Medicare HHA data, this staggered difference-in-differences analysis evaluated ownership change transactions of Medicare-certified HHAs from quarter 1 of 2016 to quarter 4 of 2019. Pretransaction and posttransaction HHA characteristics and quality-of-care outcomes were compared between HHAs that changed ownership and up to 8 matched controls. The transactions in the main analysis included (1) when an HHA remained as for-profit with a change in ownership and (2) when an HHA changed from nonprofit/public to for-profit ownership. The data were analyzed between November 2023 and September 2024.</p><p><strong>Main outcomes and measures: </strong>The primary outcomes were HHA-quarter measures of star ratings, the individual quality measures that compose the star ratings based on the Outcome and Assessment Information Set, and claims-based quality metrics, such as hospitalizations and emergency department visits. The secondary outcomes included HHA year measures of Medicare patient volume, per capita payments, and staffing levels (full-time equivalents and minutes per visit).</p><p><strong>Results: </strong>The main dataset included 294 Medicare-certified HHAs that changed ownership, matched with 2330 controls. In 3 years after an ownership change, quarterly star ratings increased by 0.18 (95% CI, 0.05-0.31) relative to matched controls, with greater increases among HHAs that converted from nonprofit/public to for-profit. No significant improvement was observed in the 60-day rates of hospital admissions or outpatient emergency department visits. Further, no significant changes were observed in the number of Medicare beneficiaries, but per capita payments increased within 2 years post-ownership change. Significant reductions were observed in full-time equivalents of registered nurses (-17% [95% CI, -31% to -3%]) and home health aides (-26% [95% CI, -39% to -13%]), as well as per-visit minutes for skilled nursing care (-5% [95% CI, -9% to -1%]), physical therapy (-3% [95% CI, -5% to 0%]), and home health aide care (-11% [95% CI, -15% to -6%]).</p><p><strong>Conclusions and relevance: </strong>In this difference-in-differences analysis of Medicare-certified HHAs, ownership change was associated with higher star ratings and Medicare per capita payments, but not with claims-based quality measures. Reduction in staffing levels after ownership change raises concerns about implications for quality of care.</p>","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243767"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11530943/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559433","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":"New Directions for Population Health Science and Scholarship.","authors":"Sandro Galea, Mohammed Abba-Aji","doi":"10.1001/jamahealthforum.2024.4566","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2024.4566","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e244566"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142607387","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":"Strategic Manufacturer Response to the Medicaid Rebate Cap Removal.","authors":"Joseph F Levy, Mariana P Socal, Jeromie M Ballreich","doi":"10.1001/jamahealthforum.2024.3624","DOIUrl":"10.1001/jamahealthforum.2024.3624","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243624"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568456/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142640411","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":"The Curious Persistence of Site-Dependent Payments.","authors":"Barak D Richman, Elizabeth Plummer, Ge Bai","doi":"10.1001/jamahealthforum.2024.3616","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2024.3616","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243616"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559437","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":"Using Bayh-Dole Act March-In Rights to Lower US Drug Prices.","authors":"Lisa Larrimore Ouellette, Bhaven N Sampat","doi":"10.1001/jamahealthforum.2024.3775","DOIUrl":"10.1001/jamahealthforum.2024.3775","url":null,"abstract":"<p><strong>Importance: </strong>In December 2023, the Biden-Harris Administration released a proposed framework for exercising government march-in rights (effectively granting compulsory licenses for those patents to generic drug makers) under the Bayh-Dole Act on patents on taxpayer-funded drugs, which has renewed questions about whether march-in rights could promote cost savings through generic competition or harm pharmaceutical innovation.</p><p><strong>Objectives: </strong>To determine the feasibility of using march-in rights to remove patent barriers to generic competition.</p><p><strong>Design, setting, and participants: </strong>This cross-sectional study examined government funding information from multiple sources for patents listed in the Food and Drug Administration (FDA) Orange Book from 1985 to 2023. Data analysis was completed in August 2024.</p><p><strong>Exposures: </strong>New drug applications (NDAs) with Orange Book-listed patents, including (1) all new molecular entities (NMEs) approved from 1985 to 2022; (2) all NDAs with an Orange Book patent listed between 1985 and 2023; and (3) NDAs with unexpired patents listed in a recent (October 2023) edition of the Orange Book.</p><p><strong>Main outcomes and measures: </strong>The main outcome was whether the drugs had any or all patents that were public-sector patents subject to the Bayh-Dole Act, based on combining different data sources for identifying patents that resulted from federal funding. Public-sector patents resulting from intramural research, which are not subject to march-in rights under the Bayh-Dole Act, were identified separately.</p><p><strong>Results: </strong>Of 883 new molecular entities approved from 1985 to 2022, 68 (8%) had a Bayh-Dole patent, but only 18 (2%) had solely Bayh-Dole patents. Of 2832 drugs with patents listed for 1985 to 2023, 142 (5%) had a Bayh-Dole patent, but only 38 (1%) had solely Bayh-Dole patents. Of 1213 drugs with Orange Book patents listed in October 2023, 41 (3%) had a Bayh-Dole patent, but only 14 (1%) had solely Bayh-Dole patents.</p><p><strong>Conclusion and relevance: </strong>This cross-sectional study found that, although Bayh-Dole march-in rights could remove patent barriers to generic entry for a few drugs, their overall effect would be limited.</p>","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243775"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11530938/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559438","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":"Cross-Sector Support for a Policy Framework to Tackle Social Determinants of Health.","authors":"Stuart M Butler","doi":"10.1001/jamahealthforum.2024.4809","DOIUrl":"https://doi.org/10.1001/jamahealthforum.2024.4809","url":null,"abstract":"","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e244809"},"PeriodicalIF":9.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142631933","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":"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":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design and setting: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;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}